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Additive Manufacturing (AM) is a fast-growing approach to produce personalized oral dosage forms. Even though some AM technologies are promising as alternative to conventional compounding with resulting dosage manipulation, they still suffer from a lack of quality control. Due to the high regulatory demands and standards applied to dosage forms in the case of dose accuracy and tablet properties such as friability, effective quality control is a key feature in promoting AM as a valid technology for patient-tailored medications. One of the AM techniques used is selective laser sintering, which allows for capturing the surface state layer-by-layer during the printing process. It provides the opportunity to apply non-destructive quality control based on image analysis extracting essential data at each layer of the sintering process. This work is devoted to establishing the value of data gathered via thermal image analysis for the subsequent quality control.

Additive Manufacturing (AM) is a fast-growing approach to produce personalized oral dosage forms. Even though some AM technologies are promising as alternative to conventional compounding with resulting dosage manipulation, they still suffer from a lack of quality control. Due to the high regulatory demands and standards applied to dosage forms in the case of dose accuracy and tablet properties such as friability, effective quality control is a key feature in promoting AM as a valid technology for patient-tailored medications. One of the AM techniques used is selective laser sintering, which allows for capturing the surface state layer-by-layer during the printing process. It provides the opportunity to apply non-destructive quality control based on image analysis extracting essential data at each layer of the sintering process. This work is devoted to establishing the value of data gathered via thermal image analysis for the subsequent quality control.

Additive Manufacturing (AM) is a fast-growing approach to produce personalized oral dosage forms. Even though some AM technologies are promising as alternative to conventional compounding with resulting dosage manipulation, they still suffer from a lack of quality control. Due to the high regulatory demands and standards applied to dosage forms in the case of dose accuracy and tablet properties such as friability, effective quality control is a key feature in promoting AM as a valid technology for patient-tailored medications. One of the AM techniques used is selective laser sintering, which allows for capturing the surface state layer-by-layer during the printing process. It provides the opportunity to apply non-destructive quality control based on image analysis extracting essential data at each layer of the sintering process. This work is devoted to establishing the value of data gathered via thermal image analysis for the subsequent quality control.

Additive Manufacturing (AM) is a fast-growing approach to produce personalized oral dosage forms. Even though some AM technologies are promising as alternative to conventional compounding with resulting dosage manipulation, they still suffer from a lack of quality control. Due to the high regulatory demands and standards applied to dosage forms in the case of dose accuracy and tablet properties such as friability, effective quality control is a key feature in promoting AM as a valid technology for patient-tailored medications. One of the AM techniques used is selective laser sintering, which allows for capturing the surface state layer-by-layer during the printing process. It provides the opportunity to apply non-destructive quality control based on image analysis extracting essential data at each layer of the sintering process. This work is devoted to establishing the value of data gathered via thermal image analysis for the subsequent quality control.

Biopharmaceutics, in connection with pharmacokinetics, is the field that investigates and describes everything that happens with a medicinal product and the active substance between the moment of administration, the moment it exerts its action and the moment it is eliminated from the body. Biopharmaceutics connects the physico-chemical properties of an active substance and its dosage form, especially through the drug release characteristics, with its fate and action in the living organism. Actually biopharmaceutics describes how medicine formulation technologies can affect pharmacokinetics and pharmacodynamics. The route of administration, the way the active substance is released from the dosage form, and the way the body handles (absorbs, distributes, metabolises and excretes) the active substance, together determine its (duration of) action, its efficacy and the occurrence of adverse effects. This chapter explains general principles of biopharmaceutics and its relation to pharmacokinetics in the light of their implications on the design of medicines. It describes the general biopharmaceutical principles that are relevant to the major routes of administration: parenteral, oromucosal, oral, rectal, dermal, nasal, pulmonary and ocular. Topics discussed include solubility and dissolution, bioavailability, partition coefficient and pH partition theory, the biopharmaceutical classification system (BCS), excipient-, food-, drug- and herb-drug interactions, first-pass effects and drug metabolism, bioequivalence and new developments in the field of advanced drug delivery systems.

Additive Manufacturing (AM) is a fast-growing approach to produce personalized oral dosage forms. Even though some AM technologies are promising as alternative to conventional compounding with resulting dosage manipulation, they still suffer from a lack of quality control. Due to the high regulatory demands and standards applied to dosage forms in the case of dose accuracy and tablet properties such as friability, effective quality control is a key feature in promoting AM as a valid technology for patient-tailored medications. One of the AM techniques used is selective laser sintering, which allows for capturing the surface state layer-by-layer during the printing process. It provides the opportunity to apply non-destructive quality control based on image analysis extracting essential data at each layer of the sintering process. This work is devoted to establishing the value of data gathered via thermal image analysis for the subsequent quality control.

Orodispersible films (ODFs) have served as an emerging platform for the delivery of drugs in a convenient way. They have numerous advantages, the significant one is simplicity of administration for special populations such as pediatric and geriatric as well as patients with swallowing difficulty. Besides, the advantages include accurate dosing and fast action. The ODFs are efficiently designed with detailed knowledge of drug and polymers as well as a suitable selection of method. Many conventional and advance formulation strategies have been used for the development of ODFs. The biopharmaceutical concerns of active pharmaceutical ingredients (APIs) are given in this review in light of the fact that ODFs can be utilized to increase the bioavailability of APIs. The basic critical issues such as good mechanical properties, water solubility of the API and taste masking are very important to be considered during the development of ODFs. The knowledge of critical quality concerns of ODFs will be helpful in the future development of ODF. As ODFs remain in the mouth until complete degradation, taste, texture and mouth-feel are the qualities that in all respects liable for acceptability of the patient. An assortment of packaging choices is also accessible for ODFs. This review focuses on the different critical concerns of ODF related to composition, bio-pharmaceutical, manufacturing, quality tests, packaging and acceptability. Additionally, potential barriers in the ODFs development are discussed in details. Therefore, this review is an informative bundle of ODFs concerns from the product development stage to the end-user acceptability.

