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Cosmeceuticals are a branch of cosmetic products that forms a bridge between cosmetic and drug products. It is a fast-growing branch of the cosmetic industry, especially after the introduction of novel formulation and manufacturing techniques such as lipid nanoparticles (LNPs). These LNPs-based cosmeceutical products offer several advantages such as enhanced bioavailability of cosmeceutical active ingredients (CAIs), improved aesthetic appeal, and stability of the final products. However, the use of these LNPs may raise some concerns about possible side effects of these LNPs and potential hazards to the customer's health. Accordingly, an update that focuses on the use of this important branch of nanoparticles is necessary since most review papers are dealing with all types of nanocarriers in the same review with little focus on LNPs. Therefore, in the current review, a detailed analysis of the advantages and disadvantages of LNPs in this field was highlighted, to emphasize the LNPs-based cosmeceuticals on the market, as well as the potential risk posed by LNPs on exposure and recently introduced regulatory guidelines to address them. In addition, if these products can be a candidate as products that meet the sustainable development goals raised by the UN are discussed.

The purpose of this questionnaire-based cross-sectional study was to investigate the knowledge, perceptions, and attitudes regarding halal pharmaceuticals among sharia practitioners in Palestine. A total of 420 sharia practitioners with different educational levels were included. This was a cross-sectional study conducted between March and July 2021 with the use of a standardized, self-administered questionnaire. Volunteers were selected throughout Palestine using a systematic random selection approach. The data were summarized using descriptive statistics (mean, standard deviation, frequency, percentage, median, and interquartile range). The Chi-square and Fisher's exact tests were used to examine the relationship between demographic factors and the knowledge, attitude, and perception scores, respectively. The results revealed that sharia practitioners have relatively good and positive knowledge toward halal pharmaceuticals. The main knowledge of most halal pharmaceuticals was about 50.2%, yet there is still significant latitude in their knowledge of a few issues. The main attitude and perception score was about 96.4%. The results showed a positive and fair correlation between knowledge and attitude (r = 0.153, P 0.001) and also between knowledge and perception (r = 0.341, P 0.001). In addition, there is a good correlation between attitude and perception (r = 0.681, P 0.001). The study concluded that better knowledge of halal pharmaceuticals is associated with positive perceptions and behaviors. The government, pharmaceutical manufacturers, religious scholars, and health care professionals should collaborate to achieve the goal of using halal medications.

a series of benzodioxole compounds were synthesized and evaluated for their cytotoxic activity against cervical (Hela), colorectal (Caco-2), and liver (Hep3B) cancer cell lines. Compounds 5a, 5b, 6a, 6b, 7a and 7b showed very weak or negligible anticancer activity with IC50 3.94-9.12 mM. On the contrary, carboxamide containing compounds 2a and 2b showed anticancer activity. Both 2a and 2b reduced Hep3B secretions of α-fetoprotein (α-FP) to 1625.8 ng/ml and 2340 ng/ml, respectively, compared to 2519.17 ng/ml in untreated cells. The results also showed that compound 2a has potent anticancer activity against Hep3B cancer cell line. Furthermore, in cell cycle analysis, compound 2a induced arrest in the G2-M phase in value of 8.07% that was very close to the activity of doxorubicin (7.4%). These results indicate that compound 2a has a potent and promising antitumor activity. However, benzodiazepine derivatives (7a and 7b) showed moderate antioxidant activity with IC50 values of 39.85 and 79.95 μM, respectively compared with the potent antioxidant agent Trolox (IC50 = 7.72 μM).

This study aimed to develop a topical emulgel formulation from olive oil and lemongrass (LG) extracts and to evaluate its

Pharmaceutical film coating is considered a key part in the production of solid pharmaceutical dosage forms since it gives superior organoleptic properties products. In addition, it can improve the physical and chemical stability of dosage forms, and modify the release characteristics of the drug. Several troubleshooting problems such as twinning mottling, chipping, etc., may arise during or after or even during the shelf life of the film coated dosage forms. These troubleshooting problems may be due to tablet core faults, coating formulation faults and/or coating process faults. These problems must be overcome to avoid unnecessary product problems. Film coating as well as other parts of the pharmaceutical technology is subjecting to continuous innovation. The innovation may be at different levels including pharmaceutical excipients, processes, software, guidelines and equipment. In fact, of particular note is the growing interest in process analytical technology, quality by design, continuous coating processing and the inclusion of new ready for use coating formulations. In this review, we tried to explore and discuss the status of pharmaceutical film coating, the challenges that face this manufacturing process and the latest technological advances in this important manufacturing process.

The emergence of resistance for antipedicular agents and the need of potent acetylcholinesterase (AChE) therapeutics for the treatment of a neurodegenerative disorder such as Alzheimer disease has led researchers to the exploration of new therapeutic alternatives such as natural volatile oils. Therefore, the current investigation aimed to identify the components of Satureja capitata L. volatile oil (VO), and examine the VO anticholinesterase, and antipedicular activities. The plant phytoconstituents were identified using Gas chromatography mass spectrometry (GC-MS) method, while the anticholinesterase activity was determined against butyryl- and acetyl-cholinesterase using Ellman’s method. In addition, antipedicular activity was established using the diffusion method. The obtained GC-MS results identified 16 compounds in S. capitata VO with the major constituents being carvacrol, γ-terpinene, and p-cymene. Anticholinesterase analysis showed a marked inhibition potential against acetyl- and butyryl-cholinesterase enzymes with half maximal inhibitory concentration (IC50) values of 28.24±0.97 μg/ml and 92.31±1.22 μg/ml, respectively in comparison with the reference compound galantamine, which has IC50 values against the same enzymes of 5.21±0.07 μg/ml and 10.33±0.37 μg/ml, respectively. In addition, the VO, at a concentration of 20%, was effective against head lice, similar to benzyl benzoate, which resulted in 100% mortality. In addition, the VO completely inhibited the emergence of lice nits after 6 and 14 days. On the basis of the obtained results, S. capitata VO is a promising natural alternative to synthetic antipedicular and anticholinesterase drugs, which can be employed in drug development, and may lead to new candidates against head lice and neurodegenerative diseases.

