Pregabalin stomach floating-type slow-release tablet and preparation method thereof

A technology of pregabalin and sustained-release tablets, which is applied in the field of pregabalin gastric floating sustained-release tablets and the preparation thereof, can solve the problems of decreased release of preparations, poor water solubility, complex components, etc., and achieves high bioavailability, good absorption effect

Active Publication Date: 2018-12-21
AC PHARMA CO LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, this type of fatty alcohol or fatty acid has complex components and is easy to age, which leads to a decrease in the release of the preparation during storage and affects produc...

Method used

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  • Pregabalin stomach floating-type slow-release tablet and preparation method thereof
  • Pregabalin stomach floating-type slow-release tablet and preparation method thereof
  • Pregabalin stomach floating-type slow-release tablet and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-24

[0036] Pregabalin gastric floating sustained-release tablets were prepared according to the components and prescription quantities shown in Tables 1 to 4.

[0037] For Examples 1 to 10 and 13 to 22, after mixing all tablet components except magnesium stearate in a mixing tank for 15 minutes, continue mixing with magnesium stearate through a 24-mesh standard sieve for 5 minutes to obtain a total blend , and then compressed into tablets with a weight of 1 g or 1.125 g using a die with a size of 19.1 mm×10.0 mm.

[0038] For Examples 11-12 and 23-24, pregabalin and cross-linked polyvinylpyrrolidone were premixed in a high-shear granulation pot for 2 minutes, and then wet granulated with water as a binder. The granules are then blended with the remaining ingredients except the magnesium stearate. Then continue to mix with magnesium stearate passing through a 24-mesh standard sieve for 5 minutes to obtain a total mixture, and finally compress it into tablets with a weight of 1 g o...

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PUM

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Abstract

The invention discloses a pregabalin stomach floating-type slow-release tablet. The pregabalin stomach floating-type slow-release tablet comprises an active ingredient, a framework material, a swelling agent and an excipient. The active ingredient is pregabalin and pharmacologically acceptable salt, a solvate, a hydrate or a complex thereof. The framework material is combination of any one or moreof hydroxypropyl methylcellulose, hydroxypropylcellulose, acrylic resin and derivatives thereof, wherein the active ingredient accounts for 7-33% of a total weight of the slow-release tablet, the framework material accounts for 5-50% of the total weight of the slow-release tablet, the swelling agent accounts for 5-55% of the total weight of the slow-release tablet, and the balance of the excipient. The pregabalin stomach floating-type slow-release tablet is capable of, through selecting the suitable combination of the framework material and the swelling agent, achieving the following purposes: 1) prolonging residence time of the slow-release tablet in a stomach, enabling a drug to be continuously released and absorbed, and reducing fluctuation of blood concentration; and 2) reducing the physiological condition effect of a patient, and enabling the efficacy of the slow-release tablet to have a smaller individual difference.

Description

technical field [0001] The invention belongs to the technical field of medicine, and in particular relates to a pregabalin gastric floating sustained-release tablet and a preparation method thereof. Background technique [0002] Pregabalin, whose chemical name is (S)-(+)-3-aminomethyl-5-methylhexanoic acid, is a γ-aminobutyric acid analogue, which is mainly used clinically to treat peripheral neuropathic Pain and adjunctive treatment of partial partial epilepsy. At present, only pregabalin immediate-release preparations (capsules and oral solutions) are available on the market for this product, and the administration method is 2-3 times a day. [0003] Pregabalin immediate-release preparations need to be administered multiple times a day, which will lead to significant fluctuations in the blood drug concentration of the drug, resulting in dose-related side effects and low drug utilization. The development of a once-daily sustained-release formulation can not only improve p...

Claims

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Application Information

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IPC IPC(8): A61K9/22A61K47/38A61K47/32A61K47/10A61K31/197A61P25/02A61P25/08
CPCA61K9/2027A61K9/2031A61K9/2054A61K9/2095A61K31/197A61P25/02A61P25/08
Inventor 刘锋何一鸣梁文伟赖树挺谭晓峰
Owner AC PHARMA CO LTD
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