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Claims for Patent: 4,444,769

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Claims for Patent: 4,444,769

Title: Antihypertensive diuretic combination composition and associated method
Abstract:A novel combination pharmaceutical composition is described, together with a method for making the same, wherein the pharmaceutically active ingredients are separately milled and then formed into separate granules, and only thereafter blended together to form the combination composition. The method for achieving this novel combination composition is also described. In particular, a novel combination composition of triamterene and hydrochlorothiazide having improved bioavailability and novel effectiveness to prevent or eliminate hypokalemic side effects is also described.
Inventor(s): Blume; Cheryl D. (Morgantown, WV), Bonner; Paul H. (Morgantown, WV)
Assignee: Mylan Pharmaceuticals, Inc. (Morgantown, WV)
Application Number:06/456,311
Patent Claims: 1. A method of administering a solid antihypertensive diuretic medication to a patient composed of at least one hydrochlorothiazide-active thiazide ingredient and at least one triamterene-active pteridine ingredient which effectively inhibits and/or reverses benzothiadiazide-induced hypokalemia, and which consists essentially in forming a solid unit dose composition composed of, as active ingredients,

finely-divided particles of said benzothiadiazine ingredient which has been first separately admixed with at least one finely-divided pharmaceutically acingredient, and

finely-divided particles of said pteridine ingredient, which had been first separately admixed with at least one finely-divided pharmaceutically-acceptable ingredient including a non-toxic pharmaceutically acceptable inert carrier materials of the class including wicking agents, surfactants, disintegrants, lubricants, and compacting aids

with said relatively hydrophobic pteridine ingredient particles being substantially isolated from direct content with said benzothiadiazide ingredient particles in said composition, and

said composition exhibiting a sufficiently enhanced bioavailability of said pteridine ingredient, with respect to the bioavailability thereof in a solid composition having said finely divided active ingredients present in intimate admixture with each other, such that benzothiadiazide-induced hypokalemia is effectively resisted or reversed, at dose levels of said benzothiadiazide ingredient effective for antiphypertensive and diuretic control,

and administering said composition orally to said patient.

2. A method according to claim 1 wherein said unit dose composition is formulated as a capsule.

3. A method according to claim 1 wherein said unit dose composition is formulated as a tablet, said tablet containing an additional lubricant blended in with said active ingredients in the formulation of said tablet.

4. A method according to claim 1 wherein said respective finely-divided particles of each of said respective active ingredients is first separately blended together with said inert carrier materials, and separately compacted, after which they are respectively separately comminuted to form respective granules which are thereafter blended to form the combination composition.

5. A method according to claim 1 wherein said benzothiadiazide ingredient is hydrochlorothiazide and said pteridine ingredient is triamterene at a weight ratio of triamterene to hydrochlorothiazide of from 1.25 to 1.75:1.

6. A method according to claim 5 wherein said weight ratio is 1.5:1.

7. A granularly-heterogenous composition having combined pharmaceutically-effective antihypertensive, diuretic and antihypokalemic properties composed of

(a) discrete, separately formed first granules containing finely-divided particles of a triamterene active pteridine ingredient admixed with at least one finely-divided pharmaceutically-acceptable inert ingredient,

and

(b) discrete, separately formed second granules containing finely-divided particles of a hydrochlorothiazide active benzothiadiazine ingredient admixed with at least one finely-divided pharmaceutically-inactive inert ingredient,

with said first and second granules being admixed and blended together in amounts such that the resulting blended composition has a weight ratio of said pteridine ingredient to said benzothiadiazine ingredient provides an effective bioavailability of said pteridine to control the hypokalemic condition induced by the dosage amount of said benzothiadiazide.

8. A composition according to claim 7 wherein said finely-divided pharmaceutically inactive inert ingredients are of the class including wicking agents, disintegrants, surfactants, lubricants and compacting aids.

9. A composition according to claim 8 wherein said pteridine ingredient is triamterene and said benzothiadiazide ingredient is hydrochlorothiazide.

10. A composition according to claim 9 wherein said weight ratio is about 1.5:1.

11. A composition according to claim 7 formulated as a unit dosage capsule.

12. A composition according to claim 7 formulated as a unit dosage tablet, which includes at least one lubricant blended with said first and second granules.
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