Pharmaceutical formulations

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Matrices

Reexamination Certificate

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Details

C424S469000, C424S480000, C424S493000, C424S499000

Reexamination Certificate

active

10269551

ABSTRACT:
The invention provides a controlled-release pharmaceutical formulation for oral administration comprising 4-amino-6,7-dimethoxy-2-(5-methanesulfonamido-1,2,3,4-tetrahydroisoquinol-2-yl)-5-(2-pyridyl)quinazoline, or a pharmaceutically acceptable salt thereof; and a pharmaceutically acceptable adjuvant, diluent or carrier; characterized in that the formulation is adapted to release at least 50% by weight of the 4-amino-6,7-dimethoxy-2-(5-methanesulfonamido-1,2,3,4-tetrahydroisoquinol-2-yl)-5-(2-pyridyl)quinazoline, or the pharmaceutically acceptable salt thereof, after 6 hours in Apparatus 1 described in the United States Pharmacopoeia 24 (2000), pp 1941–1943, having 1 litre vessels, baskets of 40 mesh (0.4 mm apertures), a rotation speed of 100 rpm, and a dissolution medium consisting of 900 ml of 0.01 M hydrochloric acid containing 0.7% w/v sodium chloride at 37° C.Formulations according to the invention are suitable for the treatment of BPH.

REFERENCES:
patent: 6106864 (2000-08-01), Dolan et al.
patent: 6149940 (2000-11-01), Maggi et al.
patent: 6596900 (2003-07-01), Blakemore et al.
patent: 0466986 (1992-01-01), None
patent: 1123705 (2001-08-01), None
patent: WO9830560 (1998-07-01), None
patent: WO0164672 (2001-09-01), None

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