Gabapentin tablet and preparation method thereof

Abstract

The invention belongs to the technical field of medicines, and particularly discloses a gabapentin tablet and a preparation method thereof. According to the invention, micro powder treatment is performed on active components of gabapentin and lactose, and polyvidone K30 is added into a recipe to be used as an adhesive for preparing a finished tablet. The gabapentin tablet is prepared according to the method disclosed by the invention, so that the content uniformity of the prepared preparation conforms to the specification, a new selection can be provided for epileptics with different disease characteristics, and the requirements for treating epilepsy and neurologic diseases can be furthest satisfied.

Description

Invention field [0001] The invention relates to a pharmaceutical preparation for treating epilepsy and a preparation method thereof, belonging to drugs for neurosurgery or general surgery diseases, in particular to a gabapentin tablet and a preparation method thereof. Background of the invention [0002] The quality standard of gabapentin tablets is included in the 32nd edition of the United States Pharmacopoeia (USP32), which is marketed and widely used in European and American countries. Gabapentin tablets are also on the market in China. This product was originally a drug for the treatment of epilepsy, a single drug: it is 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 systemic Seizures; combination medication: children and adults aged 3 and over who have partial seizures with or without secondary generalized seizures. Later, it was discovered...

AI Technical Summary

Problems solved by technology

U.S. Patent No. 6,294,198B1 discloses a prescription and preparation method of a high-content gabapentin tablet, and its tablet contains more than 76% of gabapentin. This patent thinks that the existence of gabapentin raw material in crystal form is the main reason for the poor formability of the high-content tablet, 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, a large amount of cellulose is used and the drug particles are embedded in the polymer material, so it is impossible to 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

Chinese patent discloses (publication number: CN1720025A) a kind of wet granulation method, and its main feature is that part binder is added in the medicine powder earlier with solid form, then uses remaining binder granulation liquid, carries out granulation pressure Although the problem of wet granulation has been solved, 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 that of multiple wet granulation (only the first Part binder dry method adds); Chinese patent discloses (publication number: CN1321083A) a kind of preparation method of gabapentin coating granule and application thereof, relate to the gabapentin tablet that granulates tabletting with this disclosed patent method, although there are very good The dissolution rate in vitro is high, but the biggest deficiency is that the drug content in the tablet is too small, and there are too many excipients (greater than 45%), which is very inconvenient to use and does not meet the requirements of "three small" and "three convenient" of modern pharmaceuticals. causing changes in the stability of the drug

[0005] But existing literature all does not disclose and comprises gabapentin 10~30%, filler 50%~98%, binding agent 2%~6%, and lubricant 0.5%~2% gabapentin tablet pharmaceutical preparation, also does not give any Notes about the proportions of its pharmaceutical preparations

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