EP1827453A1 - Compositions de sulfonyluree et procede de preparation de ces dernieres - Google Patents

Compositions de sulfonyluree et procede de preparation de ces dernieres

Info

Publication number
EP1827453A1
EP1827453A1 EP05808478A EP05808478A EP1827453A1 EP 1827453 A1 EP1827453 A1 EP 1827453A1 EP 05808478 A EP05808478 A EP 05808478A EP 05808478 A EP05808478 A EP 05808478A EP 1827453 A1 EP1827453 A1 EP 1827453A1
Authority
EP
European Patent Office
Prior art keywords
composition
sulfonylurea
gliclazide
mixtures
polymer
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.)
Withdrawn
Application number
EP05808478A
Other languages
German (de)
English (en)
Inventor
Amit Krishna Antarkar
Nirav Mahendra Wing A-1 Flat No. 201 KAMDAR
Sangeeta Amalesh Karle
Chriag Bhupendra Shah
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.)
Inventia Healthcare Pvt Ltd
Original Assignee
Themis Laboratories Pvt 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 Themis Laboratories Pvt Ltd filed Critical Themis Laboratories Pvt Ltd
Publication of EP1827453A1 publication Critical patent/EP1827453A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61K9/2013—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
    • 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
    • A61K9/20—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 pH independent sustained release pharmaceutical composition comprising sulfonylurea and a process for its preparation:
  • Diabetes mellitus is a major health care problem characterized by marked increase in glucose levels in the blood.
  • Other complication of diabetes includes heart disease, foot complications, diabetic neuropathy, gastroparesis and kidney disease. In gastroparesis the vagus nerve is damaged. The muscles of the stomach and intestines do not work normally, and the movement of food is slowed or stopped.
  • the pH of the intestinal fluid generally varies from 6 to 8.
  • the pH of the stomach ranges from 1.5 - 5 and gastric emptying time ranges from 2 - 4 hours. Gastric emptying time is further increased in gastroparesis condition.
  • the acidic contents of the stomach are emptied into the duodenum, dropping the pH of the duodenum to 4.5 - 5.
  • the pH of the duodenum is slowly brought back to normal by pancreatic secretion.
  • Sulfonylurea is insulin secretion enhancer used in the treatment of type Il diabetes mellitus.
  • Representative examples includes acetohexamide, chlorpropamide, glipizide, gliclazide, glibenclamide, glimepiride, gliquidone, glisoxepid, glibornuride, gliamilide, glycopyramide, glisentide, glisolamide, glicetanile, gliflumide, glymidine, glyparamide, tolpyrramide, glyhexamide, phenbutamide, tolazamide, tolbutamide and tolcyclamide, carbutamide, glybuthiazole, glybuzole, glypinamide phenbutamide, glyclopyamide and glycylamide and their pharmaceutically acceptable salts.
  • sulfonylureas are hydrophobic weak acid, insoluble in water and acidic pH and soluble towards neutral to alkaline pH of the intestine from 6 - 8. Their solubility increase with increasing pH. Sulfonylurea being administered with food will remain in stomach and duodenum, the contents of which are acidic in nature (pH 4 - 5) for about 2 to 5 hours.
  • condition to be fulfilled is to formulate a dosage form that releases sulfonylurea independent of pH in a wider pH range prevalent in the gastro- intestinal tract.
  • PCT publication WO00/18373 discloses matrix tablet for prolonged release of gliclazide, comprising a combination of cellulose polymer compound and glucose syrup.
  • the composition contains 2 to 20%w/w of glucose syrup as one of the essential ingredients.
  • 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.
  • the PCT publication WO00/18373 fails to provide matrix tablet that release gliclazide insensitive to the variation in the pH from 4 - 6, which is the pH of the stomach and duodenum in the fed state where the tablet resides for about 2 - 5 hours.
