WO2008062470A2 - Forme posologique à libération contrôlée stabilisée de gliclazide - Google Patents

Forme posologique à libération contrôlée stabilisée de gliclazide Download PDF

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Publication number
WO2008062470A2
WO2008062470A2 PCT/IN2007/000496 IN2007000496W WO2008062470A2 WO 2008062470 A2 WO2008062470 A2 WO 2008062470A2 IN 2007000496 W IN2007000496 W IN 2007000496W WO 2008062470 A2 WO2008062470 A2 WO 2008062470A2
Authority
WO
WIPO (PCT)
Prior art keywords
dosage form
gliclazide
controlled release
pharmaceutical dosage
solid oral
Prior art date
Application number
PCT/IN2007/000496
Other languages
English (en)
Other versions
WO2008062470A3 (fr
Inventor
Gour Samanta
Rajneesh Shrivastava
Bhavesh Shah
Jaya Abraham
Original Assignee
Torrent Pharmaceuticals Limited
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 Torrent Pharmaceuticals Limited filed Critical Torrent Pharmaceuticals Limited
Publication of WO2008062470A2 publication Critical patent/WO2008062470A2/fr
Publication of WO2008062470A3 publication Critical patent/WO2008062470A3/fr

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Classifications

    • 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
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K31/64—Sulfonylureas, e.g. glibenclamide, tolbutamide, chlorpropamide
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • 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
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Definitions

