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Claims for Patent: 6,103,260

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Claims for Patent: 6,103,260

Title: Simethicone/anhydrous calcium phosphate compositions
Abstract:The invention relates to antifoam oral solid dosage form preparations formed from a free flowing granular composition comprising an admixture of simethicone and either one or both of granular anhydrous tribasic calcium phosphate or dibasic calcium phosphate wherein the admixture is a uniform granular composition of not more than 1000 micron particle size which is suitable for compression into a solid dosage form for oral administration.
Inventor(s): Luber; Joseph R. (Quakertown, PA), Madison; Glenn (Lansdale, PA), McNally; Gerard (Strafford, PA)
Assignee: McNeil-PPC, Inc. (Skillman, NJ)
Application Number:08/896,189
Patent Claims: 1. An antifoam simethicone free-flowing granular composition suitable for use as an oral solid dosage form preparation formed by (i) preparing a granular composition consisting essentially of an admixture of (a) simethicone and (b) granular anhydrous tribasic or dibasic calcium phosphate or a mixture thereof; wherein the simethicone is adsorbed by the granular anhydrous tribasic or dibasic calcium phosphate or mixture thereof, and wherein the simethicone/calcium phosphate admixture is a uniform granular composition of not more than 1000 micron particle size, and (ii) admixing the uniform granular composition with one or more excipients to form the free-flowing granular composition.

2. An oral solid dosage form of claim 1 wherein said dosage form is in the form of a unit dose compressed swallowable or chewable tablet, or caplet, gelcap, capsule, lozenge or fast dissolving wafer.

3. An oral solid dosage form of claim 1 further containing one or more excipients in addition to said free flowing granular composition.

4. An oral solid dosage form of claim 3 wherein said excipients are selected from one or more fillers, binders, sweeteners, artificial sweeteners, lubricants, glidants, disintegrants, colors, adsorbents, acidifying agents, and flavoring agents.

5. An oral solid dosage form of claim 1 wherein the simethicone content of the dosage form comprises about 8% to about 20% w/w.

6. An oral solid dosage form of claim 5 further containing crystalline sorbitol, microcrystalline cellulose and anhydrous tribasic or dibasic calcium phosphate as excipients in addition to the free flowing granular composition of simethicone and granular anhydrous tribasic or dibasic calcium phosphate.

7. An antifoam simethicone oral solid dosage form preparation formed by (i) preparing a free-flowing granular composition consisting essentially of an admixture of (a) simethicone and (b) granular anhydrous tribasic or dibasic calcium phosphate or a mixture thereof; wherein the simethicone is adsorbed by the granular anhydrous tribasic or dibasic calcium phosphate or mixture thereof to form the free-flowing granular composition, and wherein the simethicone/calcium phosphate admixture is a uniform granular composition of not more than 1000 micron particle size, and (ii) admixing the free-flowing granular composition with one or more excipients and one or more additional active ingredients suitable for the treatment of gastrointestinal disorders, to form the oral solid dosage form preparation.

8. The oral solid dosage form of claim 7 wherein the additional active ingredient is selected from one or more of the following: H2 receptor antagonists, proton pump inhibitors, antidiarrheal agents, gastrointestinal motility agents, and antacids.

9. A free flowing granular composition comprising an admixture of (a) simethicone and (b) granular anhydrous tribasic or dibasic calcium phosphate or a mixture thereof; wherein the simethicone/calcium phosphate admixture is a uniform granular composition of not more than 1000 micron particle size.

10. The free flowing granular composition of claim 9 wherein the proportionate amounts of the ingredients of the granular admixture composition is about 10-70% w/w simethicone and about 30-90% w/w granular anhydrous tribasic or dibasic calcium phosphate.

11. The free flowing granular composition of claim 9 further containing either Silicon Dioxide in an amount of about 0.5-4% w/w or anhydrous calcium phosphate powder in an amount of about 1-30% w/w of the granular composition.

12. A process for producing a free flowing granular composition of a simethicone antifoam agent for compression into solid oral dosage forms which comprises forming an admixture of granular anhydrous tribasic and/or dibasic calcium phosphate, the simethicone antifoam agent and optionally a scavenger by adding the simethicone to the granular anhydrous tribasic or dibasic calcium phosphate and the optional scavenger, dry blending until uniform and shearing to assure a uniform free flowing granular composition .
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