Tamsulosin hydrochloride sustained-release pellets and preparation method thereof

A technology of tamsulosin hydrochloride and pellets, which can be used in pharmaceutical formulations, medical preparations with non-active ingredients, drug combinations, etc., can solve the problems of unstable coating efficiency with drug content and no release situation.

Inactive Publication Date: 2012-01-18
JIANGSU UNIV +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The disadvantage is that the dosage of tamsulosin hydrochloride is very small, if the method of coating is simply used to load the drug, the drug content will be unstable due to the difference in coating efficiency
[0006] CN200380109413.3 discloses a controlled-release pharmaceutical composition of tamsulosin hydrochloride, which adds one or more rate-controlling polymers to the pellet core, and achieves a controlled-release effect through a single-layer coating. Also only the results in the pH6.8 medium, no release in the pH1.2 medium

Method used

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  • Tamsulosin hydrochloride sustained-release pellets and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0027] Weigh 170 g of microcrystalline cellulose and 10 g of croscarmellose sodium, mix them uniformly, add 180 g of water (containing 269 mg of medicine) to make a soft material, and use a Mini250 extrusion spheronizing fluidized coating machine to prepare medicine-containing pills.

[0028] The drug-containing pills were dried at 50°C for 1 hour, took out and weighed 100g, put them into a Mini250 extruding spheroid fluidized coating machine to preheat for 10min, 60% Su Lisi (ie 15% aqueous ethylcellulose dispersion) coated with 105 g, taken out, and dried at 50° C. for 40 min. Then place the Mini250 type extrusion tumbling fluidized coating machine, Kolicoat MAE 30DP Formula coating liquid (containing 14.5% of polymer, 2.2% of talc, 1.3% of polyethylene glycol 60001.3%) coated 12g, took out, and dried at 50°C for 2 hours to obtain tamsulosin hydrochloride sustained-release pellet preparation.

Embodiment 2

[0030] Weigh 180g of microcrystalline cellulose, 20g of croscarmellose sodium, mix well, add water 210g (containing 371mg of medicine) to make a soft material, and a Mini250 type extrusion spheronizing fluidized coating machine prepares medicine-containing pills.

[0031] The drug-containing pills were dried at 50°C for 1 hour, took out and weighed 100g, put them into a Mini250 extruding spheroid fluidized coating machine to preheat for 10min, 60% Su Lisi (ie 15% ethylcellulose aqueous dispersion) coated with 108g, taken out, and dried at 50°C for 40min. Then place the Mini250 type extrusion tumbling fluidized coating machine, Kolicoat MAE 30DP Formula coating liquid (containing 14.5% of polymer, 2.2% of talc, 1.3% of polyethylene glycol 60001.3%) was coated with 15g, taken out, and dried at 50°C for 2 hours to obtain tamsulosin hydrochloride sustained-release pellet preparation.

Embodiment 3

[0033] Weigh 190 g of microcrystalline cellulose and 30 g of croscarmellose sodium, mix them uniformly, add 210 g of water (containing 371 mg of medicine) to make a soft material, and use a Mini250 extrusion spheronizing fluidized coating machine to prepare medicine-containing pills.

[0034] The drug-containing pills were dried at 50°C for 1 hour, took out and weighed 100g, put them into a Mini250 extruding spheroid fluidized coating machine to preheat for 10min, 60% Su Lisi (ie 15% aqueous ethylcellulose dispersion) coated 110 g, taken out and dried at 50° C. for 40 min.

[0035] Take it out and place it in a Mini250 extrusion spheroid fluidized coating machine, Kolicoat MAE 30DP Formula coating liquid (containing 14.5% of polymer, 2.2% of talc, 1.3% of polyethylene glycol 60001.3%) coated 18g, took out and dried at 50°C for 2 hours to obtain tamsulosin hydrochloride sustained-release pellet preparation.

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Abstract

The invention discloses tamsulosin hydrochloride sustained-release pellets, which are prepared by coating medicament-containing blank pellets, wherein the blank pellets contain microcrystalline cellulose, soluble starch, lactose and croscarmellose sodium. Two layers of coating liquid are a Surelease sustained-release coating material and an enteric-coating material Kolicoat MAE 30DP respectively and the tamsulosin hydrochloride sustained-release pellets are capsules. The tamsulosin hydrochloride sustained-release pellets of the invention adopt the sustained-release coating material and the enteric-coating material to control the release of medicaments. The prepared tamsulosin hydrochloride sustained-release pellet capsules release less than 40 percent of medicaments in hydrochloric acid solution with a pH value of 1.2 in two hours and release 40 to 70 percent (about 60 percent) of medicaments in phosphate buffer solution with a pH value of 6.8 in three hours and over 70 percent (about90 percent) of medicaments in five hours, so the prepared tamsulosin hydrochloride sustained-release pellet capsules meet the requirements of quality standards. The invention discloses a preparation method of the tamsulosin hydrochloride sustained-release pellets.

Description

technical field [0001] The invention relates to a sustained-release pellet preparation and a preparation method thereof, in particular to a tamsulosin hydrochloride sustained-release pellet preparation and a preparation method thereof. Background technique [0002] Tamsulosin hydrochloride is a selective α-1 blocking agent for prostate smooth muscle, and it is a drug that has a therapeutic effect on urinary tract obstructive lesions caused by benign prostatic hyperplasia. The daily dose is 0.2-0.8mg . Compared with other α-1 blockers, such as doxazosin and terazosin, tamsulosin hydrochloride is more selective for prostate smooth muscle, and its dosage is therefore smaller, in order to prevent its rapid absorption and cause The increase of its blood concentration causes side effects such as orthostatic hypotension, and it is a better choice to prepare it into a sustained-release preparation. [0003] Currently, the reported patents related to tamsulosin hydrochloride mainly...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/16A61K9/48A61K31/18A61K47/38A61P13/08
Inventor 徐希明余江南朱源张正艮游明霞金霞顾孝红孙田江陆宏国
Owner JIANGSU UNIV
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