  • Sulfonylurea being administered with food would remain in contact with acidic pH (pH 4 - 6) of stomach and duodenum for about 2 to 5 hours. This contact time in acidic pH is further increased in gastroparesis which is one of the complications of diabetes mellitus. None of the dosage formulation disclosed in the prior art releases sulfonylurea independent of pH in a wide pH range prevalent in the gastro-intestinal tract. There is a long standing need in the industry to provide pharmaceutical composition comprising sulfonylurea that exhibits independent drug release profile in a wide pH range prevalent in the gastro-intestinal tract in the fed state.
  • the object of the present invention is to provide once a day sustained release pharmaceutical compositions comprising sulfonylurea that provides consistent blood levels with minimized peaks and trough of drug concentration in the blood.
  • Another object of the invention is to provide sustained release pharmaceutical compositions comprising sulfonylurea exhibiting substantially independent drug release profile in a wider pH range prevalent in the gastro-intestinal tract.
  • the present invention provides sustained release pharmaceutical compositions comprising sulfonylurea for once a day administration that provides consistent blood levels of sulfonylurea with minimized peaks and troughs of sulfonylurea concentration in blood thereby enabling patient compliance with the treatment of type Il diabetes mellitus.
  • the pharmaceutical composition of the present invention comprises sulfonylurea, polymer, disaccharide and / or monosaccharide exhibiting drug release profile substantially pH independent over a wider pH range.
  • the present invention further provides process for preparing such pharmaceutical compositions.
  • Figure 1 shows the % cumulative release profile of gliclazide from the matrix tablets as of example 1 in dissolution medium of pH 4.5, 6.8 and 7.4
  • Figure 2 shows the % cumulative release profile of gliclazide from the matrix tablets as of example 2 in dissolution medium of pH 4.5, 6.8 and 7.4
  • composition of the present invention is 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.
  • the matrix tablet of the present invention can be prepared by wet granulation method or dry granulation method or direct compression method.
  • Wet granulation method is the preferred method which comprises step of: • Mixing drug, polymer, disaccharide and / or monosaccharide and optionally pharmaceutical acceptable additive in a suitable mixer to obtain drug mixture;
  • the solvent used for wetting the drug mixture is selected from water, alcohol, methylene chloride, acetone or their suitable mixture. Alcohol includes methanol, ethanol and isopropanol. Solvent or solvent mixture used for wetting the drug mixture optionally contains binder.
  • direct compression method the drug is mixed with polymer, disaccharide and / or monosaccharide and optionally pharmaceutical additive to obtain directly compressible mixture that can be compressed into tablet.
  • dry granulation method the mixture of drug with atleast one excipient is compacted or slugged. The resulting mass is screened to obtain granules of desired mesh size followed by mixing with other ingredients and lubricants if required and compression.
  • the pharmaceutical composition comprising sulfonylurea, polymer, disaccharide and / or monosaccharide exhibits release of sulfonylurea substantially independent of pH.
  • the release profile of sulfonylurea is substantially independent of the pH of the dissolution medium over a wide pH range (pH 4.5 - 7.4) for about 8 to 10 hours.
  • the invention disclosed in the PCT publication WO00/18373 releases gliclazide independent to the variation in the pH range from 6 to 8.
  • the pharmaceutical composition of the present invention releases gliclazide (sulfonylurea) substantially independent to the variation in a wider pH range i.e. 4 to 8, which is more desirable.
  • the pharmaceutical composition of the present invention exhibits linear drug release profile for a period of atleast 8 hours. 50% of the drug is released from the pharmaceutical composition from about 4 to 8 hours preferably from about 4 to 6 hours in dissolution media of pH from 4.5 to 7.4.
  • Sulfonylurea is selected from gliclazide, glibenclamide, glimepiride, glipizide and gliquidone and is preferably gliclazide.
  • the particle size of sulfonylurea is less than 150 microns, preferably less than 100 microns and more preferably less than 50 microns.