Ivermectin is a gamma amino butyric acid (GABA)-gated-Cl-channels modulator, which has been used orally in the treatment of numerous parasitic infections. The study target was to set up a stable, efficient 0.2% w/v ivermectin solution, which would be achieved from pure ivermectin powder as a source of the active pharmaceutical ingredient. Several trial solutions were prepared. The most fitting solution, with respect to its organoleptic properties, was chosen for additional investigation, including the solution's physical stability. Two storage conditions, room temperature (25°C, 60% relative humidity) and accelerated stability chambers (40°C, 75% relative humidity) were subjected to guarantee the physical stability of the solution through the 3-month study period. Furthermore, other quality tests were assessed, (e.g., pH, assay, organoleptic properties, microbial contamination) for the same latter period. Quantification of ivermectin was validated utilizing a high-performance liquid chromatography analytical method. The adopted solution showed accepted organoleptic properties. The pH of the solutions was approximately 5 and remained unchanged during the stability study. The mean percent of remained ivermectin solution was close to 97% ± 0.2 at room temperature. Ivermectin solution was additionally tested for microbial contamination, and it was free from any microbial contamination (E. coli bacteria: Negative/mL, yeast and molds count:10 cfu/mL and aerobic microbial count results in10 cfu/mL). The adopted formula showed the best physical stability within at least the three months of storage at both room and accelerated conditions. Ivermectin solution was successfully prepared from its pure powder. This formula provides a stable, efficient oral solution for those who suffer from swallowing difficulties or patients in the intensive care unit who cannot receive the medication in a solid dosage form. Using the suggested formula, community and hospital pharmacists could prepare an effective, high quality ivermectin oral solution using pure ivermectin powder.

Background: Rutin is available on the market as a topical formulation for the treatment of several conditions, such as internal bleeding, hemorrhoids, and varicose veins. However, these gels have low solubility and limited bioavailability due to their decreased lipid solubility. Objective: In this study, we aimed to synthesize potentially novel lipophilic rutin prodrugs. The suggested library of these rutin prodrugs includes changing the solubility profile to facilitate rutin transport across biological barriers, thereby improving drug delivery through topical application. Methods: Six rutin derivatives were synthesized based on the ester prodrug strategy. The synthesized compounds were formulated as topical ointments, and their permeability via Franz diffusion was measured. An ultraviolet (UV) analytical method was developed in our laboratories to quantify rutin derivatives both as raw materials and in final dosage forms. The analytical method was then validated. Results: The results of Franz diffusion analyses showed that transdermal permeability increased by 10_Fo.jpgl height=""d for decaacetylated rutin compared to the other esterified rutins. A simple analytical method for the analysis of the formulated rutin ester was developed and validated. Moreover, the formulated ointment of decaacetylated rutin in our research laboratory was found to be stable under stability accelerated conditions. Synthesis of potentially more lipophilic compounds would yield novel rutin prodrugs suitable for topical formulation. Conclusion: This project provides a synthetic approach for many similar natural products. The research idea and strategy followed in this research project could be adapted by pharmaceutical and herbal establishments.

Background Electronic tongue (ET) is a well-established technology that is used to detect the taste of a food or a medicinal product and to differentiate between different products based on their tastes. In addition, it can be used to monitor environmental parameters and biochemical and biological processes. Purpose This study aims to assess any correlation between the results of pharmacopeial quality control (ie, assay, impurities, and dissolution, etc) and ET analysis for reconstituted cefdinir (CR) suspension over 10 days (ie, shelf-life). Methods The reconstituted CR suspension was tested for several quality attributes such as dissolution behavior, pH, assay, related substances, and microbial contamination. An HPLC analytical method was verified and then used for chemical analysis. The taste of CR reconstituted suspension was followed over 10 days and was then compared with the quality control results. Moreover, Pearson's correlation test was used to find a correlation between chemical analysis results and ET results. Results Pearson's test of correlation showed a significant correlation (p-value

Rowa’ Al Ramahi,1 Abdel Naser Zaid,1 Nawaf Abu-Khalaf21Pharmacy Department, Faculty of Medicine and Health Sciences, An-Najah National University, Nablus, Palestine; 2Department of Agricultural Biotechnology, College of Agricultural Sciences and Technology, Palestine Technical University-Kadoorie (PTUK), Tulkarm, PalestineBackground: Electronic tongue (ET) is a simple device that may have some applications in the medical field as an alternative tool to traditional diagnostic methods. The aim of this study is to evaluate the potential use and accuracy of ET in the diagnosis of certain bacterial infections.Methods: An alpha-Astree ET was used for the detection of known bacterial strains Staphylococcus aureus (ATCC 25923), Escherichia coli (ATCC 25922), and Pseudomonas aeruginosa (ATCC 27853) which were tested at three-time intervals; 15, 18, and 24 hrs (hr). This was used to build a qualitative and quantitative mathematical model to detect the presence of bacteria at the earliest possible time. When the model is robust, new unknown samples were tested after 15 hrs of bacterial growth. Samples were identified using multivariate data analysis techniques.Results: Principal Component Analysis (PCA) scores showed that ET can distinguish between the three bacteria at different times 15, 18, and 24 hrs using different sensors. In the PCA scores plots, the discrimination index was 83% at 15 hrs, 88% at 18 hrs, and 96% at 24 hrs, the variances explained by the two principal components were 84%, 99%, and 97% at 15, 18, and 24 hrs, respectively. Fifteen hours was the earliest time at which the bacteria could be detected. Then six samples of E.coli (as unknown samples) were tested after 15 hrs of inoculation, the two discrimination function explained about 100% of the variance (ie, 79.7+22.3%) and all unknown samples were identified as E.coli.Conclusion: ET could differentiate between types of bacteria in addition to identifying unknown bacterial cultures (E. coli) at times shorter than that required in the current culture-based methods (24–48 hrs), this could be of a great value in early diagnosis of life-threatening infections.Keywords: electronic tongue, sensors, bacteria, diagnosis

