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WO2005092319A1 - Compositions pharmaceutiques a desintegration rapide, comprenant du nateglinide et un delitant - Google Patents

Compositions pharmaceutiques a desintegration rapide, comprenant du nateglinide et un delitant Download PDF

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Publication number
WO2005092319A1
WO2005092319A1 PCT/IB2005/000814 IB2005000814W WO2005092319A1 WO 2005092319 A1 WO2005092319 A1 WO 2005092319A1 IB 2005000814 W IB2005000814 W IB 2005000814W WO 2005092319 A1 WO2005092319 A1 WO 2005092319A1
Authority
WO
WIPO (PCT)
Prior art keywords
rapidly disintegrating
pharmaceutical composition
nateglinide
composition according
disintegrant
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/IB2005/000814
Other languages
English (en)
Inventor
Romi Barat Singh
Anu Shilpa
Vishnubhotla Nagaprasad
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Ranbaxy Laboratories Ltd
Original Assignee
Ranbaxy Laboratories Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Ranbaxy Laboratories Ltd filed Critical Ranbaxy Laboratories Ltd
Publication of WO2005092319A1 publication Critical patent/WO2005092319A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

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
    • A61K31/198—Alpha-amino acids, e.g. alanine or edetic acid [EDTA]
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin

Definitions

  • the present invention relates to rapidly disintegrating pharmaceutical compositions of nateglinide and processes for making these compositions.
  • Background of the Invention Nateglinide is an amino acid derivative that lowers blood glucose levels by stimulating insulin secretion from the pancreas. It is widely indicated as monotherapy to lower blood glucose in patients with Type 2 diabetes. It is also indicated for use in combination with Metformin.
  • Presently nateglinide oral tablets are available in 60mg or 120mg strengths and are marketed by Novartis under the trade name STARLIX®.
  • the tablets include nateglinide, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, iron oxides, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, providone, talc, and titanium dioxide. It is known that when taken orally, nateglinide exhibits an excellent effect of lowering the blood sugar level and is particularly effective in controlling post-prandial blood sugar levels. However, it was found that co-administration with food may impair absorption of nateglinide and that absorption is delayed if nateglinide is taken after food intake.
  • U.S. Patent No. 6,641,841 describes a process of preparing a tablet comprising nateglinide and a disintegrant selected from group consisting of low substituted hydroxypropylcellulose, sodium carboxymethyl cellulose, calcium carboxymethyl cellulose and croscarmellose sodium.
  • the object of the present invention is to provide a tablet composition of nateglinide that achieves rapid disintegration, which is believed to play a major role in the dissolution and absorption process.
  • Rapid disintegration may be of paramount significance in eliminating the erratic absorption behaviour related to co-administration with food, and may help in eliciting a more beneficial therapeutic effect.
  • the present invention relates to a tablet composition containing nateglinide as the active ingredient and sodium starch glycolate and crospovidone as disintegrants.
  • Summary of the Invention in one general aspect there is provided a rapidly disintegrating pharmaceutical composition that includes nateglinide and a disintegrant selected from sodium starch glycolate, crospovidone and mixtures thereof.
  • the disintegrant may be present in a concentration ranging from about 2% to about 40% w/w.
  • the composition may be a tablet or a capsule.
  • the tablet may be coated.
  • the composition may further include pharmaceutically acceptable excipients selected from filler, binder, surfactant, lubricant, coloring and flavoring agent.
  • the filler may be one or more of corn starch, lactose, white sugar, sucrose, glucose, sorbitol, calcium carbonate, calcium phosphate-dibasic, calcium phosphate-tribasic, calcium sulfate, microcrystalline cellulose, silicified microcrystalline cellulose, cellulose powdered, dextrates, dextrins, dextrose, fructose, kaolin, lactitol, mannitol, sorbitol, starch, starch pregelatinized, and mixtures thereof.
