Antimicrobial and Cytotoxic Activity of Novel Imidazolium-Based Ionic Liquids.

In this study, a series of 10 novel 1-methyl-3-octyloxymethylimidazolium derivatives carrying various anionic moieties (4-hydroxybenzenesulfonate, benzenesulfonate, carvacroloxyacetate, chloride, formate, propionate, thymoloxyacetate, vanillinoxyacetate, eugenoloxyacetate and trimethylacetate) were synthesized. Compounds were tested for their antimicrobial activity against six microbe strains (Staph-ylococcus aureus, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli, Enterococcus faecalis, and Candida albicans), cytotoxic activity against the mouse melanoma cell line (B16 F10), and surface active properties. All synthesized compounds exhibited antimicrobial activity (expressed as minimum inhibitory concentration; in range of 0.10-27.82 mM/L), especially against Gram-positive bacteria and fungi. In addition, all compounds demonstrated cytotoxicity on B16 F10 cells (IC50 values 0.0101-0.0197 mM/L). Surface properties defined as CMC values, ranged from 0.72 to 32.35 mmol L-1. The obtained results provide an insight into the promising activity of a novel group of quaternary imidazolium derivatives having ionic liquid properties. The most potent compounds, containing a thymoloxyacetate and eugenoloxyacetate moiety, could be candidates for new antimicrobial agents or surfactants.

Structure-Activity Relationships of the Imidazolium Compounds as Antibacterials of Staphylococcus aureus and Pseudomonas aeruginosa.

This paper presents the results of structure-activity relationship (SAR) studies of 140 3,3'-(α,ω-dioxaalkan)bis(1-alkylimidazolium) chlorides. In the SAR analysis, the dominance-based rough set approach (DRSA) was used. For analyzed compounds, minimum inhibitory concentration (MIC) against strains of Staphylococcus aureus and Pseudomonas aeruginosa was determined. In order to perform the SAR analysis, a tabular information system was formed, in which tested compounds were described by means of condition attributes, characterizing the structure (substructure parameters and molecular descriptors) and their surface properties, and a decision attribute, classifying compounds with respect to values of MIC. DRSA allows to induce decision rules from data describing the compounds in terms of condition and decision attributes, and to rank condition attributes with respect to relevance using a Bayesian confirmation measure. Decision rules present the most important relationships between structure and surface properties of the compounds on one hand, and their antibacterial activity on the other hand. They also indicate directions of synthesizing more efficient antibacterial compounds. Moreover, the analysis showed differences in the application of various parameters for Gram-positive and Gram-negative strains, respectively.

Cost-effectiveness analysis of lung cancer screening with low-dose computerised tomography of the chest in Poland.

AIM OF THE STUDY: To determine the cost-effectiveness of lung cancer (LC) screening with low-dose computerised tomography of the chest, as compared to an approach without screening, reimbursed today by the National Health Fund (NHF) in Poland. MATERIAL AND METHODS: In order to analyse the current costs of diagnostic and therapeutic procedures of a model LC patient treated today, a model group consisting of 199 consecutive patients diagnosed and treated in the Oncology Centre in Bydgoszcz, Poland from January 2007 to April 2010 was used. The number and type of performed procedures in this group was obtained from the Polish Register of Neoplasms and the NHF. Only direct medical costs were analysed. To calculate the total costs of screening, diagnostics, and treatment of the hypothetical LC patient who would have cancer diagnosed with screening CT, data from the literature and costs calculated for the model group were used. Prices of procedures were obtained from the price list of the NHF on 30 April 2010 and did not change from that time until June 2014. One-way sensitivity analysis was performed. RESULTS: The average cost per LC patient, diagnosed and treated without screening, is 5567.50 EUR, and median LC-specific survival is one year. In the hypothetical LC patient with cancer diagnosed by screening, the average cost is 13689.35 EUR per LC patient, with a median LC-specific survival of at least seven years. A calculated incremental cost-effectiveness ratio (ICER) is 1353.64 EUR/year of life gained. CONCLUSIONS: Lung cancer screening with low-dose CT would be highly cost-effective in Poland.

