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Details for Patent: 4,547,498

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Details for Patent: 4,547,498

Title: Pharmaceutical combination composition and associated method
Abstract:A novel combination pharmaceutical composition is described, together with a method for making the same, wherein the pharmaceutcially 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 bioavialability 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)
Filing Date:Feb 17, 1984
Application Number:06/581,411
Claims:1. A method for forming a granularly-heterogenous composition having combined pharmaceutically-effective diuretic anti-hypokalemic and antihypertensive activity comprising the steps of

mixing finely-divided particles of a triamterene-active pteridine ingredient with at least one finely-divided pharmaceutically-acceptable inert ingredient to form a first mixture, and granulating said first mixture to form first granules composed of a homogeneous blend of the particles of said first mixture;

separately mixing finely-divided particles of a hydrochlorothiazide-active benzothiadiazide ingredient with at least one finely-divided pharmaceutically-acceptable inert ingredient to form a second mixture, and separately granulating said second mixture to form second granules composed of a homogeneous blend of the particles of said second mixture;

thereafter physically blending together said thusformed first and second granules while substantially retaining the respective identities of said first and second granules, in respective amounts such that in the resulting blended composition the weight ratio of said pteridine ingredient to said benzothiadiazide ingredient provides an effective bioavailable amount of said pteridine to control the hypokalemic condition induced by the dosage amount of said benzothiadiazide.

2. A method according to claim 1 wherein said pteridine ingredient is triamterene and said benzothiadiazine ingredient is hydrochlorothiazide.

3. A method according to claim 2 wherein the triamterene:hydrochlorothiazide weight ratio is from 1.25 to 1.75:1.

4. A method according to claim 3 wherein said weight ratio is about 1.5:1.

5. A method according to claim 2 wherein said finely-divided triamterene particles have a size range such that at least 95% pass through a 200 mesh screen, and said finely-divided hydrochlorothiazide particles have a size range such that at least 95% pass through a 100 mesh screen.

6. A method according to claim 5 wherein said granules have a size range from not more than 5% being larger than 2 mm to not more than 20% being smaller than 0.075 mm.

7. A method according to claim 6 wherein said granules have a size range such that not more than 5% have a dimension exceeding 1.5 mm.

8. A method according to claim 5 wherein said pharmaceutically-acceptable inert ingredients are of the class including wicking agents, disintegrants, surfactants, lubricants and compacting aids.

9. A method according to claim 8 wherein said wicking agent has a longitudinal dimension greater than would pass through a screen of about 200 mesh.
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