Milana Vuković

Laboratory education in pharmacy should enable students to perform analytical procedures and critically interpret findings within a broader professional context. This study proposes a three-hour multidisciplinary laboratory exercise for senior pharmacy students, revisiting complexometric titration previously learned in Analytical Chemistry through the analysis of commercial zinc dietary supplements. Students work in pairs to calculate apparent zinc contents using EDTA titration, process data, compare results with label claims, and apply pharmacopoeial content uniformity concepts as educational benchmarks. Guided discussion connects analytical findings with formulation composition, dietary supplement regulation, and the distinction between supplements and medicines. Preliminary experiments with acid-dissolved model zinc compounds assessed linearity, recovery, and selected excipient effects. Direct titration of five commercial supplements yielded apparent zinc contents corresponding to 95.79–136.84% of label claims. Quantitative recovery and freedom from matrix interference were not established for the commercial formulations; these results therefore support discussion of method limitations rather than confirmed assessments of product quality. The contribution lies in using an established, accessible technique to connect analytical chemistry, pharmaceutical technology, bromatology, and regulatory science through authentic samples and critical data interpretation. The proposed framework offers opportunities for multidisciplinary learning, while its educational effectiveness requires structured assessment.

Background/Objectives: Poor aqueous solubility limits the oral absorption and bioavailability of many active pharmaceutical ingredients. Simple formulation approaches suitable for hospital and community pharmacy compounding are therefore needed. This study aimed to develop and evaluate melt-filled hard capsules containing nifedipine, a model of poorly water-soluble BCS class II drug, using polyethylene glycol (PEG) carriers to improve dissolution performance. Methods: PEG blends of different molecular weights (PEG 400, PEG 1500, and PEG 4000) were prepared by melt mixing, followed by incorporation of nifedipine and manual filling into hard gelatin capsules. The formulations were characterized regarding mass variation, drug content, in vitro dissolution, rheological behavior, and solid-state properties using Fourier transform infrared (FTIR) spectroscopy. Dissolution profiles were kinetically modeled and compared with pure nifedipine. Results: All capsules met pharmacopoeial requirements for mass uniformity and showed acceptable drug content. PEG-based melt-filled formulations exhibited markedly enhanced dissolution compared with crystalline nifedipine. Faster drug release was associated with lower-molecular-weight PEGs and reduced viscosity, with the PEG 400/PEG 1500 blend demonstrating the most rapid dissolution. Rheological analysis confirmed shear-thinning behavior, while FTIR findings suggested intermolecular interactions and partial amorphization of nifedipine within the PEG matrices. Conclusions: This study provides a translational adaptation of solid dispersion principles into a compounding-compatible melt-filling approach.

Background: As the overall prevalence of dietary supplements (DS) use in pediatric populations is high, these products should be strictly regulated. However, regulatory frameworks for DS in the European Union and Serbia share inconsistencies and ambiguities which may compromise pediatric DS safety. Objective: To identify and critically assess the regulatory and practical issues in defining, labeling, advertising, and use of pediatric dietary supplements in the EU and Serbia. Methods: This review focused on identifying and assessing inconsistencies, gaps, and other regulatory challenges, as well as marketing practices affecting consumer safety through the assessment of legal and policy frameworks of the European Union and Serbia, and peer-reviewed articles, pertaining to the definition, labeling, and advertising of pediatric dietary supplements, that were assessed for contextual evidence on related, evidence-based, and practice-based information. Results: The analysis identified five critical areas of concern within the current regulations for pediatric DS: (i) the absence of universal and clear product definition, (ii) the lack of uniform, age-appropriate composition standards, (iii) potential safety risks related to ambiguous composition standards, arbitrary age cut-offs, and lack of age-appropriate reference values specific to DS, (iv) misuse of labels and unfair advertising practices, and (v) practical aspects of pediatric DS use and the limited role of healthcare providers in it. Conclusions: Regulating pediatric DS is a complex task due to the diversity of the pediatric population. Regulatory systems must be ready to swiftly resolve all inconsistencies and adjust to new scientific developments and market changes in order to ensure our primary goal—children’s health and safety.

