The Value of In Vitro Dissolution in Drug Development - Pharmaceutical Technology

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The Value of In Vitro Dissolution in Drug Development
A Position Paper from the AAPS In Vitro Release and Dissolution Focus Group


Pharmaceutical Technology
Volume 33, Issue 4, pp. 52-64

Conclusion

Dissolution testing continues to add value throughout the drug-development continuum. It serves as a tool for characterizing an API; developing, selecting, and optimizing formulations; studying drug-release mechanisms; ensuring batch-to-batch consistency; monitoring stability; and demonstrating bioequivalence between formulations. Dissolution testing can also help link the design space and target product profile. With the increasing application of BCS and QbD approaches, the value and appropriateness of dissolution testing for a given product will need to be assessed. Dissolution may not be needed or may be replaced by a suitable related or surrogate test to control the critical quality attributes of the product. Increased scientific understanding and experiences should lead to harmonized principles recognized by both industry and regulatory agencies with regard to the continued use and value of dissolution testing.

Acknowledgment

The authors wish to acknowledge the thoughts, ideas, and comments from the In Vitro Release and Dissolution Testing Focus Group. They also wish to thank Mary Ann Quarry, PhD, for her editorial input.

Cheng Tong is a senior principal scientist at Pfizer Inc., Ruben Lozano is a principal scientist at Bristol-Myers Squibb, Yun Mao is a research fellow at Merck Co., Tahseen Mirza is a director at Novartis, Raimar Löbenberg is an associate professor at the University of Alberta in Canada, Beverly Nickerson is an associate research fellow at Pfizer Inc., Vivian Gray is president of V.A. Gray Consulting, and Qingxi Wang* is a director at at Merck Co., tel. 215.652.1302, fax 215.652.2835,
. All authors are part of the American Association of Pharmaceutical Scientists (AAPS) In Vitro Release and Dissolution Focus Group.

*To whom all correspondence should be addressed.

References

1. E. Galia et al., "Evaluation of Various Dissolution Media for Predicting In Vivo Performance of Class I and II Drugs," Pharm. Res. 15 (5), 698–705 (1998).

2. A. Avdeef, "Solubility of Sparingly Soluble Ionizable Drugs," Adv. Drug Deliv. Rev. 59 (7), 568–590 (2007).

3. G.L. Amidon et al., "A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of In Vitro Drug Product Dissolution and In Vivo Bioavailability," Pharm. Res. 12 (3), 413–420 (1995).

4. N. Donauer and R. Löbenberg, "A Mini Review of Scientific and Pharmacopeial Requirements for the Disintegration Test," Int. J. Pharm. 345 (1–2), 2–8 (2007).

5. E.S. Kostewicz et al., "Predicting the Precipitation of Poorly Soluble Weak Bases Upon Entry in the Small Intestine," J. Pharm. Pharmacol. 56 (1), 43–51 (2004).

6. J. Emami, "In Vitro–In Vivo Correlation: From Theory to Applications," J. Pharm. Sci. 9 (2), 31–51 (2006).

7. R. Löbenberg et al., "Dissolution Testing as a Prognostic Tool for Oral Drug Absorption: Dissolution Behavior of Glibenclamide," Pharm. Res. 17 (4), 439–444 (2000).

8. H. Wei et al., "Physiochemical Characterization of Five Glyburide Powders: A BCS Based Approach to Predict Oral Absorption," Eur. J. Pharm. Sci. (2008), in press.


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