Spheroids

Details Spheroids Spheroids

1987-11-19

1989-07-04

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Particulate form

424461, 424495, 424496, 424497, 424498, 424470, A61K 916

Patent

active

048449105

ABSTRACT:
A controlled release pharmaceutical composition comprising a plurality of film coated spheroids, the film coated spheroids comprising a 3-alkylxanthine, a non-water soluble spheronising agent and between 4% and 9% (by weight) water, wherein the in-vitro dissolution rate of the 3-alkylxanthine from the film coated spheroids, when measured by the USP Paddle Method at 100 rpm in 900 ml aqueous buffer (pH 6.5 at 37.degree. C.) is between 7.5% and 25.0% (by wt) release after 1 hour, between 22.5% and 45.0% (by wt) release after 2 hours, between 40.0% and 60.0% (by wt) release after 3 hours, between 50.0% and 75.0% (by wt) release after 4 hours, between 70.0% and 92.5% (by wt) release after 6 hours, and between 80.0% and 100.0% (by wt) release after 8 hours. Preferably the water content is between 4% and 8%, especially between 4% and 7% (by wt) of the film coated spheroid formulation. The preferred 3-alkylxanthine is theophylline (anhydrous or hydrate), whilst the preferred spheronising agent is microcrystalline cellulose.

REFERENCES:
patent: 3492397 (1970-01-01), Peters et al.
patent: 3576759 (1971-04-01), Powell et al.
patent: 4587118 (1986-05-01), Hsiao
patent: 4748023 (1988-05-01), Tamas et al.

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