Gelatin Capsule Shell Cross-Linking - Pharmaceutical Technology

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Gelatin Capsule Shell Cross-Linking
The authors develop a pratical approach to avoid unwanted interactions between pepsin and SLS in dissolution Tier II tests.


Pharmaceutical Technology
Volume 35, Issue 5, pp. 62-68

Conclusion

Gelatin capsule shell cross-linking is a common problem for a capsule formulation during stress or stability studies at accelerated storage conditions. Switching the stressed capsule shells and blends with fresh ones can easily prove that the shells are the cause of slowed dissolution. SLS deactivates pepsin despite its advantages and wide use as a surfactant. However, stepwise addition of pepsin and SLS respectively enables each agent to take effect separately. Therefore, SLS need not be abandoned during dissolution method development for gelatin capsule formulations.

Acknowledgment

The authors are grateful to Chris Connolly, manager of analytical development; Jack Chen, supervisor of analytical development; and Andy Cleaver, supervisor of analytical development, for coordinating tasks. We are also grateful to Wendy Liu, chemist in analytical development, for conducting dissolution tests, and Rajeev Bhatnagar, senior technical project lead, for providing fresh capsule blends.

Xiling Song* is senior research associate, Yong Cui is scientist, and Minli Xie is senior scientist, all at Small Molecule Pharmaceutical Sciences, Genentech, 1 DNA Way, South San Francisco, CA 94080,
*To whom all correspondence should be addressed. Submitted: Nov. 10, 2010. Accepted: Feb. 7, 2011

References

1. S. Singh, R. Manikandan, and S. Singh, Pharm. Technol. 24 (5), 58–72, (May 2000).

2. K.S. Murthy, N.A. Enders, and M.B. Fawzi, Pharm. Technol. 13 (3), 72–86 (1989).

3. K.S. Murthy, R.G. reisch, Jr., and M.B. Fawzi, Pharm. Technol, 13 (6), 53–58 (1989).

4. S. Singh et al., Pharm. Technol. 26 (4) 36–58, (2002).

5. USP33–NF28 (US Pharmacopeial Convention, Rockville, MD, 2010), p. 719.

6. M.F.S. Whisler, J. S. Staton, and R. B. DePrince, poster presentation at AAPS conference (New Orleans, LA, 1999).

Citation: When referring to this article, please cite it as "X.Song, Y.Cui, M.Xie, "Gelatin Capsule Shell Cross Linking," Pharmaceutical Technology 35 (5) 62–68 (2011)."


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