Taste-Masked Formulations of Raltegravir
AssigneeMerck Sharp & Dohme Corp.
InventorsKaren Cassidy Thompson, Kimberly Nicole Kaighn, Indra Neil Mukherjee, Catherine Elizabeth Diimmler, Hedy Teppler Weiser, Christopher Mancinelli
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Abstract
Disclosed are taste-masked pharmaceutical formulations of raltegravir comprising coated API granules mixed with a screened powder excipient blend in either tablet or sachet form. The core and coated granules are produced using a Wurster process for enhanced control of particle size. Also disclosed are methods of treating HIV, e.g., in pediatric populations.
Claims33
A pharmaceutical composition for oral administration wherein the active agent consists of raltegravir potassium and which comprises a plurality of taste-masked granules, each of which comprises:
- a core granule comprising raltegravir potassium and a binder, and
- (ii) a taste-masking polymer composition that forms a coating on the core granule, wherein said taste-masking polymer composition comprises an ethyl cellulose dispersion,
- wherein said pharmaceutical composition is in the form of a chewable tablet or sachet.
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A process for preparing a pharmaceutical composition comprising the steps of:
- a) granulating raltegravir and a binder into granules by a Wurster granulating process;
- b) coating said granules with a taste-masking agent by a Wurster coating process;
- c) preparing an extragranular matrix comprising a binder, a disintegrant, a flavoring agent and a lubricant;
- and,
- d) compressing said granules and said matrix into a tablet.
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Dependencies are inferred from the claim text.