Gabapentin tablets and methods for their preparation

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...