CONTEXT: Vitamin D is purported to offer wide ranging and numerous health benefits leading to increased interest from manufacturers of medicines and dietary supplements. Elderly patients frequently require vitamin D supplementation due to reduced sun exposure and dietary intake. There are ever increasing numbers of vitamin D formulations in the global market. However, due to a lack of regulatory restrictions for some of these products the quality of these dosage forms can be of some concern. OBJECTIVES: To study vitamin D formulations available in the global market and evaluate physic-chemical properties of selected formulations from the New Zealand market. METHOD: The first component of this study consisted of a search for different vitamin D formulations available in selected countries. The second component of the study involved assaying selected vitamin D formulations available in New Zealand. Vitamin D was extracted from capsule, tablet and emulsion formulations and quantified using a validated High Performance Liquid Chromatography (HPLC) method. RESULTS: Of the 14 analysed formulations, only 60% were within 100±10 % of the label claim. The two registered, prescription formulations available exhibited vitamin D levels of 90±4% and 97±2% of the labeled amount, while non-registered, non-prescription dietary supplements had vitamin D levels ranging from 8±2% to 201±29% of the labeled amount. CONCLUSIONS: Dietary supplements do not require strict regulation and showed a large variation in the percentage label claim of vitamin D. Prescription formulations which are more strictly regulated gave content values within standard acceptance ranges. Vitamin D has proven health benefits and also the potential to cause harm, therefore there is a need for tougher regulations of dietary supplements to ensure acceptable quality.
CONTEXT: Vitamin D is purported to offer wide ranging and numerous health benefits leading to increased interest from manufacturers of medicines and dietary supplements. Elderly patients frequently require vitamin D supplementation due to reduced sun exposure and dietary intake. There are ever increasing numbers of vitamin D formulations in the global market. However, due to a lack of regulatory restrictions for some of these products the quality of these dosage forms can be of some concern. OBJECTIVES: To study vitamin D formulations available in the global market and evaluate physic-chemical properties of selected formulations from the New Zealand market. METHOD: The first component of this study consisted of a search for different vitamin D formulations available in selected countries. The second component of the study involved assaying selected vitamin D formulations available in New Zealand. Vitamin D was extracted from capsule, tablet and emulsion formulations and quantified using a validated High Performance Liquid Chromatography (HPLC) method. RESULTS: Of the 14 analysed formulations, only 60% were within 100±10 % of the label claim. The two registered, prescription formulations available exhibited vitamin D levels of 90±4% and 97±2% of the labeled amount, while non-registered, non-prescription dietary supplements had vitamin D levels ranging from 8±2% to 201±29% of the labeled amount. CONCLUSIONS: Dietary supplements do not require strict regulation and showed a large variation in the percentage label claim of vitamin D. Prescription formulations which are more strictly regulated gave content values within standard acceptance ranges. Vitamin D has proven health benefits and also the potential to cause harm, therefore there is a need for tougher regulations of dietary supplements to ensure acceptable quality.
Authors: N Gueli; W Verrusio; A Linguanti; F Di Maio; A Martinez; B Marigliano; M Cacciafesta Journal: Arch Gerontol Geriatr Date: 2011-04-01 Impact factor: 3.250