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

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...

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 product quality. Moreover, its water solubility is poor, and when it is used in a large amount, it is easy to affect the release of the drug, resulting in low or no efficacy of the drug. take effect

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