L. Perrigo Company

Deepak K Thassu

A method of obtaining improved reproducibility of dissolution profiles of dosage forms containing pharmaceutically active particles includes steps of screening raw pharmaceutically active particles to obtain or isolate particles having a desired monomodal particle size distribution. The particles having a monomodal particle size distribution may be incorporated into a solid oral dosage form to provide a highly reproducible dissolution profile. Two or more collections or particles having different monomodal particle size distributions may be combined and incorporated into solid oral dosage forms to provide predictable dissolution profiles.

Pharmaceutically active particles of a monomodal particle size distribution and method

A solid orally administrable pharmaceutical dosage form for the treatment of gastric disorders includes a first portion containing a therapeutically effective amount of a histamine H -receptor antagonist, and a second portion immediately adjacent the first portion without an intervening barrier disposed between the first portion and the second portion, the second portion containing a therapeutically effective amount of an antacid. Physical separation of the active ingredients into two different portions without a separating barrier has been found sufficient to prevent degradation of the histamine H -receptor antagonist due to contact with the antacid. The invention therefore provides stabilization of a histamine H -receptor antagonist-antacid combination tablet which is comparable to known multiple portion tablets, but without an intervening barrier between the antacid portion and the histamine H -receptor antagonist portion. Therefore, the benefits of the prior art are achieved at a reduced cost by eliminating a barrier and manufacturing steps associated with the provision of a barrier, as is conventional.

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West Henrietta, NY, United States of America

Deepak K Thassu