Process for preparing the combination products of triamterene and hydrochlorothiazide

Claim 1

A process for producing a pharmaceutically active composition having combined diuretic, antihypokalemic and antihypertensive activity comprising the steps of (a) blending finely divided particles of a triamterene-active pteridine ingredient, a finely-divided hydrochlorothiazide-active benzothiadiazide and pharmaceutically acceptable inert ingredients to form a homogeneous mixture; (b) adding to said homogeneous mixture a granulation liquid which is prepared by dispersing/dissolving a suitable binder and an acid component in a solvent to form a wet mass; (c) milling of said mass to form granules; and (d) blending the resulting granules with additional pharmaceutically acceptable inert ingredients wherein the weight ratio of said triamterene active ingredient to said hydrochlorothiazide active ingredient in the resulting composition is sufficient to control the hypokalemic effect induced by hydrochlorothiazide.

Claim 9

A method of treating hypertension comprising administering a solid antihypertensive diuretic medication wherein said solid medication is composed essentially of hydrochlorothiazide and triamterene and wherein said solid medication is formed by blending finely divided particles of triamterene, finely divided particles of hydrochlorothiazide and a wicking, binding, disintegration agent to form a homogeneous mixture, adding to said homogeneous mixture a granulation liquid which is prepared by dispersing/dissolving a suitable binder and malic acid in the presence of water to form a wet mass, milling of said wet mass to form granules, drying of the wet granules, sizing of the dried granules, and blending of said sized granules with a lubricant agent and a disintegrant agent so that in the resulting composition the weight ratio of said triamterene to said hydrochlorothiazide is sufficient to control the hypokalemic effect induced by hydrochlorothiazide.

Claim 10

A method of treating hypertension comprising administering a solid antihypertensive diuretic medication wherein said solid medication is composed essentially of hydrochlorothiazide and triamterene and wherein said solid medication is formed by blending finely divided particles of triamterene, finely divided particles of hydrochlorothiazide and a wicking, binding, disintegration agent to form a homogeneous mixture, adding to said homogeneous mixture a granulation liquid which is prepared by dispersing/dissolving a suitable binder and malic acid in the presence of water to form a wet mass, milling of said wet mass to form granules, drying of the wet granules, sizing of the dried granules, and blending of said sized granules with a lubricant agent and a disintegrant agent so that in the resulting composition the weight ratio of said triamterene to said hydrochlorothiazide is sufficient to control the hypokalemic effect induced by hydrochlorothiazide.