  • the binder may be one or more of polyvinylpyrollidone, methyl cellulose, hydroxypropyl cellulose, hydroxy propyl methyl cellulose, gelatin, gum Arabic, ethyl cellulose, polyvinyl alcohol, pullulan, pregelatinized starch, agar, tragacanth, sodium alginate, propylene glycol, and mixtures thereof.
  • the surfactant may be one or more of sodium lauryl sulphate, polysorbate 80, polaxomers and mixtures thereof.
  • the lubricant may be one or more of colloidal anhydrous silica, stearic acid, magnesium stearate, calcium stearate, talc, hydrogenated pastor oil, sucrose esters of fatty acids, microcrystalline wax, yellow beeswax, white beeswax and mixtures thereof.
  • the rapidly disintegrating pharmaceutical composition may be prepared by direct compression, dry granulation, or wet granulation.
  • the process may include: blending nateglinide, disintegrant, filler and surfactant; granulating the blend with an aqueous solution of binder; drying and sizing the granules; blending the dried granules with a lubricant; and compressing the lubricated granules into a tablet.
  • a rapidly disintegrating tablet that includes nateglinide and a disintegrant selected from sodium starch glycolate, crospovidone or mixtures thereof.
  • the composition further includes lactose, microcrystalline cellulose, polyvinyl pyrrolidone, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate.
  • Embodiments of the process may include one or more of the features described above.
  • a process for the preparation of a rapidly disintegrating tablet that includes nateglinide and a disintegrant selected from sodium starch glycolate, crospovidone or mixtures thereof.
  • the composition further includes lactose, microcrystalline cellulose, polyvinyl pyrrolidone, sodium lauryl sulphate, colloidal silicon dioxide and magnesium stearate.
  • the process includes: blending nateglinide, disintegrant, lactose, microcrystalline cellulose, colloidal silicon dioxide and sodium lauryl sulphate; granulating the blend with an aqueous solution of polyvinyl pyrrolidone; drying and sizing the granules; blending the dried granules with disintegrant, colloidal silicon dioxide and magnesium stearate; and compressing the blend into a tablet.
  • a rapidly disintegrating medicament for the prevention, delay of progression, or treatment of metabolic disorders.
  • the rapidly disintegrating medicament includes nateglinide and a disintegrant selected from a group consisting of sodium starch glycolate, crospovidone or mixtures thereof.
  • Embodiments of the medicament may include one or more of the following features or those described above.
  • the metabolic disorder may be type 2 diabetes mellitus or a disease or condition associated with diabetes mellitus.
  • the details of one or more embodiments of the inventions are set forth in the description below. Other features, objects and advantages of the inventions will be apparent from the description and claims.
  • 'nateglinide' as used herein includes nateglinide in a free or pharmaceutically acceptable salt form selected from an acid addition salt, for example as a sodium salt or as a maleate. It also includes the B- or H-type crystal modification of nateglinide, more particularly the B-type.
  • the active ingredient or a pharmaceutically acceptable salt thereof may also be used in form of a hydrate or may include other solvents used for crystallization.
  • Nateglinide may be present either substantially in the form of one optically pure enantiomer or as a mixture, racemic or otherwise, of enantiomers.
  • Nateglinide may be administered to a warm-blooded animal in a dosage range of about 5 to 1200 mg/day, more preferably 10 to 1000 mg/day, and most preferably 25 to 800 mg/day, especially when the warm-blooded animal is a human of about 70 kg body weight.
  • Nateglinide can be present in an amount of about 5% to about 70% (w/w), and most preferably about 15% to about 40% (w/w), based on the total weight of the dry composition.
  • the term "rapid disintegration" or “rapidly disintegrating” as used herein is intended to describe a tablet comprising nateglinide that has a disintegration time of less than or equal to ten minutes in an appropriate medium.