Background Electronic tongue (ET) is a simple device that may have some applications in the medical field as an alternative tool to traditional diagnostic methods. The aim of this study is to evaluate the potential use and accuracy of ET in the diagnosis of certain bacterial infections. Methods An alpha-Astree ET was used for the detection of known bacterial strains Staphylococcus aureus (ATCC 25923), Escherichia coli (ATCC 25922), and Pseudomonas aeruginosa (ATCC 27853) which were tested at three-time intervals; 15, 18, and 24 hrs (hr). This was used to build a qualitative and quantitative mathematical model to detect the presence of bacteria at the earliest possible time. When the model is robust, new unknown samples were tested after 15 hrs of bacterial growth. Samples were identified using multivariate data analysis techniques. Results Principal Component Analysis (PCA) scores showed that ET can distinguish between the three bacteria at different times 15, 18, and 24 hrs using different sensors. In the PCA scores plots, the discrimination index was 83% at 15 hrs, 88% at 18 hrs, and 96% at 24 hrs, the variances explained by the two principal components were 84%, 99%, and 97% at 15, 18, and 24 hrs, respectively. Fifteen hours was the earliest time at which the bacteria could be detected. Then six samples of E.coli (as unknown samples) were tested after 15 hrs of inoculation, the two discrimination function explained about 100% of the variance (ie, 79.7+22.3%) and all unknown samples were identified as E.coli. Conclusion ET could differentiate between types of bacteria in addition to identifying unknown bacterial cultures (E. coli) at times shorter than that required in the current culture-based methods (24-48 hrs), this could be of a great value in early diagnosis of life-threatening infections.

Background: Origanum syriacum (O. syriacum) is a very popular edible and medicinal plant in the East Mediterranean countries. The aims of the current study were to use microwave-ultrasonic assisted hydrodistillation (MUAHD) method to produce essential oils (EOs) from wild O. syriacum samples collected from four different geographical areas in The West Bank using water as a solvent, determine the phytochemical profile using GC-MS analysis and assess their antioxidant and antibacterial potential. Methods: Essential oils were produced using MUAHD method. Gas chromatography coupled with mass spectrometer detector (GC-MS) was employed for phytochemical analysis. In vitro antibacterial and antioxidant potentials were carried out. Results: Differences in the EOs yield among the four Origanum samples were observed. GC-MS analysis of EOs revealed terpenes as the major constituents; monoterpenes (22–56%) and oxygenated monoterpenes (28–57%). Thymol, α-terpinene and carvacrol represent the bulk of all phytochemicals detected by GC-MS analysis. γ-Terpinene-rich EOs, exhibited the highest antioxidant capacity. Thymol-rich EOs were found to be most effective against Staphylococcus aureus and Methicillin-Resistant Staphylococcus aureus (MRSA) (MIC 390 µg/mL). Alpha-terpinene-rich chemotype EOs exhibited the highest inhibitory effect of Pseudomonas aeruginosa (MIC of 1560 µg/mL). Interestingly, γ-terpinene-rich EO showed promising antibacterial properties against Enterococcus faecium (MIC 97 µg/mL) and a powerful anti-oxidant effect (91.45% ±2.30). Conclusion: The current study supports the use of MUAHD as a time-saving, cost-effective, environment-friendly method for production of high quality O. syriacum EO for potential use as a natural complementary treatment and in the prevention of bacterial infections as well as oxidation by free radicals without compromising the quantity. Keywords: Antibacterial, Antioxidant, Essential oil, GC-MS, Microwave-ultrasonic assisted hydrodistillation, Origanum syriacum

Background Food may affect the oral absorption of drugs. Purpose The aim of the present study was to investigate the influence of food on the oral absorption of clarithromycin by evaluating the effect of media parameters, such as pH, bile secretions and food composition, on the release of the drug from immediate release tablets, using in vitro and in silico assessments. Method The solubility, disintegration and dissolution profiles of clarithromycin 500 mg immediate release tablets in compendial media with/without the addition of a homogenized FDA meal as well as in biorelevant simulated intestinal media mimicking fasting and fed conditions were determined. These in vitro data were input to GastroPlus™, which was used for developing a physiological absorption model capable of anticipating the effect of food on clarithromycin absorption. Level A in vitro-in vivo linear correlations were established using a mechanistic absorption modelling based deconvolution approach. Results The pH of the media has a profound effect on clarithromycin solubility, tablet disintegration and drug release. Clarithromycin has lower solubility in biorelevant media compared with other media, due to complex formation with bile salts. Clarithromycin tablets exhibited prolonged disintegration times and reduced dissolution rates in the presence of the standard FDA meal. The simulation model predicted no significant food effect on the oral bioavailability of clarithromycin. The developed IVIVC model considered SIF, acetate buffer and FaSSIF media to be the most relevant from the physiological standpoint. Conclusion The intake of a standard FDA meal may have no significant effect on the oral bioavailability of clarithromycin immediate release tablet.

