Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

Soft gelatin capsules (SGC) are popularly used pharmaceutical dosage forms, whose critical quality attributes are efficient opening/rupture, disintegration, and dissolution. Unlike oral capsules, however, rectal capsules must dissolve in minimal fluid and hydrodynamics, without digestive enzymes to break down the crosslinking of gelatin if any. Therefore, a reliable biomimetic method is needed to characterize SGC rupture/disintegration during rectal administration. This article demonstrates how qualitative physical attributes testing, a method that has recently been approved for use by the World Health Organization, can be used to achieve these goals.

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Peer-Reviewed

Submitted: Sept. 4, 2018
Accepted: Oct. 16, 2018

About the author

Yasvanth Ashokraj^*, [email protected], Swati Laud, Kalpesh Sawant, Prashant Modak, and Praveen Date all work in Integrated Product Development at CIPLA.

^*To whom all correspondence should be addressed.

Article Details

Pharmaceutical Technology
Vol. 43, No. 1
January 2019
Pages: 41–45

Citation

When referring to this article, please cite it as Y. Ashokraj et al., “Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules,” Pharmaceutical Technology 43 (1) 2019.