  • the present invention relates to stabilized controlled release dosage form of Gliclazide exhibiting pH independent release profile over a wide range having one or more release controlling polymer and free from saccharide component and optionally free from binder and process for preparing the same.
  • Gliclazide is usually administered by oral route in the form of immediate release and modified release tablet.
  • Diamicron® MR is the modified release tablet of gliclazide available in the market prepared by using inactive .ingredients like calcium hydrogen phosphate ⁇ dihydrate, maltodextrin, hypromellose, magnesium stearate and anhydrous colloidal silica.
  • Gliclazide is a weak acidic drug with pKa about 5.8 having hydrophobic nature. It belongs to class II of the biopharmaceutical classification in which dissolution rate is the controlling step in drug absorption.
  • solid oral pharmaceutical dosage forms are comprised of immediate release (IR) dosages in the form of tablets or capsules. These IR dosage forms release the active drug substance into the body of a subject at a rate that is initially very high followed by a rapid decline.
  • IR dosage form One potential result of an IR dosage form is that the subject may have varying degrees of blood level fluctuation, which may result in transient therapeutic overdose, followed by a period of therapeutic under dosing.
  • Another disadvantage with regard to immediate release dosage form is frequent dosing which ultimately results in poor patient compliance.
  • One of the most frequently utilized methods to extend the drug release and action in the body and/or control blood level fluctuations is modification of the pharmaceutical dosage form. This is usually achieved by any of the systems known to skilled in the art but not limited to Monolithic matrix, Gradient matrix, Membrane controlled system, Swelling controlled system, Ion exchange resin system, Osmotically controlled system, Geometrically modified system.
  • Controlled release drug delivery systems deliver drug to body so as to establish therapeutically effective blood levels of the active ingredient and once these blood levels are achieved they continue to maintain constant blood levels for long duration.
  • controlled release system lower the incidence, of adverse effects or side effects.
  • Very importantly controlled release systems reduce the frequency of dosing leading to convenience to the patients in terms of dosing and compliance to the specified dosage regimens.
  • US6056977 describes once daily controlled release formulation of sulfonylurea comprising a heteropolysaccharide, a homopolysaccharide, and an inert diluent, an alkalizing agent and solubilizing agent.
  • the patent is particularly related to glipizide formulation.
  • WOOOl 8373 discloses the matrix tablet for prolonged release of Gliclazide comprising a combination of cellulose polymer and glucose syrup.
  • the composition contains 2-20% w/w of glucose syrup as an essential ingredient.
  • the publication state that the combination of cellulose compound and glucose syrup (maltodextrin) ensures prolonged, continuous and consistent release of gliclazide which is insensitive to the variations in pH of the dissolution medium from pH 6 to 8.
  • IN 194218 discloses process for preparation of controlled release antidiabetic composition of gliclazide using approximately 25.8% of gliclazide and other pharmaceutically acceptable excipients like controlled release polymers, binders, lubricants and glidants.
  • the controlled release matrix tablet prepared by authors consists of lactose, HPMC, maltodextrin, Kollidon SR.
  • WO2006061697 Al discloses sustained release sulfonylurea composition in the form of matrix tablet and comprises sulfonylurea, polymer, disaccharide and / or monosaccharide exhibiting the release of said sulfonylurea substantially independent of the pH over a wide pH range (4-8).
  • WO 2006 123213 Al discloses modified release composition of gliclazide using one or more controlled release polymers, one or more binders and optionally one or more pharmaceutically acceptable excipients.
  • gliclazide which is an antidiabetic drug and used for the control of high blood sugar level
  • dosage 1 form used to control the high blood sugar level should ideally not contain any material which results in the increase in the blood sugar level.
  • Applicants of the present invention surprisingly found a simple and easy to manufacture stabilized controlled release dosage form of Gliclazide exhibiting pH independent release profile using one or more release controlling polymer, without using saccharide component and optionally without using binder.
  • the present invention relates to stabilized controlled release dosage form of Gliclazide exhibiting pH independent release profile over wide range having one or more release controlling polymer and free from saccharide component and optionally free from binder.
  • the first object of the present invention is to provide controlled release dosage form of Gliclazide exhibiting pH independent release profile over wide pH range of the gastro intestinal tract without using saccharide component.