Lavandula dentata L. and Origanum syriacum L. essential oils have numerous health benefits and properties, such as possessing common components with a variant degree of depressive actions in the central nervous system. We investigated the depressive property of these oils on AMPA receptors, which are responsible for most of the fast-excitatory neurotransmission in the CNS and play a critical role in synaptic plasticity. Since excessive activation of AMPARs has been linked to neurotoxicity leading to various pathologies, we hypothesize that these oils have a neuroprotective role by acting directly on the kinetics of AMPARs. Using Gas Chromatography-Mass Spectrometry (GC/MS) and patch-clamp electrophysiology, the essential oils of L. dentata flowers and O. syriacum leaves were characterized and the whole cell currents were measured with and without the administration of the oils onto HEK293 cells. The current study results showed that the biophysical properties of AMPA receptor subunits showed a decrease in desensitization rate of GluA1 and GluA2 homomers, using O. syriacum, while administering L. dentata oil decreased the desensitization rate of GluA1 and GluA2 homomers, as well as GluA1/2 heteromers. As for the deactivation rate, both oils slowed the deactivation kinetics of all AMPA receptor subunits. Intriguingly, between the two oils, the effect of desensitization and deactivation was of a greater significance for L. dentata oil than O. syriacum. Our data suggest that the two oils contain components that are essential to identify, as those active components underlie the oils’ neuronal depressive properties reported, and to extract them to synthesize a potent neuroprotective drug to treat neurological diseases potentially.

Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor that is used orally in conjunction with diet and exercise to control sugar levels in type 2 Diabetes Mellitus patients. This study aimed to extemporaneously prepare SiP solution (1% w/v) using pure Sitagliptin phosphate (SiP) powder and assess its stability according to pharmaceutical regulatory guidelines. Four SiP solutions, coded T1, T2, T3, and T4, were extemporaneously prepared using pure SiP powder as a source of API. The most suitable one, in terms of general organoleptic properties, was selected for further investigations, including stability studies. For this last purpose, samples of the T4 solution were kept under two storage conditions, room temperature (25˚C and 60% Relative Humidity) and accelerated stability conditions (40˚C and 75% Relative Humidity). Assay, pH, organoleptic properties, related substances, and microbial contamination were evaluated for 4 consecutive weeks. A High-Performance Liquid Chromatography (HPLC) analytical method was developed and validated to be used for the analysis and quantification of SiP in selected solution formulation. The adopted formula had a pH on the average of 3 to 4. During the stability tests, all pH values remained constant. Furthermore, after 4 weeks of storage under both conditions, the SiP concentration was close to 100%. A stable SiP extemporaneous solution was successfully prepared using pure SiP powder. Patients with swallowing problems who use feeding tubes and are unable to take oral solid dosage forms may benefit from this research. Community pharmacists can prepare the solution using sitagliptin powder as the source of the active ingredient.

Maintaining safety and efficacy is an important task when splitting a tablet. This Pharmacy practice affords the patient with unavailable required dose, easy swallowing, and cost-saving measure. To access the role of formulation variables on the weight uniformity test of halves tablets. Uncoated and coated placebo tablets were prepared using wet granulation technique. After compression, hardness, disintegration time, friability and weight variation were evaluated according to the USP test. Both coated and uncoated tablets were dived and the obtained halves were weighed and the uniformity of halves was assessed for each kind of tablets. Despite the hardness, size, tablet shape (oval, disc, capsule), all of them passed the splitting test except for the disc shape which showed %RSD higher than 6%. However, hardness and the coating had a generally positive trend on tablet breaking since they gave low% RSD. These findings suggest that the disc shape particle is not suitable for breaking. In addition, film coating, as well as high hardness may give better uniformity of the obtained halves, since a decrease in the calculated %RSD was observed.

Introduction Protection of skin from wrinkles and pigmentation changes are among the most common challenges for modern science and cosmetics. These are caused by unusual disruption of connective tissue, the formation of free radicals and ultraviolet radiation. The current research is the first study to compare the phytoconstituents, antioxidant, sun protection factor (SPF) and skin wrinkles prevention effects using four different solvents fractions for the traditional plant Alkanna tinctoria (L.) root bark. Methods Qualitative and quantitative phytoconstituents, antioxidant activity, sun protection factor and anti-elastase (skin wrinkles prevention) effects were assessed using standard pharmaceutical and cosmeceuticals assays. Results The results of antioxidant, anti-elastase and sun protection factor activities were the highest for the acetone fraction with IC50 8.51 ± 1.94 μg/ml, 10.02 ± 0.3 μg/ml and SPF value of 6.38, respectively. However, these results may occur due to its high contents of flavonoids and phenols which were 26.55 ± 1.6 mg of QUE/g and 59.48 ± 0.56 mg of GAE/g plant acetone fraction, respectively. Conclusion The acetone fraction of A. tinctoria root bark could be a promising candidate for cosmetic and pharmaceutical preparations due to the potential antioxidant, anti-elastase enzyme and sun protection activities.

The emergence of pathogenic microbes with increased resistance to established antibiotics provides a major incentive for the discovery of new antimicrobial agents. Herbals may provide valuable solutions for this global problem. In addition, the replacement of harmful synthetic antioxidants with natural ones may prevent various serious diseases. The present investigation describes for the first time the antioxidant and antimicrobial activities of the aqueous and organic extracts of Helichrysum sanguineum, Moluccella spinosa and Styrax officinalis plants aerial parts. The free radical scavenging activity was estimated using the 2,2-diphenyl-1-picrylhydrazyl method, while the antimicrobial activity was evaluated against selected microbial strains from American Type Culture Collection and clinical isolates such as Shigella sonnie, Staphylococcus aureus, Enterococcuss feacium, Escherichia coli, Pseudomonas aeruginosa, Candida albicans, Epidermophyton floccosum and Methicillin Resistant Staphylococcus aureus (MRSA) using minimum inhibitory concentration assay. A mixture of phytochemical compounds was found in all of the studied plants extracts which also showed remarkable potentials of antioxidant and antimicrobial activities. The current study provides initial data that justify the use and importance of these plants in the Palestinian traditional medicine. In addition, it provides evidence that the aqueous and organic extracts of H. sanguineum, M. spinosa and S. officinalis exhibited interesting antioxidant activity comparing with Trolox. Furthermore, the organic extract of H. sanguineum strongly exhibited bacterial growth of S. aureus, E. faecium and MRSA which suggested to be used as antibiotic alternative or as sufficient natural food preservative.