  • the percentage of sulfonylurea in the pharmaceutical composition ranges from about 0.001 %w/w to about 90%w/w of the composition, preferably from about 1%w/w to about 45% w/w and more preferably from about 1.25%w/w to about 40%w/w.
  • the unit dose of sulfonylurea may vary from active to active but generally ranges from about 0.01 mg to about 200mg.
  • the unit dose of gliclazide in the present invention generally ranges from about 15mg to about 120mg.
  • the unit dose of glipizide, glibenclamide and glimepiride in the present invention generally ranges form about 0.1 mg to about 20mg.
  • Polymer is selected from cellulose ethers, acrylic acid polymers and copolymer, methacrylic acid copolymer, acrylates, polymethacrylates, xanthan gum, guar gum, locust bean gum, polyethylene oxide, alginic acid and its salt such as sodium, potassium, ammonium, calcium salt, high molecular weight polyethylene glycol or their mixtures and is preferably cellulose ethers.
  • the preferred cellulose ethers are selected from alkylcellulose, hydroxyalkylcellulose and carboxyalkylcellulose such as methylcellulose (MC), ethylcellulose (EC), hydroxyethylcellulose (HEC), hydroxypropylmethylcellulose (HPMC), hydroxypropylcellulose (HPC), and carboxymethylcellulose (CMC) and its pharmaceutical acceptable salts such as sodium, potassium and calcium salt.
  • Preferred polymers are HPMC and sodium CMC.
  • Cellulose ethers are available in various grades depending on their viscosities from about 3 cps to about 1 ,00,000 cps.
  • the pharmaceutical composition of the present invention contains atleast one polymer having viscosity greater than 1000 cps when measured at 25.deg. centigrade.
  • the nominal viscosity at 20 0 C of a 2%w/w aqueous solution of HPMC is not less than 3000cps.
  • the nominal viscosity at 25°C of a 1%w/w aqueous solution of HPC or HEC or CMC or its salt such as sodium CMC is not less than 1500cps.
  • Such polymers having lower viscosity can also be used provided the composition contains atleast one polymer having relative high viscosity as mentioned above.
  • the amount of the cellulose ether used in the composition is upto about 75%w/w of the composition, preferably from about 5% to about 50%w/w of the composition, more preferably from about 7.5% to about 30%w/w and most preferably from about 10% to about 20%w/w of the composition.
  • the disaccharide and / or monosaccharide content vary from about 15% to about 80% w/w of the composition, preferably from about 20% to about 70%w/w of the composition.
  • Disaccharide is selected from lactose, sucrose, maltose, galactose, trehalose and maltitol or their mixtures and is preferably lactose.
  • Monosaccharide is selected from glucose, fructose, galactose, dextrose, mannose, xylose, arabinose, ribose, ribulose or their mixtures and is preferably dextrose.
  • the composition optionally comprises other pharmaceutical acceptable additives.
  • Pharmaceutical acceptable additives include diluents, binder, flow regulating agent, lubricant, surfactant, alkalizing agents, pH modifiers, buffering agent's colorants or their mixtures.
  • Diluents are selected from glucose, mannitol, sorbitol, compressible sugar, sugar alcohol, monobasic sodium phosphate, dibasic sodium phosphate, tribasic sodium phosphate, calcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, crosslinked carboxymethylcellulose and its salts such as sodium, potassium and calcium salt, sodium starch glycolate, pregelatinized starch, starch 1500, crospovidone, cyclodextrins and its derivatives, carboxymethylcellulose and its salts such as sodium, potassium and calcium salt, starch, calcium sulfate, microcrystalline cellulose or their mixture.
  • Binder is selected from cellulose ethers, xanthan gum, guar gum, acacia, tragacanth, gelatin, carragenan, locust bean gum, karaya gum, agar, chitosan, polyvinyl alcohol, polyvinylpyrrolidone (povidone) and gelatin and their mixture preferably cellulose ethers and povidone.
  • Cellulose ethers is preferably selected from alkylcellulose, hydroxyalkylcellulose and carboxyalkylcellulose and includes methylcellulose (MC), hydroxypropylmethylcellulose (HPMC), ethylcellulose (EC), hydroxypropylcellulose (HPC), hydroxyethylcellulose (HEC), carboxymethylcellulose (CMC) and its salt such as sodium, potassium, calcium etc.
