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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*, email@example.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.
Vol. 43, No. 1
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.