  • Disintegrants used in the present invention maybe selected from sodium starch glycolate and crospovidone or mixtures thereof. The disintegrant can be present in an amount of about 2% to about 40% (w/w), and most preferably about 5% to about 30% (w/w), by weight based on the total weight of the dry composition.
  • the rapidly disintegrating pharmaceutical composition as described herein may include other pharmaceutically acceptable excipients in addition to nateglinide and a disintegrant.
  • examples of other pharmaceutically acceptable excipients as used herein include fillers, binders, surfactants, lubricants, glidants, colors and the like.
  • the fillers may be selected from one or more of corn starch, lactose, white sugar, sucrose, glucose, sorbitol, calcium carbonate, calcium phosphate-dibasic, calcium phosphate-tribasic, calcium sulfate, microcrystalline cellulose, silicified microcrystalline cellulose, cellulose powdered, dextrates, dextrins, dextrose, fructose, kaolin, lactitol, mannitol, sorbitol, starch, starch pregelatinized, colloidal silicon dioxide or mixtures thereof.
  • binders examples include polyvinylpyrrolidone, methyl cellulose, hydroxypropyl cellulose, hydroxy propyl methyl cellulose, gelatin, gum Arabic, ethyl cellulose, polyvinyl alcohol, puUulan, pregelatinized starch, agar, tragacanth, sodium alginate, propylene glycol or mixtures thereof.
  • suitable surfactants include sodium lauryl sulphate, polysorbate 80, polaxomer 407 and the like.
  • Suitable lubricants and glidants include colloidal silicon dioxide, stearic acid, magnesium stearate, calcium stearate, talc, hydrogenated castor oil, sucrose esters of fatty acids, microcrystalline wax, yellow beeswax, white beeswax or mixtures thereof.
  • the coloring agents of the present invention may be selected from any FDA approved colors for oral use.
  • the rapidly disintegrating pharmaceutical composition includes nateglinide in a free or pharmaceutically acceptable salt form and a disintegrant selected from sodium starch glycolate, crospovidone or mixtures thereof.
  • the composition may contain one or more fillers.
  • the filler may be selected from lactose, microcrystalline cellulose and mixtures thereof.
  • the composition may contain one or more binders.
  • polyvinylpyrrolidone may be a binder.
  • the composition may contain at least one other antidiabetic compound.
  • the antidiabetic compound may be selected from glitazones, sulfonyl urea derivatives and metformin., in each case in free form or in form of a pharmaceutically acceptable salt thereof!
  • the rapidly disintegrating pharmaceutical composition of nateglinide and disintegrant selected from sodium starch- glycolate, crospovidone or mixtures thereof, may be used in the preparation of a medicament for the prevention, delay of progression or treatment of metabolic disorders, in particular of type 2 diabetes mellitus or a disease or condition associated with diabetes mellitus.
  • the solid dose formulation can b e prepared by processes known in the art., such as wet granulation, dry granulation or direct compression and may be in the form of tablets or capsules.
  • nateglinide tablets may be prepared by blending nateglinide, filler, surfactant and disintegrant; granulating the blend with a binder solution; drying the granules; sizing; lubricating and compressing the lubricated granules.
  • nateglinide tablets may be prepared by blending nateglinide, filler, disintegrant, surfactant and binder; granulating the blend with a solvent; drying the granules; sizing; lubricating arid compressing the lubricated granules.
  • Granulation may be carried out in fluidized bed dryer, a top spray granulator, or a rapid mixer granulator of the conventional type. Sizing can be performed by milling and/or pulverizing.
  • nateglinide tablets may be prepared by blending nateglinide, filler, disintegrant, surfactant and binder; compacting or slugging the " blend; breaking the compacts or slugs to make granules; lubricating and compressing the lubricated granules.
  • nateglinide tablets may be prepared by blending nateglinide, filler, disintegrant, surfactant, binder and lubricant followed by compression of the blend into a tablet. The tablets may optionally be coated with film forming agents and/or pharmaceutically acceptable excipients.