  • Flow regulating agent and lubricants are selected from talc, colloidal silicon dioxide, glyceryl monostearate, sodium benzoate, sodium lauryl sulfate, glyceryl behenate, stearic acid and its salt such as magnesium stearate, calcium stearate or their mixture. The invention is further illustrated with non-limiting examples.
  • Example 1 deals with the preparation of matrix tablet comprising a mixture of cellulose polymer (HPMC) and disaccharide (lactose monohydrate).
  • HPMC cellulose polymer
  • lactose monohydrate disaccharide
  • the process involves mixing gliclazide, HPMC K100M (Methocel K100M) and lactose monohydrate in a suitable mixer to obtain drug mixture.
  • the drug mixture was wet granulated using a mixture of isopropyl alcohol and water.
  • the resulting wet granules were dried in a suitable drier.
  • the dried granules were milled and sifted through desired mesh to obtain granules of desired particle size.
  • These granules were blended with talc, Colloidal silicon dioxide and magnesium stearate.
  • the resulting granules were compressed using a rotary compression machine to obtain tablets of desired hardness.
  • Gliclazide matrix tablet comprising a mixture of atleast two polymers and disaccharide or monosaccharide
  • Examples 2 - 5 deals with the preparation of matrix tablets comprising a mixture of two cellulose polymers (HPMC and sodium CMC) and a disaccharide (lactose monohydrate) or monosaccharide.
  • the process involves mixing gliclazide, HPMC K4M (Methocel K4M) / HPMC K100M (Methocel K100M), sodium CMC (Ceekol 30,000), lactose monohydrate or dextrose and dibasic calcium phosphate dihydrate in a suitable mixer to obtain drug mixture.
  • the drug mixture was wet granulated using HPMC E05 / povidone k30 solution in a mixture of isopropyl alcohol and water.
  • the resulting wet granules were dried in a suitable drier.
  • the dried granules were milled and sifted through desired mesh to obtain granules of desired particle size.
  • These granules were blended with talc, colloidal silicon dioxide and magnesium stearate.
  • the resulting granules were compressed using a rotary compression machine to obtain tablets of desired hardness.
  • Example 6 Table 3: Gliclazide matrix tablet comprising a mixture of two HPMC polymers of different viscosities and disaccharide
  • Example 5 Ingredients mg / tablet
  • Example 6 deals with the preparation of gliclazide matrix tablets comprising a mixture of two HPMC polymers of different viscosities and a disaccharide (lactose).
  • the process involves mixing gliclazide, HPMC K100M (Methocel K100M) and HPMC K100LV (Methocel K100LV), lactose monohydrate and dibasic calcium phosphate dihydrate in a suitable mixer to obtain drug mixture.
  • the drug mixture was wet granulated using povidone k30 solution in a mixture of isopropyl alcohol and water.
  • the resulting wet granules were dried milled and sifted through desired mesh and were blended with talc, colloidal silicon dioxide and magnesium stearate.
  • the resulting granules were compressed using a rotary compression machine to obtain tablets of desired hardness.
  • Sustained release matrix tablet containing gliclazide when analyzed in phosphate buffer of pH 4.5, pH 6.8 and pH 7.4 exhibits in-vitro drug release profile of N. MT 35% of gliclazide released after 1 hour; from about 10% to about 60% of gliclazide released after 3 hours;
  • NMT and “NLT” stands for "Not More Than” and “Not Less than” respectively.
  • ANOVA was performed on the mean value of the rate of drug released from 6 tablets of example 1 in three different dissolution media of pH 4.5, 6.8 and 7.4. The result indicates that statistically there is no significant difference in the rate of drug released at 5% level.
  • the present invention provides pharmaceutical compositions comprising sulfonylurea suitable for once a day administration and exhibiting in-vitro drug release profile substantially independent of the pH of the dissolution medium of wide pH range ensuring less fluctuation and provides consistent and regular release of the drug in blood irrespective of the pH that is prevalent in the gastro-intestinal tract thereby minimizing inter and intra subject variation.

