Table of Contents
ISRN Pharmaceutics
Volume 2013, Article ID 458625, 4 pages
http://dx.doi.org/10.1155/2013/458625
Research Article

Stability of Betaine Capsules

1Faculty of Pharmacy, Université de Montréal, P.O. Box 6128, Downtown Station, Montreal, QC, Canada H3C 3J7
2CHU Ste-Justine, 3175, ch. de la Côte-Sainte-Catherine, Montreal, QC, Canada H3T 1C5

Received 22 April 2013; Accepted 22 May 2013

Academic Editors: J. Lee, Y. Murata, A. I. Segall, and V. Tantishaiyakul

Copyright © 2013 Mirza Akram Hossain et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Betaine is used to treat homocystinuria and is not available in Canada as a formulated drug. In order to facilitate the administration of this compound to patients, a capsule formulation and an evaluation of its stability were required. Capsule formulations of betaine were developed (160 mg and 625 mg of betaine per capsule). As betaine has no chromophore, an HPLC-ELSD analytical method was also developed. The critical quality attributes of these formulations were evaluated (content assay, content uniformity, and dissolution) as well as their stability. Capsules with acceptable quality attributes were produced. These capsules remained stable for 1 year when stored in airtight containers at controlled room temperature. However, shelf life decreased dramatically in nonairtight containers at 30°C (3 months for the lactose-containing capsules of 160 mg and 6 months for the capsules of 625 mg).