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Oral pharmaceutical formulations for antipsychotic agent

IP.com Disclosure Number: IPCOM000011780D
Publication Date: 2003-Mar-14
Document File: 1 page(s) / 26K

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Oral Pharmaceutical Formulations for Antipsychotic Agent

Oral dosage forms capable of releasing 2mg to 40mg of the active pharmaceutical ingredient represented by the chemical formula shown in Figure 1, optionally in the form of its salts or hydrates, to human patients following administration may contain the following components (all percentages expressed as w/w with respect to the total finished weight of the dosage form):

a compressed core comprising 0.1% to 5% of the active pharmaceutical ingredient represented by the chemical formula shown in Figure 1, 35% to 55% of a sugar-type diluent, 1% to 4% of a naturally occurring clathrate e.g. betadex, 30% to 50% of a diluent selected from microcrystalline celluloses, 0.1% to 2% of an internally cross-linked sodium carboxy methylcellulose disintegrant and optionally other conventional tabletting excipients selected from known lubricants, opacifiers, glidants and/or anti-caking agents in amounts from 0.1% to 2%, said core prepared by combining complexed active ingredient, with mixed diluents, granulating and compressing lubricated granules; and

a coating agent prepared by combining a solution comprising 1% to 2% hydroxypropyl methylcellulose phthalate, 0.01% to 0.5% of a plasticiser derived from citric acid and 0.01% to 1% of a hydroxide of an alkali or alkaline earth metal with a suspension containing 0.01% to 1% each of conventional tabletting excipients selected from known lubricants, opacifiers, glidants and/or anti-caking a...