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Claims for Patent: 5,536,729

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Claims for Patent: 5,536,729

Title: Rapamycin formulations for oral administration
Abstract:The present invention provides novel oral rapamycin formulations which have, per 100 ml of the formulation, from about 0.01 grams to about 5.0 grams of rapamycin, from about 0.05% to about 10% by volume of surfactant, and from about 75% to about 99.95% by volume of a solution of phospholipid or lecithin in which the phospholipid or lecithin therein is 40% to 75% by weight.
Inventor(s): Waranis; Robert P. (Chazy, NY), Leonard; Thomas W. (Willmington, NC)
Assignee: American Home Products Corporation (Madison, NJ)
Application Number:08/301,179
Patent Claims: 1. A composition comprising, per 100 ml of composition, from about 0.01 gram to about 5.0 grams of rapamycin, and a solvent system, said solvent system comprising from about 0.05 to 10% by volume of a surfactant, and from about 75 to 99.95% by volume of a phospholipid solution in which the phospholipid therein is 40% to 75% by weight.

2. The composition of claim 1 wherein the phospholipid solution is a lecithin solution.

3. A composition of claim 1 containing from about 0.03 gram to about 1.0 gram of rapamycin per 100 ml, and a solvent system containing from about 0.10 ml to about 5 ml of surfactant per 100 ml, and from about 90 to about 99.95 ml of a phosholipid solution, the solution containing from about 40% to about 70% by weight of phospholipid in a suitable solvent, per 100 ml.

4. The composition of claim 1 which contains, per 100 ml composition, from about 0.03 gram to about 0.8 grams rapamycin, from about 0.10 ml to about 5 ml of surfactant, and from about 95 to about 99.9 ml of a 50% phospholipid solution.

5. The composition of claim 1 which contains, per 100 ml composition, from about 0.05 grams to about 0.5 grams rapamycin, from about 0.5 ml to about 5 ml of surfactant, and from about 95 to about 99.5 ml of a 50% phospholipid solution.

6. The composition of claim 1 which contains, per 25 ml composition, 0.025 g of rapamycin, 0.270 g of surfactant, and a 50% phospholipid solution q.s. to 25 ml.

7. The composition of claim 1 which contains, per 25 ml composition, 0.125 g of rapamycin, 0.270 g of surfactant, and a 50% phospholipid solution q.s. to 25 ml.

8. The composition of claim 1 which contains, per 100 ml composition, 1.0 g of rapamycin, 1.0 ml of surfactant, and a 50% phospholipid solution q.s. to 100 ml.

9. The composition of claim 1 which is contained within a pharmaceutically acceptable starch capsule.

10. The composition of claim 1 which is contained within a pharmaceutically acceptable gelatin capsule.

11. The composition comprising, per 100 ml composition, from about 0.01 grams to about 5.0 grams of rapamycin and a solvent system comprising:

a) from about 0.05% to about 10% by volume of surfactant,

b) from about 0.1% to about 50% by volume of absolute ethanol, and

c) from about 40% to about 99.85% by volume of a phospholipid solution, the phospholipid solution being from about 40% to about 75% by weight phospholipid.

12. The composition of matter of claim 11 wherein the phospholipid solution is a lecithin solution.

13. The composition of claim 11 comprising, per 100 ml composition, from about 2.0 to about 3.0 grams of rapamycin and a solvent system comprising:

a) from about 3% to about 7.5% by volume of surfactant,

b) from about 5% to about 20% by volume of absolute ethanol, and

c) from about 40% to about 92% by volume of a phospholipid solution, the phospholipid solution being from about 40% to about 60% by weight phospholipid.

14. The composition of claim 11 comprising, per 100 ml composition, 2.5 grams of rapamycin, 5.0 ml of surfactant, about 12.67 ml of absolute ethanol, and a 50% phospholipid solution q.s to 100 ml.
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