Importance

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Abstract

A pharmaceutical composition in the form of a bilayer tablet comprising: (a) a first discrete portion made with Formulation (A) which comprises a sympathomimetic drug, or a pharmaceutically acceptable salt thereof, and a first carrier base material which provides a sustained-release of the sympathomimetic drug or the pharmaceutically acceptable salt thereof, said first carrier base material comprising a mixture of: (i) a filler; (ii) a cellulose binder selected from the group consisting of hydroxypropyl methylcellulose, hydroxypropyl cellulose, and mixtures thereof, wherein the hydroxypropyl cellulose has a molecular weight of at least 80,000; (iii) ethylcellulose; (iv) a wax; and (v) a lubricant; and (b) a second discrete portion made with Formulation (B) which comprises a piperidinoalkanol compound, or a pharmaceutically acceptable salt thereof, and a second carrier base material which provides an immediate-release of the piperidinoalkanol or the pharmaceutically acceptable salt thereof, said second carrier base comprising a mixture of: (i)' a sugar; (ii)' a disintegrant; and (iii)' a lubricant. The bilayer tablets exhibit acceptable content uniformity under USP requirements, resist lamination and have acceptable physical strength during the self life.

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First Claim