Objectives To understand the barriers and facilitators of medication administration to aged care residents with swallowing difficulties. Methods Health‐care workers in aged care facilities across Australia involved in medication administration to residents completed an online survey. Results Of 355 respondents, 90.9% reported ‘everyday’ encounters with residents with swallowing difficulties and 94.1% modified medications to facilitate administration. Time constraints (63.4%) and workload (69.0%) were common barriers. Only 39.0% believed swallowing abilities are considered at the prescribing stage. Pill size (95.8%), polypharmacy (75.2%) and lack of alternative formulations (74.9%) contributed to these challenges. Support from other health‐care professionals (91.5%) and training (85.9%) were the most favoured facilitators. Conclusion Health‐care workers are faced with various challenges when caring for residents with swallowing difficulties. Promoting multidisciplinary collaborations, provision of training and medication review services, and improving skill mix and staffing composition in aged care facilities are needed to address these challenges.

Aims: Estimating the monetary value of the convenience of using influenza antivirals approved in Japan from a patient perspective using a conjoint analysis. Methods: An online survey (August 2020) was performed on individuals aged 20–64 years living in Japan who had taken oral or inhalant antivirals for influenza treatment in the 2018/19 or 2019/20 seasons. Efficacy and safety were assumed to be equivalent among the antivirals. The attributes for the conjoint analysis included route (oral or inhalant), duration, frequency of administration, and out-ofpocket expenses. A conditional logit model was applied as a baseline model. The monetary value of each attribute was calculated by comparing the same utility of the linearly interpolated level of the out-of-pocket attribute. Another survey to determine the experiences of the latest antiviral intake was also conducted on the same respondents. Results: Of the respondents, 1,550 were men and 1,587 were women. The monetary value for oral antivirals was estimated to be higher, saving JPY 741 (USD 7.06, as of August 2020), compared with inhalant. Regarding the length and frequency of administration, five days corresponds to an increase of JPY 2,072, compared with one day, and twice a day corresponds to a JPY 574 increase compared to once a day. Conclusions: The results suggest that – among the antivirals approved in Japan – the monetary value of the utility is the highest in the single dose oral antiviral, baloxavir marboxil (baloxavir). Although the drug cost was highest in baloxavir among the brand antivirals, the difference in the value of utility for influenza patient was estimated to be larger than the difference in the drug costs. Limitations: Although individuals with diverse attributes from all over the country were included in the survey, they are not necessarily a representative population of the Japanese society., Journal of Medical Economics, 24(1), pp.244-254; 2021

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.

The current manufacturing solutions for oral solid dosage forms are fundamentally based on technologies from the 19th century. This approach is well suited for mass production of one-size-fits-all products; however, it does not allow for a straight-forward personalization and mass customization of the pharmaceutical end-product. In order to provide better therapies to the patients, a need for innovative manufacturing concepts and product design principles has been rising. Additive manufacturing opens up a possibility for compartmentalization of drug products, including design of spatially separated multidrug and functional excipient compartments. This compartmentalized solution can be further expanded to modular design thinking. Modular design is referring to combination of building blocks containing a given amount of drug compound(s) and related functional excipients into a larger final product. Implementation of modular design principles is paving the way for implementing the emerging personalization potential within health sciences by designing compartmental and reactive product structures that can be manufactured based on the individual needs of each patient. This review will introduce the existing compartmentalized product design principles and discuss the integration of these into edible electronics allowing for innovative control of drug release. (c) 2021 Published by Elsevier B.V.

The current manufacturing solutions for oral solid dosage forms are fundamentally based on technologies from the 19th century. This approach is well suited for mass production of one-size-fits-all products; however, it does not allow for a straight-forward personalization and mass customization of the pharmaceutical end-product. In order to provide better therapies to the patients, a need for innovative manufacturing concepts and product design principles has been rising. Additive manufacturing opens up a possibility for compartmentalization of drug products, including design of spatially separated multidrug and functional excipient compartments. This compartmentalized solution can be further expanded to modular design thinking. Modular design is referring to combination of building blocks containing a given amount of drug compound(s) and related functional excipients into a larger final product. Implementation of modular design principles is paving the way for implementing the emerging personalization potential within health sciences by designing compartmental and reactive product structures that can be manufactured based on the individual needs of each patient. This review will introduce the existing compartmentalized product design principles and discuss the integration of these into edible electronics allowing for innovative control of drug release. (c) 2021 Published by Elsevier B.V.

Although oral drug delivery is the preferred administration route and has been used for centuries, modern drug discovery and development pipelines challenge conventional formulation approaches and highlight the insufficient mechanistic understanding of processes critical to oral drug absorption. This review presents the opinion of UNGAP scientists on four key themes across the oral absorption landscape: (1) specific patient populations, (2) regional differences in the gastrointestinal tract, (3) advanced formulations and (4) food-drug interactions. The differences of oral absorption in pediatric and geriatric populations, the specific issues in colonic absorption, the formulation approaches for poorly water-soluble (small molecules) and poorly permeable (peptides, RNA etc.) drugs, as well as the vast realm of food effects, are some of the topics discussed in detail. The identified controversies and gaps in the current understanding of gastrointestinal absorption-related processes are used to create a roadmap for the future of oral drug absorption research.(c) 2021 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).

Tato bakalářská práce se zabývá 3D tiskem lékových forem s obsahem biopolymerů. V první kapitole jsou popsány druhy lékových forem a způsoby jejich dělení. Druhá kapitola je výčet biopolymerů, které byly pro 3D tisk již použity a třetí kapitola obsahuje metody 3D tisku k tomu použité. Poslední část práce se věnuje návrhu dvou pevných lékových forem, jejich výrobě metodou 3D tisku a ověření jejich mechanických vlastností., This bachelor thesis focuses on the topic of 3D printing of dosage forms containing biopolymers. The first chapter describes types of dosage forms and their classification. The second chapter is a list of biopolymers that have already been used for 3D printing and the third chapter describes the 3D printing methods used to do so. The last part of this thesis describes the designing of two solid dosage forms, their production by 3D printing, and verification of their mechanical properties., Fakulta chemicko-technologická, 1. Prezentace výsledků bakalářské práce. 2. Diskuze k posudku vedoucího bakalářské práce. 3. Studentka zodpověděla všechny dotazy a připomínky k BP., Dokončená práce s úspěšnou obhajobou

Although oral drug delivery is the preferred administration route and has been used for centuries, modern drug discovery and development pipelines challenge conventional formulation approaches and highlight the insufficient mechanistic understanding of processes critical to oral drug absorption. This review presents the opinion of UNGAP scientists on four key themes across the oral absorption landscape: (1) specific patient populations, (2) regional differences in the gastrointestinal tract, (3) advanced formulations and (4) food-drug interactions. The differences of oral absorption in pediatric and geriatric populations, the specific issues in colonic absorption, the formulation approaches for poorly water-soluble (small molecules) and poorly permeable (peptides, RNA etc.) drugs, as well as the vast realm of food effects, are some of the topics discussed in detail. The identified controversies and gaps in the current understanding of gastrointestinal absorption-related processes are used to create a roadmap for the future of oral drug absorption research.(c) 2021 The Author(s). Published by Elsevier B.V. This is an open access article under the CC BY license (http:// creativecommons.org/licenses/by/4.0/).

