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Dutasteride and composition capsules for treating alopecia

A technology of dutasteride and its composition, which is applied in the field of composition capsules, can solve problems such as the inability to reduce the single dosage of dutasteride, increase the risk of high-grade prostate cancer, and the safety and efficacy cannot be guaranteed, and achieve convenience Hair loss treatment, bioavailability enhancement, and effect in treatment of male androgenetic alopecia

Inactive Publication Date: 2019-04-26
NANJING CHIA TAI TIANQING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the commercially available products of dutasteride are all capsules of 0.5 mg, the main function is to reduce the risk of acute urinary retention (AUR) and surgery for patients with benign prostatic hyperplasia with moderate and severe symptoms, and may increase Risk of High-Grade Prostate Cancer
The indivisibility of capsules makes it impossible to reduce the single dose of dutasteride, and the safety and efficacy cannot be guaranteed

Method used

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  • Dutasteride and composition capsules for treating alopecia
  • Dutasteride and composition capsules for treating alopecia
  • Dutasteride and composition capsules for treating alopecia

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0022] Preparation of dutasteride soft capsules: Dutasteride soft capsules were prepared with 1 / 4 of the composition ratio of the dutasteride preparation AVODART prepared by Glaxo Company.

Embodiment 2

[0024] Preparation of Dutasteride Soft Capsules:

[0025] Content composition: Dutasteride 0.125g, caprylic capric triglyceride 30g, glycerol monooleate 35g, Tween-2070g, PEG-50 hydrogenated castor oil 78g, Transcultol P 35g, 2,6-di-tert-butyl 0.02g of p-cresol;

[0026] Preparation method: Take caprylic capric triglyceride, glycerol monooleate, Tween-20, PEG-50 hydrogenated castor oil, Transcultol P in the prescribed amount, heat up to 40-45°C and stir evenly, add the prescribed amount of Dota Androstamine and 2,6-di-tert-butyl-p-cresol were mixed evenly, emulsified quickly to obtain stable contents, and 1000 soft capsules were prepared.

[0027] After storing for 6 months, the content of its main drug migrated into the capsule shell was measured, which was 0.7%.

Embodiment 3

[0029] Preparation of Dutasteride Soft Capsules:

[0030] Content Composition Dutasteride 0.125g, Caprylic Capric Triglyceride 27g, Glyceryl Monooleate 38g, Tween-2077g, PEG-50 Hydrogenated Castor Oil 79g, Transcultol P 39g, 2,6-Di-tert-butyl p-cresol 0.01g; adopt the method for embodiment 2 to prepare 1000 soft capsules.

[0031] After storing for 6 months, the content of its main drug migrated into the capsule shell was measured, which was 0.8%.

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Abstract

The invention discloses dutasteride and composition capsules for treating alopecia. The single capsule contains 0.125mg of the dutasteride; the single composition capsule contains 0.125mg of the dutasteride and 0.3-0.4mg of minoxidil. By exponentially decreasing the effective dose of the dutasteride in the single capsule, the composition capsules not only do not influence the efficacy of dutasteride in the treatment of patients with benign prostatic hyperplasia with moderate or severe symptoms (four capsules are taken in a single dose), but also can be prepared by combining a small dose of thedutasteride with minoxidil for use, thus effectively treating the male androgenetic alopecia. Furthermore, the prepared composition capsules can effectively treat the alopecia by being directly and orally taken.

Description

technical field [0001] The invention relates to a dutasteride soft capsule and a composition capsule prepared by using dutasteride and minoxidil. Background technique [0002] Dutrsteride, the chemical name is N-{2,5-bis(trifluoromethyl)phenyl}-3-carbonyl-4-azandrostamine-5α-androst-1-ene-17β -Formamide, having a chemical structure shown in Formula 1, is a drug developed by GlaxoSmithKline (GSK) for the prevention and treatment of benign prostatic hyperplasia. It was approved by the FDA in June 2003 and listed in the United States. In 2011 was allowed to enter China. Dutasteride is a 5α-reductase inhibitor, and it is also a drug that can simultaneously inhibit two types of 5α-reductase, type I and type II. Compared with finatasteride, dutasteride acts more rapidly and more significantly, and has the advantage of dual inhibition. [0003] In the study of the drug efficacy of dutasteride, it was found that due to its 5α reductase inhibitory effect, it can reduce hair loss i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K47/14A61K47/26A61K47/44A61K31/58A61K31/506A61P17/14
CPCA61K9/4858A61K9/4866A61K31/506A61K31/58A61P17/14A61K2300/00
Inventor 冯艳
Owner NANJING CHIA TAI TIANQING PHARMA
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