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Background: Children represent a particularly vulnerable demographic in the context of drug-resistant (DR) tuberculosis (TB) due to their increased likelihood of close contact with adults diagnosed with the disease. Approximately 25 000–30 000 children develop DR-TB annually. While treatment success rates for DR-TB in children surpass those in adults, children and adolescents encounter distinct challenges throughout the diagnosis and treatment of DR-TB (including MDR-TB, Pre-XDR TB, and XDR-TB). Aim: To identify current practices in drug administration to children diagnosed with DR-TB where appropriate dosage forms are not available in South Africa. Method: An observational study was carried out at the study site to determine how medication prescribed was manipulated and administered by nursing staff to paediatric patients in the wards. Results: The observational study identified 8 drugs used in DR-TB at the study site, where some manipulation to the formulation was necessary to enable administration to paediatric patients. Linezolid and para-aminosalicylic acid are the only drugs available and registered in the South Africa in a formulation that is suitable for administration to paediatric patients. Activities carried out by nursing staff to enable the administration of DR-TB medication included cutting capsules and tablets and dissolving the tablet or capsule contents in distilled water to obtain the required suitable dose. Discussion: Lack of availability of suitable dosage forms for paediatrics patients results in several challenges, such as additional time required for drug preparation, increased time duration of medication administration, and unpalatability of drugs. These challenges may subsequently affect compliance and therapeutic outcomes of the treatment of paediatric patients, especially as outpatients. Conclusion: Research needs to focus on the development of appropriate dosage forms for the paediatric population and focus on identifying cases of DR-TB in children. This will assist in building evidence to advocate for registration of child-friendly dosage forms thereby ensuring a sustainable supply of medication. [ABSTRACT FROM AUTHOR]

Background: Among the non-traditional antibacterial agents in development, only a few targets critical Gram-negative bacteria such as carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter baumannii or cephalosporin-resistant Enterobacteriaceae. Endolysins and their genetically modified versions meet the World Health Organization criteria for innovation, have a novel mode of antibacterial action, no known bacterial cross-resistance, and are being intensively studied for application against Gram-negative pathogens. Methods: The study presents a multidisciplinary approach, including genetic engineering of LysECD7-SMAP and production of recombinant endolysin, its analysis by crystal structure solution following molecular dynamics simulations and evaluation of antibacterial properties. Two types of antimicrobial dosage forms were formulated, resulting in lyophilized powder for injection and hydroxyethylcellulose gel for topical administration. Their efficacy was estimated in the treatment of sepsis, and pneumonia models in BALB/c mice, diabetes-associated wound infection in the leptin receptor-deficient db/db mice and infected burn wounds in rats. Results: In this work, we investigate the application strategies of the engineered endolysin LysECD7-SMAP and its dosage forms evaluated in preclinical studies. The catalytic domain of the enzyme shares the conserved structure of endopeptidases containing a putative antimicrobial peptide at the C-terminus of polypeptide chain. The activity of endolysins has been demonstrated against a range of pathogens, such as Klebsiella pneumoniae, A. baumannii, P. aeruginosa, Staphylococcus haemolyticus, Achromobacter spp, Burkholderia cepacia complex and Haemophylus influenzae, including those with multidrug resistance. The efficacy of candidate dosage forms has been confirmed in in vivo studies. Some aspects of the interaction of LysECD7-SMAP with cell wall molecular targets are also discussed. Conclusions: Our studies demonstrate the potential of LysECD7-SMAP therapeutics for the systemic or topical treatment of infectious diseases caused by susceptible Gram-negative bacterial species and are critical to proceed LysECD7-SMAP-based antimicrobials trials to advanced stages. [ABSTRACT FROM AUTHOR]

Measuring the viscosity of pharmaceutical dosage forms is a crucial process. Viscosity provides information about the stability of the composition, the release rate of the drug, bioavailability, and, in the case of injectable drug formulations, even the force required for injection. However, measuring viscosity is a complex task with numerous challenges, especially for non-Newtonian materials, which include most pharmaceutical formulations, such as gels. Selecting the appropriate shear rate is critical. Since viscosity in many systems is highly temperature-dependent, stable temperature control is necessary during the measurement. Using microfluidics technology, it is now possible to perform rheological characterization and conduct fast and accurate measurements. Small sample volumes (even below 500 µL) are required, and viscosity determination can be carried out over a wide range of shear rates. Nevertheless, the pharmaceutical application of viscometers operating on the principle of microfluidics is not yet widespread. In our work, we compare the results of measurements taken with a microfluidic chip-based viscometer on different pharmaceutical forms (gels, solution) with those obtained using a traditional rotational viscometer, evaluating the relative advantages and disadvantages of the different methods. The microfluidics-based method enables time- and sample-efficient viscosity analysis of the examined pharmaceutical forms. [ABSTRACT FROM AUTHOR]

Abstract Background Children represent a particularly vulnerable demographic in the context of drug-resistant (DR) tuberculosis (TB) due to their increased likelihood of close contact with adults diagnosed with the disease. Approximately 25 000–30 000 children develop DR-TB annually. While treatment success rates for DR-TB in children surpass those in adults, children and adolescents encounter distinct challenges throughout the diagnosis and treatment of DR-TB (including MDR-TB, Pre-XDR TB, and XDR-TB). Aim To identify current practices in drug administration to children diagnosed with DR-TB where appropriate dosage forms are not available in South Africa. Method An observational study was carried out at the study site to determine how medication prescribed was manipulated and administered by nursing staff to paediatric patients in the wards. Results The observational study identified 8 drugs used in DR-TB at the study site, where some manipulation to the formulation was necessary to enable administration to paediatric patients. Linezolid and para-aminosalicylic acid are the only drugs available and registered in the South Africa in a formulation that is suitable for administration to paediatric patients. Activities carried out by nursing staff to enable the administration of DR-TB medication included cutting capsules and tablets and dissolving the tablet or capsule contents in distilled water to obtain the required suitable dose. Discussion Lack of availability of suitable dosage forms for paediatrics patients results in several challenges, such as additional time required for drug preparation, increased time duration of medication administration, and unpalatability of drugs. These challenges may subsequently affect compliance and therapeutic outcomes of the treatment of paediatric patients, especially as outpatients. Conclusion Research needs to focus on the development of appropriate dosage forms for the paediatric population and focus on identifying cases of DR-TB in children. This will assist in building evidence to advocate for registration of child-friendly dosage forms thereby ensuring a sustainable supply of medication.

Abstract Background Among the non-traditional antibacterial agents in development, only a few targets critical Gram-negative bacteria such as carbapenem-resistant Pseudomonas aeruginosa, Acinetobacter baumannii or cephalosporin-resistant Enterobacteriaceae. Endolysins and their genetically modified versions meet the World Health Organization criteria for innovation, have a novel mode of antibacterial action, no known bacterial cross-resistance, and are being intensively studied for application against Gram-negative pathogens. Methods The study presents a multidisciplinary approach, including genetic engineering of LysECD7-SMAP and production of recombinant endolysin, its analysis by crystal structure solution following molecular dynamics simulations and evaluation of antibacterial properties. Two types of antimicrobial dosage forms were formulated, resulting in lyophilized powder for injection and hydroxyethylcellulose gel for topical administration. Their efficacy was estimated in the treatment of sepsis, and pneumonia models in BALB/c mice, diabetes-associated wound infection in the leptin receptor-deficient db/db mice and infected burn wounds in rats. Results In this work, we investigate the application strategies of the engineered endolysin LysECD7-SMAP and its dosage forms evaluated in preclinical studies. The catalytic domain of the enzyme shares the conserved structure of endopeptidases containing a putative antimicrobial peptide at the C-terminus of polypeptide chain. The activity of endolysins has been demonstrated against a range of pathogens, such as Klebsiella pneumoniae, A. baumannii, P. aeruginosa, Staphylococcus haemolyticus, Achromobacter spp, Burkholderia cepacia complex and Haemophylus influenzae, including those with multidrug resistance. The efficacy of candidate dosage forms has been confirmed in in vivo studies. Some aspects of the interaction of LysECD7-SMAP with cell wall molecular targets are also discussed. Conclusions Our studies demonstrate the potential of LysECD7-SMAP therapeutics for the systemic or topical treatment of infectious diseases caused by susceptible Gram-negative bacterial species and are critical to proceed LysECD7-SMAP-based antimicrobials trials to advanced stages.