The use of amorphous drug delivery systems is an attractive approach to improve the bioavailability of low molecular weight drug candidates that suffer from poor aqueous solubility. However, the pharmaceutical performance of many neat amorphous drugs is compromised by their tendency for recrystallization during storage and lumping upon dissolution, which may be improved by the application of coatings on amorphous surfaces. In this study, hot melt coating (HMC) as a solvent-free coating method was utilized to coat amorphous carvedilol (CRV) particles with tripalmitin containing 10% (w/w) and 20% (w/w) of polysorbate 65 (PS65) in a fluid bed coater. Lipid coated amorphous particles were assessed in terms of their physical stability during storage and their drug release during dynamic in vitro lipolysis. The release of CRV during in vitro lipolysis was shown to be mainly dependent on the PS65 concentration in the coating layer, with a PS65 concentration of 20% (w/w) resulting in an immediate release profile. The physical stability of the amorphous CRV core, however, was negatively affected by the lipid coating, resulting in the recrystallization of CRV at the interface between the crystalline lipid layer and the amorphous drug core. Our study demonstrated the feasibility of lipid spray coating of amorphous CRV as a strategy to modify the drug release from amorphous systems but at the same time highlights the importance of surface-mediated processes for the physical stability of the amorphous form.

The use of amorphous drug delivery systems is an attractive approach to improve the bioavailability of low molecular weight drug candidates that suffer from poor aqueous solubility. However, the pharmaceutical performance of many neat amorphous drugs is compromised by their tendency for recrystallization during storage and lumping upon dissolution, which may be improved by the application of coatings on amorphous surfaces. In this study, hot melt coating (HMC) as a solvent-free coating method was utilized to coat amorphous carvedilol (CRV) particles with tripalmitin containing 10% (w/w) and 20% (w/w) of polysorbate 65 (PS65) in a fluid bed coater. Lipid coated amorphous particles were assessed in terms of their physical stability during storage and their drug release during dynamic in vitro lipolysis. The release of CRV during in vitro lipolysis was shown to be mainly dependent on the PS65 concentration in the coating layer, with a PS65 concentration of 20% (w/w) resulting in an immediate release profile. The physical stability of the amorphous CRV core, however, was negatively affected by the lipid coating, resulting in the recrystallization of CRV at the interface between the crystalline lipid layer and the amorphous drug core. Our study demonstrated the feasibility of lipid spray coating of amorphous CRV as a strategy to modify the drug release from amorphous systems but at the same time highlights the importance of surface-mediated processes for the physical stability of the amorphous form.

Aims: Several drug classes are now available to achieve a satisfactory metabolic control in patients with type 2 diabetes (T2DM), but patients’ preferences may differ. Methods: In a discrete-choice experiment, we tested T2DM patients’ preferences for recent antidiabetic drugs, in the event that their treatment might require intensification. The following attributes were considered: (a) route of administration; (b) type of delivery; (c) timing; (d) risk of adverse events; (e) effects on body weight. Twenty-two possible scenarios were built, transferred into 192 paired choices and proposed to 491 cases naïve to injectable treatments and 171 treated by GLP-1 receptor agonists (GLP-1RAs). Analyses were performed by descriptive statistics and random effects logit regression model. Results: Preferences according to dosing frequency, risk of nausea and urinary tract infections (UTls) were similar across groups, age, sex and BMI. Administration route and delivery type accounted for 1/3 of relative importance; the risk of UTIs, nausea and dosing frequency for ≈ 20% each, and weight loss for only 6%. Two significant interactions emerged (p < 0.01): type of delivery × group, and weight change × BMI class. Irrespective of previous treatment, the three preferred choices were injectable, coupled with weekly dosing and a ready-to-use device (first two choices). In a regression model, being naïve or non-naïve changed the ranking of preferences (p < 0.001), and the order was systematically shifted towards injectable medications in non-naïve subjects. Conclusion: Easy-to-deliver, injectable treatment is preferred in T2DM, independently of treatment history, and previous experience with GLP-1RAs strengthens patients’ willingness to accept injectable drugs.

Tato bakalářská práce je literární rešerší na téma vstřebávání léčiv v různých částech gastrointestinálního traktu. Jsou v ní popsány fyziologické atributy ovlivňující absorpci léčiva. Mezi nejdůležitější aspekty vstřebávání patří pH prostředí, které se výrazně podílí na disoluci lékové formy. Práce dále pojednává o lékových systémech pro přívod léčiva do distální části GIT. Absorpce účinné látky zejména v kolonu s sebou nese mnoho výhod a to jak u systémově tak i lokálně působících léčiv, které se používají při léčbě gastrointestinálních onemocněních. Poslední část je věnována možnostem simulace průchodu léčiva gastrointestinálním traktem v podmínkách in vitro., This bacherol thesis is literary research focused on drugs absorption in various parts of the gastrointestinal tract. It describes the physiological attributes affecting drug absorption. The most important aspects of absorption are the pH of the GIT, which contributes significantly to the dissolution of the dosage form. The work also discusses drug delivery systems for the delivery of drug to the distal part of the GIT. The absorption of the active pharmaceutical ingredient, especially in the column, entails many advantages. Advantages are for both for systemically and locally acting drugs which are used in the treatment of gastrointestinal diseases. The last part is devoted to the possibility of simulating the passage of the drug through the gastrointestinal tract in vitro., Fakulta chemicko-technologická, 1. Prezentace výsledků bakalářské práce. 2. Diskuze k posudku vedoucího práce. 3. Studentka zodpověděla všechny dotazy a připomínky k BP., Dokončená práce s úspěšnou obhajobou

Drug delivery techniques are an integral component in modern medical practices. Numerous drugs have been designed to exploit drug delivery systems, primarily oral administration, as it is preferred by the public for treatment of animals and humans. Butorphanol is a commonly used opioid analgesic drug for pain relief in avian species. The pharmacokinetic reports on butorphanol suggest that it is metabolised and cleared from an avian body at a much faster rate when compared to mammals. A single intravenous injection of butorphanol at 2 mg/kg provides analgesia for only 2 hours. When given at higher doses, butorphanol starts to produce side effects such as hyperventilation, cardiac insufficiency, coma and death. Therefore, there is a need to develop a slow release drug delivery system for butorphanol which can prolong the duration of analgesia without the side effects.

