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Pharmaceutical composition including dutasteride and capsule formulation comprising the same

一种度他雄胺、组合物的技术，应用在包含度他雄胺的药物组合物领域，能够解决胶囊尺寸增加、患者依从性低、老年患者不方便等问题，达到改善稳定性的效果

Inactive Publication Date: 2018-06-08
YUYU PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] However, in order to fill the active ingredient dutasteride into soft gelatin capsules, a large amount of oil and surfactant needs to be used, resulting in an increase in the size of the capsules
Large capsule size may lead to low patient compliance due to patients' inability or unwillingness to swallow large size formulations
In particular, considering that the vast majority of benign prostatic hyperplasia patients are elderly patients, the large size of dutasteride capsules has the disadvantage that taking such a large capsule is very inconvenient for elderly patients, and thus patient compliance is low

Method used

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  • Pharmaceutical composition including dutasteride and capsule formulation comprising the same
  • Pharmaceutical composition including dutasteride and capsule formulation comprising the same
  • Pharmaceutical composition including dutasteride and capsule formulation comprising the same

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0059] Into a 3 L preparation vessel equipped with a stirrer was added 1,040 g of propylene glycol monolaurate, and 5 g of dutasteride was slowly added thereto under stirring and completely dissolved. Thereto were added 33 g of polyoxyethylene 40 hydrogenated castor oil and 22 g of poloxamer 124, and the resulting mixture was stirred to prepare a solubilized composition. Soft capsule shells are prepared according to methods known in the art using gelatin, plasticizers and the like. After filling 110 mg of the prepared solubilized composition into oval soft capsules with a size of 2 using a rotary automatic filler, the soft capsule preparations for oral administration were prepared through drying and sorting.

Embodiment 2-8

[0061] Into a 500 mL preparation vessel equipped with a stirrer was added 104 g of propylene glycol monolaurate, and 0.5 g of dutasteride was slowly added thereto under stirring and completely dissolved. Thereto was added a surfactant in an amount shown in Table 1 below, the resulting mixture was stirred and thoroughly mixed, and then 0.01 g of butylhydroxytoluene was added thereto and dissolved to prepare a solubilized composition. Soft capsule shells were prepared using methods known in the art as in Example 1. After filling 110 mg of the prepared solubilized composition into oval soft capsules with a size of 2 using a rotary type automatic filler, they were dried and sorted to prepare soft capsule preparations for oral administration.

[0062] 【Table 1】

[0063]

Embodiment 9-15

[0065] To a 500 mL preparation vessel equipped with a stirrer was added propylene glycol monolaurate in the amount shown in Table 2 below, and 0.5 g of dutasteride was slowly added thereto under stirring and completely dissolved. Thereto was added a surfactant in an amount shown in Table 2 below, and after the resulting mixture was stirred and thoroughly mixed, butylated hydroxytoluene was added thereto and dissolved to prepare a solubilized composition. Soft capsule shells were prepared in the same manner as in Example 1. After filling 110 mg of the prepared solubilized composition into oval soft capsules with a size of 2 using a rotary type automatic filler, a soft capsule preparation for oral administration was prepared through drying and sorting processes.

[0066] 【Table 2】

[0067]

[0068]

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PUM

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Abstract

The present disclosure relates to a pharmaceutical composition comprising dutasteride and propylene glycol monolaurate, and a capsule formulation comprising the same.

Description

technical field [0001] The present invention relates to a pharmaceutical composition comprising dutasteride and a capsule formulation comprising it. Background technique [0002] U.S. Patent No. 5,565,467 discloses dutasteride (chemical name: 17β-N-(2,5-bis(trifluoromethyl))phenylcarbamoyl-4-aza-5α- androst-1-en-3-one), which is a 5-alpha reductase inhibitor, is useful in the treatment of benign prostatic hyperplasia, prostate cancer, and male pattern hair loss (androgenetic alopecia). [0003] <Formula (I)> [0004] [0005] Dutasteride with Soft gelatin capsules are commercially available containing 0.5 mg dutasteride dissolved in a mixture of 349.5 mg caprylic / capric mono- and diglycerides and butylhydroxytoluene (BHT). [0006] However, in order to fill the active ingredient dutasteride into soft gelatin capsules, it is necessary to use a large amount of oil and surfactant, resulting in an increase in the size of the capsules. Large-sized capsules may lead ...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/58A61K9/48A61K47/30
CPCA61K9/4866A61K31/58A61P5/28A61P13/08A61P17/14A61P35/00A61P43/00A61K9/4858A61K47/10A61K47/14A61K47/44
Inventor 白泰坤金世延安卿镇金周姬朴映准
Owner YUYU PHARMA INC