  • the another object of the present invention is to provide controlled release dosage form of Gliclazide exhibiting pH independent release profile over wide pH range of the gastro intestinal tract without using binder.
  • the another object of the present invention is to provide controlled release dosage form of Gliclazide exhibiting pH independent release profile over wide pH range of the gastro intestinal tract without using binder and saccharide component.
  • the another object of the present invention is to provide controlled release dosage form of Gliclazide exhibiting pH independent release profile over wide pH range of the gastro intestinal tract by using magnesium stearate in an amount of less than 1.1% and more preferably less than 0.6% of the total weight of the composition.
  • the another object of the present invention is to provide controlled release dosage form of Gliclazide exhibiting pH independent release profile over wide pH range of the gastro intestinal tract without using Povidone.
  • the another object of the present invention is to provide controlled release dosage form of Gliclazide exhibiting pH independent release profile over wide pH range of the gastro intestinal tract using release controlling polymer either singly or in combination.
  • the present invention relates to controlled release dosage form of Gliclazide, wherein use of anhydrous Calcium Hydrogen Phosphate provides stability to the composition.
  • It is yet another object of the invention is to provide the process for preparing such pharmaceutical dosage form either by a wet or dry granulation method or by direct compression.
  • Figure-I shows the % cumulative release profile of gliclazide from the matrix tablets of example 1 in dissolution medium of pH 6.2, 6.8 and 7.4.
  • Controlled release refers to the release of an active ingredient such as a drug from a composition, formulation or dosage form in which the active ingredient is released according to a desired profile over an extended period of time and is taken to encompass sustained" release, modified release, prolonged release, delayed release and the like.
  • dosage form refer to physically discrete units to be administered in single or multiple dosages, each unit containing a predetermined quantity of active material in association with the required excipients.
  • the quantity of active material is that calculated to produce the desired therapeutic effect upon administration of one or more of such units.
  • the dosage form used herein selected from tablets, capsule, sachets, pellets, beads, microspheres, microcapsules, pills, powders, lozenges, or granules.
  • saccharide component includes excipients such as glucose syrup, lactose, maltodextrin, starch, modified starch, microcrystalline cellulose, dextrose, mannitol, lactitol, xylitol, cyclodextrin, Sucrose, Glucose, Galactose, Fructose, Sorbitol, Maltose, Maltitol, Isomalt, Xanthan gum and the like, Carrageenan, Starch, Polydextrose, Trehalose, Cellobiose etc.
  • the dosage form of the present invention comprises the gliclazide in a range of about 1 mg to about 300 mg.
  • dosage forms may contain 10 mg to about 200 mg. More preferably dosage forms may contain from 30 to 80 mg.
  • gliclazide used herein includes gliclazide free base, pharmaceutically acceptable salts, solvates, or mixtures thereof.
  • the controlled release pharmaceutical dosage form of the present invention comprises release controlling polymer and optionally other pharmaceutically acceptable excipients but free from saccharide component and optionally free from binder.
  • the release controlling polymer used herein is selected from but not limited to methylcellulose, ethylcellulose, hydroxyethylcellulose, propylcellulose, hydroxypropylcellulose, hydroxypropyl methylcellulose (Hypromellose), carboxymethylcellulose, polymethyl methacrylate, polyethyl methacrylate, polybutyl methacrylate, polyisobutyl methacrylate, polyhexyl methacrylate, poly isodecyl methacrylate, polylauryl methacrylate, polyphenyl methacrylate, polymethyl acrylate, polyisopropyl acrylate, polyisobutyl acrylate, polyoctadecyl acrylate, polyethylene, polypropylene, polyethylene oxide, polyethylene terephthalate, polyvinyl isobutyl
  • the release controlling polymer used for the present invention is selected form hydroxyethylcellulose, hydroxypropylcellulose and hydroxypropyl methylcellulose (Hypromellose, HPMC). More preferably the release controlling polymer used herein is hydroxypropyl methylcellulose.
  • the release controlling polymer used herein is the combination of two polymers having different viscosity.
  • the polymer may be added intragranularly and/or extragranularly, preferably polymer is added intragranularly and extragranularly.
  • the release controlling polymer present in the invention is preferably in a quantity from 5 to 70%w/w, more preferably from 7 to 50% w/w, with respect to the total weight of the pharmaceutical dosage form.
  • the release controlling polymer when used in the present invention as a combination of two polymers having different viscosity for providing a controlled release of active ingredient from a pharmaceutical dosage form, the required ratio between the low viscosity and high viscosity polymer is from 10: 1 to 1: 3, preferably from 6: 1 to 1:2, and more preferably from 3: 1 to 1 : 1.
