Tamsulosin hydrochloride cotrolled-releasing tablet preparation and preparing method thereof

Abstract

The present invention discloses a tamulosin osmotic pump type controllably-released tablet preparation and its preparation method. Said preparation is composed of double-layer table core, semipermeable film with small pres and moisture-proof film. Its double-layer table core is formed from medicine-containing layer and assistant layer, in which the medicine-containing layer contains 10-99% of ethylene pyrrolidone polymer and / or ethylene pyrrolidone copolymer, and the assistant layer contains 10-80% of water-insoluble polymer, at the same time, in the assistant layer 10-80% of hydrophilic polymer with osmotic activity and 5-50% of osmotic pressure accelerator are contained.

Description

technical field [0001] The invention relates to the field of pharmaceutical preparations, in particular to an osmotic pump type drug delivery preparation containing an active drug tamsulosin or a pharmaceutically acceptable salt thereof, which can make the drug enter the gastrointestinal tract at a controlled rate. It also relates to a preparation method of the controlled-release tablet preparation. Background technique [0002] Tamsulosin hydrochloride is an α-adrenoceptor antagonist developed by Yamanouchi Pharmaceutical Co., Ltd., Japan, for the treatment of benign prostatic hyperplasia (BPH). Enlargement of the prostate gland in adult men is very common, medically known as benign prostatic hyperplasia or benign prostatic hypertrophy. Many BPHs cause obstruction of the urethra and progressive loss of bladder function, which can lead to incomplete emptying of the bladder. Benign prostatic hyperplasia is clinically manifested as changes or problems in urination, such as w...

AI Technical Summary

Problems solved by technology

The reasons are as follows: 1) The controlled-release tablet prepared by using vinylpyrrolidone polymer and / or vinylpyrrolidone copolymer as the carrier has a short time lag, and the drug can take effect quickly after taking it, and its release characteristics are minimal or not affected by food. effect, while polyoxyethylene will cause a relatively long time lag after taking the drug due to its low water absorption rate and hydration rate

2) Vinylpyrrolidone polymers and / or vinylpyrrolidone copolymers have better thermal stability than polyoxyethylene. The glass transition temperature (Tg) of povidone with different molecular weights ranges from 130°C to 176°C. Povidone K-90 (Plasdone K-90) has a glass transition temperature of 174°C, copovidone S-630 (Plasdone S-630) has a glass transition temperature of 105°C, and polyoxyethylene has a typical glass transition temperature range of 65°C ~67°C, so PEO does not have ideal thermal stability, which may cause problems in the preparation of osmotic pump tablets as well as in storage

For example, solvent drying is difficult during granulation

Since the drying temperature should not normally exceed 40°C, it is easy to cause a high residual amount of organic solvents; if the drying is to be relatively complete, a relatively long drying time is required; during the high-speed tableting process, if the die is used repeatedly, the heat will cause the temperature to reach 50 When the temperature is around ℃, if PEO is used, adverse phenomena such as sticking and punching are prone to occur, so special cooling facilities are required to control the temperature of the die or reduce the tableting speed

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