Gabapentin tablet and preparation method thereof

Abstract

The invention belongs to the field of medicine preparation and relates to a gabapentin tablet which is prepared by wet granulation and prepared mainly from the following raw materials by weight percentage: 80.0% or more of gabapentin, 4.0-17.0% of low-substituted hydroxypropyl cellulose, 0.5-2.5% of adhesive, 0.1-2.5% of stabilizer and 0.5-1.5% of lubricant. The invention further provides a preparation method of the gabapentin tablet. The gabapentin raw material adopted in the invention has good formability and high physical strength after being crushed. Besides, the gabapentin raw material can be prepared by adopting an ordinary wet granulation method and has the characteristics of simple preparation and low cost. The gabapentin tablet provided by the invention has the advantages of very high dissolution in vitro, high content of gabapentin, less application auxiliary materials and high convenience for use, thus meeting modern medicine's requirements of 'small in three aspects' and 'convenient in three aspects', and can be prepared by adopting an ordinary wet granulation method and has the characteristics of simple preparation and low cost.

Description

technical field [0001] The invention belongs to the field of pharmaceutical preparations, and relates to a gabapentin tablet and a preparation method thereof. Background technique [0002] The quality standard of gabapentin tablets is recorded in the United States Pharmacopoeia 32 edition (USP32), and it is listed and widely used in European and American countries, and gabapentin tablets are also listed in China. This product was originally a drug for the treatment of epilepsy, single drug: suitable for the treatment of adults and children over 12 years old (including newly diagnosed patients) suffering from simple or complex partial seizures, with or without secondary generalized seizures Seizures; Combination Use: Children and adults 3 years of age and older with partial seizures with or without secondary generalized seizures. Later, it was found that gabapentin has definite curative effect on various neuralgia, and now this product has become a standard medicine for trea...

AI Technical Summary

Problems solved by technology

U.S. Patent No. 6,294,198B1 discloses a prescription and preparation method of high-content gabapentin tablets, which contain more than 76% gabapentin. This patent believes that the existence of gabapentin raw materials in crystal form is the main reason for the poor formability of high-content tablets, so The main purpose of preparing granules by spraying is to improve the physical strength of tablets, which is an ideal preparation method, but the spray granulation equipment needs to be used, which requires high equipment requirements. More importantly, according to the United States Pharmacopoeia, gabapentin tablets are available in Dissolution of more than 80% within 45 minutes is enough, but because the patent needs to increase the strength of the tablet, it uses a large amount of cellulose and embeds the drug particles in the polymer material, so it cannot put forward higher requirements for the dissolution of the product; in addition, the raw material The change of particle size on the physical properties of the product is also not studied in this patent

The Chinese patent discloses (publication number: CN1720025A) a wet granulation method, the main feature of which is that part of the binder is added to the powder in solid form, and then the remaining binder is used to granulate the liquid for granulation. Although it solves some problems of wet granulation, it uses more excipients, the content of gabapentin in the finished product is also low, and the in vitro dissolution of the drug is not very satisfactory. The method is essentially the same as multiple wet granulation (only the first Part of the binder is added by dry method); Chinese patent discloses (publication number: CN1321083A) a preparation method and application of gabapentin coated granules, and relates to gabapentin tablets granulated and compressed by the disclosed patent method, although there are very good The in vitro dissolution rate, but the biggest deficiency is too little drug content in the tablet, and too many excipients (more than 45%) are used, which is very inconvenient to use and does not meet the requirements of "three small" and "three convenient" of modern pharmaceuticals, and may also causing changes in the stability of the drug

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