Usability is a key factor in ensuring safe and efficacious use of medicines. However, several studies showed that people experience a variety of problems using their medicines. The purpose of this study was to identify design features of oral medicines that cause use problems among older patients in daily practice. A qualitative study with semi-structured interviews on the experiences of older people with the use of their medicines was performed (n=59). Information on practical problems, strategies to overcome these problems and the medicines' design features that caused these problems were collected. The practical problems and management strategies were categorised into 'use difficulties' and 'use errors'. A total of 158 use problems were identified, of which 45 were categorized as use difficulties and 113 as use error. Design features that contributed the most to the occurrence of use difficulties were the dimensions and surface texture of the dosage form (29.6% and 18.5%, respectively). Design features that contributed the most to the occurrence of use errors were the push-through force of blisters (22.1%) and tamper evident packaging (12.1%). These findings will help developers of medicinal products to proactively address potential usability issues with their medicines.

Computer-aided drug design has been a rapidly developing discipline that garnered increasing amount of attention in recent years. Much of these generous efforts were devoted to virtual screening of drug-size compounds. A fragment-based approach to the subject is relatively unexplored. Taking advantage of the vast amount of structural information made available by the protein databank, we designed a protocol that elucidates fragment-binding hotspots with Instance-based learning techniques. The predictions were based upon statistical inference about local chemical environment of a target protein. By analysing a thoroughly sampled conformational space of Human CDK2, we were able to arrive at a natural definition of fragment-binding hotspots, which is fragment-binding spots attested against conformational change. The identified fragment-binding hotspots were validated against crystallised counterparts with consistency. Besides reporting pockets and fragments native to the existing ligand-bound CDK2 crystals, preliminary results also suggest for putative allosteric sites alongside fragments unprecedented in CDK2 crystals.

Computer-aided drug design has been a rapidly developing discipline that garnered increasing amount of attention in recent years. Much of these generous efforts were devoted to virtual screening of drug-size compounds. A fragment-based approach to the subject is relatively unexplored. Taking advantage of the vast amount of structural information made available by the protein databank, we designed a protocol that elucidates fragment-binding hotspots with Instance-based learning techniques. The predictions were based upon statistical inference about local chemical environment of a target protein. By analysing a thoroughly sampled conformational space of Human CDK2, we were able to arrive at a natural definition of fragment-binding hotspots, which is fragment-binding spots attested against conformational change. The identified fragment-binding hotspots were validated against crystallised counterparts with consistency. Besides reporting pockets and fragments native to the existing ligand-bound CDK2 crystals, preliminary results also suggest for putative allosteric sites alongside fragments unprecedented in CDK2 crystals.

Previous reports revealed several concerns related to the quality of marketed folic acid dietary supplements with potential influence on their efficacy, such as underdosages of the folic acid content, complexity of composition and the failure to meet the disintegration and/or dissolution requirements. This study was aimed to compare various marketed folic acid supplements, formulated as single- or multicomponent products, by testing their weight variation, friability, hardness, disintegration and dissolution properties according to the compendial requirements; accompanied with the investigation of influence of composition on the dosage form properties. The obtained results revealed significant differences in mechanical and dissolution properties between the tested supplements, especially between the single- and multicomponent products, where most of the multicomponent products failed to meet the compendial requirements for either dissolution or disintegration. These findings indicate the need for harmonized and strict regulatory requirements for the quality of multicomponent dietary supplements.

Computer-aided drug design has been a rapidly developing discipline that garnered increasing amount of attention in recent years. Much of these generous efforts were devoted to virtual screening of drug-size compounds. A fragment-based approach to the subject is relatively unexplored. Taking advantage of the vast amount of structural information made available by the protein databank, we designed a protocol that elucidates fragment-binding hotspots with Instance-based learning techniques. The predictions were based upon statistical inference about local chemical environment of a target protein. By analysing a thoroughly sampled conformational space of Human CDK2, we were able to arrive at a natural definition of fragment-binding hotspots, which is fragment-binding spots attested against conformational change. The identified fragment-binding hotspots were validated against crystallised counterparts with consistency. Besides reporting pockets and fragments native to the existing ligand-bound CDK2 crystals, preliminary results also suggest for putative allosteric sites alongside fragments unprecedented in CDK2 crystals.

A 17-year-old female with recently relapsed acute lymphoblastic leukaemia and a treatment course complicated by rhinocerebral mucormycosis infection developed severe peripheral neuropathy during the treatment for mucormycosis infection. This was felt to be a medication side effect. Her peripheral neuropathy was refractory to many well-established treatments, but ultimately responded dramatically and consistently to a novel therapy, topical doxepin cream (5%). This case report is the first published report of the application of topical doxepin cream for treatment of peripheral neuropathy in a paediatric patient.

Marketing research of the modern range of antifungal drugs has been conducted according to the data of the State Expert Center of the Ministry of Public Health of Ukraine and Morion information retrieval program. The share of manufacturing countries of these drugs, and the ratio of different dosage forms and drug subgroups of the drugs studied by group D 01A have been determined according to the unified anatomic-therapeutic and chemical classification system ATC (Anatomical Therapeutic Chemical)., Проведены маркетинговые исследования современного ассортимента лекарственных средств противогрибкового действия по данным Государственного экспертного центра МОЗ Украины и информационно-поисковой программы «Морион». Установлено долю стран-производителей этих лекарственных средств, соотношение различных лекарственных форм и лекарственных подгрупп в соответствии с унифицированной анатомо-терапевтической и химической классификационной системой АТС (Anatomical Therapeutic Chemical) исследуемых ЛС по группе D 01A., Проведено маркетингові дослідження сучасного асортименту лікарських засобів протигрибкової дії за даними Державного експертного центру МОЗ України та інформаційно-пошукової програми «Моріон». Встановлено частку країн виробників цих лікарських засобів, співвідношення різних лікарських форм та лікарських підгруп відповідно до уніфікованої анатомо-терапевтичної та хімічної класифікаційної системи АТС (Anatomical Therapeutic Chemical) досліджуваних ЛЗ за групою D 01A.