Background Many generic pharmaceutical products are currently available on the market place worldwide. Recently, there is a growing concern on the quality and efficacy of generic products. However, health care professionals such as physicians and pharmacists are in difficult situations to choose among alternatives. Purpose The aim of this study is to assess the effectiveness of the in silico technique (Gastro Plus®) in the biowaiver study and whether similarity and dissimilarity factors (f 2 and f 1 respectively) are effective in this regard. Method The concentration of amlodipine in the sample was calculated by comparing the absorbance of the sample with that of a previously prepared amlodipine standard solution using validated HPLC method. The dissolution profile for each product (brand and generics) was constructed. The similarity (f2) and dissimilarity (f 1) factors were calculated for the generic product according to equation 1 and 2. GastroPlus™ software (version 9.0, Simulations Plus Inc., Lancaster, CA, USA) was used to predict the absorption profiles of amlodipine from the generic product Amlovasc® and the reference Norvasc®. Conclusion These results may provide a rationale for the interchangeability between the RLD and generic version based on in vitro release profiles in silico technique especially in a lower strength dose drug.

In this study, the in vitro and in vivo interchangeability between generic candesartan 16 mg and the branded formulation was assessed. The in vitro release of these products was conducted in 3 pH media (1.2, 5.0, and 6.8), and similarity factors (f2 ) were calculated. This bioequivalence study was a randomized, 2-period crossover study that included 42 healthy adult male subjects under fasting conditions with a 9-day washout. The pharmacokinetic (PK) parameters AUC0-last , AUC0-∞ , and Cmax , tmax , and the elimination half-life time were assessed based on the plasma concentrations of candesartan, using a newly developed and validated liquid chromatography-tandem mass spectrometry bioanalytical method with acceptable degrees of linearity, sensitivity, precision, and accuracy. The geometric mean (ng·h/mL) of the AUC0-∞ for the test and brand was 1595.49 and 1620.54, respectively, and the Cmax (ng/mL) was 160.91 and 160.88, respectively. The 90%CIs of geometric mean ratios (test-to-reference ratios) were 98.26%, 98.45%, and 99.86% for AUC0-last , AUC0-∞ , and Cmax respectively. These PK parameters lie within the US Food and Drug Administration- and European Medicines Agency-specified bioequivalence limit (80%-125%). Both products were well tolerated by all the subjects. The tested drug product was bioequivalent to the reference drug and had the same safety profile.

Background Sunlight exposure affects all skin types causing skin tanning, burns or even skin cancer. Sunscreens were invented to prevent these outcomes by scattering or absorbing the UV light. Aims This study aimed to verify the effectiveness of Mansur method in SPF measurement and to find out how much reliable the labeled sun protection factor (SPF) value for the products that are imported to Palestine knowing that they are considered as cosmetics and they don't undergo tests by the Ministry Of Health (MOH). Materials In this research, sun protection factor (SPF) was determined for 16 commercially available sunscreen products using Mansur equation which was also validated; moreover sunscreen classification, product phase determination and pH measurement were also done. Results Sun protection factor values were mostly 50, 43.75% of the analyzed samples were close to the labeled SPF, 31.25% were under the labeled value, and 25% SPF value above the labeled value. All samples exhibited a pH close to skin pH. 62% of them were found to be O/W. Cosmetic companies and importers should focus on pediatric sunscreens, since only 12.5% are pediatric sunscreens. Conclusions Ministry Of Health should ask prove about the quality of an SPF value of sunscreens for final registration of these products. More instructions should be available on the label regarding the proper use especially, if they are not water proof.

Introduction: In the last thirty years, interests in searching for plants with potential antimicrobial and antioxidant activities have been increased due to their probable health benefits. This study aimed to investigate the antimicrobial and antioxidant effects of various solvents fractions of Bupleurum lancifolium. Methods: The antioxidant activities of four fractions of Bupleurum lancifolium were assessed by 2,2-diphenyl-1-picrylhydrazyl (DPPH ) scavenging assay, while the antimicrobial activity was assessed by broth microdilution method. The antimicrobial activity of four plant fractions was examined against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, Shigella sonnie and Enterococcus faecium American Type Culture Collection reference strains. Results: The fractionation extraction method succeeds in the assessment of the antibacterial and antioxidant activity of B. lancifolium plant. Hence the methanolic fraction has antioxidant potential with 33.03% of inhibition according to the Trolox antioxidant standard molecule, while n-hexane and methanol fractions showed powerful antibacterial activity against E. faecium and S. sonnie strains with Minimum Inhibitory Concentration (MIC )1.5625 mg/ml for both fractions. Conclusion: All plant fractions have potent antioxidant and antibacterial activities. Further investigations, i.e. isolation, identification, and clinical assessment, of the active compound(s) are needed for the possible formulation of new therapeutic alternatives. [J Complement Med Res 2017; 6(4.000): 401-406]

Purpose The stability of an extemporaneously prepared rosuvastatin suspension stored over 30 days under various storage conditions was evaluated. Methods Rosuvastatin suspension was extemporaneously prepared using commercial rosuvastatin tablets as the source of active pharmaceutical ingredient. The organoleptic properties, dissolution profile, and stability of the formulation were investigated. For the stability studies, samples of the suspension were stored under 2 storage conditions, room temperature (25 °C and 60% relative humidity) and accelerated stability chambers (40 °C and 75% relative humidity). Viscosity, pH, organoleptic properties, and microbial contamination were evaluated according to the approved specifications. High-performance liquid chromatography was used for the analysis and quantification of rosuvastatin in selected samples. Microbiological investigations were also conducted. Results The prepared suspension showed acceptable organoleptic properties. It showed complete release of rosuvastatin within 15 minutes. The pH of the suspension was 9.8, which remained unchanged during the stability studies. The microbiological investigations demonstrated that the preparation was free of any microbial contamination. In addition, the suspension showed stability within at least the period of use of a 100-mL rosuvastatin bottle. Conclusion Extemporaneously prepared rosuvastatin 20-mg/mL suspension was stable for 30 days when stored at room temperature.

