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US 2014/0178469 A1Published application
Stable benzimidazole formulation
AssigneeDexcel Pharma Technologies Ltd.
InventorsAdel PENHASI, Avi AVRAMOFF, Maxim GOMBERG, Valerie AZOULAY
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Abstract
A benzimidazole formulation which lacks an intermediate layer and yet which is stable both during storage and during the passage through the stomach, and which has low levels of residual volatile excipients, including but not limited to residual alkalinizing agents and/or residual solvents.
Claims30
A method for preparing a stable composition for a benzimidazole derivative, comprising:
- neutralizing one or more enteric polymers to a pH of at least 6.5 with at least two alkalizing agents, wherein at least one of said at least two alkalinizing agents is a volatile alkalinizing agent and at least one of said at least two alkalinizing agents is a non-volatile alkalinizing agent;
- layering said one or more enteric polymers over a substrate comprising the benzimidazole derivative, wherein said pH of said single coating layer after being applied to said substrate is in the range of from about 4.5 to about 6.5 as measured in 30 ml of distilled water at 20-25° C., wherein said one or more enteric polymers is layered directly over said substrate, without an intermediate layer between said substrate and said one or more enteric polymers;
- and
- forming a single coating layer of said one or more enteric polymers over said substrate such that said composition comprises less than 500 parts per million of residual volatile alkalizing agents relative to composition weight and wherein said composition comprises at least one residual non-volatile alkalizing agent.
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Dependencies are inferred from the claim text.