Oral delivery of biopharmaceuticals, for example peptides and proteins, constitutes a great challenge in drug delivery due to their low chemical stability and poor permeation across the intestinal mucosa, to a large extent limiting the mode of administration to injections, which is not favouring patient compliance. Nevertheless, cell-penetrating peptides (CPPs) have shown promising potential as carriers to overcome the epithelium, and this minireview highlights recent knowledge gained within the field of CPP-mediated transepithelial delivery of therapeutic peptides and proteins from the intestine. Two approaches may be pursued: co-administration of the carrier and therapeutic peptide in the form of complexes obtained by simple bulk mixing, or administration of covalent conjugates demanding more advanced production methodologies. These formulation approaches have their pros and cons, and which is to be preferred depends on the physicochemical properties of both the specific CPP and the specific cargo. In addition to the physical epithelial barrier, a metabolic barrier must be overcome in order to obtain CPP-mediated delivery of a cargo drug from the intestine, and a number of strategies have been employed to delay enzymatic degradation of the CPP. The mechanisms by which CPPs translocate across membranes are not fully understood, but possibly involve endocytosis as well as direct translocation, and the CPP-mediated transepithelial delivery of cargo drugs thus likely involves similar mechanisms for the initial membrane interaction and translocation. However, the mechanisms responsible for transcytosis of the cargo drug, if taken up by an endocytic mechanism, or direct translocation across the epithelium are so far not known., Oral delivery of biopharmaceuticals, for example peptides and proteins, constitutes a great challenge in drug delivery due to their low chemical stability and poor permeation across the intestinal mucosa, to a large extent limiting the mode of administration to injections, which is not favouring patient compliance. Nevertheless, cell-penetrating peptides (CPPs) have shown promising potential as carriers to overcome the epithelium, and this minireview highlights recent knowledge gained within the field of CPP-mediated transepithelial delivery of therapeutic peptides and proteins from the intestine. Two approaches may be pursued: co-administration of the carrier and therapeutic peptide in the form of complexes obtained by simple bulk mixing, or administration of covalent conjugates demanding more advanced production methodologies. These formulation approaches have their pros and cons, and which is to be preferred depends on the physicochemical properties of both the specific CPP and the specific cargo. In addition to the physical epithelial barrier, a metabolic barrier must be overcome in order to obtain CPP-mediated delivery of a cargo drug from the intestine, and a number of strategies have been employed to delay enzymatic degradation of the CPP. The mechanisms by which CPPs translocate across membranes are not fully understood, but possibly involve endocytosis as well as direct translocation, and the CPP-mediated transepithelial delivery of cargo drugs thus likely involves similar mechanisms for the initial membrane interaction and translocation. However, the mechanisms responsible for transcytosis of the cargo drug, if taken up by an endocytic mechanism, or direct translocation across the epithelium are so far not known.

BackgroundBudesonide foam, a rectally administered, second-generation corticosteroid with extensive hepatic first-pass metabolism, is efficacious for the treatment of mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis.AimThe aim of this study was to comprehensively assess the safety and pharmacokinetic profile of budesonide foam.MethodsData from five phase III studies were pooled to further evaluate safety, including an open-label study (once-daily treatment for 8 weeks), an active-comparator study (once-daily treatment for 4 weeks), and two placebo-controlled studies and an open-label extension study (twice-daily treatment for 2 weeks, then once daily for 4 weeks). Data from the placebo-controlled studies and two phase I studies (i.e., patients with mild-to-moderate ulcerative colitis and healthy volunteers) were pooled to evaluate the pharmacokinetics of budesonide foam.ResultsA similar percentage of patients reported adverse events in the budesonide foam and placebo groups, with the majority of adverse events being mild or moderate in intensity (93.3 vs 96.0%, respectively). Adverse events occurred in 41.4 and 36.3% of patients receiving budesonide foam and placebo, respectively. Mean morning cortisol concentrations remained within the normal range for up to 8 weeks of treatment; there were no clinically relevant effects of budesonide foam on the hypothalamic-pituitary-adrenal axis. Population pharmacokinetic analysis demonstrated low systemic exposure after budesonide foam administration.ConclusionsThis integrated analysis demonstrated that budesonide foam for the induction of remission of distal ulcerative colitis is safe overall, with no clinically relevant effects on the hypothalamic-pituitary-adrenal axis.

BackgroundBudesonide foam, a rectally administered, second-generation corticosteroid with extensive hepatic first-pass metabolism, is efficacious for the treatment of mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis.AimThe aim of this study was to comprehensively assess the safety and pharmacokinetic profile of budesonide foam.MethodsData from five phase III studies were pooled to further evaluate safety, including an open-label study (once-daily treatment for 8 weeks), an active-comparator study (once-daily treatment for 4 weeks), and two placebo-controlled studies and an open-label extension study (twice-daily treatment for 2 weeks, then once daily for 4 weeks). Data from the placebo-controlled studies and two phase I studies (i.e., patients with mild-to-moderate ulcerative colitis and healthy volunteers) were pooled to evaluate the pharmacokinetics of budesonide foam.ResultsA similar percentage of patients reported adverse events in the budesonide foam and placebo groups, with the majority of adverse events being mild or moderate in intensity (93.3 vs 96.0%, respectively). Adverse events occurred in 41.4 and 36.3% of patients receiving budesonide foam and placebo, respectively. Mean morning cortisol concentrations remained within the normal range for up to 8 weeks of treatment; there were no clinically relevant effects of budesonide foam on the hypothalamic-pituitary-adrenal axis. Population pharmacokinetic analysis demonstrated low systemic exposure after budesonide foam administration.ConclusionsThis integrated analysis demonstrated that budesonide foam for the induction of remission of distal ulcerative colitis is safe overall, with no clinically relevant effects on the hypothalamic-pituitary-adrenal axis.