In this review, we aim to highlight the advantages, challenges, and limitations of electronic tongues (e-tongues) in pharmaceutical drug development. The authors, therefore, critically evaluated the performance of e-tongues regarding their qualification to assess peroral formulations containing bitter active pharmaceutical ingredients. A literature search using the keywords 'electronic', 'tongue', 'bitter', and 'drug' in a Web of Science search was therefore initially conducted. Reviewing the publications of the past decade, and further literature where necessary, allowed the authors to discuss whether and how e-tongues perform as expected and whether they have the potential to become a standard tool in drug development. Specifically highlighted are the expectations an e-tongue should meet. Further, a brief insight into the technologies of the utilized e-tongues is given. Reliable protocols were found that enable (i) the qualified performance of e-tongue instruments from an analytical perspective, (ii) proper taste-masking assessments, and (iii) under certain circumstances, the evaluation of bitterness. [ABSTRACT FROM AUTHOR]

A spectrofluorimetric method using fluorescent carbon dots (CDs) was developed for the selective detection of azelnidipine (AZEL) pharmaceutical in the presence of other drugs. In this study, N‐doped CDs (N‐CDs) were synthesized through a single‐step hydrothermal process, using citric acid and urea as precursor materials. The prepared N‐CDs showed a highly intense blue fluorescence emission at 447 nm, with a photoluminescence quantum yield of ~21.15% and a fluorescence lifetime of 0.47 ns. The N‐CDs showed selective fluorescence quenching in the presence of all three antihypertensive drugs, which was used as a successful detection platform for the analysis of AZEL. The photophysical properties, UV–vis light absorbance, fluorescence emission, and lifetime measurements support the interaction between N‐CDs and AZEL, leading to fluorescence quenching of N‐CDs as a result of ground‐state complex formation followed by a static fluorescence quenching phenomenon. The detection platform showed linearity in the range 10–200 μg/ml (R2 = 0.9837). The developed method was effectively utilized for the quantitative analysis of AZEL in commercially available pharmaceutical tablets, yielding results that closely align with those obtained from the standard method (UV spectroscopy). With a score of 0.76 on the 'Analytical GREEnness (AGREE)' scale, the developed analytical method, incorporating 12 distinct green analytical chemistry components, stands out as an important technique for estimating AZEL. [ABSTRACT FROM AUTHOR]

Aim: To appraise and synthesize research investigating optimizing the administration of solid oral dosage forms (SODFs) to adults with swallowing difficulties. Design: An integrative review. Methods: An electronic search was conducted on Medical Literature Analysis and Retrieval System Online (Public Medline interface), Elsevier SciVerse Scopus and Scientific Electronic Library Online (updated February 2023). Restriction regarding the publication date was not considered for the inclusion of records. Studies addressing risks, general aspects, recommendations about patient postural adjustments, swallowing techniques, swallowing aids and aspects of concealment of SODFs were included. Results: Fifty-three records published between 2002 and 2021 were included. The main administration risks were aspiration, asphyxia and solid oral dosage form-induced oral/oesophageal mucosal lesions. The most frequent general aspect reported was administering one oral dosage form at a time. The sitting position was the most patient postural adjustment mentioned. The most frequently reported solid oral dosage form swallowing technique was the lean-forward method for capsules. Solid oral dosage form swallowing aids cited: tongue and throat lubricant and solid oral dosage form coating device, swallowing cup and swallowing straw. Conclusion: The literature data on administering SODFs for adults with swallowing difficulties were appraised and synthesized. Some aspects, for example, not administering SODFs simultaneously, can make swallowing safer. Postural adjustments and solid oral dosage form swallowing aids are important to avoid administration risks. Swallowing SODFs can be easier if learned by techniques. Liquid and food are helpful as vehicles, and several of these have been listed. Implications for the Profession and/or Patient Care: By optimizing the contributing factors of administering oral pharmacotherapy, the nurse can use appropriate practices to improve patient safety. Additionally, knowing and establishing the administration aspects are reasonable steps for standardizing care for patients with swallowing oral dosage form difficulties. Impact: • This study addressed administering SODFs to adult patients with swallowing difficulties. • The administration of SODFs to adult patients with swallowing difficulties can be optimized if only one oral dosage form at a time is administrated and if patient postural adjustments, swallowing techniques and swallowing aids are used. • This investigation will impact the care of patients with swallowing difficulties. Reporting Method: The authors declare they adhered to the relevant EQUATOR guidelines and report following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) 2020 Statement. [ABSTRACT FROM AUTHOR]

The isocratic RP-HPLC method was developed and validated for the analysis of clopidogrel bisulfate counterfeited with acetyl salicylic acid and applied for the determination of clopidogrel bisulfate in pharmaceutical dosage forms. Clopidogrel bisulfate is commonly counterfeited with acetyl salicylic acid and it is not labeled to contain acetyl salicylic acid due to their similar pharmacological effect in inhibiting platelet aggregation. The mobile phase was composed of potassium dihydrogen phosphate buffer 0.02M (pH 2.8) and methanol 30:70 (v/v). The flow rate was 1.5mL/min. The Diode array detector was set at 220 nm. The linearity ranges were 10-70 µg/mL and 6-50 µg/mL for clopidogrel bisulfate and acetyl salicylic acid, respectively. The retention time was 2.5 min and 10.23 min for clopidogrel bisulfate and acetyl salicylic acid, respectively. The method was validated according to ICH guidelines. The developed method was successfully applied for the determination of clopidogrel bisulfate counterfeited with acetyl salicylic acid as well as the estimation of clopidogrel bisulfate in its different dosage forms. [ABSTRACT FROM AUTHOR]

The objective of this study was to identify the cause-effect relationships between various data related to vaginal dosage forms, such as composition, process parameters (condition attributes), and quality (decision attribute), by employing a mathematical data mining approach that utilizes rough set theory. The analyzed data were organized in a tabular format known as an information system. Objects were labeled as rows, and attributes as columns, with attribute-values serving as entries. Each formulation was described by its condition attributes (composition, manufacturing process, quality parameters), while the decision attribute indicated the quality of the formulation (expressed as pH after vaginal tablet or pessary application) and enabled classification as correct/incorrect or good/bad. The decision rules generated by the study provide insights into the relationships between the condition attributes and the decision attribute. They highlight the importance of LA content and LA:polymer ratios in maintaining physiological pH. Additionally, the findings confirm the favorable impact of chitosan on pH regulation while indicating that the type of formulation (pessaries or tablets) does not significantly affect the classification of objects. Decision rules with high confirmation coefficients of condition attributes can help in developing optimal formulations. These decision rules contain essential information that describes the cause-and-effect relationships and are free of redundant information. They form the basis for understanding and optimizing processes and establishing a design space. [ABSTRACT FROM AUTHOR]

