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Evaluation of vitamin D medicines and dietary supplements and the physicochemical analysis of selected formulations

The journal of nutrition, health & aging volume 17, pages 158–161 (2013)Cite this article

Abstract

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.

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Authors and Affiliations

  1. School of Pharmacy, University of Auckland, Auckland, New Zealand

    Sanjay Garg, D. Sabri, J. Kanji, P. S. Rakkar, Y. Lee, N. Naidoo & D. Svirskis

  2. School of Pharmacy and Medical Sciences, University of South Australia, Adelaide, Australia

    Sanjay Garg

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  1. Sanjay Garg
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  2. D. Sabri
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Correspondence to Sanjay Garg.

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Garg, S., Sabri, D., Kanji, J. et al. Evaluation of vitamin D medicines and dietary supplements and the physicochemical analysis of selected formulations. J Nutr Health Aging 17, 158–161 (2013). https://doi.org/10.1007/s12603-012-0090-4

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  • DOI: https://doi.org/10.1007/s12603-012-0090-4

Key words

  • Vitamin D
  • stability
  • analysis
  • marketed vitamin formulations