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A pharmaceutical composition comprising gabapentin

A technology of gabapentin and composition, applied in the field of pharmaceutical compositions containing gabapentin, can solve problems such as easy confusion of excipient selection

Inactive Publication Date: 2007-07-18
ZAMBON GRP SPA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0012] The ability to identify suitable excipients to control the formation of lactam impurities, given the difficulties faced in the past in identifying suitable excipients, but also the fact that there is often confusion about the need for attention in terms of excipient selection it's amazing

Method used

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  • A pharmaceutical composition comprising gabapentin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0037] General procedure for preparing the pharmaceutical composition according to the invention

[0038] In a Turbula Mod. T2F mixer from the Bachofen company (Basil-Switzerland) equipped with a 2 liter capacity metal container, the powder mixture was mixed in the container at a speed of 10 rpm for 10 minutes at room temperature, wherein all Said powder mixture consists of gabapentin and suitable excipients which do not promote the conversion of gabapentin to the corresponding lactam impurity.

[0039] Depending on the amounts of the ingredients introduced, the powder mixture thus obtained can give compositions in the following value ranges:

[0040] Gabapentin accounts for 50-99% of the total weight of the composition;

[0041] The glidant accounts for 0.5-5% of the total weight of the composition;

[0042] The lubricant accounts for 0.1-8% of the total weight of the composition;

[0043] The diluent comprises 0-50% of the total weight of the composition.

[0044] The p...

Embodiment 2

[0046] Following the procedure described in Example 1, the following pharmaceutical compositions were prepared. Amounts of components are expressed in percent by weight of the total composition.

[0047] Composition 1

[0048] Gabapentin 75%

[0049] Sorbitol 15%

[0050] Alginic Acid 4%

[0051] Hydrogenated Castor Oil 5%

[0052] Tricalcium Phosphate 1%

[0053] Composition 2

[0054] Gabapentin 70%

[0055] Fructose 12.5%

[0056] Colloid 10%

[0057] Carrageenan lambda 5%

[0058] Glyceryl Behenate 0.5%

[0059] Tricalcium Phosphate 2%

[0060] Composition 3

[0061] Gabapentin 90%

[0062] Mannitol 3%

[0063] Calcium Alginate 1%

[0064] Hydrogenated Castor Oil 3%

[0065] Tricalcium Phosphate 3%

[0066] Composition 4

[0067] Gabapentin 95%

[0068] Tricalcium Phosphate 4%

[0069] Glyceryl Behenate 1%

[0070] Composition 5

[0071] Gabapentin 80%

[0072] Xylitol 10%

[0073] Erythritol 1%

[0074] Maltodextrin 5%

[0075] Glyceryl B...

Embodiment 3

[0104] By using the IN-CAP type automatic capsule making machine of Dott.Bonapace company (Milan-Italy), the pharmaceutical composition of Example 2 is used to fill capsules made of hard gelatin and cellulose alone to obtain the gabapentin medicine in capsule form preparation.

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Abstract

The present invention relates to pharmaceutical compositions comprising gabapentin and a mixture of excipients capable of not promoting the conversion of gabapentin into the corresponding lactamic impurity, processes for their preparation and capsules that contain said compositions.

Description

field of invention [0001] The present invention relates to pharmaceutical compositions. Specifically, the present invention relates to a pharmaceutical composition comprising gabapentin. Background of the invention [0002] Gabapentin is the generic name for 1-aminomethyl-1-cyclohexyl-acetic acid, a drug known to have antiepileptic activity and is also effective in the treatment of neuropathic pain. [0003] The molecular structure general formula of known lactam is as follows: [0004] [0005] The lactam as a degradation product is a great drawback during the preparation and storage of gabapentin because of its toxicity. [0006] Attempts have been made in the past to prevent the formation of this unwanted lactam by-product, thereby stabilizing pharmaceutical compositions comprising gabapentin. [0007] U.S. Patent 6054482 named Gödecke AG seems to solve this problem by enabling less Gabapentin was converted to the corresponding lactam at 0.2% due to the presence of...

Claims

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Application Information

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IPC IPC(8): A61K31/195A61K9/14A61K9/48
CPCA61K47/02A61K9/4858A61K9/4866A61K47/44A61K47/14A61K31/195A61K9/485A61P25/00A61P25/08A61P29/00
Inventor L·兰帕尔迪A·德拉扎里A·格拉萨诺
Owner ZAMBON GRP SPA
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