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Sustained release oral dosage forms of gabapentin

A technology of gabapentin and sustained-release tablets, which can be used in pill delivery, medical preparations containing active ingredients, peptide/protein ingredients, etc., and can solve problems such as dose dumping and rupture

Inactive Publication Date: 2005-09-14
RANBAXY LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Also, dosage forms can rupture after contact with food in the gastrointestinal tract, potentially leading to dose dumping

Method used

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Examples

Experimental program
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Effect test

preparation example Construction

[0042] The sustained-release dosage forms described herein are prepared by mixing gabapentin with at least one rate-controlling polymer and other excipients, wet granulating the mixture with water or a binder solution, drying and sieving the wet granules, and The granules are compressed into tablets. While this method is satisfactory, other methods, including those described below, can be used to prepare sustained release dosage forms.

[0043] Gabapentin can exist in the form of free base, hydrate, such as monohydrate or any other pharmaceutically acceptable salt, the anion of inorganic acid (calculated by chloride content) is less than 100ppm, and the lactam content is less than 0.05% of the gabapentin weight, Although other pharmaceutically acceptable amounts can be used. Gabapentin may comprise from about 100 mg to about 1200 mg by weight of the tablet.

[0044] In general, the rate controlling polymer can be a hydrophilic or a hydrophobic polymer; particularly suitable ...

Embodiment 1

[0057] In the rapid mixing granulator, gabapentin is mixed with part of hydroxypropyl methylcellulose and microcrystalline cellulose, and granulated with the remaining part of hydroxypropyl methylcellulose in water. The wet mass is dried, properly sieved, lubricated with magnesium stearate and colloidal silicon dioxide and compressed with suitable implements. The tablets were then coated with OPADRY to a composition of about 2% w / w by weight.

Embodiment 2 and 3

[0059] Gabapentin was mixed with mannitol and part of hydroxypropyl methylcellulose in a rapid mixing granulator and dispersed with an aqueous solution / dispersion of polyvinylpyrrolidone / vinyl acetate copolymer and the remaining part of hydroxypropylmethylcellulose The body is granulated. The wet mass is dried, suitably sieved, mixed with poloxamer, magnesium stearate and talc and compressed with suitable implements. The tablets were then coated with OPADRY to a composition of about 2% w / w by weight.

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PUM

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Abstract

The present invention relates to sustained release oral dosage forms of gabapentin and at least one rate controlling polymer, and a process for the preparation of the sustained release oral dosage forms, and a process for the preparation thereof. The sustained release tablet includes gabapentin or a pharmaceutically acceptable salt or hydrates thereof and at least one rate-controlling polymer such that the tablet provides therapeutically effective plasma levels of gabapentin for a period of up to about 12 hours.

Description

field of invention [0001] The present invention relates to sustained release oral dosage forms of gabapentin and at least one rate controlling polymer, and methods of making sustained release oral dosage forms. Background of the invention [0002] Gabapentin (1-(aminomethyl)cyclohexaneacetic acid) is a gamma-amino acid analogue effective in the treatment of epilepsy. Gabapentin is indicated for the adjunctive treatment of partial seizures with and without secondary generalization in adults with epilepsy. Gabapentin has also been approved in some countries for the treatment of neuralgia. [0003] Some people with epilepsy need to take medicine throughout their life, while others only need to take medicine for a limited period of time. The importance of taking medication at regular intervals is well known. But it's also well known that not all patients remember to take the proper dose at the same time each day. Therefore, multiple dose regimens are not only inconvenient bu...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/00A61K9/20A61K9/22A61K31/195A61P25/08
CPCA61K9/2054A61K9/0065A61K9/2027A61K31/195A61P25/08
Inventor M·查拉R·S·拉古凡石A·兰帕尔
Owner RANBAXY LAB LTD
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