Posting Date: 28–Apr–2008
Reposting Date: 27–May–2011
Expert Committee: General Chapters—Dosage Forms
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, section 9.08(c), USP is postponing, for a third time, General Chapter <2040> Disintegration and Dissolution of Dietary Supplements, Dissolution Soft Gelatin Capsules official date to December 1, 2011.
Affected Text
The General Chapter, under Dissolution section, second paragraph (USP 34–NF 29, p. 874), retains the following text to exempt soft gelatin capsules from the Dissolution requirements. "Soft gelatin capsule preparations of dietary supplements meet the requirements for Disintegration." The text indicates that soft gelatin capsules will meet the requirements for Disintegration rather than the requirements for Dissolution:
Background
The aforementioned sentence to exempt Dissolution requirements for soft gelatin capsules was included by Interim Revision Announcement (IRA) revision effective on January 1, 1995 following the conclusions of the USP Open Conference on Nutritional Supplements held in Cambridge Massachusetts in May 1994. USP intended to indicate that soft gelatin capsules will meet the requirements for Disintegration rather than the requirements for Dissolution. Concomitantly with the IRA revision, USP also stated that "At a later date a revision may be proposed in PF to delete the sentence specifying that soft gelatin capsule preparations meet the requirements for Disintegration, and thereby implement the Dissolution requirements for all capsule preparations.
The proposal to delete the sentence was published in PF 32(6) [Nov–Dec 2006]. No negative comments were received for the proposal and therefore the sentence was deleted from USP 31–NF 27, which became official on May 1, 2008. Industry representatives responded that many dietary supplements formulated in soft gelatin capsules would not comply with the change by the official date. Therefore, the Dietary Supplements—Performance Standards Expert Committee and the Chair of the Council of Experts approved postponing the official date of the Dissolution requirements to May 1, 2009. After receiving further comments that requested an extension to permit time for validation of alternative Dissolution tests, a postponement of the official date to May 1, 2010 was implemented by Revision Bulletin posted in May 2009.
USP received further proposals for an alternative Dissolution Test with validation data from one sponsor and commitment from others to review the issue. At the beginning of the revision process, the estimated date for official adoption of the new proposal for alternative dissolution test was August 1, 2011, when First Supplement to USP 34–NF 29 becomes official. Since the revision process for the proposal for alternative dissolution test has been extended, the date for official adoption is now December 1, 2011, together with the Second Supplement to USP 34–NF 29. Corresponding with the new official date for the new alternative dissolution test, the General Chapters—Dosage Forms Expert Committee has approved this revised postponement date for the exemption of dissolution requirements for soft gelatin capsules until December 1, 2011.
Should you have any questions, please contact Dr. Gabriel Giancaspro, Director, Dietary Supplements (301-816-8343 or gig@usp.org).