Introduction Antibiotic resistance has become a serious global concern, and the discovery of novel antimicrobial herbal constituents may provide valuable solutions to overcome this problem. It is important to identify new sources of natural antioxidants and antimicrobials. The present study describes for the first time the antioxidant, and antibacterial activities of various fractions of Ononis pubescens L., a traditional Palestinian medicinal plant. Methods Antimicrobial activity was tested against selected strains from American Type Culture Collection (ATCC) and clinical isolates including Shigella sonnie, Staphylococcus aureus, Entrococuss feacium, Escherichia coli, Pseudomonas aeruginosa, Methicillin Resistant Staphylococcus aureus (MRSA), Candida albicans and Epidermatophyto flacosum using minimum inhibitory concentration (MIC) assay, while antioxidant activity was analyzed using the 2,2-diphenyl-1-picrylhydrazyl (DPPH) free radical scavenging method. Results A mixture of phytochemicals was found in all of the studied fractions of O. pubescens, which also showed remarkable potential with antioxidant and antimicrobial activities. Conclusion The current study provides initial data that justify the use and importance of Ononis species in Palestinian folkloric medicine. Our results showed that Ononis pubescens n-hexane fraction has powerful antibacterial bioactivity against Staphylococcus aureus, as well as the acetone, n-hexane and methanol fractions which showed excellent potential against Epidermatophyto flacosum fungi, while the acetone fraction showed the highest antioxidant activity among other fractions. Further investigations are needed to identify and characterize these constituents.

Carvedilol poly(d,l)-lactide nanoparticles/microparticles were prepared. The size and morphology of the developed particles were optimized to study the carvedilol release profile by studying the ef...

Background The clinical implications of food-drug interactions may have to be taken seriously into account with oral drugs administration in order to minimize variations in drug bioavailability. Food intake may alter physiological changes in the pH and viscosity of the gastrointestinal lumen, which could affect the oral absorption of drugs. Purpose The aim of the present study was to have an insight on the effect of media parameters: viscosity and pHon the oral absorption of ciprofloxacin HCl from solid formulations using a model food: Corchorus olitorius (Jute) Soup. Methods In vitro disintegration and dissolution rates of ciprofloxacin tablet were evaluated using compendia buffer media in the presence/absence of C. olitorius leaves. These in vitro data were then input to GastroPlus™ to predict ciprofloxacin absorption profiles under fasted and fed states. Results The present study demonstrated the significance of luminal pH and viscosity on the dissolution and disintegration of solid formulations following postprandial ingestion of the viscous soup. The tablets showed prolonged disintegration times and reduced dissolution rates in this soup, which could be attributed to the postprandial elevation in media viscosity and reduced solubility at elevated gastricpH. The predicted model under fed state showed no impact on AUC but prolonged Tmax and a decrease in Cmax. Conclusion Concomitant intake of C. olitorius soup with ciprofloxacin might have negative effect on the rate of drug release from conventional immediate release tablets.

Introduction Several species that belong to the genus Astragalus have been used in Palestinian folk medicine to treat various infectious and non-infectious diseases. This study aimed to assess the phytochemical and biological activities of four Astragalus species growing wild in Jerusalem. Methods Phytochemical screening, estimation of total phenols, flavonoids and tannin contents, as well as antimicrobial and antioxidant activities were investigated for Astragalus aleppicus , Astragalus angustifolius , Astragalus annularis, and Astragalus boeticus . Phytochemical screening, evaluation of total phenols, flavonoids, tannins contents as well as antioxidant properties were investigated by using standard phytochemical methods. Detection of antimicrobial activities for both the aqueous and the methanolic extracts were performed using the broth micro-dilution method. The antimicrobial activities were examined against Staphylococcus aureus , Escherichia coli , Pseudomonas aeruginosa American Type Culture Collection reference strains, as well as against Methicillin Resistant Staphylococcus aureus and Candida albicans clinical isolates. Results A mixture of phytochemical compounds was found in the extracts of all tested Astragalus species. A. boeticus was found to contain high levels of total phenols, flavonoids and tannins with remarkable potential of antioxidant and antimicrobial activities. The current study provides initial data that justify the use and importance of Astragalus species in Palestinian folkloric medicine. Conclusion Our results showed that A. boeticus was superior to the other 3 species in all the conducted tests. In fact, it had the highest polyphenolic content. In addition, its aqueous extract showed the highest antibacterial activity, while the methanolic extract showed the highest antifungal and antioxidant activities. Further studies are needed to identify and characterize these constituents.

Background Electronic tongue (ET) is a well-established technology that is used to detect the taste of a food or a medicinal product and to differentiate between different products based on their tastes. In addition, it can be used to monitor environmental parameters and biochemical and biological processes. Purpose This study aims to assess any correlation between the results of pharmacopeial quality control (ie, assay, impurities, and dissolution, etc) and ET analysis for reconstituted cefdinir (CR) suspension over 10 days (ie, shelf-life). Methods The reconstituted CR suspension was tested for several quality attributes such as dissolution behavior, pH, assay, related substances, and microbial contamination. An HPLC analytical method was verified and then used for chemical analysis. The taste of CR reconstituted suspension was followed over 10 days and was then compared with the quality control results. Moreover, Pearson’s correlation test was used to find a correlation between chemical analysis results and ET results. Results Pearson’s test of correlation showed a significant correlation (p-value