Topical application of simvastatin acid sodium salt and atorvastatin calcium salt in vitiligo patients. Results of the randomized, double-blind EVRAAS pilot study.

Contemporary treatment of vitiligo remains a great challenge to practitioners. The vast majority of currently conducted clinical trials of modern therapeutic methods are focused on systemic medications, while there is only a very limited number of reports on new topical treatment in vitiligo. With their pleiotropic activities statins turned out to be efficient in the treatment of various autoimmune/autoinflammatory disorders. The randomized, double-blind placebo-controlled study of topical administration of the active forms of simvastatin and atorvastatin has been designed to evaluate their efficacy in patients with vitiligo. The study was registered in clinicaltrials.gov (registration number NCT03247400, date of registration: 11th August 2017). A total of 24 patients with the active form of non-segmental vitiligo were enrolled in the study. The change of absolute area of skin lesions, body surface area and vitiligo area scoring index were evaluated throughout the 12 week application of ointments containing simvastatin and atorvastatin. Measurements were performed with planimetry and processed using digital software. Use of active forms of simvastatin and atorvastatin did not result in a significant repigmentation of the skin lesions throughout the study period. Within the limbs treated with topical simvastatin, inhibition of disease progression was significantly more frequent than in the case of placebo (p = 0.004), while the difference was not statistically significant for atorvastatin (p = 0.082). Further studies of topical simvastatin in vitiligo patients should be considered.

Public Perception of Pharmacists in Poland.

BACKGROUND: Pharmacists constitute one of the largest groups of medical professionals and play a significant role in public health. Pharmaceutical care in community pharmacies is one of the key elements that impact the clinical outcomes of patients. The main objective of this study was to evaluate the public perception of pharmacists in Poland, as well as the knowledge of and willingness of Polish people to use pharmaceutical care services. METHODS: This study was carried out in 2017 on 1435 people. The research tool was an anonymous online questionnaire. RESULTS: Of the participants, 61% considered pharmacists to have a position of public trust, and 25% trusted pharmacists to a lesser extent than representatives of other medical professions. The participants stated that pharmacists were kind (74%) and helpful (69%). For 52% of the participants, pharmacists were fully competent to provide information on medications. Twenty-eight percent of the participants ask pharmacists for advice related to medicinal products. Poles' knowledge on pharmaceutical care was low (44% of the respondents knew this notion). Sixty-six percent of the participants were willing to use pharmaceutical consultations (43% free of charge, and 23% for a nominal fee). CONCLUSIONS: Although the overall perception of patients towards pharmacists was positive in Poland, it is essential to educate patients on the possibilities of using pharmaceutical services, and to promote the role of pharmacists in healthcare systems.

The Quality and Reliability of Information in the Summaries of Product Characteristics.

The Summary of Product Characteristics (SmPC) is an obligatory document concerning a medicine required (among other things) for the authorization of a medicinal product. The purpose of the SmPC is to provide product information to healthcare professionals. A necessary condition for this is to ensure that the SmPC is clear and precise. However, neither European nor national legislation obliges marketing authorization holders to review the SmPC in terms of its readability and understandability prior to the registration of a medicine. To date, research on SmPCs has focused on accuracy and completeness; however, the literature lacks information on the extent to which SmPCs meet the needs of healthcare professionals concerning the readability of the information they contain. The main objective of this article is to point out the lack of precision in the legal provisions for the preparation of SmPCs concerning the comprehensibility of the provisions. The article points to the lack of testing of the SmPC in terms of accessibility and transparency for healthcare professionals, highlighting that the document does not meet the needs of healthcare professionals in providing adequate information about medicines. It shows that the current rules and guidelines for the preparation of the registration dossier for a medicinal product are not entirely precise and contain numerous shortcomings.

