IN VITRO EVALUATION OF DISSOLUTION PROFILE OF TWO COMMERCIALLY AVAILABLE FOLIC ACID PREPARATIONS
Keywords:
In vitro equivalence, Folic acid, Dissolution, Overage, USPAbstract
Objectives: Folic acid is a water-soluble B vitamin that is naturally present in some foods such as dark green leafy vegetables and dairy products, added to others such as fortified breads, and available as a dietary supplement. In a study performed in the United States, out of nine multivitamin products, only three products met US Pharmacopeia (USP) standard for folic acid dissolution. The aim of this study is to evaluate the dissolution profile of folic acid supplements in the United Arab Emirates according to the USP standards.
Methods: Two commercial brands were collected from the market that are commonly prescribed. Water and citrate buffer (pH 6.0) were used as dissolution media.
Results: Both products passed the dissolution testing of releasing the required amount of drug substance (75%) within 60 minutes. Also, both products contain an over age of up to 150% of the labeled amount to ensure the availability of the claimed amount.
Conclusion: The study indicates that dissolution test is well established, reproducible, reliable and valuable tool for characterizing a drug product at different stages in its lifecycle. The use of citrate buffer showed a significant change in the release of folic acid from the tablets.
Â
Downloads
References
Carmel R. Folic acid. In: Modern Nutrition in Health and Disease. M Shils, M Shike, A Ross, B Caballero, R Cousins, editors. 11th ed. Baltimore, MD: Lippincott Williams & Wilkins; 2005. p. 470-81.
Scholl TO, Johnson WG. Folic acid: influence on the outcome of pregnancy. Am J Clin Nutr 2000;71(5 Suppl):1295S-303S.
Institute of medicine (US) standing committee on the scientific evaluation of dietary reference intakes and its panel on folate, other b vitamins, and choline. dietary reference intakes for thiamin, riboflavin, niacin, vitamin b6, folate, vitamin b12, pantothenic acid, biotin, and choline. washington (DC): National academies press (US); 1998; Available from: http://www.ncbi.nlm.nih.gov/books/NBK114310/.
The office of dietary supplements folate. Dietary supplement fact sheet. [updated 2012 Dec 14;cited 2014 Dec 15]; Available from: http://ods.od.nih.gov/factsheets/Folate-Health Professional/#en2.
Nutritional Supplements. In: USP 23/NF 18. United States Pharmacopeial Convention, Rockville, MD; 1995. p. 2129-207.
Hoag SW, Ramachandruni H, Shangraw RF. Failure of prescription prenatal vitamin products to meet USP standards for folic acid dissolution. J Am Pharm Assoc (Wash) 1997;NS37(4):397-400.
Sculthorpe NF, Davies B, Ashton T, Allison S, McGuire DN, Malhi JS. Commercially available folic acid supplements and their compliance with the British Pharmacopoeia test for dissolution. J Public Health Med 2001;23(3):195-7.
Ottaway PB. The stability of vitamins in fortified foods and supplements. In: Food fortification and supplementation: technological, safety and regulatory aspects. Ottaway PB, editor. 1st ed. Cambridge, England: CRC; 2008. p. 88-106.
DeBernardi DP. Inventor; Shaklee Corporation, assignee. Folic acid in solid dosage forms. United States patent US; 2002.
Disintegration and dissolution of dietary supplements. In: USP 32/NF 27, Supplement 9. United states pharmacopeial convention, Rockville, MD; 2009. p. 782-5.
Matias R, Ribeiro PRS, Sarraguçaa MC, Lopes JA. A UV spectrophotometric method for the determination of folic acid in pharmaceutical tablets and dissolution tests. Anal Methods 2014;(6):3065-71.
Du J, Hoag SW. Characterization of excipient and tableting factors that influence folic acid dissolution, friability, and breaking strength of oil and water-soluble multivitamin with mineral tablets. Drug Dev Ind Pharm 2003;(29):1134–47.
Younis IR, Stamatakis MK, Callery PS, Meyer-Stout PJ. Influence of pH on the dissolution of folic acid supplements. Int J Pharm 2009;367(1-2):97-102.
Drugdex. Micromedex [Internet]; Greenwood Village, CO: Truven Health Analytics, Inc. 2014. Folic acid; [cited 2014 Oct 23]; Available from: http://www.micromedexsolutions.com.