Introduction: Topical ketoprofen formulations provide localized analgesic and anti-inflammatory effects while reducing systemic adverse events associated with oral administration. Franz diffusion cells, are widely used to evaluate the permeation and dissolution rate of active pharmaceutical ingredient in topical formulations.Aim: The aim of this study was to perform macroscopic and microscopic analysis of ketoprofen gel formulations available in the Republic of Serbia, to examine the in vitro release rate using 3D printed Franz cells, as well as to analyze the influence of the type of receptor medium on the release rate of ketoprofen.Material and Method: Two ketoprofen gel formulations were examined. Macroscopic and microscopic analysis were performed under normal and polarized light. Ketoprofen content was determined by UV/VIS spectrophotometry. In vitro release studies were carried out using 3D-printed Franz diffusion cells with synthetic membranes as diffusion barriers. Phosphate buffer pH 7.4 and 70% (v/v) ethanol were used as receptor media.Results: Both ketoprofen gels were transparent, and exhibited similar gloss. Formulation A demonstrated lower structural integrity and stickiness than Formulation B. The ketoprofen in both formulations was within ± 5% of the declared value. In vitro release test showed that Formulation A exhibited a faster release of ketoprofen compared to Formulation B in both phosphate buffer and ethanol. Formulation B had lower spreadability comparing to Formulation A.Conclusion: These results highlight the potential of 3D printed Franz diffusion cells in future for in vitro evaluation of authorized topical formulations in the Republic of Serbia, where different receptor media can be used, which further allows better comparison of formulations under different experimental conditions.

Liquid-filled hard gelatin capsules may have pertinent advantages both for therapeutic effect and extemporaneous preparations of medicines. Alpha lipoic acid is a substance used in medicines and dietary supplements and there is a need for creating an appropriate formulation which would be suitable for each individual patient or consumer. Based on its biopharmaceutical and physical chemical characteristics, eight different capsule formulations were designed and characterized. Silicon dioxide was added to form a semisolid content and prevent leakage. The formulation filled with alpha lipoic acid solution in polyethylene glycol 400 showed the best performance. Although the addition of silicon dioxide to the formulation with polyethylene glycol 400 led to a change in both flow character and viscosity, the release rate did not show a statistically significant decrease (more than 85% of content was released after 5 min testing). Applied technique is a simple and an appropriate approach for compounding and could be used for other substances with similar properties.

On the Serbian market, Alpha-lipoic acid (ALA) is available in 7 drug formulations and over 50 dietary supplements (DS). This study aimed to analyze and compare the consumption of ALA drugs and DS. The data on drug consumption were obtained from the annual reports of the Medicines and Medical Devices Agency of Serbia, while the data for DS were sourced from IMS Health's monthly audit reports. The consumption of ALA drugs significantly increased during 2010-2016 (R² = 0.753, F(1, 5) = 15.219, p = 0.011), with a notable drop observed in 2017. The consumption of ALA DS surged by 156.67% from 2018 to 2020, reaching 0.77 DDD/1000 inhabitants/day, with a notable increase observed at the end of 2020. From January to October 2021, the consumption doubled compared to the same period in 2020, reaching 1 DDD/1000 inhabitants/day. The increase in ALA drug consumption during 2010-2016 paralleled the registration and clinical adoption of ALA drugs. A significant drop in 2017 might have resulted from registering new ALA DS. However, during 2018-2020, ALA drugs were more commonly consumed compared to ALA DS. The increased consumption of ALA DS at the end of 2020 was associated with the COVID-19 epidemic. While both drugs and DS offer 600 mg ALA doses, only drug regulations ensure quality and efficacy, highlighting the need for stricter regulations on DS to enhance consumer safety and information.

Diabetes mellitus (DM) is a significant public health challenge in Serbia, mirroring the situation in other European middle-income countries. The aims of this study were to examine the disease-related characteristics and management of diabetes, as well as the prevalence of use of dietary supplements (DS) among diabetes patients in Serbia, and to analyze the effects of the coronavirus pandemic on DM patients in Serbia. The study was carried out as an online, observational, cross-sectional study involving 422 adult diabetes type 1 (DM1) and type 2 (DM2) patients residing in Serbia. DM1 patients were more likely than DM2 patients to self-control glucose levels (p < 0.001). Almost one-third of DM2 patients (31.4%) did not know their HbA1c value. Polypharmacy has been reported by 9.7% of DM1 patients and 23.5% of DM2 patients. During the coronavirus pandemic increased anxiety levels for one-third of respondents was noticed. The prevalence of DS use among DM patients was very high (95.3%), with vitamin C, zinc, vitamin D and magnesium being the most commonly used. Women were more likely to use vitamin D (p = 0.001) and magnesium DS (p = 0.005) than men. Most patients (76.9%) faced limited access to healthcare services during the coronavirus pandemic with, sometimes, detrimental consequences. A significant portion of respondents (41.2%) consulted a pharmacist more often in 2021 than in previous years. Special caution is needed regarding the potential interactions of DS with chronic therapy. To enhance diabetes care, Serbia needs more accessible mental health support, improved diabetes education, expanded CGM availability, and carefully planned emergency healthcare measures for chronic patients.