Lanperisone formulation
AssigneeNippon Kayaku Kabushiki Kaisha
InventorsHiroshi Ohtaki, Rie Joshita
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Abstract
A lanperisone hydrochloride compression-molded formulation comprising the first granules containing lanperisone hydrochloride and the second granules containing substantially no lanperisone hydrochloride but at least one pharmaceutical additive(s) selected from the group consisting of sugars, crystalline celluloses and cellulose derivatives is an excellent formulation which has a high storage stability because the decomposition of lanperisone hydrochloride is suppressed.
Claims15
A lanperisone hydrochloride compression-molded formulation comprising
- (i) first granules containing lanperisone hydrochloride, and
- (ii) second granules containing substantially no lanperisone hydrochloride but at least one pharmaceutical additive selected from the group consisting of sugars, crystalline cellulose and cellulose derivatives.
A formulation according to claim 1 or 5, which has a tensile strength of at least 10 kg/cm.sup.2.
A formulation according to claim 1 or 5, wherein the contents of lanperisone hydrochloride and its optical isomer after storage of the formulation at 65.degree. C. for 7 days are 90 wt % or more and 3 wt % or less, respectively, based on the sum of the following weights (a) and (b):
- (a) the total weight of lanperisone hydrochloride and its optical isomer contained in the formulation after said storage, and
- (b) the weight of decomposed-lanperisone hydrochloride calculated from the weight of pyrrolidine hydrochloride, which is formed by decomposition of lanperisone hydrochloride, contained in the formulation after said storage.
A formulation according to claim 1 or 5, wherein a time required for dissolution of 75 wt % of lanperisone hydrochloride in the whole formulation is 5 minutes or less in water.
A lanperisone hydrochloride compression-molded formulation which comprises lanperisone hydrochloride, a sugar, a crystalline cellulose and a cellulose derivative as essential constituents and satisfies the following conditions:
- the formulation has a tensile strength of at least 10 kg/cm.sup.2, and the contents of lanperisone hydrochloride and its optical isomer after storage of the formulation at 65.degree. C. for 7 days are 90 wt % or more and 3 wt % or less, respectively, based on the sum of the following weights (a) and (b):
- (a) the total weight of lanperisone hydrochloride and its optical isomer contained in the formulation after the storage, and
- (b) the weight of lanperisone hydrochloride calculated from the weight of pyrrolidine hydrochloride contained in the formulation after the storage.
Dependencies are inferred from the claim text.