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Abstract

The present invention is directed to compositions comprising nanoparticulate heterocyclic amide derivative and preferably zafirlukast nanoparticles, also collectively referred to as 'active ingredient,' having improved solubility in water. The nanoparticles of the composition have an effective average particle size of less than about 2,000 nm, and are useful in the treatment of asthma. The invention also relates to a multiparticulate modified release composition comprising the active ingredient that in operation delivers the drug in a pulsed or bimodal manner for the treatment of asthma. The controlled release composition comprises an immediate release component and a modified release component. The immediate release component comprises a first population of heterocyclic amide derivative, and preferably zafirlukast particles, and the modified release component comprises a second population of heterocyclic amide derivative, and preferably zafirlukast nanoparticles, and a controlled release component, wherein the combination of the immediate release and modified release components in operation delivers the active ingredient in a pulsed or bimodal manner. The heterocyclic amide derivative can be released from the multiparticulate particles in an erosable, diffusion or osmotic controlled release system.

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First Claim