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oral pharmaceutical formulations for proton pump inhibitor Disclosure Number: IPCOM000011782D
Publication Date: 2003-Mar-14
Document File: 1 page(s) / 27K

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Oral Pharmaceutical Formulations for Proton Pump Inhibitor

Acid-Labile benzimidazole active ingredients such as the compound represented by the chemical formula shown in Figure 1, optionally in the form of its salts, and/or hydrates e.g. its sodium sesquihydrate form in amounts from 20mg to 40 mg may be orally administered to human patients when contained in a formulation as disclosed herein.� Such formulations ensure targeted delivery and protection of the active ingredient after administration to prevent acid degradation.� The formulation comprises the following components:

A compressed tablet core having a moisture content below 1.5% containing 8% to 15% of an active ingredient represented by the chemical formula shown in Figure 1 optionally as its sodium sesquihydrate salt, 8% to 15% of a naturally occurring clathrate e.g. betadex, 15% to 30% of an alkali- or alkaline earth-metal carbonate, 40% to 60% of a microcrystalline cellulose, 0.01% to 1% of one or more cross-linked cyclic amide polymers and 0.01% to 5% of a low-substituted hydroxypropyl ether of cellulose, optionally in conjunction with other conventional tabletting excipients e.g. known lubricants, opacifiers, glidants and/or anti-caking agents;

an intermediate barrier layer coated upon said core comprising 70% to 90% of a non-ionic, water-soluble ether of methylcellulose, 5% to 10% of a polyethylene glycol having average number of monomers between 68 and 204 (molecular weight range 3000 to 9000) and other conve...