Deploying and Maintaining Standards of New Pharmacy Services Provision in Poland-Introducing the National Pharmacist Competencies Assessment Tool: Pre-Registration Exam-Results of the Pilot Project.

Despite the functioning of the Bologna Declaration, the knowledge and skills of graduates educated in different countries may differ significantly. Therefore, this article aims to present the differences in results of the final exam in pharmacy among Polish pharmacy students. This exam was modeled on the British national exam supervised by the General Pharmaceutical Council. The exam was conducted in three cities in Poland, among a total of 175 final-year students (a full sample of those eligible was 451 with 276 refusals (38.58% response rate)). Taking the exam was voluntary and anonymous. The results indicate that none of the Polish students achieved the 70% mark required to pass the Great Britain exam. Significant differences in test results were noticed between cities. Students achieved the best average exam result in Bydgoszcz (46.35%), then in Warsaw (38.81%) and Lódz (38.35%). The pharmaceutical education system in Poland requires complete changes that will prepare future pharmacists for clinical work.

Implementation of the Patient Counselling Service at the Cancer Hospital in Radom, Poland.

Background: Non-adherence occurs in various groups of patients, including those with chronic diseases. One strategy to increase adherence among oncological patients is to individualise treatment and expand pharmaceutical care. Pharmaceutical labels that remind patients how they should take their medications are of great importance in this respect. Objective: The main objective of this study was to evaluate medication adherence in oncological patients, and to gather their opinions on the individual medication labelling system as an element of effective treatment. Methods: The study was conducted in 2021 among 82 patients of the oncological department of the Centre of Oncology in Radom. The research tool was a questionnaire consisting of personal data and two parts relating to the patient's disease and the medication labelling system. Results: Nearly half of the respondents reported that they forget to take medications and how they should take them. These problems increased with the age of the patient and the number of administered medications. Of the respondents, 89% stated that the labels with dosing information are helpful. Over 67% agreed that these labels should be affixed to all medications. Nearly 90% of the respondents believed the labels should be available in all pharmacies. Conclusions: Non-adherence is a common phenomenon among oncological patients. Pharmacists providing a labelling service for medicinal products can play a significant role in reducing this phenomenon.

Access to Medicines via Non-Pharmacy Outlets in European Countries-A Review of Regulations and the Influence on the Self-Medication Phenomenon.

Non-pharmacy trade concerns the sale of medicinal products outside of pharmacies, such as limited-service pharmacies, supermarkets, petrol stations, shops open to the public, and kiosks. Access to medicinal products via non-pharmacy outlets varies across the European countries, with a general deregulation of this market area observable. Increasing the availability of medicines by allowing patients to obtain them outside of pharmacies contributes to the spread of self-medication. The aim of this article was to review the legal regulations enabling the non-pharmacy trade in OTC (over the counter) medicinal products in European countries, with particular emphasis on the analysis of active substances contained in medicines available in the non-pharmacy trade. This analysis has made it possible to distinguish three categories of countries: (1) where there is a non-pharmacy trade in OTC medicinal products, (2) where there is a limited non-pharmacy trade in OTC medicines, (3) where there is only a pharmacy trade in OTC medicinal products. In the context of these considerations, we highlight the impact of patient access to medicinal products via non-pharmacy sources on raising the prevalence of self-medication. This article identifies the advantages and risks of self-medication, emphasising the role of the pharmacist as an advisor to patients within the scope of the therapies used.

The Awareness of Risks Associated with OTC Drugs Available in Non-Pharmacy Outlets among Polish Patients-A Cross-Sectional Study.