The purpose of this study was to formulate printable dosage forms for a poorly soluble drug (piroxicam; PRX) and to gain understanding of critical parameters to be considered during development of such dosage forms. Liquid formulations of PRX were printed on edible paper using piezoelectric inkjet printing (PIJ) and impression printing (flexography). The printed dosage forms were characterized using scanning electron microscopy with energy dispersive X-ray spectroscopy (SEM-EDX) and the amount of drug was determined using high-performance liquid chromatography. Solutions of PRX in polyethylene glycol 400 (PEG-400):ethanol (40:60) and in PEG-400 were found to be optimal formulations for PIJ and flexography, respectively. SEM-EDX analysis revealed no visible solid particles on the printed dosage forms indicating the drug most likely remained in solution after printing. More accurate drug deposition was obtained by PIJ as compared with flexography. More than 90% drug release was achieved within 5 min regardless of printing method used. The solubility of drug in solvents/cosolvents, rheological properties of formulations, properties of substrate, feasibility and accuracy of the printing methods, and detection limit of analytical techniques for characterization of printed dosage forms are some of the concerns that need to be addressed for development of printable dosage forms of poorly soluble drugs.

The purpose of this study was to formulate printable dosage forms for a poorly soluble drug (piroxicam; PRX) and to gain understanding of critical parameters to be considered during development of such dosage forms. Liquid formulations of PRX were printed on edible paper using piezoelectric inkjet printing (PIJ) and impression printing (flexography). The printed dosage forms were characterized using scanning electron microscopy with energy dispersive X-ray spectroscopy (SEM-EDX) and the amount of drug was determined using high-performance liquid chromatography. Solutions of PRX in polyethylene glycol 400 (PEG-400):ethanol (40:60) and in PEG-400 were found to be optimal formulations for PIJ and flexography, respectively. SEM-EDX analysis revealed no visible solid particles on the printed dosage forms indicating the drug most likely remained in solution after printing. More accurate drug deposition was obtained by PIJ as compared with flexography. More than 90% drug release was achieved within 5 min regardless of printing method used. The solubility of drug in solvents/cosolvents, rheological properties of formulations, properties of substrate, feasibility and accuracy of the printing methods, and detection limit of analytical techniques for characterization of printed dosage forms are some of the concerns that need to be addressed for development of printable dosage forms of poorly soluble drugs.

A simple and sensitive HPTLC method for separation and determination of tiapride hydrochloride and its degradation products has been developed and evaluated. Analysis of tiapride hydrochloride and impurities III, VII, and VIII, was performed on silica gel 60F(254) HPTLC plates using methylene chloride-methanol-concentrated ammonia, 9:1.6:0.1 (v/v) as mobile phase. Detection was performed at 240 nm. All validation requirements, specificity, linearity (r >= 0.997), recovery (95.08-100.39%), limit of quantification (0.1-0.2%), and robustness were examined and fulfilled, and the proposed method can be successfully applied for the quality control analysis of commercially available tablets and injections.

Purpose. To highlight the role of the nursing professional in containing the generation of antibiotic-resistant bacteria, through safe practices in the administration of antibiotics. Methodology. Approximately 1,200 publication of biomedical research were verified from the data base of the Medline, Highwire, Docement, among others. Results. It was verified that the inadequate use of medicines along with wrong practices to control infections in hospitals, inappropriate therapeutical schemes, lack of adherence to antibiotics administration protocols by the nursing professional has largely caused the increase of bacterial resistance. Discussion. Control of infectious diseases is currently harder to achieve as a consequence of the increase of the bacterial resistance to antimicrobials, which are those with greater incidence in the development of the infections. Resolution WHA51.171 of the World Health Organization of 1998 proposes to implement a strategy to improve the access and use of antimicrobials, which contributes to containing the emergence of resistant bacteria. Conclusions. The implementation of strategies for the use of antibiotics by the nursing professional, concerning the application of safe management protocols in the administration of antibiotics becomes an input that can be used to stop the emergence and spreading of resistant bacteria in infections related to health care., Objetivo. Destacar o papel que o profissional de enfermaria exerce para conter a geração de bactérias resistentes aos antibióticos, mediante práticas seguras na administração destes. Metodologia. Revisaram-se aproximadamente 1200 publicações de pesquisa biomédica na base de dados do Medline, Highwire, Docemet, entre outras. Resultados. Encontrou-se que a utilização inadequada de medicamentos com práticas incorretas para controlar infecções nos hospitais, o inapropriado regime terapêutico, a falta de aderência aos protocolos na administração de antibióticos por parte do profissional de enfermagem, causará em grande medida o incremento da resistência bacteriana. Discussão. O controle das doenças infecciosas, na atualidade, é mais difícil de alcançar como consequência do aumento da resistência bacteriana aos antimicrobianos, que são os que têm uma maior incidência no desenvolvimento destas infecções. A resolução WHA51.171 da Assembleia Mundial da Saúde de 1998, OMS, propõe como estratégia, melhorar o aceso e a utilização dos antimicrobianos, o que contribui a conter a aparição de bactérias resistentes. Conclusões. A implementação de estratégias para o uso dos antibióticos por parte do profissional da enfermagem, em relação à aplicação dos protocolos de manejo seguro na administração dos antibióticos, transforma-se em um contributo que desde a profissão se pode efetuar para conter o surgimento e a disseminação de bactérias resistentes nas infecções associadas ao cuidado da saúde., Objetivo. Destacar el papel que el profesional de enfermería ejerce para contener la generación de bacterias resistentes a los antibióticos, mediante prácticas seguras en la administración de estos. Metodología. Se revisaron aproximadamente 1.200 publicaciones de investigación biomédica en la base de datos del Medline, Highwire, Docemet, entre otras. Resultados. Se encontró que la utilización inadecuada de medicamentos con prácticas incorrectas para controlar infecciones en los hospitales, el inapropiado régimen terapéutico, la falta de adherencia a los protocolos en la administración de antibióticos, por parte del profesional de enfermería, han llevado en gran medida al incremento de la resistencia bacteriana. Discusión. El control de las enfermedades infecciosas, en la actualidad, es más difícil de lograr como consecuencia del aumento de la resistencia bacteriana a los antimicrobianos, que son los que tienen una mayor incidencia en el desarrollo de estas infecciones. La Resolución WHA51.171 de la Asamblea Mundial de la Salud de 1998, OMS, propone, como estrategia, mejorar el acceso y la utilización de los antimicrobianos, lo que contribuye a contener la aparición de bacterias resistentes. Conclusiones. La implementación de estrategias para el uso de los antibióticos, por parte del profesional de enfermería, en relación con la aplicación de los protocolos de manejo seguros en la administración de los antibióticos, se convierte en un aporte que desde la profesión se puede efectuar para contener el surgimiento y la diseminación de bacterias resistentes en las infecciones asociadas al cuidado de la salud.