  • Hypromellose is available in various grades having viscosity in the range of 3 cps to 100,000 cps when measured at 25°C at the 2 % concentration in water.
  • the other pharmaceutically acceptable excipients are selected from the following categories but not limited to diluents, binders, fillers, anti-adherents, lubricants, surfactants, alkalizing agents, pH modifiers, buffering agents, stabilizers, and other excipients known to the person skilled in the art.
  • the term "binders" is intended to mean inert substance used to form the bridge between the drug particles with other excipients.
  • Binder may be selected from copolyvidone, shellac, zein, gelatin, polymethacrylates, synthetic resins, eudragits, cellulose polymers and the like.
  • the binder may be present in an amount ranging from 0.0 % to 25 % by weight of the composition. It was surprisingly found that the impurity levels in formulation increases by the use of binders such as povidone.
  • the term "diluents" or “fillers” is intended to mean inert substances x used as fillers to create the desired bulk, flow properties, and compression characteristics in the preparation of dosage form. If desired, more than one diluent or fillers can be used. Such compounds as used herein include calcium hydrogen phosphate (dihydrate), calcium hydrogen phosphate (anhydrous), tribasic calcium phosphate, calcium carbonate, kaolin, magnesium carbonate, magnesium oxide and the like. More preferably the diluent or filler used herein is calcium hydrogen phosphate (anhydrous). The "diluent” or “filler” is present in the composition in the range of 40% to 80% by weight of dosage form. It was observed that composition devoid of glucose syrup and containing calcium hydrogen phosphate
  • Impurity A p-Tolunesulphonamide
  • Anti-adherents agent may be used to prevent the tablet from sticking to the tablet punch and die wall and may be selected from talc, kaolin, finely divided silicon dioxide, colloidal silicon dioxide, glyceryl monostearate, and the like.
  • the anti-adherent agent may be present in an amount ranging from 0.1 % to 20 % by weight of the composition.
  • Lubricants can be selected from the group comprising of stearic acid, Polyethylene glycol, Magnesium stearate, Calcium stearate, Zinc stearate, Talc or Silica, Hydrogenated caster oil and Sodium stearyl fumarate.
  • the lubricant may be present in an amount ranging from 0.1 % to 10 % by weight of the composition.
  • the lubricant used herein is magnesium stearate in an amount of less than 1.1% and more preferably less than 0.6% of the total weight of the composition.
  • the composition can be stabilized by using pharmaceutically acceptable excipients known to the person skilled in the art.
  • solvent comprises without limitation water, isopropyl alcohol, dichloromethane, etc and mixtures thereof.
  • the present invention provides the pH independent, controlled and consistent release of the drug over wide pH range of the gastrointestinal tract.
  • the instant invention can be prepared using any of the process given below:
  • step 1 Preparation of binder solution in suitable solvent.
  • step 2 Preparation of binder solution in suitable solvent.
  • step 2 Granulation of step 1 with step 2 solution followed by drying & sizing.
  • step 3 Blending of step 3 granules with lubricant and optionally with other pharmaceutically acceptable excipients.
  • Process B 1. Sifting & Mixing of Gliclazide, with diluent and other pharmaceutically acceptable excipients.
  • step 2 Addition of solvents to step 1 followed by drying & sizing.
  • step 3 Blending of step 2 granules with lubricant and optionally with other pharmaceutically acceptable excipients. 4. Optionally compressing the granules from step 3.
  • Process C Process C:
  • step 2 Slugging the blend of step 1. 3. Milling and sifting the slugs from step 2.
  • step 3 Blending of step 3 granules with lubricant and optionally other pharmaceutically acceptable excipient.
  • gliclazide may have particle size distribution as below: 1. D 90 less than 70 microns preferably less than 60 microns but greater than 20 microns.
  • D 50 less than 30 microns preferably less than 20 microns but greater than 7 microns.
  • the dissolution of the present invention was determined by following method:
  • the release profile of gliclazide from the pharmaceutical dosage form is substantially independent of the pH of the dissolution medium over a wide pH range.
  • the pharmaceutical dosage form of the present invention releases gliclazide substantially independent to the variation in a wider pH range. This would also ensure consistent and regular release of drug throughout the gastrointestinal tract independent of pH.
  • composition was prepared according to the process and formula as described in example- 1 with following changes:
  • Figure-I The % cumulative release profile of gliclazide in dissolution medium of pH 6.2, 6.8 and 7.4.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Inorganic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

