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Compositions comprising 5-alpha reductase inhibitors and serms and methods of use thereof

A composition and reductase technology, applied in the field of 5α reductase inhibitors and selective estrogen receptor modulators, can solve problems such as bone mass loss and increased rate of bone remodeling

Inactive Publication Date: 2007-06-27
GTX INCORPORATED
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Thus, when androgen or estrogen deprivation occurs, the result is an increased rate of bone remodeling that tilts the balance of resorption and formation in favor of resorption, resulting in an overall loss of bone mass

Method used

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  • Compositions comprising 5-alpha reductase inhibitors and serms and methods of use thereof
  • Compositions comprising 5-alpha reductase inhibitors and serms and methods of use thereof
  • Compositions comprising 5-alpha reductase inhibitors and serms and methods of use thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0111] 5-ARI and SERM composition

[0112] In one embodiment, scored tablets for oral use may be prepared containing 500 mg of each active ingredient. In one embodiment, the tablet may be prepared from the following ingredients:

[0113] Gm.

[0114] 17β-N,N-Diethylcarbamoyl-4-methyl-4-aza-5α-androstan-3-one 5000

[0115] Toremifene 5000

[0116] Starch, U.S.P. 350

[0117] Talc, U.S.P. 250

[0118] Calcium stearate 35

[0119] The active ingredient was granulated with 4% w. / v. methylcellulose U.S.P. (1500 cps) in water. In other embodiments, 0.1, 1, 5, 10, 15, 25, 50 and 100 mg of Tablets of each active ingredient. A blend of the remaining ingredients is added to the dry granules and the final blend is compressed into tablets of suitable weight.

[0120] Capsules - In another embodiment, hard gelatin capsules for oral use, each containing 250 mg of active ingredient, can be prepared from:

[0121] Gm.

[0122] 17B-N,N-Diethylcarbamoyl-4-methyl-4-aza-5α-androstan-3-...

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Abstract

This invention provides for combinations of 5 alpha reductase inhibitors and SERMs. These combinations are useful in: 1) preventing prostate carcinogenesis in a subject;2) preventing the recurrence of, suppressing, inhibiting or reducing the incidence of prostate carcinogenesis in a subject; 3) treating a subject with prostate cancer; 4) suppressing, inhibiting or reducing the incidence of prostate cancer in a subject; 5) treating a subject with pre-malignant lesions of prostate cancer; 6) suppressing, inhibiting or reducing the incidence of pre-malignant lesions of prostate cancer in a subject; 7) reducing the incidence, inhibiting, suppressing, preventing and / or treating androgen-deprivation induced conditions in men suffering from prostate cancer, such as androgen-deprivation induced osteoporosis, bone fractures, loss of bone mineral density (BMD), hot flashes and / or gynecomastia.; and 8) treating polycystic ovarian syndrome and reducing the incidence, inhibiting, suppressing, preventing and / or treating diabetes, cardiovascular disease, breast cancer and endometrial cancer in women suffering from polycystic ovarian syndrome.

Description

technical field [0001] The present invention relates to combinations of 5α reductase inhibitors and selective estrogen receptor modulators. These combinations are used for: 1) preventing the occurrence of prostate cancer in an individual; 2) preventing the recurrence of prostate cancer in an individual, suppressing, inhibiting the occurrence of prostate cancer in an individual, or reducing the incidence of prostate cancer in an individual; 3) treating patients with prostate cancer 4) suppressing, suppressing prostate cancer in an individual or reducing the incidence of prostate cancer in an individual; 5) treating an individual with pre-exacerbating lesions of prostate cancer; 6) suppressing, suppressing pre-exacerbating lesions of prostate cancer in an individual or reducing the individual 7) Inhibition, suppression, prevention and / or treatment of androgen deprivation-induced disorders such as androgen deprivation-induced osteoporosis, fractures, bone mineral density in men w...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/56A61K31/075
CPCA61K31/47A61K31/138A61K45/06A61K31/56A61P13/08A61P15/00A61P19/10A61P35/00A61P43/00A61P5/28A61P5/32A61P9/00A61P3/10A61K2300/00
Inventor 米切尔·S.·斯坦纳卡伦·A.·韦韦尔卡杜安·D.·米勒
Owner GTX INCORPORATED
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