OBJECTIVE Ethanol is a common excipient used in liquid medications to enhance solubility and inhibit bacterial growth. While the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have released guidance for how much ethanol is acceptable in medicines, many medications contain more than the recommended amount. The objective of this study was to determine what effect these medications would have on blood alcohol concentration (BAC) for pediatric patients, defined as those medications that would increase the BAC by ≥2.5 mg/dL. METHODS A list of medications dispensed to pediatric patients from a single hospital over a period of 4 months was obtained. The package inserts of these medications were reviewed to determine ethanol content. Typical doses were used to determine the amount of ethanol pediatric patients weighing 10, 20, and 40 kg would receive. The theoretical BAC was then calculated for each medication containing ethanol. RESULTS Seven hundred ninety-six medications were dispensed for pediatric patients during the study period, of which 33 contained ethanol. Seven medications would be projected to increase the BAC above 2.5 mg/dL with a normal pediatric dose. CONCLUSION While most medications do not contain ethanol, we found 7 that contained enough ethanol to potentially raise the BAC above 2.5 mg/dL. Health care practitioners should consider the ethanol content of medications prior to recommending them in children and when assessing overdoses. [ABSTRACT FROM AUTHOR]

Background: to assess the intuitiveness of parents' administration of pediatric emergency devices (inhalation, rectal, buccal, nasal, and auto-injector). Methods: We invited parents without prior experience to administer the five devices to dummy dolls. We observed whether the parents chose the correct administration route and subsequently performed the correct administration procedures without clinically relevant errors. We interviewed parents for their self-assessment of their own administration performance and willingness to administer devices in actual emergencies. Results: The correct administration route was best for the inhalation device (81/84, 96% of parents) and worst for the intranasal device (25/126, 20%). The correct administration procedures were best for the buccal device (63/98, 64%) and worst for the auto-injector device (0/93, 0%). Their own administration performance was rated to be best by parents for the inhalation device (59/84, 70%) and worst for the auto-injector device (17/93, 18%). The self-assessment of the correct administration overestimated the correct administration procedures for all the devices except the buccal one. Most parents were willing to administer the inhalation device in an emergency (67/94, 79%), while the fewest were willing to administration procedures the auto-injector device (28/93, 30%). Conclusions: Intuitiveness concerning the correct administration route and the subsequent correct administration procedures have to be improved for all the devices examined. The parents mostly overestimated their performance. Willingness to use a device in an actual emergency depended on the device. [ABSTRACT FROM AUTHOR]

This article presents a study conducted at a rural tertiary care hospital to examine the prescribing pattern of antibacterials in different disease conditions. The study involved 800 patients selected through random sampling. The results showed that the majority of antibacterials were prescribed in tablet form, followed by drops and syrup. The study also identified the distribution of antibacterials according to routes of drug administration, with the oral route being the most common. The study found that respiratory infections were the most common condition, followed by ear, nose, and throat infections. Genitourinary infections and injuries were also reported, while in 2.1% of prescriptions, the diagnosis was not mentioned. The study also noted that females outnumbered males in the study population, and a significant number of patients had no formal education. The findings of this study can be used to develop rational prescribing guidelines based on disease patterns in the region. [Extracted from the article]

Compounding is currently an integral part of pharmacy practice, and it is essential to the provision of healthcare. Compounding is an important therapeutic option in all areas of medicine, with relevance to dermatological treatments. Compounding topical medicines can be time-consuming and requires specialized equipment. In this regard, the use of proprietary topical liquid and semisolid vehicles/bases can be a good alternative and a more sustainable approach. This review provides an overview of existing proprietary vehicles/bases, summarizing their properties and applications and identifying existing commercial and information gaps. Creams emerge as the foremost topical base, followed by gels and ointments. Besides acting locally on the skin, almost a third of these proprietary bases/vehicles are also suitable for the transdermal application of APIs. Information regarding composition and compatibilities/incompatibilities with APIs is not always provided by the manufacturer, constraining a complete analysis of all proprietary topical bases/vehicles considered. The collection and organization of this information are important not only for pharmacy practice and physician prescription, helping to select the best vehicles/bases, but also for the industry to identify opportunities for innovation. [ABSTRACT FROM AUTHOR]

Measuring the viscosity of pharmaceutical dosage forms is a crucial process. Viscosity provides information about the stability of the composition, the release rate of the drug, bioavailability, and, in the case of injectable drug formulations, even the force required for injection. However, measuring viscosity is a complex task with numerous challenges, especially for non-Newtonian materials, which include most pharmaceutical formulations, such as gels. Selecting the appropriate shear rate is critical. Since viscosity in many systems is highly temperature-dependent, stable temperature control is necessary during the measurement. Using microfluidics technology, it is now possible to perform rheological characterization and conduct fast and accurate measurements. Small sample volumes (even below 500 µL) are required, and viscosity determination can be carried out over a wide range of shear rates. Nevertheless, the pharmaceutical application of viscometers operating on the principle of microfluidics is not yet widespread. In our work, we compare the results of measurements taken with a microfluidic chip-based viscometer on different pharmaceutical forms (gels, solution) with those obtained using a traditional rotational viscometer, evaluating the relative advantages and disadvantages of the different methods. The microfluidics-based method enables time- and sample-efficient viscosity analysis of the examined pharmaceutical forms.

Biofilms are complex microbial communities formed by the attachment of bacteria or fungi to surfaces encased in a self-produced polymeric matrix. These biofilms are highly resistant to conventional antimicrobial therapies. The resistance mechanisms exhibited by biofilms include low antibiotic absorption, sluggish replication, adaptive stress response, and the formation of dormant-like phenotypes. The eradication of biofilms requires alternative strategies and approaches. Nanotechnological drug delivery systems allow excellent control over the drug chemistry, surface area, particle size, particle shape, and composition of nanostructures. Nanoformulations can enhance the efficacy of antimicrobial agents by improving their bioavailability, stability, and targeted delivery to the site of infection that helps biofilm eradication more effectively. In addition to nanoformulations, the route of administration and choice of dosage forms play a crucial role in treating biofilm infections. Systemic administration of antibiotics is effective in controlling systemic infection and sepsis associated with biofilms. Alternative routes of administration, such as inhalation, vaginal, ocular, or dermal, have been explored to target biofilm infections in specific organs. This review primarily examines the utilisation of nanoformulations in various administration routes for biofilm management. It also provides an overview of biofilms, current approaches, and the drawbacks associated with conventional methods. [ABSTRACT FROM AUTHOR]

For acyclovir (ACV) determination in bulk and dosage forms, quick, sensitive, straightforward, and eco-friendly ultrasound-assisted dispersive liquid-liquid microextraction (UA-DLLME)-based spectrophotometric method has been created and validated. ACV with 1,2-naphthoquine-4-sulfonate (NQS) react in alkaline medium to produce a yellow-colored product, which is the basis of the newly created method. Investigation and optimization were done on the crucial experimental variables influencing ACV's extraction effectiveness. At ?max = 495 nm, the minuscule organic droplets were detected. The linearity was present from 0.1 to 3.0 µg/mL under ideal circumstances, with a linear correlation coefficient of 0.9995. The detection limit was 0.03 µg/mL and quantification limit was 0.1 µg/mL. 22.50 was the enrichment factor. Relative standard deviation (RSD%) as accuracy at 2.0 µg/mL of ACV was 1.0%, with good recovery (99.30%). The developed UA-DLLME method was effectively used to determine the ACV in dosage forms, and the validation was evaluated. Results from the suggested technique for dosage forms and pure ACV were in excellent agreement with the results from the official method. [ABSTRACT FROM AUTHOR]

