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WO2011042793A8 - Stabilized pharmaceutical composition comprising gabapentin with minimum levels of pharmaceutically acceptable inert excipients - Google Patents

Stabilized pharmaceutical composition comprising gabapentin with minimum levels of pharmaceutically acceptable inert excipients Download PDF

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Publication number
WO2011042793A8
WO2011042793A8 PCT/IB2010/002516 IB2010002516W WO2011042793A8 WO 2011042793 A8 WO2011042793 A8 WO 2011042793A8 IB 2010002516 W IB2010002516 W IB 2010002516W WO 2011042793 A8 WO2011042793 A8 WO 2011042793A8
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WO
WIPO (PCT)
Prior art keywords
pharmaceutical composition
composition according
gabapentin
excipients
pharmaceutically acceptable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2010/002516
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French (fr)
Other versions
WO2011042793A1 (en
Inventor
Pradeep G. Surve
Pankaj S. Mandpe
Unmesh H. Chavan
Alpesh K. Chhunchha
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Micro Labs Ltd
Original Assignee
Micro Labs Ltd
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Filing date
Publication date
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Publication of WO2011042793A1 publication Critical patent/WO2011042793A1/en
Publication of WO2011042793A8 publication Critical patent/WO2011042793A8/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19—Carboxylic acids, e.g. valproic acid
    • A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/284—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone

