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Claims for Patent: 5,338,732

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Claims for Patent: 5,338,732

Title: Megestrol acetate formulation
Abstract:The present invention relates to a novel oral pharmaceutical composition of micronized megestrol acetate at a concentration of 15 to 150 mg/mL comprising polysorbate at a concentration of 0.005% to 0.015% weight/volume and polyethylene glycol at a concentration of 5-30% weight/volume which composition forms a stable flocculated suspension in water. The invention further comprises the micronized megestrol acetate formulation described above with added preservatives, buffers, sweeteners and flavoring agents.
Inventor(s): Atzinger; Anne E. (Lebanon, IN), Bequette; Robert J. (Evansville, IN), Davis; Robert E. (Evansville, IN)
Assignee: Bristol-Myers Squibb Company (New York, NY)
Application Number:07/882,218
Patent Claims: 1. An oral pharmaceutical composition comprising micronized megestrol acetate at a concentration of 15 to 150 mg/mL in combination with polysorbate at a concentration of 0.005% to 0.015% weight/volume and polyethylene glycol at a concentration of greater than 5% weight/volume which composition forms a stable flocculated suspension in water.

2. The composition of claim 1 wherein the concentration of micronized megestrol acetate is 20 to 120 mg/mL.

3. The composition of claim 1 wherein the concentration of micronized megestrol acetate is 40 mg/mL.

4. The composition of claim 1 wherein polysorbate 80 is employed.

5. The composition of claim 1 wherein the concentration of polyethylene glycol is from 5% to 30% weight/volume.

6. The composition of claim 1 wherein the concentration of polyethylene glycol is 12 to 24% weight/volume.

7. The composition of claim 1 wherein the concentration of polyethylene glycol is 20% weight/volume.

8. The composition of claim 1 wherein the concentration of polysorbate is 0.01% weight/volume.

9. The composition of claim 1 with buffering, sweetening and flavoring agents.

10. An oral pharmaceutical composition comprising on a percent weight/volume basis megestrol acetate 4%, polyethylene glycol 1450 20%, polysorbate 80 0.01% xanthan gum 0.2%, sodium benzoate 0.2% citric acid 0.244%, sodium citrate 0.015%, sucrose 5%, lemon-lime flavor 0.091%, and the remainder purified water which composition forms a stable flocculated suspension in water.
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