Process development challenges to accommodate a late-appearing stable polymorph: A case study on the polymorphism and crystallization of a fast-track drug development compound

Organic Process Research and Development

Volumn 9, Issue 6, 2005, Pages 933-942

  Desikan, Sridhar ^a   Parsons Jr , Rodney L ^a   Davis, Wayne P ^a,b   Ward, James E ^c   Marshall, Will J ^d   Toma, Pascal H ^e  

^a BRISTOL MYERS SQUIBB   (United States)

^b Hovione LLC   (United States)

^c Mettler Toledo AutoChem   (United States)

^d DUPONT COMPANY   (United States)

^e ABBOTT LABORATORIES   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 28944454413     PISSN: 10836160     EISSN: None     Source Type: Journal    
DOI: 10.1021/op0501287     Document Type: Article

References (8)

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3. Chemburkar, S. R. et al. Dealing with the impact of Ritonovir Polymorphs on the Late Stages of Bulk Drug Process Development. Org. Process Res. Dev. 2000, 4, 413-417.
4. Magnus, N. A.; Confalone, P. N.; Storace, L.; Patel, M.; Wood, C. C.; Davis, W. P.; Parsons, Rodney, L., Jr. General Scope of 1,4-Diastereoselective Additions to a 2(3H)-Quinazolinone: Practical Preparation of HIV Therapeutics. J. Org. Chem. 2003, 68, 754-761.
5. Magnus, N. A.; Confalone, P. N.; Storace, L. A new asymmetric 1,4-addition method: Application to the synthesis of the HIV nonnucleoside reverse transcriptase inhibitor. Tetrahedron Lett. 2000, 41(17), 3015-3019.
6. Amidon, G. L.; Lennernas, H.; Shah, V. P.; Crison, J. R. A theoretical basis for a biopharmaceutic drug classification: the correlation of in vitro drug product dissolution and in vivo bioavailability. Pharm. Res. 1995, 12, 413-420.
7. Burger A.; Ramberger, R. On the Polymorphism of Pharmaceutical and Other Molecular Crystals. I. Theory of Thermodynamic Rules. Mikrochim. Acta [Wein] 1979, II, 259-271.
8. Burger A.; Ramberger, R. On the Polymorphism of Pharmaceutical and Other Molecular Crystals. II. Applicability of Thermodynamic Rules. Mikrochim. Acta [Wein] 1979, II, 273-316.