BACKGROUND: Many OTC drugs are available in non-pharmacy outlets, and as such the risk of overuse and/or improper use of this class of drugs is more likely. In light of this observation, our study was conducted with the aim of exploring opinions on non-pharmaceutical distribution among Polish patients. This study was a part of an informative project to educate patients about the possible risks associated with the use of OTC medicines. METHODS: We conducted a cross-sectional study among Polish patients in which we used an authorial questionnaire, previously tested via content, face validity, and a pilot study. The questionnaire was distributed both electronically and in a traditional form. RESULTS: 'Time saving' had a statistically significant role in the patient's decision about purchasing drugs in a non-pharmacy outlet (p = 0.0052; R = 0.276994). The lack of a pharmacist's consultation/advice (p = 0.0072; R = -0.3290490), improper storage (p = 0.0044; R = -0.238246), risk of overdose (p = 0.0125; R = -0.189564), and the risk of purchasing out-of-date drugs (p = 0.0125; R = -0.145411), as well as the risk of purchasing falsified drugs (p = 0.0265; R = -0.159428), were all associated with the patient's non-willingness to purchase drugs in non-pharmacy outlets. Patients supported the idea of the elimination of non-pharmacy outlet distribution (p = 0.0074; R = -0.195932); they also emphasized that they are advocates of purchasing drugs only in community pharmacies (p = 0.0006; R = -0.238625). CONCLUSION: Patients are aware of the risks associated with buying drugs outside of community pharmacies. They perceived pharmacists as professional health care advisors and supported the fact that OTC drugs should be available only via pharmaceutical distribution.

Patient counselling service with the use of pictograms as the example of pharmacist intervention to improving compliance and medicine safety.

BACKGROUND: Pharmaceutical pictograms have been designed to help communicate medication instructions to patients. Pictograms used within a patient counseling service can significantly improve medication compliance and adherence. The study aimed to assess the improvement of adherence to therapy with the use of pictogram intervention in comparison to standard pharmacy practice in community pharmacies. METHODS: Pictograms informing about the proper way of using metoprolol prolonged release tablets were designed to be used on the packages of the drug in community pharmacies. Pharmacies belonging to a pharmacy practice-based research network were randomly assigned to a group using pictograms when dispensing the drug or one following their normal practice. At the first visit, all patients answered a structured questionnaire about their medication behavior in the preceding 7 days. The same questions were asked 4 weeks later to follow-up treatment adherence change and compare patients from pictogram group and standard practice group. Descriptive statistics was used to analyze the data, and the McNemar test was used to compare categorical data at baseline and follow-up. RESULTS: Of a total of 253 patients screened, 117 and 104 patients completed the study in the standard practice and pictogram groups, respectively. The use of pictograms significantly improved medication adherence in the following areas: not omitting doses (p < 0.0001), not crushing tablets (p = 0.004), number of tablets/day (p = 0.49), and time of use (p = 0.001), compared to the standard practice group. CONCLUSIONS: Our results suggest that pictograms are effective in conveying messages about the proper way of using medications, and they increase treatment adherence, in comparison to standard dispensing practice.

Quality of Pharmaceutical Services in Independent Pharmacies and Pharmacy Chains in Poland from the Patient Perspective.

INTRODUCTION: Patient satisfaction is a key factor in the evaluation of the quality of healthcare services. Measuring patient satisfaction is common in outpatient, specialist, and hospital healthcare, and is also significant in relation to pharmaceutical services. The pharmacy market in Poland has been undergoing transformations for many years. Legal regulations implemented in 2002 resulted in a rapid growth of pharmacy chains and a decrease in the number of independent pharmacies. This situation may have translated into changes in the quality of pharmaceutical services. OBJECTIVE: The objective of this study was to evaluate patient satisfaction with services provided in independent pharmacies and pharmacy chains in Poland. PATIENTS AND METHODS: A total of 163 patients using randomly selected community pharmacies in Poland were enrolled in the study. A modified Community Pharmacy Patient Questionnaire (CPPQ) was used. RESULTS: The patients highly valued pharmaceutical services provided in Polish pharmacies. The level of service was slightly higher in pharmacy chains. The lowest-rated area was the provision of information on medications, with independent pharmacies higher-rated in this respect. The patients were open to additional services in pharmacies and supported the development of pharmaceutical care. CONCLUSION: Independent pharmacies and pharmacy chains ensure a similar level of services for patients in Poland. Pharmacy staff should place a special emphasis on providing patients with comprehensive information on medications. The development of pharmaceutical care in Poland will require appropriate legislative preparation.

