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Hydrochloric tamsulosin sustained-release capsule and its preparation method

A technology of sustained-release capsules and tamsulosin hydrochloride, which is applied in the directions of pharmaceutical formulations, medical preparations without active ingredients, and medical preparations containing active ingredients, etc. Release and other issues, to overcome differences in gastrointestinal transfer time, promote complete and uniform absorption, and reduce fluctuations in blood drug concentrations

Active Publication Date: 2008-02-20
CHANGZHOU NO 4 PHARMA FACTORY
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The granules gradually release tamsulosin hydrochloride from the granule matrix, but the medicament is easily affected by food when taken, and there is a large difference in bioavailability when taken under fasting and fed conditions
[0010] WO2004 / 056354A discloses a controlled-release tamsulosin hydrochloride medicament, but it is only for release in the intestinal tract and does not involve food effects, and it mixes the drug and excipients to form the heart of the preparation, which cannot make the drug release smoothly. Moreover, because the dosage of the drug excipients is too large, it is not conducive to the patient to take it, and it cannot show a small food effect or does not show a food effect
WO2004 / 066991A discloses an enteric sustained-release granule for orally disintegrating tablets, but it cannot be applied to other pharmaceutical preparations due to its special prescription
[0011] So far, in the prior art, there is no record about preparing tamsulosin hydrochloride into a pharmaceutical dosage form that can overcome the food effect, and there is currently no technology that can be generally applied to various drugs to overcome the food effect of the drug

Method used

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  • Hydrochloric tamsulosin sustained-release capsule and its preparation method
  • Hydrochloric tamsulosin sustained-release capsule and its preparation method
  • Hydrochloric tamsulosin sustained-release capsule and its preparation method

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0080] Blank ball core 300g (commercially available)

[0081] Tamsulosin Hydrochloride 0.6g

[0082] Hypromellose (E5) 10g

[0083] Potassium dihydrogen phosphate 50g

[0084] Eudrugit NE 30D 240g

[0085] Triethyl citrate 5g

[0086] Talc powder 25g

[0087] Preparation:

[0088] (a) Dissolve 50 g of potassium dihydrogen phosphate in 500 ml of deionized water; under mechanical stirring, add 10 g of hypromellose (E5) to dissolve into a transparent and clear solution;

[0089] (b) 0.3 g of tamsulosin hydrochloride is dissolved in the solution prepared in step (a);

[0090] (c) adding the blank ball core to the fluidized bed, carrying out fluidized bed coating with the drug-containing solution prepared in step (b), and drying to obtain drug-containing pellets of tamsulosin hydrochloride;

[0091] (d) Disperse the prescribed amount of triethyl citrate and talcum powder in 100ml of water, shear with a high-shear homogenizer for 5 minutes, add the prescribed amount of Eudrug...

Embodiment 2

[0101] Blank ball core 300g (commercially available)

[0102] Tamsulosin Hydrochloride 0.6g

[0103] Potassium dihydrogen phosphate 50g

[0104] Hypromellose (E5) 15g

[0105] Surelease 400g

[0106] PEG4000 15g

[0107] Talc powder 25g

[0108] Preparation:

[0109] (a) Dissolve 50 g of potassium dihydrogen phosphate in 500 ml of deionized water; under mechanical stirring conditions, add 15 g of hypromellose (E5) to dissolve into a transparent and clear solution;

[0110] (b) 0.3 g of tamsulosin hydrochloride is dissolved in the solution prepared in step (a);

[0111] (c) adding the blank ball core to the fluidized bed, carrying out fluidized bed coating with the drug-containing solution prepared in step (b), and drying to obtain drug-containing pellets of tamsulosin hydrochloride;

[0112] (d) Dissolve 15g of PEG4000 in 250ml of deionized water, add 25g of talcum powder under mechanical stirring, then add the prescribed amount of Surelease aqueous dispersion solution,...

Embodiment 3

[0118] Blank ball core 300g (commercially available)

[0119] Tamsulosin Hydrochloride 0.6g

[0120] PVP K30 20g

[0121] Potassium dihydrogen phosphate 50g

[0122] Eudrugit RL100 30g

[0123] Eudrugit RS100 70g

[0124] Dibutyl sebacate 10g

[0125] Talc powder 25g

[0126] Preparation:

[0127](a) Dissolve 50 g of potassium dihydrogen phosphate in 500 ml of deionized water; under mechanical stirring, add 20 g of PVPK30 to dissolve into a transparent and clear solution;

[0128] (b) 0.3 g of tamsulosin hydrochloride is dissolved in the solution prepared in step (a);

[0129] (c) adding the blank ball core to the fluidized bed, carrying out fluidized bed coating with the drug-containing solution prepared in step (b), and drying to obtain drug-containing pellets of tamsulosin hydrochloride;

[0130] (d) Add the Eudrugit RL100 and Eudrugit RS100 of the prescription amount in 95% ethanol solution under the condition of mechanical stirring, and dissolve completely to Eudr...

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Abstract

The present invention provides a tamsulosin hydrochloride sustained-release capsule. The tamsulosin hydrochloride sustained-release capsule of the present invention can avoid the sudden release of the drug tablets and the performance differences generated from the gastric emptying differences, display minor food effect or do not display food effect, and obtain the stable curve of the plasma drug concentration and longer action time simultaneously, so as to reduce the occurrence of cardiovascular side effects, greatly improve the safety, effectiveness and compliance of the medication for the patients. The tamsulosin hydrochloride sustained-release capsule of the present invention can ensure the sustained and regular release of the main ingredient tamsulosin hydrochloride after the oral administration, and the present invention is characterized by convenient administration, durable function, stable efficacy, fewer side effects and so on.

Description

technical field [0001] The invention relates to a sustained-release capsule and a preparation method thereof, in particular to a tamsulosin hydrochloride sustained-release capsule and a preparation method thereof. Background technique [0002] Benign prostatic hyperplasia (BPH) refers to benign adenomatous hyperplasia of cells in the periurethral area of ​​the prostate, and is a common urological disease in elderly men. Tamsulosin hydrochloride is an α1 adrenergic receptor antagonist developed by Yamanouchi Pharmaceutical Co., Ltd., Japan, for the treatment of benign prostatic hyperplasia. It was first listed in Japan in 1993. [0003] The absorption and bioavailability of any therapeutic agent when administered orally is affected by many factors. These factors include the presence of food in the GI tract, since drugs generally remain in the stomach longer in the presence of food than when fasted. A drug is said to exhibit a "food effect" if the bioavailability of the drug...

Claims

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Application Information

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IPC IPC(8): A61K9/56A61K31/145A61K47/34A61P13/08
Inventor 王晓东屠永锐
Owner CHANGZHOU NO 4 PHARMA FACTORY
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