Landscapes

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

Abstract

La présente invention concerne des compositions pharmaceutiques à libération prolongée qui sont appropriées à l'administration 'une fois par jour'' et un procédé de préparation de ces compositions comprenant de la sulfonylurée, un polymère, un disaccharide et/ou un monosaccharide, présentant un profil de libération du médicament sensiblement indépendant du pH du milieu de dissolution dans une plage de pH comprise entre 4 et 8.
EP05808478A 2004-12-06 2005-11-29 Compositions de sulfonyluree et procede de preparation de ces dernieres Withdrawn EP1827453A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1297MU2004 2004-12-06
PCT/IB2005/003702 WO2006061697A1 (fr) 2004-12-06 2005-11-29 Compositions de sulfonyluree et procede de preparation de ces dernieres

Publications (1)

Publication Number Publication Date
EP1827453A1 true EP1827453A1 (fr) 2007-09-05

Family

ID=36577697

Family Applications (1)

Application Number Title Priority Date Filing Date
EP05808478A Withdrawn EP1827453A1 (fr) 2004-12-06 2005-11-29 Compositions de sulfonyluree et procede de preparation de ces dernieres

Country Status (2)

Country Link
EP (1) EP1827453A1 (fr)
WO (1) WO2006061697A1 (fr)

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2006123213A1 (fr) * 2005-05-18 2006-11-23 Ranbaxy Laboratories Limited Preparations a liberation modifiee de gliclazide
AU2006272978B2 (en) 2005-07-26 2012-06-07 Bial - Portela & Ca, S.A. Nitrocatechol derivatives as COMT inhibitors
EP1845097A1 (fr) 2006-04-10 2007-10-17 Portela & Ca., S.A. Derives de oxadiazole en tant qu' inhibiteurs de l'enzyme COMT
WO2008062470A2 (fr) * 2006-10-19 2008-05-29 Torrent Pharmaceuticals Limited Forme posologique à libération contrôlée stabilisée de gliclazide
RU2518483C2 (ru) 2007-01-31 2014-06-10 Биал-Портела Энд Ка, С.А. Режим дозирования ингибиторов комт
TR200704897A1 (tr) 2007-07-13 2009-02-23 Sanovel �La� Sanay� Ve T�Caret Anon�M ��Rket� Uzatılmış salım sağlayan gliklazid formülasyonları@
TR200708938A2 (tr) * 2007-12-26 2008-11-21 Ali̇ Rai̇f İlaç Sanayi̇ Ve Ti̇caret A.Ş. Uzatılmış salım sağlayan gliklazid tablet
ITFI20080016A1 (it) * 2008-02-05 2009-08-06 Valpharma Sa Formulazioni farmaceutiche orali contenenti gliclazide.
JP2011514380A (ja) 2008-03-17 2011-05-06 バイアル−ポルテラ アンド シーエー，エス．エー． ５−［３−（２，５−ジクロロ−４，６−ジメチル−１−オキシ−ピリジン−３−イル）［１，２，４］オキサジアゾール−５−イル］−３−ニトロベンゼン−１，２−ジオールの結晶形
FR2928836B1 (fr) * 2008-03-21 2011-08-26 Servier Lab Forme galenique secable permettant une liberation modifiee du principe actif
EP2181705A1 (fr) 2008-10-31 2010-05-05 Disphar International B.V. Formulation à libération prolongée de gliclazide
BRPI1014865B1 (pt) * 2009-04-01 2020-03-17 Bial - Portela & C.A., S.A. Composição que compreende grânulos compreendendo 2,5- dicloro- 3- (5- (3,4- dihidróxi- 5- nitrofenil)- 1,2,4- oxadiazol- 3- il)- 4,6- dimetilpiridina 1- óxido e formulação farmacêutica
TR201107482A1 (tr) 2010-12-21 2012-07-23 Sanovel İlaç San.Ve Ti̇c.A.Ş. Vildagliptin ve gliklazidin iki tabakalı kombinasyon kompozisyonu.
EP2468268B1 (fr) 2010-12-21 2017-12-13 Sanovel Ilaç Sanayi Ve Ticaret Anonim Sirketi Composition de combinaison de vildagliptine et de gliclazide
US20140045900A1 (en) 2011-02-11 2014-02-13 Bial-Portela & Ca, S.A. Administration regime for nitrocatechols
TR201103946A1 (tr) 2011-04-22 2012-11-21 Sanovel İlaç Sanayi̇ Ve Ti̇caret Anoni̇m Şi̇rketi̇ Kontrollü salım sağlayan gliklazid formülasyonları.
SI2791134T1 (sl) 2011-12-13 2020-01-31 Bial - Portela & Ca S.A. Kemična spojina, ki je uporabna kot vmesna oblika za pripravo inhibitorja katehol-o-metiltransferaze
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.
CN105193758A (zh) * 2014-06-30 2015-12-30 南京瑞尔医药有限公司 一种格列齐特缓释片及其制备方法
WO2016042568A1 (fr) * 2014-09-16 2016-03-24 Suresh Pareek Formulation à libération prolongée de gliclazide
RU2017120184A (ru) 2014-11-28 2018-12-28 БИАЛ - ПОРТЕЛА ЭНД Ка, С.А. Лекарства для замедления течения болезни паркинсона
CN104546778A (zh) * 2014-12-25 2015-04-29 北京华禧联合科技发展有限公司 一种格列齐特缓释制剂的药物组合物及其制备方法
CN116803378B (zh) * 2023-08-24 2023-11-17 北京福元医药股份有限公司 一种格列齐特缓释片剂及其制备方法