Application of Dominance-Based Rough Set Approach for Optimization of Pellets Tableting Process.

Multiple-unit pellet systems (MUPS) offer many advantages over conventional solid dosage forms both for the manufacturers and patients. Coated pellets can be efficiently compressed into MUPS in classic tableting process and enable controlled release of active pharmaceutical ingredient (APIs). For patients MUPS are divisible without affecting drug release and convenient to swallow. However, maintaining API release profile during the compression process can be a challenge. The aim of this work was to explore and discover relationships between data describing: composition, properties, process parameters (condition attributes) and quality (decision attribute, expressed as similarity factor f2) of MUPS containing pellets with verapamil hydrochloride as API, by applying a dominance-based rough ret approach (DRSA) mathematical data mining technique. DRSA generated decision rules representing cause-effect relationships between condition attributes and decision attribute. Similar API release profiles from pellets before and after tableting can be ensured by proper polymer coating (Eudragit® NE, absence of ethyl cellulose), compression force higher than 6 kN, microcrystalline cellulose (Avicel® 102) as excipient and tablet hardness ≥42.4 N. DRSA can be useful for analysis of complex technological data. Decision rules with high values of confirmation measures can help technologist in optimal formulation development.

Artificial neural networks in prediction of antifungal activity of a series of pyridine derivatives against Candida albicans.

Quantitative structure-activity relationships (QSAR) studies of antifungal activity against Candida albicans of a large series of new pyridine derivatives were conducted with the use of artificial neural networks (ANNs). The application of ANNs has been provided with respect to the prediction of antimicrobial potency of new pyridine derivatives based on their structural descriptors generated by calculation chemistry. Antifungal activity against C. albicans has been related to a number of physicochemical and structural parameters of the pyridine derivatives investigated. The activity was expressed as logarithm of the reciprocal of the minimal inhibitory concentrations, log 1/MIC. Molecular descriptors of agents were obtained from structure fragment reference databases and by quantum-chemical calculations combined with molecular modeling. A high correlation resulted between the ANN predicted antifungal activity, log 1/MIC(pred), and that one from biological experiments, log 1/MIC(exp), for the data used in the testing set of pyridine was obtained with correlation coefficient, R, on the level of 0.9112.

The Evaluation of Vitiligous lesions Repigmentation after the Administration of Atorvastatin calcium salt and Simvastatin-acid sodium salt in patients with active vitiligo (EVRAAS), a pilot study: study protocol for a randomized controlled trial.

BACKGROUND: Vitiligo is a chronic skin disorder presenting with depigmentation, the pathogenesis of which is complex but the autoimmune theory is now preferred. Multiple immunologic processes, including stimulation of the T-helper (Th)1 response, formation of autoreactive melanocyte-specific CD8+ T lymphocytes, a decrease in the blood concentration of T regulatory (Treg) cells, and an increase in interleukin (IL)-17 and interferon (IFN) concentration, have been shown to contribute to vitiligo progression and maintenance. The aim of this study is to evaluate the influence of simvastatin and atorvastatin on vitiligous lesions in patients with nonsegmental vitiligo (NSV). According to available data, statins act through several immunological pathways, potentially reversing undesirable phenomena underlying autoimmune vitiligo pathogenesis. METHODS/DESIGN: A study has been designed as a single-center, randomized, double-blind, placebo-controlled pilot study with the enrollment of at least 24 active NSV patients presenting with vitiligous lesions on both upper and lower limbs. The clinical effects of ointments containing 1% simvastatin-acid sodium salt or 1% atorvastatin calcium salt applied on a preselected limb will be assessed in comparison with vehicle ointment applied on the opposite limb. All study participants will undergo clinical evaluation using body surface area (BSA) and Vitiligo Area Scoring Index (VASI) scales at baseline and at weeks 4, 8, and 12 time points. A precise assessment of skin lesions will be performed using photographic documentation obtained during each study visit and processed with NIS-Elements software. DISCUSSION: Currently available vitiligo topical therapeutic approaches including calcineurin inhibitors and corticosteroids remain poorly effective and are associated with either relatively high cost or potentially dangerous adverse effects. The clinical application of orally administrated statins, widely used as systemic cholesterol-lowering agents, in vitiligous patients has only been tested in two clinical trials; however, data on their potential usefulness is scarce. Moreover, due to a high risk of clinically significant toxicity, topical administration was recommended by researchers. This study is the first to evaluate safety and efficacy of the topical use of statins in patients presenting with NSV. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03247400 . Registered on 05 August 2017.

