Theophylline dosage form

A - Human Necessities – 61 – K

Patent

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167/164, 167/220

A61K 31/52 (2006.01) A61K 9/32 (2006.01) A61K 9/36 (2006.01) A61K 9/50 (2006.01)

Patent

CA 2007055

ABSTRACT OF THE DISCLOSURE A sustained released pharmaceutical pellet composition for the active ingredient theophylline which is provided as a core element. The coating for the core is partially soluble at a high acidic pH to provide slow release of theophylline from the core. The coating includes at least one insoluble matrix polymer selected from the group consisting of acrylic ester polymers, methacrylic ester polymers and mixtures thereof; at least one enteric polymer selected from the group consisting of cellulose acetate phthalate, hydroxypropyl methyl-cellulose phthalate, polyvinyl acetate phthalate, methacylic acid copolymer, hydroxypropyl methylcellulose acetate succinate, shellac, cellulose acetate trimellitate and mixtures thereof and at least one partially acid soluble component selected from polyvinylpyrrolidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, polyethylene glycol, polyvinyl alcohol and monomers therefor and mixtures thereof. This coating provides for the slow release of theophylline from the core to maintain the desired effective blood levels of theophylline.

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