Natural molecules are becoming more accepted choices as cosmetic agents, many products in the market today claim to include natural components. Plants include many substances that could be of a value in the whitening of the skin and working as anti-aging agents. A wide range of articles related to natural skin whitening and anti-aging agents have been reviewed. Many plant-derived and natural molecules have shown to affect melanin synthesis by different mechanisms, examples include Arbutin, Ramulus mori extract, Licorice extract, Glabridin, Liquiritin, Kojic acid, Methyl gentisate, Aloesin, Azelaic acid, Vitamin C, Thioctic acid, Soya bean extracts, Niacinamide, α and β-hydroxy acids, Lactic acid, Chamomile extract, and Ellagic acid. Some of the widely used natural anti-aging products as natural antioxidants, collagen, hyaluronic acid, and coenzyme Q can counteract the effects of reactive oxygen species in skin cells and have anti-aging properties on the skin. It was concluded that many natural products including antioxidants can prevent UV-induced skin damage and have whitening and anti-aging effects. It is very important to develop and stabilize appropriate methods for the evaluation of the whitening and anti-aging capacity of natural products and their exact mechanism of action to ensure real efficacy based on evidence-based studies. The attention should be oriented on the formulations and the development of an appropriate vehicle to ensure suitable absorption of these natural products in addition to evaluating the suitable concentration of these molecules required having the desired effects without causing harmful side effects.

BACKGROUND: Origanum syriacum (O. syriacum) is a very popular edible and medicinal plant in the East Mediterranean countries. The aims of the current study were to use microwave-ultrasonic assisted hydrodistillation (MUAHD) method to produce essential oils (EOs) from wild O. syriacum samples collected from four different geographical areas in The West Bank using water as a solvent, determine the phytochemical profile using GC-MS analysis and assess their antioxidant and antibacterial potential. METHODS: Essential oils were produced using MUAHD method. Gas chromatography coupled with mass spectrometer detector (GC-MS) was employed for phytochemical analysis. In vitro antibacterial and antioxidant potentials were carried out. RESULTS: Differences in the EOs yield among the four Origanum samples were observed. GC-MS analysis of EOs revealed terpenes as the major constituents; monoterpenes (22–56%) and oxygenated monoterpenes (28–57%). Thymol, α-terpinene and carvacrol represent the bulk of all phytochemicals detected by GC-MS analysis. γ-Terpinene-rich EOs, exhibited the highest antioxidant capacity. Thymol-rich EOs were found to be most effective against Staphylococcus aureus and Methicillin-Resistant Staphylococcus aureus (MRSA) (MIC 390 µg/mL). Alpha-terpinene-rich chemotype EOs exhibited the highest inhibitory effect of Pseudomonas aeruginosa (MIC of 1560 µg/mL). Interestingly, γ-terpinene-rich EO showed promising antibacterial properties against Enterococcus faecium (MIC 97 µg/mL) and a powerful anti-oxidant effect (91.45% ±2.30). CONCLUSION: The current study supports the use of MUAHD as a time-saving, cost-effective, environment-friendly method for production of high quality O. syriacum EO for potential use as a natural complementary treatment and in the prevention of bacterial infections as well as oxidation by free radicals without compromising the quantity.

BACKGROUND Treatment of neuropathic pain has always been challenging, not only from the pharmaco-therapeutic/toxicological point of view, but also due to the unpredictable pharmacokinetic (PK) variations among different generic formulations of the same drug, which require further dose optimization. OBJECTIVES This progressive work aims to evaluate the bioequivalence (BE) of a generic product of 150 mg pregabalin capsule (antineuropathic drug) vs. the reference brand drug Lyrica®. METHOD An LC-MS/MS bioanalytical method was developed and validated according to the International Conference on Harmonization (ICH) guidelines in order to be used for the analysis of pregabalin in plasma. BE of capsules was tested by comparison against the reference brand capsules in accordance with the requirements of the declarations of Helsinki, the current Good Clinical Practice (GCP) Guidelines and the ICH. The resulting data were compared against corresponding pregabalin data published on other human races. RESULTS The relationship between concentration and peak area ratio was found to be linear within the range 0.096 - 6.068 µg/mL for pregabalin. The correlation coefficient (r) was equal to 0.9983. Statistical comparison of the main PK parameters showed no significant difference between test and reference. The mean Cmax values for test and reference were 4.290 and 4.164 µg/mL, and the mean AUC0-last values were 24.275 h×µg/mL and 23.674 h×µg/mL, respectively. The 90% CIs of geometric mean ratios (test/reference) for pregabalin were 100.34 - 104.78%, 100.34 - 104.70%, and 95.65 - 110.96% for AUC0-last, AUC0-∞, and Cmax, respectively, thus fall within the international specified BE limit (80 - 125%). Both products were well tolerated by all the volunteers and there were no significant differences on physical examination or in vital signs and laboratory tests between groups. All volunteers completed the study and were discharged in good health. CONCLUSION The tested generic capsules appear to be bioequivalent to the reference brand and are expected to have a similar efficacy and safety profile.

Bioequivalence studies are expensive, time consuming and invasive to humans. Accordingly, an alternative in vitro study (biowaivers) has been introduced for drugs which belong to BCS class I and III and for other strengths of already approved higher drug strength. The main objective of this study was to prove the biowaiver eligibility of a lower strength Ramipril/Hydrochlorothiazide (2.5/12.5 mg) tablets. Visual and pharmacopoeial quality tests were performed on the higher and lower generic and on the reference listed drug to determine whether they are pharmaceutically equivalent. All products were investigated using the biowaiver criteria. Dissolution profiles were conducted at pH values 1.2, 4.5 and 6.8. Difference factor (f1) and similarity factor (f2) were calculated. The tested products were successfully complied with pharmacopeial requirements. f1 was below 15 and f2 was above 50 in all dissolution conditions. Precisely, Ramipril showed release higher than 85% within 15 min. f1 and f2 for Hydrochlorothiazide were 8 and 61 respectively at the recommended discriminative pH media.These results suggest that the current biowaiver criteria could be a sufficient guarantee of bioequivalence of the lower strength of Ramizide assuming that the product is manufactured at the same site and contains same quality and grade of excipients and in a proportional amounts.

