Pharmaceutical granulate

Details Pharmaceutical granulate Pharmaceutical granulate

1994-12-29

1996-06-18

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

424458, 424465, A61K 914

Patent

active

055275435

ABSTRACT:
Disclosed is a process of preparing granules involving first preparing a carrier comprising diluent, binder, and optionally a disintegrating agent. In a container separate from said carrier, a steroid, lubricant and, optionally, an antioxidant are dissolved in an, optionally pre-heated, organic solvent. The resulting solution is added to the carrier contained within an, e.g. vacuum mixer, followed by further blending of the mixture. The organic solvent is removed from the mixture. The mixture is blended further to form granules. The process may further include incorporating a flow enhancer such as colloidal silicon dioxide into the granules. A granule for making a pharmaceutical dosage unit is granule characterized in comprising: a) a carrier comprising diluent and binder, and b) a film coating said carrier, said film comprising desogestrel and a lubricant, and has the characteristic of by retaining 90% of the desogestrel at a pressure of 150 mbar and at a temperature of 70.degree. C. over 72 hours.

REFERENCES:
patent: 4180560 (1979-12-01), Katz et al.
patent: 4729895 (1988-03-01), Makino et al.
patent: 4871548 (1989-10-01), Edgren et al.
patent: 4914089 (1990-04-01), Tax et al.
patent: 5035897 (1991-06-01), Ayer et al.
patent: 5145675 (1992-09-01), Won
patent: 5200194 (1993-04-01), Edgren et al.
patent: 5284662 (1994-02-01), Koparkar et al.

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