Tacrolimus is an immunosuppressive drug widely used in hospitals for the treatment of transplant patients. Often, hospitalized patients undergo the administration of tacrolimus in liquid pharmaceutical forms. However, this drug has been marketed only in solid form for oral use. This work aimed to develop and evaluate the stability of tacrolimus in a simple liquid formulation with comparable efficacy, safety, and stability. The analyzes were developed according to the USP method (2018), being co-validated, guaranteeing its accuracy, precision, and specificity. Based on the analyzed analyses, the derivation of tacrolimus in suspension was determined, as well as the wetting agent in its ideal proportion to obtain drug content in HPLC within acceptable limits, this being 8% polyethylene glycol 400. The formulation was observed for the evaluation of physical-chemical parameters, being grown, pH, sedimentation volume, and organoleptic characteristics. Dosing was carried out for 30 days at room temperature and a temperature of 40°C. The formulation maintained its integrity during the 30 days of storage at room temperature with content between 90 – 110%, growth above 200 cP, neutral pH, and sedimentation volume below 3 mL. However, tacrolimus is controlled sensitively to heat, observing degradation in the first ten days of analysis at 40°C, with possible formation of degradation products. Based on this work, the tacrolimus formulation developed has adequate dosage and homogeneity for 30 days and should be kept away from light and at room temperature.

In this review, we aim to highlight the advantages, challenges, and limitations of electronic tongues (e-tongues) in pharmaceutical drug development. The authors, therefore, critically evaluated the performance of e-tongues regarding their qualification to assess peroral formulations containing bitter active pharmaceutical ingredients. A literature search using the keywords ‘electronic’, ‘tongue’, ‘bitter’, and ‘drug’ in a Web of Science search was therefore initially conducted. Reviewing the publications of the past decade, and further literature where necessary, allowed the authors to discuss whether and how e-tongues perform as expected and whether they have the potential to become a standard tool in drug development. Specifically highlighted are the expectations an e-tongue should meet. Further, a brief insight into the technologies of the utilized e-tongues is given. Reliable protocols were found that enable (i) the qualified performance of e-tongue instruments from an analytical perspective, (ii) proper taste-masking assessments, and (iii) under certain circumstances, the evaluation of bitterness.

Abstract In addition to its pure form, three accurate, rapid, and simple methods have been established for determining perindopril (PRD) in its tablet form. At pH 9.0 using a borate buffer, developing the three designated methods was successful according to the reaction between PRD and 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) and the formation of a chromogen (with a yellow color) measurable at 460 nm using the spectrophotometric method (Method I). In addition, the produced chromogen was assessed using the spectrofluorimetric method (Method II) at 535 nm following excitation at 461 nm. Afterward, the same reaction product was separated and determined using the HPLC method with fluorescence detection (Method III). A Promosil C18 stainless steel column (Q7 5 mm particle size, 250–4.6 mm) has proven suitable for separation. The mobile phase adjustment was made at pH 3.0, with a 1.0 mL min −1 flow rate; its composition was methanol-sodium dihydrogen phosphate, 0.02 M (60: 40, v/v). Through concentration ranges of 5.0–60.0, 0.5–6.0, and 1.0–10.0 μg mL−1, the calibration curves were rectilinear for Methods I, II, and III, respectively, with limits of quantification (LOQ) of 1.08, 0.16 and 0.19 μg mL−1 as well as limits of detection (LOD) of 0.36, 0.05 and 0.06 μg mL−1. The developed methods were implemented to estimate PRD in tablets, and a comparison between the obtained outcomes utilizing the developed methods as well as obtained from the official method revealed that they were comparable. The official BP method was based on dissolving PRD in anhydrous acetic acid and titrating with 0.1 M perchloric acid, then the potentiometric determination of the end-point. The designated methods were also implemented in content uniformity testing with satisfying results. The reaction pathway proposal was speculated, and according to ICH Guidelines, the statistical evaluation of the data was performed. The three proposed methods were confirmed to be green, eco-friendly and safe to environment using Green Analytical procedure index (GAPI) method.

Introduction: The intravaginal drug administration enables treatment of the local and systemic diseases. The anatomy and physiology of a vagina provide several difficulties for drug technologists due to the small amount and continuous production of vaginal discharge, especially in the case of lipophilic drugs often characterized by insufficient solubility. The application of poorly soluble drug substances in the form of nanoemulsions improves their availability. However, in the case of nanoemulsion-based vaginal dosage forms, no standardized methods have been defined for testing the amount of a drug released from encapsulated form. Aim of the study: Comparison and development of a method for testing the availability of active pharmaceutical substances from vaginal nanoemulsion-based drug forms. Materials and methods: The nanoemulsion and reference products (cream and suspension) were placed in a dialysis bag separating them from the acceptor medium. The changes in the concentration of the free fraction of the model active substance – clotrimazole were assessed. The experiments were performed using 2 static methods of different mixing method (magnetic stirring and USP apparatus III) and 2 dynamic methods including the flow of the medium through the flow-through cell at 2 mL/min and 2 mL/h. The experiments were conducted for 5 h. Results: Incomplete release of the active pharmaceutical ingredient was observed for all tested formulations over the experiment. Despite the delivery of a fresh portion of the medium, low concentrations of the free clotrimazole fraction were observed for both flow-through methods i.e., a maximum of about 7.5% of the dose for the 2 mL/min flow rate and 5% for the 2 mL/h flow rate. In stationary methods, the maximum recorded concentrations of the free fraction of the drug corresponded to approx. 25% of the initial amount. For the pilot stationary method, high standard deviations (SD) were observed, which affected the low discriminatory properties of the method. The method based on the reciprocating cylinder dissolution apparatus provided results exhibiting smaller SD and more significant differences between the tested formulations. The highest concentrations among the evaluated formulations were observed for nanoemulsion or nanoemulsion and suspension, depending on the used test technique. Significantly lower doses of the drug were released from the cream in almost every test. Conclusions: The selection of the method used to assess the pharmaceutical availability of an active pharmaceutical ingredient has a crucial impact on the release profiles obtained. The stationary method using a reciprocating cylinder apparatus (USP apparatus III) had the highest measurement precision and provided the most discriminatory results.

Objective: To assess student perceptions regarding: 1) exercises designed to enhance student comprehension of the roles of pharmaceutical excipients in dosage forms and 2) the use of resources to identify the roles of excipients. Description: In-class exercises regarding the roles of excipients were implemented in a foundational pharmaceutics course. The exercises covered the topics of liquid single-phase systems, liquid multiphase systems, drug delivery to the skin, and parenteral, ophthalmic, and nasal dosage forms. Students were introduced to resources to identify the roles of excipients. The exercises included the presentation of pharmaceutical preparations with various fundamental excipients, followed by student polling and class discussion. A survey was administered to evaluate student perceptions regarding the exercises about the roles of excipients and the use of resources to identify the roles of excipients. Findings: Eighty students participated in the study (response rate = 99%). Student perceptions indicated that the exercises helped them understand the material better and enhanced their performance in the non-sterile compounding course taught concurrently with the pharmaceutics course. Students indicated that the resources they used during the exercises were lecture notes from the course (95%), lists with excipients that the instructor provided (24%), a Web search, e.g., Google, Bing (20%), the sixth edition of the Handbook of Pharmaceutical Excipients (18%), Micromedex/Martindale (16%), and the International Journal of Pharmaceutical Compounding (6%). Conclusion. Targeted excipient exercises are a practical approach to enhance student understanding and can be utilized in pharmaceutics and non-sterile compounding courses across various pharmacy curricula.