La présente invention porte sur une forme posologique à libération contrôlée stabilisée de Glyclazide, présentant un profil de libération indépendant du pH sur une large plage, ayant plusieurs polymères de contrôle de la libération et exempte de composant saccharidique et facultativement exempte de liant. L'invention porte également sur un procédé pour la préparation d'une telle forme posologique.
PCT/IN2007/000496 2006-10-19 2007-10-18 Forme posologique à libération contrôlée stabilisée de gliclazide WO2008062470A2 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
IN1731MU2006 2006-10-19
IN1731/MUM/2006 2006-10-19
IN495/MUM/2007 2007-03-16
IN495MU2007 2007-03-16

Publications (2)

Publication Number Publication Date
WO2008062470A2 true WO2008062470A2 (fr) 2008-05-29
WO2008062470A3 WO2008062470A3 (fr) 2009-01-29

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Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009082359A1 (fr) * 2007-12-26 2009-07-02 Ali Raif Ilac Sanayi Ve Ticaret A.S. Comprimé de gliclazide à libération prolongée
US20090238870A1 (en) * 2008-03-21 2009-09-24 Les Laboratoires Servier Dividable galenical form allowing modified release of the active ingredient
EP2181705A1 (fr) 2008-10-31 2010-05-05 Disphar International B.V. Formulation à libération prolongée de gliclazide
WO2013124832A3 (fr) * 2012-02-24 2013-11-07 Ranbaxy Laboratories Limited Composition pharmaceutique à libération contrôlée stabilisée comprenant du gliclazide
WO2014128116A1 (fr) 2013-02-19 2014-08-28 Sanovel Ilac Sanayi Ve Ticaret A.S. Procédé de production de formulations de gliclazide
EP2783680A1 (fr) * 2013-03-25 2014-10-01 Sanovel Ilac Sanayi ve Ticaret A.S. Formulations à libération contrôlée comprenant de la metformine et gliclazide
ITFI20130184A1 (it) * 2013-08-01 2015-02-02 Valpharma Internat S P A Una formulazione farmaceutica di gliclazide a rilascio modificato, somministrabile per via orale, e suo metodo di produzione.
WO2016042568A1 (fr) * 2014-09-16 2016-03-24 Suresh Pareek Formulation à libération prolongée de gliclazide

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005009412A1 (fr) * 2003-07-24 2005-02-03 Wockhardt Limited Compositions orales pour le traitement de maladies
WO2006061697A1 (fr) * 2004-12-06 2006-06-15 Themis Laboratories Private Limited Compositions de sulfonyluree et procede de preparation de ces dernieres
WO2006104401A1 (fr) * 2005-03-26 2006-10-05 Protemix Corporation Limited Compositions antagonistes du cuivre

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005009412A1 (fr) * 2003-07-24 2005-02-03 Wockhardt Limited Compositions orales pour le traitement de maladies
WO2006061697A1 (fr) * 2004-12-06 2006-06-15 Themis Laboratories Private Limited Compositions de sulfonyluree et procede de preparation de ces dernieres
WO2006104401A1 (fr) * 2005-03-26 2006-10-05 Protemix Corporation Limited Compositions antagonistes du cuivre

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
ARNO E A ET AL: "EUDRAGIT NE30D BASED METFORMIN/GLICLAZIDE EXTENDED RELEASE TABLETS: FORMULATION, CHARACTERISATION AND IN VITRO RELEASE STUDIES" CHEMICAL AND PHARMACEUTICAL BULLETIN, PHARMACEUTICAL SOCIETY OF JAPAN, TOKYO, vol. 50, no. 11, 1 November 2002 (2002-11-01), pages 1495-1498, XP001207838 ISSN: 0009-2363 *

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2009082359A1 (fr) * 2007-12-26 2009-07-02 Ali Raif Ilac Sanayi Ve Ticaret A.S. Comprimé de gliclazide à libération prolongée
US20090238870A1 (en) * 2008-03-21 2009-09-24 Les Laboratoires Servier Dividable galenical form allowing modified release of the active ingredient
EP2181705A1 (fr) 2008-10-31 2010-05-05 Disphar International B.V. Formulation à libération prolongée de gliclazide
WO2013124832A3 (fr) * 2012-02-24 2013-11-07 Ranbaxy Laboratories Limited Composition pharmaceutique à libération contrôlée stabilisée comprenant du gliclazide
WO2014128116A1 (fr) 2013-02-19 2014-08-28 Sanovel Ilac Sanayi Ve Ticaret A.S. Procédé de production de formulations de gliclazide
EP2783680A1 (fr) * 2013-03-25 2014-10-01 Sanovel Ilac Sanayi ve Ticaret A.S. Formulations à libération contrôlée comprenant de la metformine et gliclazide
WO2014154640A1 (fr) * 2013-03-25 2014-10-02 Sanovel Ilac Sanayi Ve Ticaret A.S. Formulations à libération contrôlée comprenant de la metformine et du gliclazide
ITFI20130184A1 (it) * 2013-08-01 2015-02-02 Valpharma Internat S P A Una formulazione farmaceutica di gliclazide a rilascio modificato, somministrabile per via orale, e suo metodo di produzione.
WO2015014987A1 (fr) 2013-08-01 2015-02-05 Valpharma International S.P.A. Formulation pharmaceutique orale à libération modifiée contenant du gliclazide
WO2016042568A1 (fr) * 2014-09-16 2016-03-24 Suresh Pareek Formulation à libération prolongée de gliclazide

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