Salt Selection in Drug Development - Pharmaceutical Technology

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Salt Selection in Drug Development
The selection of an appropriate salt form for a potential drug candidate is an opportunity to modulate its characteristics to improve bioavailability, stability, manufacturability, and patient compliance.


Pharmaceutical Technology
Volume 3, Issue 32

Conclusion

Selecting an optimal salt form for development is a critical step in ensuring the efficient and successful development of a robust product. Salt selection requires a well designed screening strategy that fulfills the essential and desirable criteria that set the standard for salt screening. In addition, salt selection procedures must also assess the regulatory, intellectual, and marketing considerations to balance the drug's physicochemical and biopharmaceutical properties against commercial considerations.

Lokesh Kumar is a student, Aeshna Amin is a student, and Arvind K. Bansal* is an associate professor at the National Institute of Pharmaceutical Education and Research, Sector-67, Phase-X, S.A.S. Nagar, Punjab 160062, India, tel +91 0 172 2214682 87, fax +91 0 172 2214692,

*To whom all correspondence should be addressed.

Submitted: Apr. 2, 2007. Accepted: Apr. 5, 2007.

References

1. C.G. Wermuth and P.H. Stahl, "Introduction," in Handbook of Pharmaceutical Salts: Properties, Selection and Use, P.H. Stahl and C.G. Wermuth, Eds. (Wiley–VCH, Weinheim, Germany, 2002), pp. 1–7.

2. S.M. Berge, L.M. Bighley, and D.C. Monkhouse, "Pharmaceutical Salts," J. Pharm. Sci. 66 (1), 1–19 (1977).

3. Tessella Scientific Software Solutions, "Automated Salts and Polymorph Screening," http://www.tessella.com/Services/CaseStudies/pdfs/e_GSK_ASAP.pdf, accessed Dec. 15, 2006.

4. B.D. Anderson and R.A. Conradi, "Predictive Relationships in the Water Solubility of Salts of a Nonsteroidal Anti-inflammatory Drug," J. Pharm. Sci. 74 (8), 815–820 (1985).

5. S.N. Bhattachar, L.A. Deschenes, and J.A. Wesley, "Solubility: It's Not Just for Physical Chemists," Drug Discov. Today 11 (21/22), 1012–1018 (2006).

6. L.D. Bighley, S.M. Berge, and D.C. Monkhouse, "Salt Forms of Drugs and Absorption," in Encyclopedia of Pharmaceutical Technology, J. Swarbrick and J.C. Boylan, Eds. (Marcel Dekker, New York, 1996), pp. 453–499.

7. "Properties of the Solid State," in Physicochemical Principles of Pharmacy, A.T. Florence and D. Attwood, Eds. (Macmillan Press Ltd., London, 3rd ed., 1998), pp. 5–34.

8. P. L. Gould, "Salt Selection for Basic Drugs," Int. J. Pharm. 33 (1–3), 201–217 (1986).

9. P.H. Stahl and M. Nakano, "Pharmaceutical Aspects of the Drug Salt Form," in Handbook of Pharmaceutical Salts—Properties, Selection, and Use, P.H. Stahl and C.G. Wermuth, Eds. (Wiley–VCH, Weinheim, Germany, 2002), pp. 83–116.

10. M.K. Chourasia and S.K. Jain, "Pharmaceutical Approaches to Colon Targeted Drug Delivery Systems," J. Pharm. Pharm. Sci. 6 (1), 33–66 (2003).


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