Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2006-03-21
2006-03-21
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S451000, C424S470000, C514S772000, C514S772300
Reexamination Certificate
active
07014866
ABSTRACT:
A solid unit oral pharmaceutical dosage form of amorphous nelfinavir mesylate is provided comprising amorphous nelfinavir mesylate in an amount of from about 400 mg to about 700 mg calculated as nelfinavir base, and a pharmaceutically acceptable water soluble, non-ionic synthetic block copolymer of ethylene oxide and propylene oxide, the copolymer having a melting point of at least about 45° C. and an HLB value at 25° C. of from about 18 to about 29, wherein the copolymer is present from about 40% to about 65% by weight of the nelfinavir mesylate. A hot melt granulation process for making the dosage form is provided.
REFERENCES:
patent: 5281420 (1994-01-01), Kelm et al.
patent: 5834472 (1998-11-01), Sangekar et al.
patent: 6001851 (1999-12-01), Albizati et al.
patent: 6045829 (2000-04-01), Liversidge et al.
patent: 6458818 (2002-10-01), Lipari et al.
patent: 6692767 (2004-02-01), Burnside et al.
patent: 2001/0018070 (2001-08-01), Shell et al.
patent: WO97/02017 (1997-01-01), None
patent: WO 98/57648 (1998-12-01), None
patent: WO 01/34118 (2001-05-01), None
patent: WO 01/89679 (2001-11-01), None
Zhang, K.E., et al., Antimicrobial Agents and Chemotherapy, vol. 45, No. 4, pp. 1086-1093 (2001).
Kaldor et al., “Viracept(Nelfinavir Mesylate, AG1343):A Potent, Orally Bioavailable Inhibitor of HIV-1 Protease” J.Med. Chem. vol. 40, pp. 3979-3985 (1997).
Bardsley-Elliot et al., “Nelfinavir: An Update on its Use in HIV Infection”, Drugs, vol. 59(3), pp. 581-620 (2000.
Infeld Martin Howard
Phuapradit Wantanee
Shah Navnit Hargovindas
Zhang Lin
Channavajjala Lakshmi
Hoffmann-La Roche Inc.
Johnston George W.
Megerditchian Samuel H.
Page Thurman K.
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