RESUMEN
OBJECTIVE: Healthcare professionals lack the knowledge about the impact of formulations on treatment effectiveness. This is further complicated by the existence of dietary supplements containing the same active pharmaceutical ingredients (API) as drug formulations [e.g., alpha-lipoic acid (ALA)], to which the strict formulation testing requirements do not apply. This research aimed to compare ALA-containing drugs and dietary supplements through the determination of uniformity of content, disintegration time and dissolution rates. MATERIALS AND METHODS: A total of seven different ALA formulations (5 dietary supplements, 2 drugs) were tested for uniformity of content, disintegration time and dissolution rates. All tests were performed in accordance with the 10th European Pharmacopoeia. ALA was determined spectrophotometrically. RESULTS: Uniformity of content testing revealed larger variations of ALA content in three formulations of dietary supplements. Dissolution curves generated at 50 and 100 rpm differed significantly. Testing requirements were met only by one dietary supplement at 50 rpm, and one drug and two dietary supplements at 100 rpm. Disintegration testing showed limited impact on the release kinetic of ALA, as opposed to formulation type. CONCLUSIONS: Considering the lack of regulation on dietary supplement formulations and the variable success of them conforming to pharmacopoeial requirements, it is an imperative for stricter regulations on the dietary supplements' formulations to be imposed globally.
Asunto(s)
Ácido Tióctico , Humanos , Suplementos DietéticosRESUMEN
OBJECTIVES: The primary objectives were to assess the prevalence of dietary supplement (DS) use and to identify specific demographic and lifestyle characteristics of DS users from Novi Sad, Serbia as well as the most commonly used DS and reasons for their use. DESIGN: Observational, cross-sectional study. SETTING AND INTERVENTIONS: Data on demographics, lifestyle and dietary supplement use of 435 adults from Novi Sad, Serbia were collected using an online questionnaire. RESULTS: In total, 435 subjects completed the questionnaire (62.3% women). Prevalence of dietary supplement use in the sample was 42.8%. More women used DS than men (pâ¯=â¯0.002). Higher use of DS was reported among individuals 65+, while the young used DS less (pâ¯=â¯0.001), but the highest proportions of DS users was from the 45-54 age group. DS were used more among those with lower education levels (pâ¯<â¯0.001) and no income (pâ¯=â¯0.009). The highest percentages of DS users reported daily intakes of fruits and moderate physical activity, were non-smokers and social drinkers. Main reason for DS use was maintaining general health. The most commonly used DS were minerals and/or vitamins (68.8%). CONCLUSIONS: We report a high prevalence of dietary supplement use in Novi Sad. DS use was associated with being a female, being older and having minimal/average income, the latter being opposite of the usual findings. Our results warrant a more detailed examination of the association between income, DS use and healthcare availability in developing countries such as Serbia.