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.
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.
28 December 2023 in Current Medical Research and Opinion
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.