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

11. A. Leone-Bay, D. Moy-Sherman, and B. R. Wilson. (Mankind Corp.), "Diketopiperazine Salts, Diketomorpholine Salts or Diketodioxane Salts for Drug Delivery," PCT Patent WO 06/23943 (2006).

12. S.I.F. Badawy, "Effect of Salt Form on Chemical Stability of an Ester Prodrug of a Glycoprotein IIb/IIIa Receptor Antagonist in Solid Dosage Forms," Int. J. Pharm. 223 (1–2), 81–87 (2001).

13. L.F. Huang and W.Q. Tong, "Impact of Solid State Properties on Developability Assessment of Drug Candidates," Adv. Drug Deliv. Rev. 56 (3), 321–334 (2004).

14. W.D. Walking et al., "Xilobam: Effect of Salt Form on Pharmaceutical Properties," Drug Dev. Ind. Pharm. 9 (5), 809–819 (1983).

15. F. Pfannkuch, H. Rettig, and P.H. Stahl, "Biological Effects 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. 117–134.

16. K.M.O. Connor and O.I. Corrigan, "Preparation and Characterisation of a Range of Diclofenac Salts," Int. J. Pharm. 226 (1–2), 163–169 (2001).

17. G.M. Dull et al. (Targacept Inc.), "Hydroxybenzoate Salts of Metanicotine Compounds," PCT Patent WO 06/53039 (2006).

18. C. Shaopei et al. (Chiron Corp.), "Pharmaceutical Acceptable Salts of Quinoline Compounds Having Improved Pharmaceutical Properties," PCT Patent WO 05/46589 (2005).

19. R.K. Verbeeck, L. Kanfer, and R.B. Walker, "Generic Substitution: The Use of Medicinal Products Containing Different Salts and Implications for Safety and Efficacy," Eur. J. Pharm. Sci. 28 (6), 1–6 (2006).

20. V.M. Raumer, J. Dannappel, and R. Hilfiker, "Polymorphism, Salts, and Crystallization: The Relevance of Solid-State Development," Chem. Today 24 (1), 41–44 (2006).

21. M.J. Bowker, "A Procedure for Salt Selection and Optimization," in Handbook of Pharmaceutical Salts—Properties, Selection and Use, P.H. Stahl and C.G. Wermuth, Eds. (Wiley–VCH, Weinheim, Germany, 2002), pp. 161–189.

22. U.J. Griesser and D.E. Braun, "Crystal Polymorphism in Pharmaceuticals: A Statistical Approach,", accessed Dec. 15, 2006.

23. W.Q. Tong, "Salt Screening and Selection: New Challenges and Considerations in the Modern Pharmaceutical R&D Paradigm,", accessed Dec. 20, 2006.


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