There is a wide inter-individual response to statin therapy including rosuvastatin calcium (RC), and it has been hypothesized that genetic differences may contribute to these variations. In fact, several studies have shown that pharmacokinetic (PK) parameters for RC are affected by race. The aim of this study is to demonstrate the interchangeability between two generic RC 20 mg film-coated tablets under fasting conditions among Mediterranean Arabs and to compare the pharmacokinetic results with Asian and Caucasian subjects from other studies. A single oral RC 20 mg dose, randomized, open-label, two-way crossover design study was conducted in 30 healthy Mediterranean Arab volunteers. Blood samples were collected prior to dosing and over a 72-h period. Concentrations in plasma were quantified using a validated liquid chromatography tandem mass spectrometry method. Twenty-six volunteers completed the study. Statistical comparison of the main PK parameters showed no significant difference between the generic and branded products. The point estimates (ratios of geometric mean %) were 107.73 (96.57–120.17), 103.61 (94.03–114.16), and 104.23 (94.84–114.54) for peak plasma concentration (Cmax), Area Under the Curve (AUC)0→last, and AUC0→∞, respectively. The 90% confidence intervals were within the pre-defined limits of 80%–125% as specified by the Food and Drug Administration and European Medicines Agency for bioequivalence studies. Both formulations were well-tolerated and no serious adverse events were reported. The PK results (AUC0→last and Cmax) were close to those of the Caucasian subjects. This study showed that the test and reference products met the regulatory criteria for bioequivalence following a 20 mg oral dose of RC under fasting conditions. Both formulations also showed comparable safety results. The PK results of the test and reference in the study subjects fall within the acceptable interval of 80%–125% and they were very close to the results among Caucasians. These PK results may be useful in order to determine the suitable RC dose among Arab Mediterranean patients.

Carvone volatile oil is a commercial product that is widely used in the food, cosmetic and pharmaceutical industry due to its fragrance, flavoring and medicinal properties. A validated HPLC method for the qualitative and quantitative analysis of this oil in raw and commercial products is not available in the literature. The aim of this study is to develop a validated new analytical HPLC method for the estimation of Carvone in raw materials and suppositories. The HPLC analysis was carried out using a reversed phase-C18 (250 × 4.0 mm, 5 μm) column. Chromatographic analysis was carried out using a Shimadzu HPLC system equipped with an LC-2010 pump, LC-2010 autosampler, LC-2010 oven, and LC-2010 UV–VIS detector. The mobile consists of two phases Methanol and 1.0 mL of trifluoroacetic acid in 1000 mL filtered and degas HPLC water. The developed HPLC analytical method was simple and was validated in accordance with FDA and ICH guidelines and showed good linearity, accuracy, precision, selectivity and the system suitability results were within the acceptance criteria. This new analytical method could be used to screen the quality of the oil in formulation studies of the final product formulations and can be applied for routine analysis of carvone in raw material as well as in pharmaceutical suppositories and can be applied in any lab and industrial batch quality control.

Ciprofloxacin is a broad spectrum fluoroquinolone antibiotic that acts by the inhibition of bacterial topoisomerase type II (DNA gyrase) and have a potent activity against Gram positive and negative bacteria. However, due to its rigid and solid-state structure it suffers from limited water solubility. Improving its pharmacokinetic properties especially its water solubility is the concern of this work through the synthesis of various derivatives of ciprofloxacin with ethylene glycols through prodrug strategy without reducing its antibacterial activity. Shake-flask method was used to measure the aqueous solubility in phosphate buffer. The ciprofloxacin analogues were adequately stable at acidic and physiological pH. Synthesized derivatives were subjected to esterase-mediated hydrolysis reaction for the release of the drug from its prodrug form and showed a total hydrolysis after 25 min. Also antibacterial activity was studied against Staphylococcus aureus and Escherichia coli. Compared to ciprofloxacin, the solubility was increased for the three derivatives, and the antimicrobial activity was enhanced up to 40%.

Background: Currently, there is an increasing interest in developing more efficient techniques for the extraction of phytochemicals. Microwaves and ultrasonic extraction methods are promising techniques that can be used for this purpose. Objectives: The purpose of this study was to investigate the impact of different extraction methods on yield, antioxidant and antimicrobial activities of volatile oil extracted from Trichodesma africanum. Materials and Methods: Volatile oil was extracted using microwave, ultrasonic, microwave-ultrasonic, and conventional hydrodistillation methods. The extracted oil was evaluated for antioxidant and antimicrobial activities. The antioxidant activity was assessed by 2,2-Diphenyl-1-picrylhydrazyl scavenging assay, whereas the antimicrobial activity was assessed by broth microdilution method. The antimicrobial activity of the volatile oils was examined against Staphylococcus aureus, Escherichia coli, and Pseudomonas aeruginosa American type culture collection reference strains, as well as against methicillin-resistant S. aureus (MRSA) and Candida albicans clinical isolates. Results: The volatile oil obtained by the four extraction methods in this study exhibited both antioxidant and antimicrobial activities. Among the four extraction methods used, the microwave-ultrasonic method yielded the largest amount (1.8% v/w) and the yield exhibited the highest antioxidant activity in terms of inhibition (91.83% ± 1.1). The minimum inhibitory concentrations for E. coli, P. aeruginosa, S. aureus, MRSA, and C. albicans were 3, 5, 6, 3, and 9, respectively. Conclusion: Among the extraction techniques used in this study, the microwave-ultrasonic method showed the best results. Moreover, this study suggests that T. africanum volatile oils contain active substances that could potentially be used both as natural preservatives in food and pharmaceutical industries as well as in developing new antimicrobial and antioxidant agents.