Tamsulosin hydrochloride sustained-release pellet preparation

A technology of tamsulosin hydrochloride and sustained-release pellets is applied in the directions of bulk delivery, urinary system diseases, amide active ingredients, etc., can solve the problems of high production cost, poor production operability, complicated process, etc. Stable and effective release, simple process effect

Active Publication Date: 2015-05-06
REGENEX PHARMA LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The oral preparation includes at least two groups of pellets with different coating thicknesses, the process is complicated, the production cycle is long, the production operability is poor, and the production cost is high
[0007] At present, most conventional sustained-release preparations containing tamsulosin hydrochloride use enteric coating to control the drug release site. Luoxin is released at the same time, resulting in a burst release phenomenon within 2 to 4 hours of taking the drug, and its direct adverse reaction is to cause orthostatic hypotension

Method used

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  • Tamsulosin hydrochloride sustained-release pellet preparation
  • Tamsulosin hydrochloride sustained-release pellet preparation
  • Tamsulosin hydrochloride sustained-release pellet preparation

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0030] Example 1 Preparation of tamsulosin hydrochloride sustained-release capsules (based on 20,000 capsules, each capsule contains 0.2 mg tamsulosin hydrochloride)

[0031] Table 1 Example 1 Tamsulosin Hydrochloride Sustained Release Pill Core Formula Composition

[0032]

[0033] Embodiment 1 preparation method:

[0034] (1) Preparation of sustained-release pellet cores: Take tamsulosin hydrochloride, Eudragit? L100-55, microcrystalline cellulose, hypromellose E5 and Eudragit? NE30D according to the formula in the above table, and put them in a wet granulator Add water and mix evenly to make a soft material, add it to a multi-functional pellet coating machine, extrude, place it in a shot blasting pot, round it, and dry the material to make a drug-containing sustained-release pellet core;

[0035] (2) Pack the slow-release coating layer: take 33.3g of Eudragit® NE30D, the coating material of the slow-release coating layer, and make it into a 15-30% coating solution, an...

Embodiment 2

[0037] Example 2 Preparation of tamsulosin hydrochloride sustained-release capsules (based on 25,000 capsules, each capsule contains 0.2mg tamsulosin hydrochloride)

[0038] Table 2 embodiment 2 tamsulosin hydrochloride sustained-release pellet core formula composition

[0039]

[0040] Embodiment 2 preparation method is the same as embodiment 1.

Embodiment 3

[0041] Example 3 Preparation of tamsulosin hydrochloride sustained-release capsules (based on 5000 capsules, each capsule contains 0.2mg tamsulosin hydrochloride)

[0042] Table 3 Example 3 Tamsulosin hydrochloride sustained-release pellet core formula composition

[0043]

[0044] Embodiment 3 preparation method is the same as embodiment 1.

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Abstract

The invention discloses a tamsulosin hydrochloride sustained-release pellet preparation. The tamsulosin hydrochloride sustained-release pellet preparation comprises a tamsulosin hydrochloride sustained-release pellet core, a sustained-release coating layer, and an enteric soluble coating layer; and is a capsule preparation. Three slow release methods including skeleton slow-release, membrane control slow-release, and enteric coating are adopted for preparation of the tamsulosin hydrochloride sustained-release pellet preparation; the obtained tamsulosin hydrochloride sustained-release pellet capsule preparation is capable of controlling releasing from the stomach to the intestine, so that adverse reaction caused by large amount absorption of tamsulosin hydrochloride in a short time is prevented. A preparation method of the tamsulosin hydrochloride sustained-release pellet preparation is simple; and in vivo release of tamsulosin hydrochloride can be controlled stably and effectively.

Description

technical field [0001] The invention relates to a slow-release pellet preparation, in particular to a slow-release pellet preparation of tamsulosin hydrochloride and a preparation method thereof. Background technique [0002] Tamsulosin hydrochloride, also known as tamsulosin hydrochloride, chemical name 5-[(2R)-2-[2-(2-ethoxyphenoxy)ethyl]amino]propyl]-2-methoxy Benzenesulfonamide hydrochloride. This product is used for the treatment of benign prostatic hyperplasia. It has a highly selective blocking effect on the urethra, bladder neck and prostatic smooth muscle. It is currently the most effective drug for treating benign prostatic hyperplasia with lower urinary tract symptoms. However, when it is administered with ordinary tablets or capsules, the rapid release in the body leads to a sudden increase in blood drug concentration, which is the main reason for its side effect of orthostatic hypotension. In order to avoid the above-mentioned side effects, researchers have ma...

Claims

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Application Information

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IPC IPC(8): A61K9/16A61K31/18A61K9/52A61P13/08A61P13/10A61P13/02
Inventor 邓子杰黄和意彭贵子陶艳王丽何清袁永玲左联卢智俊
Owner REGENEX PHARMA LTD
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