Patients' Perspective And Usefulness Of Pictograms In Short-Term Antibiotic Therapy - Multicenter, Randomized Trial.

PURPOSE: To evaluate the practical utility of pharmaceutical pictograms in routine practice in community pharmacy. The primary outcome (composite endpoint) consisted of three elements: i) complete use of the whole package of medication, ii) taking the recommended dose twice a day, and iii) subjective assessment of patients' perspective on medical information about antibiotic therapy obtained during the pharmacy consultation measured by Net Promoter Score in scale from 1 to 10 where 1 is the lowest and 10 the highest possible rating. PATIENTS AND METHODS: A multicenter, randomized controlled study was conducted. Community pharmacies (n = 64) which agreed to participate in the study were assigned to one of two groups: i) study - providing an antibiotic with pictograms placed on the external packaging of the medicinal product containing information about drug regimen (n = 32); or ii) control - providing an antibiotic according to usual pharmacy practice (n = 32). Two semi-structured interviews were performed. Data were collected from 199 patients with a mean age ± SD of 45.5 ± 17.0 years. RESULTS: In the control group, 15.7% of participants discontinued therapy before using the whole package compared with 13.4% of participants in the study group. In the control group, 81.3% of patients reported that they always took the medication twice a day as recommended by their healthcare providers compared with 80.4% of patients in the study group. The Net Promoter Score was higher for pharmacy practice with than without pictograms (71.3% vs 51.5%, respectively, p<0.005). The chance that a patient was an advocate of pharmaceutical services (scores 9 and 10) was twice as likely in the case of pharmaceutical practice supported by pictograms (p<0.02). The composite endpoint was achieved more frequently in the population using pictograms, however this difference was not statistically significant (p<0.34). CONCLUSION: The pharmaceutical pictograms are readily accepted by patients and could prove to be a valuable support for pharmacists in conducting pharmaceutical care. Further representative research is needed to evaluate the true effectiveness of this solution.

Optimization of pellets manufacturing process using rough set theory.

Pharmaceutical pellets are spherical agglomerates manufactured in extrusion/spheronization process. The composition of the pellets, the amount of active pharmaceutical ingredient (API) and the type of used excipients have an influence on the shape and quality of dosage form. A proper quality of the pellets can also be achieved by identifying the most important technological process parameters. In this paper, a knowledge discovery method, called dominance-based rough set approach (DRSA) has been applied to evaluate critical process parameters in pellets manufacturing. For this purpose, a set of condition attributes (amount of API; type and amount of excipient used; process parameters such as screw and rotation speed, time and temperature of spheronization) and a decision attribute (quality of the pellets defined by the aspect ratio) were used to set up an information system. The DRSA analysis allowed to induce decision rules containing information about process parameters which have a significant impact on the quality of manufactured pellets. Those rules can be used to optimize the process of pellets manufacturing.

The evaluation of pharmaceutical pictograms among elderly patients in community pharmacy settings - a multicenter pilot study.