DISCLOSURES: No funding was received for the writing of this letter. All authors were members of the National Academies study committee to which this letter refers, with Shortliffe as the chair. All committee members who contributed to the report were themselves vetted for potential conflicts of interest, as is described in the recently published version of the report. Lieu is an employee of Kaiser Permanente and the content does not represent the official views of Kaiser Permanente. The other authors have nothing to disclose.

Background: to assess the intuitiveness of parents’ administration of pediatric emergency devices (inhalation, rectal, buccal, nasal, and auto-injector). Methods: We invited parents without prior experience to administer the five devices to dummy dolls. We observed whether the parents chose the correct administration route and subsequently performed the correct administration procedures without clinically relevant errors. We interviewed parents for their self-assessment of their own administration performance and willingness to administer devices in actual emergencies. Results: The correct administration route was best for the inhalation device (81/84, 96% of parents) and worst for the intranasal device (25/126, 20%). The correct administration procedures were best for the buccal device (63/98, 64%) and worst for the auto-injector device (0/93, 0%). Their own administration performance was rated to be best by parents for the inhalation device (59/84, 70%) and worst for the auto-injector device (17/93, 18%). The self-assessment of the correct administration overestimated the correct administration procedures for all the devices except the buccal one. Most parents were willing to administer the inhalation device in an emergency (67/94, 79%), while the fewest were willing to administration procedures the auto-injector device (28/93, 30%). Conclusions: Intuitiveness concerning the correct administration route and the subsequent correct administration procedures have to be improved for all the devices examined. The parents mostly overestimated their performance. Willingness to use a device in an actual emergency depended on the device.

Compounding is currently an integral part of pharmacy practice, and it is essential to the provision of healthcare. Compounding is an important therapeutic option in all areas of medicine, with relevance to dermatological treatments. Compounding topical medicines can be time-consuming and requires specialized equipment. In this regard, the use of proprietary topical liquid and semisolid vehicles/bases can be a good alternative and a more sustainable approach. This review provides an overview of existing proprietary vehicles/bases, summarizing their properties and applications and identifying existing commercial and information gaps. Creams emerge as the foremost topical base, followed by gels and ointments. Besides acting locally on the skin, almost a third of these proprietary bases/vehicles are also suitable for the transdermal application of APIs. Information regarding composition and compatibilities/incompatibilities with APIs is not always provided by the manufacturer, constraining a complete analysis of all proprietary topical bases/vehicles considered. The collection and organization of this information are important not only for pharmacy practice and physician prescription, helping to select the best vehicles/bases, but also for the industry to identify opportunities for innovation.

Abstract Background Choosing the most effective chemotherapeutic agent with safest side effect profile is a common challenge in cancer treatment. Although there are standardized chemotherapy protocols in place, protocol changes made after extensive clinical trials demonstrate significant improvement in the efficacy and tolerability of certain drugs. The pharmacokinetics, pharmacodynamics, and tolerance of anti‐cancer medications are all highly individualized. A driving force behind these differences lies within a person's genetic makeup. Recent findings Pharmacogenomics, the study of how an individual's genes impact the processing and action of a drug, can optimize drug responsiveness and reduce toxicities by creating a customized medication regimen. However, these differences are rarely considered in the initial determination of standardized chemotherapeutic protocols and treatment algorithms. Because pharmacoethnicity is influenced by both genetic and nongenetic variables, clinical data highlighting disparities in the frequency of polymorphisms between different ethnicities is steadily growing. Recent data suggests that ethnic variations in the expression of allelic variants may result in different pharmacokinetic properties of the anti‐cancer medication. In this article, the clinical outcomes of various chemotherapy classes in patients of different ethnicities were reviewed. Conclusion Genetic and nongenetic variables contribute to the interindividual variability in response to chemotherapeutic drugs. Considering pharmacoethnicity in the initial determination of standard chemotherapeutic protocols and treatment algorithms can lead to better clinical outcomes of patients of different ethnicities.

This research presents a facile spectrofluorimetric technique for detecting fexofenadine (FXD) drug based on the idea of Dianthine B's Resonance Rayleigh Scattering response augmentation. A food dye, Dianthine B (DB), is a fluoresine base-structured pigment used as a food additive, flavor, bio-stainer, and for a medicational prognosis purpose. Interest in employing food additives for tagging and tracking has increased because of their safety, elevated quantum outputs, and propensity to biomaterials labeling. The planned method validated and evaluated the target drug quickly and efficiently using a direct, facile, simple, and single-pot-single-step spectrofluorimetric approach, making it more favorable to the environment. Facile coupling between FXD and Dianthine B occurred rapidly in an acidic environment. A correlation was established between the increased responsiveness of the food dye to Resonance Rayleigh Scattering signals as a result of FXD and the molecular size of the coupled product formed at 361 nm. The linear range was determined to be from 50 to 1500 ng mL−1, while the sensitivity limits were 15 ng mL−1 for LOD and 46 ng mL−1 for LOQ. Analyte-dye coupled products were studied to establish the optimal settings for the system's tunable variables. Additionally, there were no problems with the system meeting the International Council for harmonisation ICH requirements. Plus, enough of the material was retrieved for medicinal applications. The coupled product's quantum yield was evaluated. Additionally, the environmental evaluation of the proposed system was done using ecological metrics, including an eco-scale (95/100), the National Environmental Methods Index, NEMI (full green pictograms), the Green Analytical Procedure Index (GAPI), and the Analytical GREEnness Measure, AGREE (0.8/1). These results indicated that the planned method's significant level of greenness was achieved.

In many experimental applications, fluorescent probes (fluorophores or just fluors) have replaced more traditional methods because of their adaptability, sensitivity, and quantifiability. The target analyte molecule (Topiramate) does not include any fluorogenic or chromophoric groups; hence it has no fluorescence in its native state or light absorptive power when exposed to ultraviolet light, thus; it is impossible to analyze it directly and must be undergone chemical mutagenicity in its molecular structure. This phenomenon can be achieved through fluorescent probing or labeling with tagging reagent. Consequently, the current analytical methodology depends on the fluorescence probe development via the ninhydrin reagent's utility to birth a condensed fluorescent derivative that can be tracked fluorimetrically. The final product was monitored at λem 482 nm after excitation at λex 381 nm. Under appropriate conditions, topiramate's primary amine group can condense with ninhydrin (β-diketone) and phenylacetaldehyde in a buffered solution. A new, green, feasible, and selective fluorometric strategy for topiramate assay has been presented in this work. The method offers linearity at a topiramate concentration range of 0.5 – 8 μg mL−1. The method's quantum yield was rated, and the validation parameters were examined following the International Council for Harmonisation (ICH) rules. Finally, the proposed probe was efficiently employed in the topiramate testing in the batched powder and available dosage form with high accuracy, and there was no significant effect with the existence of excipients. The findings indicate an impressive alignment with the reference documented method, showing no major variations in precision and accuracy.