Background: The treatment of ulcerative colitis (UC) can place a substantial financial burden on healthcare systems. The anti-inflammatory compound 5-aminosalicylic acid (5-ASA; mesalazine) is the recommended first-line treatment for patients with UC. In this analysis, the incremental cost effectiveness ratio (ICER) of two oral formulations of 5-ASA (Mezavant and Asacol) is examined in the treatment of patients with mild-to-moderate, active UC in Germany. Methods. A Markov cohort model was developed to assess the cost effectiveness of Mezavant compared with Asacol over a 5-year period in the German Statutory Health Insurance (SHI). Drug pricing details for 2009 were applied throughout the model, and overall resource use was determined and also fitted to 2009 from published results of a large cross sectional study of German SHI patients. Cost per quality adjusted life year (QALY) was the primary endpoint for this study. Remission rates were obtained using data from a randomised, phase III trial of Mezavant with an active Asacol reference arm and a long-term, open label, safety and tolerability trial of Mezavant. Uncertainty in the study model was assessed using one-way and probabilistic sensitivity analyses applying a Monte Carlo simulation. Results: Over a 5-year period, healthcare costs for patients receiving Mezavant were 624 Euro lower than for patients receiving Asacol. Additionally, patients receiving Mezavant gained 0.011 QALYs or 18 more days in remission compared with Asacol. One-way sensitivity analyses suggest that these results are driven by both differences in the acquisition cost between mesalazine formulations and differences in treatment efficacy. Furthermore, sensitivity analyses suggest a probability of 76% for cost savings and higher QALYs with Mezavant compared with Asacol. If adherence and its influence on the remission rates and the risk of developing colorectal cancer were included in the model, the results might have even been more favorable t

ETHNOPHARMACOLOGICAL RELEVANCE: The leaf decoction of Croton zambesicus Müell. Arg. (Euphorbiaceae; syn. Croton amabilis Müell. Arg., Croton gratissimus Burch) is traditionally used in Benin to treat hypertension. AIM OF THE STUDY: As hypertension and thromboembolism are often associated in several cardiovascular diseases, we studied the potential effects of leaf extracts from Croton zambesicus on hemostasis. MATERIALS AND METHODS: We prepared the dichloromethane and aqueous extracts from the air-dried leaves of Croton zambesicus and separated the aqueous extract in its aqueous and dichloromethane fractions. The potential effects of these four extracts/fractions were investigated on red blood cells integrity using spectrophotometric lysis assays, on primary hemostasis using platelet aggregation studies and on secondary hemostasis using calibrated automated thrombin generation assays and coagulation factors inhibition tests. RESULTS: In the in vitro testing, we found that none of the tested extracts/fractions exhibit hemolytic or antiplatelet activity. However, they display a moderate but significant anticoagulant activity which would be mediated through the direct inhibition of thrombin, FXa and TF/FVIIa. The active anticoagulant compound(s) seem to be mainly in the aqueous extract and especially in its aqueous fraction. CONCLUSIONS: This experimental work reported for the first time the anticoagulant effect of leaf extracts from Croton zambesicus. These findings are of particular interest as the leaves from Croton zambesicus are commonly used in infusion by local population and may provide a new natural source for the development of original anticoagulant agents. Furthermore, this activity, associated with the vasorelaxant properties of some of its diterpenes may prove to be interesting for the prevention of cardiovascular diseases in traditional medicine.

Topical treatment is the cornerstone of therapy for patients suffering from psoriasis. Its efficacy and safety have been demonstrated in a large number of publications. However, in daily life, the treatment outcome is often less satisfactory than the results published in the literature. This phenomenon is clearly linked to non-adherence. Indeed, patients with psoriasis frequently consider the topical therapies frequently as a heavy burden. The successful management of psoriasis with topical agents requires a perfect understanding between the patient and the practionner, which provides regular renewal of the patient's motivation., English Abstract, Journal Article, info:eu-repo/semantics/published

Topical treatment is the cornerstone of therapy for patients suffering from psoriasis. Its efficacy and safety have been demonstrated in a large number of publications. However, in daily life, the treatment outcome is often less satisfactory than the results published in the literature. This phenomenon is clearly linked to non-adherence. Indeed, patients with psoriasis frequently consider the topical therapies frequently as a heavy burden. The successful management of psoriasis with topical agents requires a perfect understanding between the patient and the practionner, which provides regular renewal of the patient's motivation., English Abstract, Journal Article, info:eu-repo/semantics/published

The present study deals with the stress degradation studies on amorphous and polymorphic forms of clopidogrel bisulphate. The objective was to characterize the degradation products and postulate mechanism of decomposition of the drug under solid state stress conditions. For that, amorphous form, polymorph I and polymorph II of the drug were exposed to 40 degrees C/75% relative humidity (RH), with and without stressors for 3 months. The samples were analyzed by HPLC, and the relative extent of degradation as well as nature of decomposition was compared among three solid forms. In total, eight degradation products were observed under various stress conditions. The structures of all of them were elucidated using LC-MS/TOF and LC-MS(n) studies. While one matched the known hydrolytic decomposition product of the drug in solution, seven others were new. The postulated degradation pathway and mechanism of decomposition are discussed.

The effect of microenvironment pH, humidity, and temperature was evaluated on the stability of polymorphic and amorphous forms of clopidogrel bisulfate, when present alone or in combinations. Oxalic acid and sodium carbonate were used as solid stressors to create acidic and alkaline pH, respectively. The samples without and with stressors were subjected for 3 months to (1) 0% RH, 25% RH, 75% RH, and 85% RH at 40 degrees C and also to (2) 60 degrees C, 80 degrees C, and 100 degrees C at 0% RH. In case of solid samples without stressors, the mixture of polymorphic and amorphous forms showed more degradation than the individual forms above critical relative humidity (85% RH). Similar higher degradation was observed between 75% RH and 85% RH in case of acid-stressed samples. In alkaline microenvironment, all the samples showed identical decomposition attributed to conversion of bisulfate salt to free base. Thermal studies indicated that polymorphic forms of clopidogrel bisulfate and also its glassy amorphous form were highly resistant to temperature, whereas the rubbery state of the drug degraded significantly at temperatures of > or =80 degrees C.