INTRODUCTION: The search for new ways to optimize the use of medications by patients has led the pharmaceutical community to promote the idea of introducing pictograms into routine practice. The main intention of pictograms is to ease patient adherence and to reduce potential risks or errors associated with the use of medications. PURPOSE: To evaluate a series of pharmaceutical pictograms for patient comprehension. PATIENTS AND METHODS: The study was conducted in community pharmacies within a European Union country that belongs to the professional research network. Structured interviews were used to evaluate the pictograms for patient comprehension. This consisted of an assessment of the following: the transparency and translucency of the pictograms, health literacy, and pictogram recall. Participants were also given the opportunity to provide feedback on how to improve the pictograms. The primary endpoint was pictogram comprehension. Secondary outcomes included recall of the pictograms and pictogram translucency. RESULTS: The study included 68 patients with whom face-to-face interviews were performed. Low transparency results (≤25%) and extensive patient feedback in initial interviews led to the withdrawal of certain pictograms (n=15) from the evaluation. Among the pictograms included in the final stage of our research, 22 pictograms (62.8%) obtained an acceptable transparency level ≥66%. All pictograms passed the short-term recall test with positive results. CONCLUSION: A majority of the designed and modified pictograms reached satisfactory guess-ability scores. Feedback from patients enabled modification of the pictograms and proved that patients have an important voice in the discussion regarding the design of additional pictograms.

Awareness of the implementation of the Falsified Medicines Directive among pharmaceutical companies' professionals in the European Economic Area.

BACKGROUND: The Falsified Medicines Directive (FMD) is a response of the European Union to the increasing number of falsified medicines present in the legal supply chain within the Member States of the community. Effective implementation of the new regulations will depend on the effective cooperation of all parties involved in the distribution of medicinal products including the managers of pharmaceutical companies. OBJECTIVE: The objective of the study was to examine awareness of the Implementation of the FMD among pharmaceutical company professionals in the European Economic Area. METHODS: Sampling was conducted using a method called purposive sampling. An appropriate research tool in the form of an original questionnaire was made available to the respondents in electronic form. During the period from January 2016 to June 2016, 1,496 e-mail messages were sent. The response rate was 17.37%. RESULTS: The study included 99 women (39.3%) and 153 men (60.7%). In the study group, 95.7% of people had heard of FMD. Doctors had rarely heard about the falsified medicine directive when compared to pharmacists (p=0.0063), people working in the pharmaceutical industry (p=0.0014), and respondents with a different professional profile (p=0.0114). In the study group, 89.6% of people were aware of the role of National Medicines Verification Organization in the process of implementing the provisions of FMD into the national system of distribution of medicinal products. The number of the respondents who knew the deadline for the implementation of FMD was significantly higher in the study population, i.e. 91.9% (p=0.0001). Both the younger respondents and those with lower level of education were less aware of the time requirements posed to national regulators (p=0.0003, p=0.0023, respectively). CONCLUSIONS: Awareness of the regulations related to the implementation of the FMD, although relatively high among pharmaceutical company professionals in the EEA, is still insufficient.

Development and optimization of the activated charcoal suspension composition based on a mixture design approach.

In this study, a new drug product containing activated charcoal was designed and developed. The excipient levels in the pharmaceutical formulation were optimized using a mixture design approach. The adsorption power of the activated charcoal suspension was selected as the critical quality attribute influencing the efficacy of medical treatment. Significant prognostic models (p<0.05) were obtained to describe in detail the interrelations between excipient levels and the adsorption power of the formulation. Liquid flavour had a critical impact on the adsorption power of the suspension. Formulations containing the largest amount of liquid flavour showed the lowest adsorption power. Sorbitol was not adsorbed onto activated charcoal so strongly as liquid flavour. A slight increase in the content of carboxymethylcellulose sodium led to a marked decrease in adsorption power. The obtained mathematical models and response surface allowed selection of the optimal composition of excipients in a final drug product.