Soluble, stable and concentrated pharmaceutical composition...

Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Having -c- – wherein x is chalcogen – bonded directly to...

Reexamination Certificate

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C424S400000

Reexamination Certificate

active

07632853

ABSTRACT:
The present invention describes a soluble stable pharmaceutical composition for the administration of HIV protease inhibitors. More specifically the composition comprises a solution of an HIV protease inhibitor in a combination of suitable pharmaceutical organic solvents, a surfactant and a bioavailability enhancer. It is also described a process for the obtainment of concentrated pharmaceutical compositions used in the administration of HIV protease inhibitors compounds. The composition of the present invention is suitable for the preparation of oral solutions for the administration of active drugs and for the encapsulation in hard gelatin capsules or soft gelatin capsules.

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patent: 6232333 (2001-05-01), Lipari et al.
patent: WO-96/39142 (1996-12-01), None
patent: WO 98/57648 (1998-12-01), None
Rowe et al., Handbook of Pharmaceutical Excipients, 2006, Pharmaceutical Press, Fifth Edition, pp. 545-550 (Polyethylene Glycol).
Wikipedia, http://en.wikipedia.org/wiki/Vacuum-distillation, pp. 1-2.
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CU Boulder Organic Chemistry Undergrauate Courses, Lab Techniques, http://we.archive.or/web/20010419135852/orgchem.colorado.edu/handbksupport/dist/dist.html, pp. 1-2.
CUBoulder Organic Chemistry Undergraduate Courses, Lab Techniques, http: //web.archive.org/web/20020417050311/orgchem.colorado.edu/hndbksupport/solvremoval/solvremoval.html, pp. 1-4.
L. Eldred, The Hopkins HIV Report, “Adherence in the Era of Protease Inhibitors”, 1997.
F.M. Hecht et al., Abstract of Presentation from the 5th Conference on Retroviruses and Opportunistic Infections, Feb. 1-5, 1998, Chicago, IL.
M. Chesney et al., “Adherence to Combination Therapy in AIDS Clinical Trials (1997)”, presented at the Annual Meeting of the AIDS Clinical Trials Group, Jul. 1997, Washington, D.C.
J. Walsh et al., Abstract of presentation “Adherence to proteinase inhibitor based highly effective antiretroviral therapy (HEART)” from 12th International AIDS Conference held in Geneva, Switzerland, Jun. 28-Jul. 3, 1998.

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