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

38. USP, USP 29–NF 24 (US Pharmacopeial Convention, Rockville, MD, 2006).

39. K.R. Morris et al., "An Integrated Approach to the Selection of Optimal Salt Form for a New Drug Candidate," Int. J. Pharm. 105 (3), 209–217 (1994).

40. R. Teraoka, M. Otsuka, and Y. Matsuda, "Effects of Temperature and Relative Humidity on the Solid-State Chemical Stability of Ranitidine Hydrochloride," J. Pharm. Sci. 82 (6), 601–604 (1993).

41. H.Y. Ando and G.W. Radebaugh, "Preformulation," in Remington: The Science and Practice of Pharmacy, II, A.R. Gennaro, Ed. (Lippincott Williams and Wilkins, Baltimore, MD, 20th ed., 2002), pp. 700–720.

42. J.F. Remenar et al., "Salt Selection and Simultaneous Polymorphism Assessment via High-Throughput Crystallization: The Case of Sertraline," Org. Proc. Res. Dev. 7 (6), 990–996 (2003).

43. C.R. Gardner, C.T. Walsh, and . Almarsson, "Drugs as Materials: Valuing Physical Form in Drug Discovery," Nat. Rev. Drug. Discov. 3 (11), 926–934 (2004).

44. "Ophthalmic/Otic Dosage Forms," http://www.cop.ufl.edu/safezone/prokai/pha5100/eye.htm, accessed Dec. 20, 2006.

45. Solvias, "Introduction: Solid-State Development," http://www.solvias.com/documents/Dokumente/Downloads_news/Solvias_Salt_and_Polymorphism_Programs.pdf, accessed Dec. 30, 2006.

46. European Agency for the Evaluation of Medicinal Products, "Note for Guidance on the Investigation of Bioavailability and Bioequivalence" (EMEA, London, UK, 2001).

47. FDA, Guidance for Industry: Bioavailability and Bioequivalence Studies for Orally Administered Drug Products—General Considerations (FDA, Rockville, MD, 2000).


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