  • coating compositions comprising film-forming polymers marketed under various trade names, such as Opadry ® and Eudra-git ® .
  • the coating layers over the tablet may be applied as a solution/dispersion of coating ingredients using conventional techniques known in the art, such as spray coating in a conventional coating pan or fluidized bed processor, dip coating, and the like.
  • spray coating in a conventional coating pan or fluidized bed processor, dip coating, and the like.
  • the following examples are illustrative of the invention, and are not intended to limit the invention.
  • PROCEDURE 1. Nateglinide and colloidal silicon dioxide are sifted together. 2. Lactose, microcrystalline cellulose, a part of the sodium starch glycolate, and the nateglinide-colloidal silicon dioxide blend are mixed in a high shear blender to give a uniform dry mixture. 3. Sodium lauryl sulphate is dissolved in about 50% of the purified water and is added slowly to the dry mixture of Step 2 under fast mixing in a rapid mixer granulator (RMG). 4. Polyvinylpyrrolidone is dissolved in the remaining quantity of purified water until a clear solution is formed, and this solution is added slowly to the premix of Step 3 and the resulting bulk is granulated. 5.
  • RMG rapid mixer granulator
  • the wet granules are dried in a fluid bed drier, passed through a screen and then sized. 6.
  • the remaining part of sodium starch glycolate and colloidal silicon dioxide are mixed, passed through a screen and blended with the granules of Step 5.
  • the magnesium stearate is passed through a screen, blended with the blend of Step 6 and the total mixture is compressed into tablets.
  • PROCEDURE 1. Nateglinide and colloidal silicon dioxide are sifted together. 2. Lactose, microcrystalline cellulose, a part of the crospovidone, and the nateglinide- colloidal silicon dioxide blend are mixed in a high shear blender to give a uniform dry mixture. 3. Sodium lauryl sulphate is dissolved in about 50%) of the purified water and is added slowly to the dry mixture of Step 2 under fast mixing in a rapid mixer granulator (RMG). 4. Polyvinylpyrrolidone is dissolved in the remaining quantity of purified water until a clear solution is formed, and this solution is added slowly to the premix of Step 3 and the resulting bulk is granulated. 5.
  • RMG rapid mixer granulator
  • the wet granules are dried in a fluid bed drier, passed through a screen and then sized. 6.
  • the remaining part of the crospovidone and colloidal silicon dioxide are mixed, passed through a screen and blended with the granules of Step 5.
  • the magnesium stearate is passed through a screen, blended with the blend of Step 6 and the total mixture is compressed into tablets.
  • PROCEDURE 1. Nateglinide and colloidal silicon dioxide are sifted together. 2. Lactose, microcrystalline cellulose, sodium starch glycolate, and the nateglinide- colloidal silicon dioxide blend are mixed in a high shear blender to give a uniform dry mixture. 3. Sodium lauryl sulphate is dissolved in about 50%) of the purified water and is added slowly to the dry mixture of Step 2 under fast mixing in a rapid mixer granulator (RMG). 4. Polyvinylpyrrolidone is dissolved in the remaining quantity of purified water until a clear solution is formed, and this solution is added slowly to the premix of Step 3 and the resulting bulk is granulated. 5.
  • RMG rapid mixer granulator
  • the wet granules are dried in a fluid bed drier, passed through a screen and then subjected to sizing. 6.
  • Crospovidone and colloidal silicon dioxide are mixed, passed through a screen and blended with the granules of Step 5.
  • the magnesium stearate is passed tlirough a screen, blended with the blend of Step 6 and the total mixture is compressed into tablets.
  • Table 1 clearly indicates that compositions containing crospovidone or sodium starch glycolate as the disintegrant show a disintegration time comparable to STARLIX ® . While there has been shown and described what are the preferred embodiments of the invention, one skilled in the pharmaceutical formulation art will appreciate that various modifications in the formulations and process can be made without departing from the scope of the invention as it is defined by the appended claims.