Definitions

  • a stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients.
  • a process for preparing such pharmaceutical composition is also provided.
  • Gabapentin is an anticonvulsant that is used for preventing seizures and for treating post therapeutic neuralgia. It is described as 1 -(amino methyl) cyclohexaneacetic acid with a molecular formula of C9Hi 7 N0 2 and a molecular weight of 171.24.
  • the structural formula of Gabapentin is:
  • Gabapentin is commercially available in different dosage forms like tablets, capsules and solution form.
  • PCT publication WO 01/13894 discloses a pharmaceutical tablet comprising more than about 76 % by weight of Gabapentin.
  • PCT publication WO 05/055993 discloses a Gabapentin granulate obtained by granulating Gabapentin with polyethylene glycol having a melting point comprised between 50 and 80°C and pharmaceutical compositions containing it.
  • the pharmaceutical compositions included tablet and capsule dosage form.
  • PCT publication WO 05/072736 discloses a pharmaceutical composition of Gabapentin wherein lactum level remains below 0.5% w/w after at least 2 years of storage at 25°C and 60% relative humidity.
  • PCT publication WO 04/014356 discloses a solid pharmaceutical composition comprising Gabapentin, a basic compound that is a hydroxide or a salt of weak acid, and at least one other excipient that is not a hydroxide or a salt of a weak acid.
  • PCT publication WO 04/032905 discloses a solid pharmaceutical composition comprising Gabapentin using wet granulation method.
  • US patent 6,531 ,509 discloses pharmaceutical compositions containing substantially pure and stable Gabapentin wherein Gabapentin contains an anion of a mineral acid, such as chloride, in amounts greater than 20 ppm.
  • US 6,054,482 discloses a method of preparing Gabapentin which is free of Gabapentin lactam.
  • the recommended dose of Gabapentin for post therapeutic neuralgia is 1800 mg daily in 3 divided doses.
  • the initial dose of 300 mg daily is increased over several days to the recommended daily dose.
  • Seizures are treated with 900-1800 mg/daily in 3 divided doses. It is difficult to formulate Gabapentin composition because of its high dose. Further, it is not convenient for patient to consume formulation of a relatively larger size.
  • Gabapentin being the molecule with two functional group in the close vicinity has a tendency to make intramolecular lactam in presence of either much acidic or basic media. It , is difficult to formulate Gabapentin because of formation of intramolecular lactam. This lactam is toxic. So it is undesirable to have this impurity in the pharmaceutical composition.
  • Gabapentin being the molecule with two functional group in the close vicinity has a tendency to make intra molecular lactam in presence of either much acidic or basic media, thus absence of /or less excipient resulted in low impurity levels. Also, this composition is patient compliant.
  • a stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients.
  • the pharmaceutical composition is a solid dosage form.
  • the solid dosage form is tablet.
  • the pharmaceutical composition comprises 0.1 to 10 % w/w of the total weight of the core of the tablet.
  • the pharmaceutical composition is coated.
  • the coating is film coating.
  • a process for preparing a stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients, the said process comprising coating or mixing Gabapentin with one or more pharmaceutically acceptable inert excipients.
  • the process is wet granulation.
  • the wet granulation process includes non-aqueous granulation.
  • composition has content of lactam impurity below 0.2 % when subjected to the stability conditions of 40°C and 75% relative humidity for six months.
  • the minimum level of excipients as disclosed herein includes 0.1 to 10 % w/w of the total weight of the core, more specifically- 0.1 to 6% w/w of the total weight of the core.
  • the core may be one or more of tablet, powder, disc, caplet, granules, pellets and the like.
  • the pharmaceutical composition may be a solid dosage form.
  • the solid dosage form may be one or more of tablet, capsule, powder, disc, caplet, granules, pellets, granules in capsule, minitablets, minitablets in capsule, pellets in capsule, sachet and the like.
  • the solid dosage form also includes multilayer tablets.
  • the core as disclosed herein includes uncoated solid dosage form.
  • the pharmaceutical composition contains Gabapentin as active ingredient.
  • the active ingredient may be present in the form of powder, granules, pellets, beads, microtablets, minitablets and crystals.
  • the pharmaceutical composition comprises one or more pharmaceutically acceptable inert excipients.
  • the pharmaceutically acceptable inert excipients may be one or more of binders, disintegrants, lubricants, glidants, solvents and the like.
  • Suitable binder may be one or more of, povidone, starch, stearic acid, gums, hydroxypropyl cellulose, hydroxypropylmethyl cellulose and the like.
  • Suitable disintegrant may be one or more of starch, low-substituted hydroxypropyl cellulose, croscarmellose sodium, crospovidone, sodium starch glycolate and the like.
  • Suitable solvents may be one or more of isopropyl alcohol, methylene chloride, purified water and the like.
  • Suitable lubricant may be one or more of magnesium stearate, zinc stearate, calcium stearate, stearic acid, sodium stearyl fumarate, hydrogenated vegetable oil, glyceryl behenate and the like.
  • Suitable glidant may be one or more of colloidal silicon dioxide, talc or cornstarch and the like.
  • the solid dosage form may optionally be coated.
  • the coating may be film- coating.
  • the film coating may comprise one or more of film formers, solvents, plasticizers and the like.
  • Suitable film formers may be one or more of hydroxypropyl methyl cellulose, methyl hydroxyethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, povidone, sodium carboxymethyl cellulose, polyethylene glycol, acrylates and the like.
  • Suitable solvents may be one or more of water, ethanol, methanol, isopropanol, chloroform, acetone, methylethyl ketone, methylene chloride and the like.
  • Suitable plasticizers may be one or more of propylene glycol, castor oil, glycerin, polyethylene glycol, polysorbates, and the like.
  • the process for preparing a stabilized pharmaceutical composition comprises Gabapentin with minimum levels of pharmaceutically acceptable inert excipients, the said process comprising coating or mixing Gabapentin with one or more pharmaceutically acceptable inert excipients.
  • the pharmaceutical composition may be prepared by processes those known to ordinary skill in the art and include but not limited to dry granulation, wet granulation and direct compression.
  • the dry granulation process may include compaction or slugging.
  • the wet granulation process may include aqueous or non-aqueous granulation.
  • aqueous granulation purified water is used as the granulating liquid.
  • non-aqueous granulations the solvents like isopropyl alcohol, methylene chloride or the mixture are used as granulating liquids.
  • Hydroxypropyl cellulose was dissolved in isopropyl alcohol or methylene chloride to form a solution.
  • step 3 The granules in step 3 were dried.
  • step 4 The dried granules in step 4 were sifted and blended with Low-Substituted Hydroxypropyl Cellulose to from a blend.
  • step 5 The blend formed in step 5 was lubricated with Magnesium stearate.
  • the lubricated blend was compressed to form tablets.
  • the compressed tablets were film coated with opadry.
  • Table-2 Stability data of the pharmaceutical composition in example 1.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

There is provided a stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients. There is also provided a process for preparing such pharmaceutical composition.

