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Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor

A technology of dutasteride and hard capsules, applied in medical preparations containing active ingredients, capsule delivery, microcapsules, etc., can solve the problems of poor drug compliance, reduce the rapid action of dutasteride, etc., and achieve fast drug effect , The effect of improving drug compliance and high initial dissolution

Active Publication Date: 2019-01-04
HANMI PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, Jalyn's hard capsules have a very large size: size 00, so drug compliance among elderly patients is poor, and its initial dissolution rate of dutasteride is lower than that of a single dutasteride formulation, which tends to To reduce the rapid action of dutasteride

Method used

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  • Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor
  • Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor
  • Dutasteride- and tamsulosin-containing hard capsule complex and preparation method therefor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] Embodiment 1: prepare hard capsule compound preparation (1)

[0095] Prepare a separate dutasteride portion and a separate tamsulosin portion according to the following prescription:

[0096] -Independent dutasteride moiety-

[0097]

[0098] -Separate Tamsulosin section-

[0099]

[0100] Separate dutasteride fractions were prepared by dissolving dutasteride in monoglyceride oil and diglyceride oil, adding thereto all remaining components, and dissolving the mixture to prepare a self-emulsifying emulsion. The prepared self-emulsifying emulsion was filled into soft capsules to prepare dutasteride soft capsules. In detail, the coating composition was prepared using a capsule base material having a weight ratio of 81:46:1 gelatin:glycerol:glycine according to a conventional method for preparing a coating. Next, according to the conventional filling method, use the rotary automatic filling machine to fill the prepared self-emulsifying emulsion into 2 circles and...

Embodiment 2

[0103] Embodiment 2: prepare hard capsule compound preparation (2)

[0104]Tamsulosin granules were prepared in the same manner as in Example 1, which were then further mixed with 9 mg (5%) of crospovidone as a disintegrant, followed by tableting by a circular punch with a diameter of 6.5 mm . The obtained tamsulosin tablets and dutasteride soft capsules were filled into size 0 gelatin hard capsules (SUHEUNG Co., Ltd.) to prepare a capsule composite preparation.

Embodiment 3

[0105] Embodiment 3: prepare hard capsule compound preparation (3)

[0106] An independent dutasteride part was prepared in the same manner as in Example 1, and an independent tamsulosin part was prepared by the following prescription:

[0107] -Separate Tamsulosin section-

[0108]

[0109] Separate tamsulosin fractions were prepared by mixing all listed tamsulosin hydrochloride, microcrystalline cellulose, hypromellose and 6.0 mg talc in powder form and using A binder solution prepared by dissolving acrylic acid-ethyl acrylate copolymer in water to prepare particles. Next, the prepared tamsulosin granules were coated with an enteric coating solution by dissolving 7.0 mg of methacrylic acid-ethyl acrylate copolymer, triacetin and 3.0 mg of talc in prepared in water to prepare tamsulosin hydrochloride granules. Sucrose stearate was added thereto and mixed therewith to prepare tamsulosin granules.

[0110] The obtained tamsulosin granules and dutasteride soft capsules ...

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Abstract

An aspect of the present invention provides a hard capsule complex and a preparation method therefor, the hard capsule complex comprising, in a separate state: a dutasteride independent part comprising a dutasteride or a pharmaceutically acceptable salt thereof; and a tamsulosin independent part comprising a tamsulosin or a pharmaceutically acceptable salt thereof, wherein the dutasteride independent part is a preparation containing a self-emulsifying emulsion consisting of a dutasteride, an oil and a surfactant; the tamsulosin independent part is a solid preparation containing a sustained-release agent; the dutasteride independent part and the tamsulosin independent part are included in a separate state and can be filled into capsules 0 to 3.

Description

technical field [0001] The present disclosure relates to a hard capsule composite formulation comprising dutasteride and tamsulosin as active ingredients, more specifically, the present invention relates to a hard capsule composite formulation comprising dutasteride and tamsulosin and preparation of the hard capsule A method of composite formulation, wherein the hard capsule composite formulation exhibits the rapid onset efficacy of dutasteride and has improved drug compliance by having a reduced size. Background technique [0002] Benign prostatic hyperplasia is one of the typical diseases that occurs frequently in men aged 50 years or older, causing difficulty urinating due to the enlargement of the prostate gland. Benign prostatic hyperplasia can also cause complications, such as urinary tract infection, urolithiasis, hematuria, and renal failure. [0003] Dutasteride is a 5-α reductase inhibitor (chemical name: 17β-N-(2,5-bis(trifluoromethyl))phenylcarbamoyl-4-aza-5α-an...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K9/50A61K31/58A61K31/18
CPCA61K9/48A61K9/50A61K31/18A61K31/58A61K9/4808A61K9/4825A61K9/4833A61K9/5057A61K9/5084
Inventor 李炳俊金唇哲金载镐金用镒朴宰贤禹钟守
Owner HANMI PHARMA
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