Oral dosage forms comprising progesterone and methods of making and using the same

1. An oral pharmaceutical dosage form in a powder form contained in a pharmaceutically acceptable capsule comprising:

(a) micronized progesterone in an amount from about 40% to about 70% by weight of the capsule contents;

(b) an edible oil selected from the group consisting of safflower oil, linseed oil, soybean oil, corn oil, sunflower oil, sesame oil, olive oil, cottonseed oil, flaxseed oil, menhaden oil, and mixtures thereof, in an amount from about 5% to about 25% by weight of the capsule contents;

(c) a disintegrant in an amount from about 5% to about 25% by weight of the capsule contents; and

(d) a hydrophilic excipient in an amount ranging from about 5% to about 25% by weight of the capsule contents.

2. The dosage form of claim 1 , wherein the disintegrant is crospovidone.

3. The dosage form of claim 1 , wherein the hydrophilic excipient is selected from the group consisting of corn starch, potato starch, pregelatinized starch, povidone, polysorbate, mannitol, microcrystalline cellulose, sodium starch glycolate, and mixtures thereof.

4. The dosage form of claim 1 , further comprising an absorbant selected from the group consisting of silicon dioxide and its derivatives, micronized silicas, lactose, lactose monohydrate, methylcellulose, microcrystalline cellulose, sugars, maltodextrin, and mixtures thereof.

5. The dosage form of claim 1 , further comprising an antioxidant selected from the group consisting of adipic acid, alpha lipoic acid, ascorbyl palmitate, biotin, boron, butylated hydroxyl toluene, butylated hydroxyanisole, carotenoids, calcium citrate, sodium metabisulfate, tocopherols, and mixtures thereof.

6. The dosage form of claim 1 , further comprising a lubricant selected from the group consisting of magnesium stearate, colloidal silicon dioxide, silica gel, aluminum stearate, talc, stearic acid, sodium stearate, calcium stearate, sodium stearyl fumarate, and mixtures thereof.

7. The dosage form of claim 1 , wherein the powder is free flowing.

8. The dosage form of claim 1 , wherein the dosage form does not contain peanut oil or peanut particles.

9. The dosage form of claim 1 , wherein the drug has a mean particle size of about 1 micron to about 15 microns.

10. The dosage form of claim 1 , which contains 400 mg of the micronized progesterone.

11. A kit comprising the oral pharmaceutical dosage form of claim 1 .

12. The kit of claim 11 , further comprising printed instructions for its use.

13. The kit of claim 12 , further comprising a printed matter describing the use of the composition to treat a condition requiring oral progesterone therapy, a pre-recorded media device describing the use of the composition to treat a condition requiring oral progesterone therapy, or a planner.

14. The kit of claim 13 , wherein the printed matter is a book, booklet, brochure or leaflet.

15. The kit of claim 13 , wherein the pre-recorded media device a DVD, a videotape cassette, a CD-ROM, an audiocassette, or an audio compact disk.

16. The dosage form of claim 1 , wherein the micronized progesterone is in an amount of about 55% by weight of the capsule contents.

17. The dosage form of claim 1 , wherein the edible oil is in an amount from about 10% to about 15% by weight of the capsule contents.

18. The dosage form of claim 1 , wherein the edible oil is in an amount of about 11% by weight of the capsule contents.

19. The dosage form of claim 2 , wherein the disintegrant is in an amount from about 10% to about 20% by weight of the capsule contents.

20. The dosage form of claim 2 , wherein the disintegrant is in an amount of about 15% by weight of the capsule contents.

21. The dosage form of claim 1 , wherein the hydrophilic excipient is in an amount of about 15% by weight of the capsule contents.