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Yasvanth Ashokraj works in Integrated Product Development at CIPLA.
Prashant Modak works in Integrated Product Development at CIPLA.
Kalpesh Sawant work in Integrated Product Development at CIPLA.
Praveen Date works in Integrated Product Development at CIPLA.
Swati Laud works in Integrated Product Development at CIPLA.
This article demonstrates how qualitative physical attributes testing can be used to characterize soft gel capsule rupture/disintegration during rectal administration.
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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Submitted: Sept. 4, 2018
Accepted: Oct. 16, 2018
Yasvanth Ashokraj*, yasvanth.ashokraj@cipla.com, Swati Laud, Kalpesh Sawant, Prashant Modak, and Praveen Date all work in Integrated Product Development at CIPLA.
*To whom all correspondence should be addressed.
Pharmaceutical Technology
Vol. 43, No. 1
January 2019
Pages: 41–45
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.