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Gabapentin tablets and methods for their preparation

A gabapentin tablet and gabapentin technology are applied in the direction of pill delivery, medical preparations containing active ingredients, coatings, etc., which can solve expensive and time-consuming problems

Inactive Publication Date: 2006-01-11
RANBAXY LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

This is a time-consuming and expensive process

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0049] Example 1: Gabapentin, HPC-L (half the amount) and polyvinylpolypyrrolidone were mixed in a rapid mixing granulator, granulated with pure aqueous solution / dispersion of HPC-L, and dried in a fluidized bed dryer. The resulting dry granules were mixed with the extragranular excipients ie polyvinylpolypyrrolidone, corn starch, poloxamer, dicalcium phosphate and maltitol in a low shear blender for 15 minutes. The resulting mixture is blended with talc and magnesium stearate in a low shear blender for 10 minutes and compressed into tablets using suitable tooling.

Embodiment 2

[0050] Embodiment 2: Mix gabapentin and HPC-L (half amount) in the rapid mixing granulator, make it granulate with binder solution (i.e. the solution of the remaining amount of HPC-L in pure water), in fluidization Dry in a bed dryer. The resulting dry granules were mixed with the extragranular excipients ie polyvinylpolypyrrolidone, poloxamer and maltitol in a low shear blender for 15 minutes. Finally the resulting mixture is blended with talc and magnesium stearate in a low shear blender for 10 minutes and compressed with suitable tooling into tablets.

[0051] The tablets prepared in the above examples were coated with a coating having the following composition:

[0052] Coating formula:

[0053] Hydroxypropyl Cellulose: 15mg

[0054] Talc powder: 15mg

[0055] Pure water: appropriate amount

[0056] The tablets of Example 2 were subjected to an accelerated study for 3 months at 40°C and 75% relative humidity (RH). The resulting stability, friability and hardness data...

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PUM

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Abstract

The present invention is generally directed to methods for preparing stable gabapentin tablets by wet granulation. A wet granulation method for preparing gabapentin tablets includes forming a mixture by dry mixing of a first portion of a binder with the gabapentin, one or more excipients, or a combination of the gabapentin and the one or more excipients; and adding a second portion of the binder to the mixture, wherein the second portion of the binder is in the form of a solution or dispersion.

Description

field of invention [0001] The present invention generally relates to the preparation of stable gabapentin tablets by wet granulation. Background of the invention [0002] Gabapentin is an antiepileptic drug indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy (with or without secondary onset). Gabapentin exists in a crystalline form, which is poorly compressible and formable. These unfavorable properties of gabapentin cause capping and lamination defects during compression into tablets. [0003] Typically, these problems are overcome by incorporating compression aids in the formulation. However, the more excipients (eg, compression aids) used in the composition, the more expensive and time consuming commercial production is. Also, increasing the amount of excipients will increase the tablet size, resulting in oversized tablets, which is disadvantageous for pediatrics and those patients who have difficulty s...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/195A61K9/28A61K31/517
CPCA61K9/2077A61K9/2054A61K9/2866A61K31/517A61K9/2027A61K31/195Y02A50/30
Inventor R·马尼坎丹A·戈贾S·B·罗伊R·马利克
Owner RANBAXY LAB LTD
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