The effect of microenvironment pH, humidity, and temperature was evaluated on the stability of polymorphic and amorphous forms of clopidogrel bisulfate, when present alone or in combinations. Oxalic acid and sodium carbonate were used as solid stressors to create acidic and alkaline pH, respectively. The samples without and with stressors were subjected for 3 months to (1) 0% RH, 25% RH, 75% RH, and 85% RH at 40 degrees C and also to (2) 60 degrees C, 80 degrees C, and 100 degrees C at 0% RH. In case of solid samples without stressors, the mixture of polymorphic and amorphous forms showed more degradation than the individual forms above critical relative humidity (85% RH). Similar higher degradation was observed between 75% RH and 85% RH in case of acid-stressed samples. In alkaline microenvironment, all the samples showed identical decomposition attributed to conversion of bisulfate salt to free base. Thermal studies indicated that polymorphic forms of clopidogrel bisulfate and also its glassy amorphous form were highly resistant to temperature, whereas the rubbery state of the drug degraded significantly at temperatures of > or =80 degrees C.

The present study deals with the stress degradation studies on amorphous and polymorphic forms of clopidogrel bisulphate. The objective was to characterize the degradation products and postulate mechanism of decomposition of the drug under solid state stress conditions. For that, amorphous form, polymorph I and polymorph II of the drug were exposed to 40 degrees C/75% relative humidity (RH), with and without stressors for 3 months. The samples were analyzed by HPLC, and the relative extent of degradation as well as nature of decomposition was compared among three solid forms. In total, eight degradation products were observed under various stress conditions. The structures of all of them were elucidated using LC-MS/TOF and LC-MS(n) studies. While one matched the known hydrolytic decomposition product of the drug in solution, seven others were new. The postulated degradation pathway and mechanism of decomposition are discussed.

This review describes the different drug delivery systems containing levodopa that are used in the treatment of Parkinson's disease. Their composition, process of preparation, advantages, disadvantages and limitations are discussed as well as the major objective in the management of Parkinson's disease according to the pathology of the disease., Journal Article, Review, info:eu-repo/semantics/published

This review describes the different drug delivery systems containing levodopa that are used in the treatment of Parkinson's disease. Their composition, process of preparation, advantages, disadvantages and limitations are discussed as well as the major objective in the management of Parkinson's disease according to the pathology of the disease., Journal Article, Review, info:eu-repo/semantics/published

Within recent years the level of interest in both local and systemic vaginal drug delivery systems has increased considerably. The vagina offers advantages as a site for drug delivery, such as convenient access, prolonged retention of formulations, a great permeation area, high vaskularization, relatively low enzymatic activity, and the avoidance of first-pass metabolism. The rate and extent of drug absorption after intravaginal administration may vary depending on formulation factors, vaginal physiology, age of the patient. Peccaries, creams, gels, tablets, inserts and vaginal rings are commonly used dosage forms for vaginal drug delivery. The purpose of this communication is to provide the reader with a summary of advances made in the field of vaginal delivery with respect to preparations used in pregnancy and/or lactation., Poslednjih godina je u porastu interes za vaginalnu primenu lekova, kako sa lokalnim, tako i sa sistemskim delovanjem. Vagina omogućava niz prednosti kao mesto za primenu terapijskih sistema, kao što su jednostavnost pristupa, duže zadržavanje formulacije na mestu primene, velika površina permeacije, dobra vaskularizacija, relativno niska enzimska aktivnost i izbegavanje efekta metabolizma prvog prolaza. Brzina i obim apsorpcije nakon intravaginalne primene lekova zavisi kako od fizioloških, tako i od farmaceutsko-tehnoloških faktora vezanih za vrstu i sastav lekovitog oblika. U radu su prikazani intravaginalni terapijski sistemi namenjeni za primenu u trudnoći, za indukciju porođaja ili kod dojilja, sa posebnim osvrtom na nove sisteme: vaginalne inserte, vaginalne prstenove, bioadhezivne preparate.

Aim: The aim of the study was to investigate the swallow ability and the patient preferences of tablets and capsules with different sizes, shapes, surfaces and colours. Method: Patients were asked to swallow tablets with different surface and size, while tablets with different shape and colour were visually assessed. They were asked to indicate their preferences. Results: Gelatine capsules were found easier to swallow than tablets and coated tablets were found easier than uncoated normal tablets. The preferred colour was white both for tables and capsules, and the most disliked colours were purple tablets and brown capsules. The preferred shape was strongly arched circular for small tablets, oval for medium sized and big tablets. The difficulty to swallow tablets increased with increasing size. Conclusion: According to the results of this study, the ideal tablet is small and white, strongly arched circular and coated. If the amount of drug requires a bigger tablet, the preferred fomat is oblong or oval with a coating. In general capsules were preferred over tablets.

Aim: The aim of the study was to investigate the swallow ability and the patient preferences of tablets and capsules with different sizes, shapes, surfaces and colours. Method: Patients were asked to swallow tablets with different surface and size, while tablets with different shape and colour were visually assessed. They were asked to indicate their preferences. Results: Gelatine capsules were found easier to swallow than tablets and coated tablets were found easier than uncoated normal tablets. The preferred colour was white both for tables and capsules, and the most disliked colours were purple tablets and brown capsules. The preferred shape was strongly arched circular for small tablets, oval for medium sized and big tablets. The difficulty to swallow tablets increased with increasing size. Conclusion: According to the results of this study, the ideal tablet is small and white, strongly arched circular and coated. If the amount of drug requires a bigger tablet, the preferred fomat is oblong or oval with a coating. In general capsules were preferred over tablets.

A simple HPLC procedure, suitable for the determination of sodium fusidate (SF) in dosage forms, was developed. The method involves using a UV detector (208 nm) in the presence of basic buffered media (pH 7.25) under reversed-phase conditions (Supelcosil(R) LC18(TM), 3 mu m particles). The linear regression between the concentration of SF and the peak area, y = -4.4566 + 8.9238x with a coefficient of correlation r = 0.9985, was confirmed for SF in the concentration range from 25 mu g/ml to 150 mu g/ml. The detection limit of SF was 12.5 mu g/ml. The HPLC method was applied for the determination of SF in dosage forms: Stanicid(R) coated tablets, Stanicid(R) ointment and Stanicid(R) sterile gauze dressing. The concentrations and statistical parameters of sodium fusidate for all the investigated dosage forms were satisfactory and ranged from 100.41 to 105.39% (the R. S. D. ranged from 1.51 to 2.75%).