In addition to its pure form, three accurate, rapid, and simple methods have been established for determining perindopril (PRD) in its tablet form. At pH 9.0 using a borate buffer, developing the three designated methods was successful according to the reaction between PRD and 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole (NBD-Cl) and the formation of a chromogen (with a yellow color) measurable at 460 nm using the spectrophotometric method (Method I). In addition, the produced chromogen was assessed using the spectrofluorimetric method (Method II) at 535 nm following excitation at 461 nm. Afterward, the same reaction product was separated and determined using the HPLC method with fluorescence detection (Method III). A Promosil C18 stainless steel column (Q7 5 mm particle size, 250–4.6 mm) has proven suitable for separation. The mobile phase adjustment was made at pH 3.0, with a 1.0 mL min −1 flow rate; its composition was methanol-sodium dihydrogen phosphate, 0.02 M (60: 40, v/v). Through concentration ranges of 5.0–60.0, 0.5–6.0, and 1.0–10.0 μg mL−1, the calibration curves were rectilinear for Methods I, II, and III, respectively, with limits of quantification (LOQ) of 1.08, 0.16 and 0.19 μg mL−1 as well as limits of detection (LOD) of 0.36, 0.05 and 0.06 μg mL−1. The developed methods were implemented to estimate PRD in tablets, and a comparison between the obtained outcomes utilizing the developed methods as well as obtained from the official method revealed that they were comparable. The official BP method was based on dissolving PRD in anhydrous acetic acid and titrating with 0.1 M perchloric acid, then the potentiometric determination of the end-point. The designated methods were also implemented in content uniformity testing with satisfying results. The reaction pathway proposal was speculated, and according to ICH Guidelines, the statistical evaluation of the data was performed. The three proposed methods were confirmed to be green, eco-friendly and safe to environment using Green Analytical procedure index (GAPI) method. [ABSTRACT FROM AUTHOR]

Nanosuspensions (NSs), which are nanosized colloidal particle systems, have recently become one of the most interesting substances in nanopharmaceuticals. NSs have high commercial potential because they provide the enhanced solubility and dissolution of low-water-soluble drugs by means of their small particle sizes and large surface areas. In addition, they can alter the pharmacokinetics of the drug and, thus, improve its efficacy and safety. These advantages can be used to enhance the bioavailability of poorly soluble drugs in oral, dermal, parenteral, pulmonary, ocular, or nasal routes for systemic or local effects. Although NSs often consist mainly of pure drugs in aqueous media, they can also contain stabilizers, organic solvents, surfactants, co-surfactants, cryoprotectants, osmogents, and other components. The selection of stabilizer types, such as surfactants or/and polymers, and their ratio are the most critical factors in NS formulations. NSs can be prepared both with top-down methods (wet milling, dry milling, high-pressure homogenization, and co-grinding) and with bottom-up methods (anti-solvent precipitation, liquid emulsion, and sono-precipitation) by research laboratories and pharmaceutical professionals. Nowadays, techniques combining these two technologies are also frequently encountered. NSs can be presented to patients in liquid dosage forms, or post-production processes (freeze drying, spray drying, or spray freezing) can also be applied to transform the liquid state into the solid state for the preparation of different dosage forms such as powders, pellets, tablets, capsules, films, or gels. Thus, in the development of NS formulations, the components/amounts, preparation methods, process parameters/levels, administration routes, and dosage forms must be defined. Moreover, those factors that are the most effective for the intended use should be determined and optimized. This review discusses the effect of the formulation and process parameters on the properties of NSs and highlights the recent advances, novel strategies, and practical considerations relevant to the application of NSs to various administration routes. [ABSTRACT FROM AUTHOR]

A new, precise, and sensitive method for the determination of Metronidazole has been created. Metronidazole has been determined in both blood and dosage forms. The reaction is based on the reduction of the nitro group of metronidazole followed by coupling with the diazotized p-aminodiphenylamine to produce a soluble, colored complex measured at 515 nm. Beer-Lambert law is obeyed over the concentration range from 20 to 100 µg/mL, the molar absorptivity is 1397.88 L/mol.cm.The method has been used for the determination of metronidazole in the blood of the volunteer after 4, 6, 8, and 12 h from the administration of 500 mg tablet showing that the higher level of the drug was found after 6 h from swallowing the drug orally with excellent precision range (RSD% 0.0122-0.0387). The method has been also applied for the estimation of drug content in injection and tablet dosage forms with accuracy ranging from -4.1- to +4.0.

Dihydromyricetin (DHM) is an important natural flavonoid that has attracted much attention because of its various functions such as protecting the cardiovascular system and liver, treating cancer and neurodegenerative diseases, and anti-inflammation effect, etc. Despite its great development potential in pharmacy, DHM has some problems in pharmaceutical applications such as low solubility, permeability, and stability. To settle these issues, extensive research has been carried out on its physicochemical properties and dosage forms to produce all kinds of DHM preparations in the past ten years. In addition, the combined use of DHM with other drugs is a promising strategy to expand the application of DHM. However, although invention patents for DHM preparations have been issued in several countries, the current transformation of DHM research results into market products is insufficient. To date, there is still a lack of deep research into the pharmacokinetics, pharmacodynamics, toxicology, and action mechanism of DHM preparations. Besides, preparations for combined therapy of DHM with other drugs are scarcely reported, which necessitates the development of dosage forms for this application. Apart from medicine, the development of DHM in the food industry is also of great potential. Due to its multiple effects and excellent safety, DHM preparations can be developed for functional drinks and foods. Through this review, we hope to draw more attention to the development potential of DHM and the above challenges and provide valuable references for the research and development of other natural products with a similar structure-activity relationship to this drug.

Tobacco is one of the most planted products in worldwide and the whole Nicotiana tabacum L. plant, its leaves, flowers, seeds or roots, and individual chemical compounds have medicinal uses such as as sedative, diuretic, or expectorant. From the past to the present, tobacco has been used in various dosage forms including oral/ transdermal films, sublingual tablets, mouth/nasal spray, and inhaler. In addition, Tobacco is a very valuable plant with uses in medicine and bioengineering applications. In this review, it was aimed to give information about the tobacco plant and its medicinal uses and also the pharmaceutical dosage forms as well as novel delivery systems of nicotine compound of tobacco via comprehensively search method of the literature by using Pubmed, ScienceDirect, ISI Web of Knowledge, and Google Scholar databases for articles published in peer-reviewed journals from mostly 2016 to 2021. It is also aimed to draw attention to the pharmaceutical use of tobacco plant instead of potential harmful uses. In conclusion, there is need to be carried out new studies to enlighten the exact mechanisms of tobacco and its major compound of nicotine on other diseases such as schizophrenia, Parkinson’s disease, and prose memory and attention than smoking cessation therapy and evaluate its safety and develop more effective novel pharmaceutical dosage forms.

