Pharmaceutical composition containing tamsulosin or hydrochloride thereof and preparation method therefor

A composition, tamsulosin technology, applied in the direction of drug combination, drug delivery, pharmaceutical formulation, etc., can solve problems such as spray gun clogging, particle size change, etc., to achieve the effect of improving productivity and shortening process time

Pending Publication Date: 2022-02-15
HANMI PHARMA
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in this case, the spray gun used to spray the coating solution may clog due to the increased v

Method used

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  • Pharmaceutical composition containing tamsulosin or hydrochloride thereof and preparation method therefor
  • Pharmaceutical composition containing tamsulosin or hydrochloride thereof and preparation method therefor
  • Pharmaceutical composition containing tamsulosin or hydrochloride thereof and preparation method therefor

Examples

Experimental program
Comparison scheme
Effect test

preparation Embodiment 1

[0126] Preparation Example 1: Preparation of sustained-release core particles

[0127] Core particles containing tamsulosin hydrochloride and coated with a sustained release coating layer were prepared.

[0128] First, tamsulosin hydrochloride, hydroxypropylmethylcellulose (HPMC) serving as a binder, ethanol, and pure water were mixed in a high-speed mixer at the content ratios shown in Table 1, and then talc was added to the mixture to prepare the first coating solution. Microcrystalline cellulose (MCC, 175, particle size 150 μm to 200 μm) into the fluidized bed system and bottom spray the first coating solution onto the inert seeds. After the spraying of the first coating solution was finished, the obtained seeds were dried to prepare core particles containing tamsulosin hydrochloride.

[0129] In order to form a sustained-release coating layer on the surface of each core particle, the SR 30D(EP) was dissolved in water, and talc was added thereto to prepare a sustained...

experiment example 1

[0132] Experimental Example 1: Comparison of Physical Properties of Tablets with Different Talc Contents

[0133] Tablets include an enteric coating formed on the sustained release core granules using a fluidized bed spray process. In this case, there were differences in process time and tablet quality depending on the content of talc used as an anti-adhesive agent in the enteric coating layer. In this Experimental Example, tablets were prepared using various enteric coating solutions having different contents of talc, and the physical properties of the prepared tablets were compared.

[0134]

[0135] Tablets were prepared according to the composition shown in Table 2. As the core particles, the sustained-release core particles prepared in Preparation Example 1 were used.

[0136] To prepare an enteric coating solution, use L30-D55 (methacrylic acid-ethyl acrylate 1:1 copolymer contained at a concentration of 30%) and NE30D (ethyl acrylate-methyl methacrylate copolyme...

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Abstract

The present invention provides a pharmaceutical composition containing tamsulosin or hydrochloride thereof, and a preparation method therefor. When an enteric-coated layer is formed, a fluid-bed system can be used to form the enteric-coated layer on core particles by adjusting a content of talc, with the resultant improvement of productivity. Even though the content of talc is reduced, aggregation of enteric-coated beads can be minimized; and after coating, the enteric-coated layer does not decrease in function and acid resistance. Therefore, the pharmaceutical composition can be applied to an oral preparation.

Description

technical field [0001] The invention relates to a pharmaceutical composition containing tamsulosin or its hydrochloride and its preparation method. Background technique [0002] Tamsulosin hydrochloride is a drug that selectively acts on the genitourinary system by selectively inhibiting alpha-adrenergic receptors. It is known that tamsulosin hydrochloride relaxes the smooth muscle around the bladder and prostate to increase the speed of urination, alleviates the symptoms of benign prostatic hyperplasia, and exhibits significant efficacy with few side effects. [0003] The bioavailability of tamsulosin hydrochloride is over 90%, so it is well absorbed in the body. The half-life of tamsulosin in healthy individuals is 9 hours to 13 hours, but it is considerably longer (eg, 14 hours to 15 hours) in patients with benign prostatic hyperplasia. Therefore, tamsulosin hydrochloride need not be provided in a sustained release formulation. When it is formulated to release slowly f...

Claims

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Application Information

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IPC IPC(8): A61K31/18A61K9/26A61K47/02A61P13/00A61P13/08
CPCA61K31/18A61K9/0053A61P13/00A61P13/08A61K9/2081A61K9/501A61K9/2813A61K9/2846A61K9/5078A61K9/282A61K9/5026A61K9/5015
Inventor 曹赫俊金辉林昊泽金用镒
Owner HANMI PHARMA
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