Euro-celtique S.a.

Joanne Marchant

Stewart Thomas Leslie

Sandra Therese Malkowska

Philip J Neale

Ian R Buxton

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.

Spheroids

Iodophor-containing suppositories are provided with improved rate of iodine release from the suppository. The suppository composition comprises an iodophor, a water soluble suppository base, at least one water soluble sugar having a molecular weight of between about 90 and 550, and water in an amount of at least about 30% by weight. The molecular weight of the sugar is preferably between about 150 and 370. The preferred iodophors are providone iodine and polydextrose iodine. The preferred suppository bases are gelling polysaccharides and the preferred sugars are monosaccharides, disaccharides and sugar alcohols. The rate of iodine release is improved because of the high concentration of water together with the presence of the low molecular weight sugar.

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Cambridge, United Kingdom

Joanne Marchant