Description

STABILIZED PHARMACEUTICAL COMPOSITION COMPRISING GABAPENTIN WITH MINIMUM LEVELS OF PHARMACEUTICALLY ACCEPTABLE INERT EXCIPIENTS.
Field of the Invention
There is provided a stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients. There is also provided a process for preparing such pharmaceutical composition.
Background of the Invention
Gabapentin is an anticonvulsant that is used for preventing seizures and for treating post therapeutic neuralgia. It is described as 1 -(amino methyl) cyclohexaneacetic acid with a molecular formula of C9Hi7N02 and a molecular weight of 171.24. The structural formula of Gabapentin is:
Figure imgf000002_0001
Gabapentin is commercially available in different dosage forms like tablets, capsules and solution form.
PCT publication WO 01/13894 discloses a pharmaceutical tablet comprising more than about 76 % by weight of Gabapentin.
PCT publication WO 05/055993 discloses a Gabapentin granulate obtained by granulating Gabapentin with polyethylene glycol having a melting point comprised between 50 and 80°C and pharmaceutical compositions containing it. The pharmaceutical compositions included tablet and capsule dosage form.
PCT publication WO 05/072736 discloses a pharmaceutical composition of Gabapentin wherein lactum level remains below 0.5% w/w after at least 2 years of storage at 25°C and 60% relative humidity.
PCT publication WO 04/014356 discloses a solid pharmaceutical composition comprising Gabapentin, a basic compound that is a hydroxide or a salt of weak acid, and at least one other excipient that is not a hydroxide or a salt of a weak acid. PCT publication WO 04/032905 discloses a solid pharmaceutical composition comprising Gabapentin using wet granulation method.
US patent 6,531 ,509 discloses pharmaceutical compositions containing substantially pure and stable Gabapentin wherein Gabapentin contains an anion of a mineral acid, such as chloride, in amounts greater than 20 ppm.
US 6,054,482 discloses a method of preparing Gabapentin which is free of Gabapentin lactam.
The recommended dose of Gabapentin for post therapeutic neuralgia is 1800 mg daily in 3 divided doses. The initial dose of 300 mg daily is increased over several days to the recommended daily dose. Seizures are treated with 900-1800 mg/daily in 3 divided doses. It is difficult to formulate Gabapentin composition because of its high dose. Further, it is not convenient for patient to consume formulation of a relatively larger size.
Gabapentin being the molecule with two functional group in the close vicinity has a tendency to make intramolecular lactam in presence of either much acidic or basic media. It , is difficult to formulate Gabapentin because of formation of intramolecular lactam. This lactam is toxic. So it is undesirable to have this impurity in the pharmaceutical composition.
It was noticed by the inventors while working on the Gabapentin compositions that these problems can be avoided and thus, there is provided a stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients. Gabapentin being the molecule with two functional group in the close vicinity has a tendency to make intra molecular lactam in presence of either much acidic or basic media, thus absence of /or less excipient resulted in low impurity levels. Also, this composition is patient compliant.
Summary of the Invention
In one aspect, there is provided a stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients.
In one of the embodiments, the pharmaceutical composition is a solid dosage form. In another embodiment, the solid dosage form is tablet. In one embodiment, the pharmaceutical composition comprises 0.1 to 10 % w/w of the total weight of the core of the tablet.
In another embodiment, the pharmaceutical composition is coated. The coating is film coating.
In another aspect, there is provided a process for preparing a stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients, the said process comprising coating or mixing Gabapentin with one or more pharmaceutically acceptable inert excipients.
In another embodiment, the process is wet granulation. The wet granulation process includes non-aqueous granulation.
Detailed description of the Invention
The term 'stabilized' as used herein means that the composition has content of lactam impurity below 0.2 % when subjected to the stability conditions of 40°C and 75% relative humidity for six months.