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  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
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  • Molecular Biology (AREA)
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Abstract

L'invention concerne des compositions pharmaceutiques à désintégration rapide à base de natéglinide et leurs procédés de préparation. Ces compositions comprennent du natéglinide et un délitant choisi parmi le glycolate d'amidon de sodium, le crospovidone et des mélanges de ceux-ci.
PCT/IB2005/000814 2004-03-29 2005-03-29 Compositions pharmaceutiques a desintegration rapide, comprenant du nateglinide et un delitant Ceased WO2005092319A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN617/DEL/2004 2004-03-29
IN617DE2004 2004-03-29

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WO2005092319A1 true WO2005092319A1 (fr) 2005-10-06

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PCT/IB2005/000814 Ceased WO2005092319A1 (fr) 2004-03-29 2005-03-29 Compositions pharmaceutiques a desintegration rapide, comprenant du nateglinide et un delitant

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009105049A1 (fr) * 2008-02-22 2009-08-27 Bilim Ilac Sanayi Ve Ticaret A.S. Compositions de comprimés oraux contenant du natéglinide et un système agent tensioactif-agent de réglage du ph
CN101912373A (zh) * 2010-08-24 2010-12-15 北京京丰制药有限公司 稳定的头孢克洛分散片及其制备方法

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001026639A2 (fr) * 1999-10-08 2001-04-19 Novartis Ag Procede de traitement de troubles du metabolisme
US6559188B1 (en) * 1999-09-17 2003-05-06 Novartis Ag Method of treating metabolic disorders especially diabetes, or a disease or condition associated with diabetes
EP1334721A1 (fr) * 2000-10-24 2003-08-13 Ajinomoto Co., Inc. Preparations de medicament contenant du nateglinide
US20040034065A1 (en) * 2000-08-22 2004-02-19 Malcolm Allison Combination
WO2004067496A1 (fr) * 2003-01-23 2004-08-12 Teva Pharmaceutical Industries Ltd. Forme cristalline de nateglinide
WO2004100857A2 (fr) * 2003-05-07 2004-11-25 Akina, Inc. Granules a teneur elevee en plastique, destines a la fabrication de comprimes a dissolution rapide
WO2005051360A1 (fr) * 2003-11-28 2005-06-09 Ranbaxy Laboratories Limited Compositions pharmaceutiques comprenant de la nateglinide et un agent tensioactif

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6559188B1 (en) * 1999-09-17 2003-05-06 Novartis Ag Method of treating metabolic disorders especially diabetes, or a disease or condition associated with diabetes
WO2001026639A2 (fr) * 1999-10-08 2001-04-19 Novartis Ag Procede de traitement de troubles du metabolisme
US20040034065A1 (en) * 2000-08-22 2004-02-19 Malcolm Allison Combination
EP1334721A1 (fr) * 2000-10-24 2003-08-13 Ajinomoto Co., Inc. Preparations de medicament contenant du nateglinide
WO2004067496A1 (fr) * 2003-01-23 2004-08-12 Teva Pharmaceutical Industries Ltd. Forme cristalline de nateglinide
WO2004100857A2 (fr) * 2003-05-07 2004-11-25 Akina, Inc. Granules a teneur elevee en plastique, destines a la fabrication de comprimes a dissolution rapide
WO2005051360A1 (fr) * 2003-11-28 2005-06-09 Ranbaxy Laboratories Limited Compositions pharmaceutiques comprenant de la nateglinide et un agent tensioactif

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
XU WEI ET AL: "Preparation and quality investigation of nateglinide dispersible tablets", ACADEMIC JOURNAL - GUANGDONG COLLEGE OF PHARMACY, CN, vol. 19, no. 1, March 2003 (2003-03-01), pages 3 - 6, XP001204563, ISSN: 1006-8783 *

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009105049A1 (fr) * 2008-02-22 2009-08-27 Bilim Ilac Sanayi Ve Ticaret A.S. Compositions de comprimés oraux contenant du natéglinide et un système agent tensioactif-agent de réglage du ph
CN101912373A (zh) * 2010-08-24 2010-12-15 北京京丰制药有限公司 稳定的头孢克洛分散片及其制备方法
CN101912373B (zh) * 2010-08-24 2012-01-04 北京京丰制药有限公司 稳定的头孢克洛分散片及其制备方法

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