Currently, the global increase in resistance of pathogens to widely used antibiotics requires a return to the practice of using some classic drugs with preserved activity, finding new ways and directions of delivery of antibiotics to the locations of pathogenic microorganisms and the use of antimicrobial drugs that are not yet resistant. Doxycycline refers to antimicrobial drugs that do not yet have widespread resistance. Numerous studies of doxycycline have now been described as enhancing therapeutic effects, including COVID-19-related diseases, and finding new delivery routes to limit systemic side effects associated with high doses and avoid antibiotic resistance. The aim of the work was to analyze modern ways of doxycycline delivery, to determine the prospects for use in pharmacy, to summarize and systematize data on its functional purpose in the development of drugs with specified pharmaco-technological parameters. It is established that in the Ukrainian pharmaceutical market the range of drugs based on doxycycline hyclate is represented only by solid oral dosage forms - tablets and capsules for immediate release, but in the global pharmaceutical market there are additional dosage forms that provide parenteral delivery of doxycycline and oral forms. suspensions, syrups, dispersed tablets and delayed-release dosage forms – tablets, capsules and granules, which are the basis for the development of domestic drugs based on doxycycline. Development of new dosage forms with modified DH, such as implants, aerosols, lyophilisate for solution for injection, development of new manufacturing technologies, selection of excipients and delivery systems can improve the pharmacological action of antibiotics by reducing the dose and frequency of administration, prolonged or controlled programming. , and expanding the range of therapeutic action. Doxycycline is promising in pharmaceutical practice for the treatment of COVID-19, both due to its ability to inhibit matrix metalloproteinases (MMPs) and antiviral activity, especially against Mycoplasma pneumoniae, which is a secondary bacterial cause of pneumonia during the COVID-19 pandemic.

Novel, selective, facile, and precise spectroscopic approaches were validated to determine nilotinib hydrochloride, a tyrosine kinase inhibitor used to treat patients with chronic myeloid leukemia. These approaches depend on the reaction of the tertiary amine group of nilotinib with erythrosine B in the Britton–Robinson buffer at pH 4. Method I, depends on measuring the absorbance of the formed complex at 551 nm. The absorbance concentration plot showed linearity over the concentration range of 1.0 to 9.0 μg/ml. Method II, involved the measurement of the quenching of the native fluorescence of erythrosine B by adding nilotinib in an acidic medium. The fluorescence quenching of erythrosine B was measured at 549 nm after excitation at 528 nm. This approach showed excellent linearity in the concentration range of 0.04 to 0.7 μg/ml. The limit of detection values for Method I and Method II were 0.225 and 0.008 μg/ml, respectively, while the limit of quantitation values for Method I and Method II were 0.68 and 0.026 μg/ml, respectively. To get the optimal conditions, factors that may affect the formation of the ion‐pairing complex were thoroughly examined. The two approaches were carefully validated following the International Conference of Harmonization (ICH Q2R1) guidelines. Statistical assessment of the results achieved using the suggested and previously published comparison approaches showed no significant difference. The approaches were successful in determining nilotinib in a pharmaceutical dosage form as well as spiked human plasma samples. The eco‐friendly properties of the methods were evaluated by three different tools. [ABSTRACT FROM AUTHOR]

Radiodermatitis (RD) is a common side effect of radiation, seen as serious skin reactions such as erythema, edema, dermatitis, desquamation, necrosis. It can be seen in 2 different ways as acute RD that occurs approximately 90 days after the application of radiation and chronic RD that can occur after a longer period of time. Relief of symptoms is based on clinician’s experience in accurately assessing the risk of developing RD and estimating the extent of skin damage. The diagnosis of RD is mainly based on clinical findings and many diagnostic tools are available for this purpose. Different scoring systems are used for grading RD symptoms. RD occurs in approximately 95% of cancer patients undergoing radiotherapy (RT). Skin reactions such as moist desquamation, necrosis and ulceration caused by radiation application significantly reduce the compliance of patients to RT and cause interruption of treatment protocols. Therefore, many studies have been conducted for the prevention and treatment of RD. It is recommended to clean the skin that shows signs of RD during treatment with soap and water. Although the use of corticosteroids and silver sulfadiazine is common among the treatment options, there are also topical products that are not considered as drugs. Ointment, patch, aerosol, emulsion, emulgel, hydrogel, and paste are topical dosage forms studied or commercially available to treat RD. In this review, general information about RD was given and possible treatment options were compiled; In this regard, articles and patents on different dosage forms were examined. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study is to determine the non-pediatric dosage form (NPDF) of medications used in the general pediatric service. Material and Methods: This retrospective, descriptive study was carried out by examining the archive documents of patients under the age of 12 who had received medication therapy in the last 6 months in the general pediatric service of a university hospital. Results: The median age [interquartile range (IQR)] of the 238 patients included in the study was 2 years (1-6), and 130 (54.6%) of them were female. The most common diagnoses in patients are diabetes mellitus (10%), upper respiratory tract infections (8.4%) and pneumonia (6.9%), NPDF medications use was detected in 96 (40.3%) of the patients. Out of a total of 729 medications used by the patients, 106 (14.5%) were classified as NPDF medications. The most commonly used active ingredients among NPDF medications are allopurinol (6.3%), captopril (5%), phenobarbital (5%), furosemide (4.2%) and azathioprine (4.2%). NPDF medications were most frequently included in the cardiovascular system (26%), the digestive system (23%) and the nervous system (16%). Of the NPDF drugs, 57% were used in the 0-2 age group, 24% in the 3- 6 age group, and 19% in the 7-12 age group. There was no statistically significant difference in the distribution of NPDF drugs among patients in these age groups (p>0.05). Conclusion: It has been observed that NPDF medications are widely used in patients hospitalized in the general pediatric service. Especially the medications in the cardiovascular system group are drugs that are often used by manipulating their dosage forms. Evidence-based guidelines for the manipulation of medications are needed to improve the safety of pediatric medication therapy. [ABSTRACT FROM AUTHOR]

The aim of the work was to create an approach for the development of HPLC methods for the determination of meldonium in dosage forms with the usage of salts of chaotropic anions in mobile phases. Material and methods. Analytical equipment: Shimadzu UPLC system LC-40 PDA; Shimadzu Nexera-i LC-2040C 3D-Plus, controlled by software Lab Solution version 5.97, electronic laboratory balance RAD WAG AS 200/C, pH-meter I-160MI. Meldonium dihydrate (purity 99.3 %) was purchased from Sigma-Aldrich (Switzerland), and Vasopro capsules 500 mg were purchased from a local pharmacy. Chromatographic conditions: Agilent Zorbax C-18 SB 150×4.6 mm×3.5 μm column was used (Agilent Technologies, USA). Mobile phases: 1) 0.25 % KPF6 w/v - 0.1 % v/v 85 % H3PO4 95 % - 5 % ACN; 2) 0.3 % bis-(trifluoromethane)sulfonimide lithium salt 97 % w/v - 0.1 % v/v 85 % H3PO4 80 % - 20 % acetonitrile. Flow rate - 1 mL/min, T=32 °C, detection UV=at 4 channels - 190 nm, 195 nm, 200 nm, 205 nm. Results and discussion. We have proposed two approaches using two different salts of chaotropic anions - potassium hexafluorophosphate and bis-(trifluoromethane)sulfonimide lithium salt - for the HPLC method development. The chaotropic effects of these anions toward meldonium strongly influenced the analyte migratory behaviour. Both mobile phases involved, in addition to the use of a chaotrope, also the use of acetonitrile and pH adjustment with 0.1 % v/v 85 % H3PO4 solution. The detection wavelength (190 nm, 195 nm, 200 nm, 205 nm) was selected experimentally. The results were obtained for 8 concepts. Parameters of the chromatographic system confirm the conclusions and results of this investigation for the influence of chaotropic salts on N-containing molecules in an acidic pH medium, by increasing their retentivity and improving peak shape and uniformity homogeneity, even on the column without end-capping and base-deactivating. Validation of the analytical method was carried out following the requirements of SPhU. Conclusions. HPLC methods for the determination of meldonium in dosage forms have been developed, using positive impacts of chaotropic salts on the molecules containing N-atoms in their molecule on their retentions and peak symmetries on the chromatogram. The validation of the analytical methods showed their suitability for pharmaceutical analysis. [ABSTRACT FROM AUTHOR]