The minimum level of excipients as disclosed herein includes 0.1 to 10 % w/w of the total weight of the core, more specifically- 0.1 to 6% w/w of the total weight of the core. The core may be one or more of tablet, powder, disc, caplet, granules, pellets and the like.
The pharmaceutical composition may be a solid dosage form. The solid dosage form may be one or more of tablet, capsule, powder, disc, caplet, granules, pellets, granules in capsule, minitablets, minitablets in capsule, pellets in capsule, sachet and the like. The solid dosage form also includes multilayer tablets. The core as disclosed herein includes uncoated solid dosage form.
The pharmaceutical composition contains Gabapentin as active ingredient. The active ingredient may be present in the form of powder, granules, pellets, beads, microtablets, minitablets and crystals.
The pharmaceutical composition comprises one or more pharmaceutically acceptable inert excipients. The pharmaceutically acceptable inert excipients may be one or more of binders, disintegrants, lubricants, glidants, solvents and the like.
Suitable binder may be one or more of, povidone, starch, stearic acid, gums, hydroxypropyl cellulose, hydroxypropylmethyl cellulose and the like. Suitable disintegrant may be one or more of starch, low-substituted hydroxypropyl cellulose, croscarmellose sodium, crospovidone, sodium starch glycolate and the like.
Suitable solvents may be one or more of isopropyl alcohol, methylene chloride, purified water and the like.
Suitable lubricant may be one or more of magnesium stearate, zinc stearate, calcium stearate, stearic acid, sodium stearyl fumarate, hydrogenated vegetable oil, glyceryl behenate and the like.
Suitable glidant may be one or more of colloidal silicon dioxide, talc or cornstarch and the like.
The solid dosage form may optionally be coated. The coating may be film- coating.
The film coating may comprise one or more of film formers, solvents, plasticizers and the like.
Suitable film formers may be one or more of hydroxypropyl methyl cellulose, methyl hydroxyethyl cellulose, ethyl cellulose, hydroxypropyl cellulose, povidone, sodium carboxymethyl cellulose, polyethylene glycol, acrylates and the like.
Suitable solvents may be one or more of water, ethanol, methanol, isopropanol, chloroform, acetone, methylethyl ketone, methylene chloride and the like.
Suitable plasticizers may be one or more of propylene glycol, castor oil, glycerin, polyethylene glycol, polysorbates, and the like.
The process for preparing a stabilized pharmaceutical composition comprises Gabapentin with minimum levels of pharmaceutically acceptable inert excipients, the said process comprising coating or mixing Gabapentin with one or more pharmaceutically acceptable inert excipients.
The pharmaceutical composition may be prepared by processes those known to ordinary skill in the art and include but not limited to dry granulation, wet granulation and direct compression.
The dry granulation process may include compaction or slugging. The wet granulation process may include aqueous or non-aqueous granulation. When, aqueous granulation, purified water is used as the granulating liquid. When, non-aqueous granulations, the solvents like isopropyl alcohol, methylene chloride or the mixture are used as granulating liquids.
While the present invention has been described in terms of its specific embodiments, certain modifications and equivalents will be apparent to those skilled in the art and are intended to be included within the scope of the present invention.
Example: Table- 1 : Pharmaceutical composition of the invention
Figure imgf000006_0001
Procedure:
1 . Gabapentin was sifted.
2. Hydroxypropyl cellulose was dissolved in isopropyl alcohol or methylene chloride to form a solution.
3. Gabapentin in step 1 was granulated with solution in step 2 to form granules.
4. The granules in step 3 were dried.
5. The dried granules in step 4 were sifted and blended with Low-Substituted Hydroxypropyl Cellulose to from a blend.
6. The blend formed in step 5 was lubricated with Magnesium stearate.
7. The lubricated blend was compressed to form tablets.
8. The compressed tablets were film coated with opadry.
Stability data:
The packaged tablets of the above example were subjected to the stability studies of 40°C and 75% relative humidity for 6 months. Quantitative determination of lactam impurity in the composition was used as the stability indicating test. The results given in Table 2.
Table-2: Stability data of the pharmaceutical composition in example 1.
Figure imgf000007_0001