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6056977A (en) * 1997-10-15 2000-05-02 Edward Mendell Co., Inc. Once-a-day controlled release sulfonylurea formulation
AP1243A (en) * 1999-02-01 2004-02-02 Servier Lab Core tablet for controlled release of gliclazide after oral administration.

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO2006061697A1 *

Also Published As

Publication number Publication date
WO2006061697A1 (fr) 2006-06-15

Similar Documents

Publication Publication Date Title
EP1827453A1 (fr) Compositions de sulfonyluree et procede de preparation de ces dernieres
US20040202718A1 (en) Dosage form for treatment of diabetes mellitus
US6875793B2 (en) Once-a-day controlled release sulfonylurea formulation
JP5600328B2 (ja) グルコピラノシルジフェニルメタン誘導体を含む医薬組成物、その医薬剤形、それらの調製方法及び患者の血糖コントロールを改善するためのそれらの使用
TWI483943B (zh) 醫藥組合物、醫藥劑型、其製備方法及其用途
US5451409A (en) Sustained release matrix system using hydroxyethyl cellulose and hydroxypropyl cellulose polymer blends
US20060088594A1 (en) Highly compressible controlled delivery compositions of metformin
US6416786B1 (en) Sustained release tablet containing hydrocolloid and cellulose ether
US20030187074A1 (en) Oral compositions for treatment of diabetes
WO2008062273A2 (fr) Forme posologique solide administration orale contenant une combinaison de médicaments antidiabétiques
CZ20012661A3 (cs) Matricová tableta pro prodlouľené uvolňování gliclazidu po orálním podání
WO2008062470A2 (fr) Forme posologique à libération contrôlée stabilisée de gliclazide
US20050118256A1 (en) Extended release alpha-2 agonist pharmaceutical dosage forms
JP4063386B2 (ja) 速放性経口医薬品組成物
WO2005092293A1 (fr) Formulations de metformine
EP2181705A1 (fr) Formulation à libération prolongée de gliclazide
WO2018185669A1 (fr) Compositions effervescentes comprenant de la saxagliptine ou un sel de celle-ci
WO2004091600A1 (fr) Preparation solide pour l'usage par voie orale
US20090017116A1 (en) Extended release gliclazide formulations
US20160303051A1 (en) Burst Drug Release Compositions
US20170273923A1 (en) Method of administering divalproex
KR100804829B1 (ko) 나테글리나이드 함유 경구 투여용 약학 조성물
EP4281048A1 (fr) Composition de furazdine à libération prolongée
AU2002348712A1 (en) Dosage form for treatment of diabetes mellitus
CA2645318A1 (fr) Compositions pharmaceutiques contenant de la metformine

Legal Events

Date Code Title Description
PUAI Public reference made under article 153(3) epc to a published international application that has entered the european phase

Free format text: ORIGINAL CODE: 0009012

17P Request for examination filed

Effective date: 20070704

AK Designated contracting states

Kind code of ref document: A1

Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IS IT LI LT LU LV MC NL PL PT RO SE SI SK TR

DAX Request for extension of the european patent (deleted)
RAP1 Party data changed (applicant data changed or rights of an application transferred)

Owner name: INVENTIA HEALTHCARE PRIVATE LIMITED

STAA Information on the status of an ep patent application or granted ep patent

Free format text: STATUS: THE APPLICATION HAS BEEN WITHDRAWN

18W Application withdrawn

Effective date: 20100909