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Claims for Patent: 5,908,638

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Claims for Patent: 5,908,638

Title: Pharmaceutical compositions of conjugated estrogens and methods for their use
Abstract:This invention relates to novel pharmaceutical compositions and methods for their preparation containing conjugated estrogens for the treatment of peri-menopausal, menopausal and post-menopausal disorders in women. The novel pharmaceutical compositions comprise a carrier base material and conjugated estrogens formed into a solid unit dosage form possessing a regular incremental release of the medicament upon oral administration. Further, the invention comprises the combination of conjugated estrogens with progestogens in a solid, shaped dosage unit. Specifically, the invention comprises the use of an organic excipient such as high molecular weight hydroxyalkyl alkylcelluloses. The use of an organic excipient such as hydroxypropylmethylcellulose in a stable, solid dosage formulation containing either conjugated estrogens alone or in combination with a progestogen is described.
Inventor(s): Huber; Harold Eugene (Cincinnati, OH), Ryan; Mary Katherine (Mainville, OH)
Assignee: Duramed Pharmaceuticals, Inc. (Cincinnati, OH)
Application Number:08/690,407
Patent Claims: 1. A pharmaceutical composition in a solid, unit dosage form capable of oral administration for the hormonal treatment of peri-menopausal, menopausal and post-menopausal disorders in a woman comprising:

conjugated estrogens coated onto one or more organic excipients forming a powdered conjugated estrogen composition where said composition is substantially free of inorganic excipients and further comprises about 30-70% gel-forming organic excipient and about 30-70% non-gel forming organic excipient by weight and having less than about 2.5% free water by weight and greater than 2.5% total water wherein said solid unit dosage form is coated with a moisture barrier coating comprising ethylcellulose.

2. A pharmaceutical composition of claim 1 in which said organic excipients include a mixture of one or more gel-forming hydroxyalkylalkylcelluloses and a hydroxyalkyl cellulose wherein said organic excipients constitutes more than about one third by weight of the solid unit dosage form.

3. A pharmaceutical composition of claim 2 in which the gel-forming organic excipients are a mixture of one or more hydroxypropylmethylcelluloses and 0-33% of methyl cellulose or other cellulose ether.

4. A pharmaceutical composition of claim 1 wherein said powdered conjugated estrogen composition further includes at least about 40% by weight of a non-gel forming organic excipient.

5. A pharmaceutical composition of claim 4 wherein said non-gel forming organic excipient is selected from the group consisting of lactose, mannitol, and cellulose derivatives.

6. A pharmaceutical composition of claim 1 wherein said conjugated estrogens is selected from the group consisting of the sodium sulfate esters of estrone, equilin, 17-.alpha.-dihydroequilin, 17-.beta.-dihydroequilin and 17-.alpha.-estradiol.

7. A pharmaceutical composition of claim 1 wherein said moisture barrier coating is 0.5-8.0% of the total weight of said solid unit dosage form.

8. A pharmaceutical composition of claim 1 wherein the solid unit dosage form is a tablet.

9. A pharmaceutical composition of claim 8 further comprising at least one additional hormone deposited on said tablet after the application of said moisture barrier coat.

10. A pharmaceutical composition of claim 9 wherein said hormone is selected from the group consisting of progesterone, medroxyprogesterone, medroxyprogesterone acetate, testosterone, methyltestosterone and combinations thereof.

11. A pharmaceutical composition of claim 9 wherein said hormone is bonded to said tablet by a polymeric film.

12. A pharmaceutical composition of claim 11 wherein said polymeric film is selected from the group consisting of hydroxypropylmethylcellulose and ethylcellulose aqueous dispersion.

13. A pharmaceutical composition of claim 9 further comprising two or more coatings with one outer coating comprising a polymeric film and at least one additional hormone.

14. A pharmaceutical composition of claim 13 wherein said hormone is selected from the group consisting of progesterone, medroxyprogesterone, medroxyprogesterone acetate, testosterone, methyltestosterone, and combinations thereof.

15. A pharmaceutical composition of claim 14 wherein said hormone is micronized.

16. A pharmaceutical composition of claim 13 wherein said polymeric film contains about 10-30% solids by weight.

17. A pharmaceutical composition of claim 16 wherein said polymeric film further comprises a surfactant.

18. A pharmaceutical composition of claim 17 wherein said surfactant is selected from the group consisting of polyoxyethylene (20) sorbitan monolaurate, polyoxyethylene (20) sorbitan monopalmitate, polyoxyethylene (20) sorbitan monostearate, polyoxyethylene (20) sorbitan monooleate, and polyoxyethylene (20) sorbitan trioleate.

19. A pharmaceutical composition of claim 13 wherein said polymeric film further comprises a plasticizer.

20. A pharmaceutical composition of claim 19 wherein said plasticizer is selected from the group consisting of dibutyl sebacate or triethyl citrate.
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