Claims

We Claim:
1. A stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients.
2. The pharmaceutical composition according to claim 1, wherein the composition is in the form of solid dosage form.
3. The pharmaceutical composition according to claim 2, wherein the composition is tablet.
4. The pharmaceutical composition according to claim 1 , wherein the level of excipients is from 0.1 to 10 % w/w of the core.
5. The pharmaceutical composition according to claim 4, wherein the level of excipients is from 0.1 to 6 % w/w of the core.
6. The pharmaceutical composition according to claim 1 , wherein the excipients may be one or more of binders, disintegrants, lubricants, glidants, and solvents.
7. The pharmaceutical composition according to claim 6, wherein the binders may be one or more of povidone, starch, stearic acid, gums, hydroxypropyl cellulose, hydroxypropylmethyl cellulose.
8. The pharmaceutical composition according to claim 6, wherein the disintegrants may be one or more of starch, low-substituted hydroxypropyl cellulose, croscarmellose sodium, crospovidone, sodium starch glycolate.
9. The pharmaceutical composition according to claim 6, wherein the lubricants magnesium stearate, zinc stearate, calcium stearate, stearic acid, sodium stearyl fumarate, hydrogenated vegetable oil, glyceryl behenate.
10. The pharmaceutical composition according to claim 6, wherein the glidants colloidal silicon dioxide, talc, cornstarch.
1 1. The pharmaceutical composition according to claim 6,. wherein the solvents isopropyl alcohol, methylene chloride, water.
12. The pharmaceutical composition according to claim 1 , wherein the composition is film coated.
13. The pharmaceutical composition according to claim 12, wherein the excipients may comprise one or more of film formers, solvents, plasticizers.
14. A process for preparing a stabilized pharmaceutical composition comprising Gabapentin with minimum levels of pharmaceutically acceptable inert excipients, the process comprising coating or mixing Gabapentin with one or more pharmaceutically acceptable inert excipients.
15. The process according to claim 14, wherein the process is wet granulation.
16. The process according to claim 15, wherein the process is non-aqueous granulation.
PCT/IB2010/002516 2009-10-06 2010-09-28 Stabilized pharmaceutical composition comprising gabapentin with minimum levels of pharmaceutically acceptable inert excipients Ceased WO2011042793A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN2309/MUM/2009 2009-10-06
IN2309MU2009 2009-10-06

Publications (2)

Publication Number Publication Date
WO2011042793A1 WO2011042793A1 (en) 2011-04-14
WO2011042793A8 true WO2011042793A8 (en) 2011-07-14

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Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6294198B1 (en) * 1999-08-24 2001-09-25 Purepac Pharmaceutical Co. Pharmaceutical tablet formulation containing gabapentin with improved physical and chemical characteristics and method of making the same
AU2003267732A1 (en) * 2002-10-08 2004-05-04 Ranbaxy Laboratories Limited Gabapentin tablets and methods for their preparation
CN1832736A (en) * 2003-08-05 2006-09-13 兰贝克赛实验室有限公司 Stable extended-release oral dosage form of gabapentin
GB0400993D0 (en) * 2004-01-16 2004-02-18 Norton Healthcare Ltd Stable gabapentin compositions
WO2006077492A1 (en) * 2005-01-24 2006-07-27 Ranbaxy Laboratories Limited Sustained release oral dosage forms of gabapentin

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