Introduction: As an interdisciplinary field, drug delivery relies on the developments of modern science and technology. Correspondingly, how to upgrade the traditional dosage forms for a more efficacious, safer, and convenient drug delivery poses a continuous challenge to researchers.Methods, results and discussion: In this study, a proof-of-concept demonstration was conducted to convert a popular traditional liquid dosage form (a commercial oral compound solution prepared from an intermediate licorice fluidextract) into a solid dosage form. The oral commercial solution was successfully encapsulated into the core–shell nanohybrids, and the ethanol in the oral solution was removed. The SEM and TEM evaluations showed that the prepared nanofibers had linear morphologies without any discerned spindles or beads and an obvious core–shell nanostructure. The FTIR and XRD results verified that the active ingredients in the commercial solution were compatible with the polymeric matrices and were presented in the core section in an amorphous state. Three different types of methods were developed, and the fast dissolution of the electrospun core–shell nanofibers was verified.Conclusion: Coaxial electrospinning can act as a nano pharmaceutical technique to upgrade the traditional oral solution into fast-dissolving solid drug delivery films to retain the advantages of the liquid dosage forms and the solid dosage forms.

Regardless of age, diabetes is one of the most prevalent diseases that people deal with. There are several various types of diabetes medications available, but metformin is the most popular. This primary purpose of this article is to provide a comparison of various dosage forms used for treatment of diabetes. However, oral insulin therapy has a number of potential advantages and would be practical for patients. The study and development of oral insulin is a fascinating subject in the study of diabetes. We are making progress toward creating an insulin formulation that won't require injections before to meals, which will enhance the quality of life and mental health of more than nine million type 1 diabetics worldwide. Despite the fact that it is only currently available in injectable form, insulin is nevertheless crucial for the management of diabetes. The ultimate goal for improving simplicity of use and providing therapeutic benefits stemming from its direct distribution to the portal vein and liver is the development of an oral insulin. [ABSTRACT FROM AUTHOR]

Tobacco is one of the most planted products in worldwide and the whole Nicotiana tabacum L. plant, its leaves, flowers, seeds or roots, and individual chemical compounds have medicinal uses such as as sedative, diuretic, or expectorant. From the past to the present, tobacco has been used in various dosage forms including oral/transdermal films, sublingual tablets, mouth/nasal spray, and inhaler. In addition, Tobacco is a very valuable plant with uses in medicine and bioengineering applications. In this review, it was aimed to give information about the tobacco plant and its medicinal uses and also the pharmaceutical dosage forms as well as novel delivery systems of nicotine compound of tobacco via comprehensively search method of the literature by using Pubmed, ScienceDirect, ISI Web of Knowledge, and Google Scholar databases for articles published in peer-reviewed journals from mostly 2016 to 2021. It is also aimed to draw attention to the pharmaceutical use of tobacco plant instead of potential harmful uses. In conclusion, there is need to be carried out new studies to enlighten the exact mechanisms of tobacco and its major compound of nicotine on other diseases such as schizophrenia, Parkinson's disease, and prose memory and attention than smoking cessation therapy and evaluate its safety and develop more effective novel pharmaceutical dosage forms. [ABSTRACT FROM AUTHOR]

A medicine can be administered in varied dosage forms which are having different environmental impacts. Two dosage forms of paracetamol (tablet and syrup) have the same function but are prepared and packaged differently, meaning that the environmental impacts arising out of their production will be of different magnitude. This study utilizes the life cycle assessment technique to find and compare the environmental impacts of two dosage forms of the paracetamol. Life cycle assessment software 'GaBi' v 8.0 has been utilized to carry out this study. Midpoint and endpoint impact assessment methods from 'ReCiPe' impact assessment method are used to carry out the life cycle impact assessment. The midpoint impact assessment results show that syrup production has 90% contribution in climate change impact category and more than 50% environment impact in fine particulate matter formation, fossil depletion, freshwater consumption, freshwater eutrophication, freshwater ecotoxicity, ionizing radiation, photochemical ozone formation, stratospheric ozone depletion, and terrestrial ecotoxicity midpoint impact categories. Tablet production has major impacts in 3 midpoint impact categories that are human toxicity, ionizing radiation, and metal depletion. Syrup production has major impacts (more than 70%) in 8 out of the 11 endpoint impact categories considered, while tablet production has a major impact in 3 impact categories that are human toxicity and ionizing radiation endpoint impact categories. Syrup production has a visibly higher impact in more number of midpoint as well as endpoint impact categories considered. The environmental hotspot is, however, dependent on the individual impact categories. The results of the study add to the existing knowledge of environmental sustainability assessment in the pharmaceutical sector and will benefit the environmental managers to better manage the environmental sustainability of pharmaceutical products. [ABSTRACT FROM AUTHOR]

Text mining (TM) applications in the field of biomedicine are gaining great interest. TM tools can facilitate formulation development by analyzing textual information from patent databases, scientific articles, summary of products characteristics, etc. The aim of this study was to utilize TM tools to perform qualitative analysis of paracetamol (PAR) and ibuprofen (IBU) formulations, in terms of identifying and evaluating the presence of excipients specific to the active pharmaceutical ingredient (API) and/or dosage form. A total of 152 products were analyzed. Web-scraping was used to retrieve the data, and Python-based open-source software Orange 3.31.1 was used for TM and statistical analysis (ANOVA) of the obtained results. The majority of marketed products for both APIs were tablets. The predominant excipients in all tablet formulations were povidone, starch, microcrystalline cellulose and hypromellose. Povidone, stearic acid, potassium sorbate, maize starch and pregelatinized starch occurred more frequently in PAR tablets. On the other hand, titanium dioxide, lactose, shellac, sucrose and ammonium hydroxide were specific to IBU tablets. PAR oral suspensions more frequently contained dispersible cellulose; liquid sorbitol; methyl and propyl parahydroxybenzoate, glycerol and acesulfame potassium. Specific excipients in other PAR dosage forms, such as effervescent tablets, hard capsules, oral powders, solutions and suspensions, as well as IBU gels and soft capsules, were also evaluated.

Objectives: The study objective of the present study was to screen the dosage of matrix material and clarify the safety evaluation of Hataagqi-19 hydrogel patch. Methods: Single factor and orthogonal experiments were used to screen, and the best matrix ratio was screened out with peel strength, peel ability, viscosity, spread ability, uniformity, as evaluation indicators. Long term toxicity test was carried out in SD rats in order to test general conditions such as: body weight, food intake, electrocardiogram, blood, urine, and biochemical indicators, organ coefficients and histopathological changes. Moreover, skin allergic reaction tests were done to observe the allergic responce. Results: The ratio of the gel patch matrix is NP-700: aluminum glycolate: glycerol: carbomer = 6: 0.35: 35: 0.40; the ratio of azone and propylene glycol is 1: 1, and the total penetration enhancer dosage is 5%. Hataagqi-19 preparation had no obvious long-term toxicity or skin allergies. Conclusions: The Hataagqi-19 hydrogel patch prepared with the best ratio and transdermal agent showed good performance and safety. Furthermore, we did not observed toxic side effects, and the preparation process is feasible and reliable.