Evaluating a New Quality Control Test for Soft Gelatin Rectal Capsules

January 2, 2019
Yasvanth Ashokraj

Yasvanth Ashokraj works in Integrated Product Development at CIPLA.

,
Prashant Modak

Prashant Modak works in Integrated Product Development at CIPLA.

,
Kalpesh Sawant

Kalpesh Sawant work in Integrated Product Development at CIPLA.

,
Praveen Date

Praveen Date works in Integrated Product Development at CIPLA.

,
Swati Laud

Swati Laud works in Integrated Product Development at CIPLA.

Pharmaceutical Technology, Pharmaceutical Technology-01-02-2019, Volume 43, Issue 1
Pages: 41–45

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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Peer-Reviewed

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

About the author

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.

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.

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