HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS		QUICK SEARCH:   [advanced] Author: Keyword(s): Year:  Vol:  Page:

This Article Full Text Full Text (PDF) Submit a response Alert me when this article is cited Alert me when eLetters are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Poon, I. O. Articles by Liang, D. Search for Related Content PubMed PubMed Citation Articles by Poon, I. O. Articles by Liang, D.

IVY O. POON, PHARM.D., BCPS, is Assistant Professor of Pharmacy Practice, College of Pharmacy and Health Sciences, Texas Southern University (TSU), Houston. DIANA S.-L. CHOW, PH.D., is Associate Professor of Pharmaceutics, College of Pharmacy, University of Houston, Houston. DONG LIANG, PH.D., is Associate Professor of Pharmaceutics, College of Pharmacy and Health Sciences, TSU.

Address correspondence to Dr. Liang at the College of Pharmacy and Health Sciences, Texas Southern University, 3100 Cleburne Street, Houston, TX 77004 (liang_dx{at}tsu.edu).

Purpose. The dissolution profiles of nonprescription extended-release niacin and inositol niacinate products were studied using the prescription extended-release niacin, Niaspan, as a reference. Methods. Seven nonprescription extended-release and 12 nonprescription inositol niacinate products were collected from community and online pharmacies in the United States. Extended-release Niaspan was used as a reference. Dissolution profiles were examined by the United States Pharmacopeia dissolution test, using a paddle method. Release samples were removed every 30 minutes for up to 240 minutes. Niacin was quantified by high-performance liquid chromatography. Results. Ten out of the 12 inositol niacinate products were capsules and 6 of the 7 extended-release formulations were tablets. During the initial 30-minute dissolution study of inositol niacinate products, free niacin was released to various degrees. One product achieved fast dissolution, with >30% cumulative release of niacin. The cumulative percentage of niacin released at 240 minutes of all inositol niacinate products was statistically different (p < 0.0001). The majority of these products reached a plateau of releasing niacin in one to two hours, which was maintained until the end of the study. Six out of the seven extended-release niacin products had extended-release profiles. Five products showed a statistically higher dissolution rate (p < 0.05) than that of Niaspan. Conclusion. Significant variations in dissolution profiles were noted among the 7 nonprescription extended-release and 12 nonprescription inositol niacinate products in vitro, and their dissolution rates were not comparable to that of the prescription extended-release niacin. Further studies are warranted to correlate such dissolution data with their in vivo efficacy. Index terms: Antilipemic agents; Control, quality; Dissolution rates; Dosage forms; Drugs, over the counter; Formulations; Inositol niacinate; Niacin; Release; Sustained-action medications