WO2020098904A1 - Forme posologique contenant de la metformine et un inhibiteur de la dipeptidyl peptidase iv - Google Patents

Forme posologique contenant de la metformine et un inhibiteur de la dipeptidyl peptidase iv Download PDF

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Publication number
WO2020098904A1
WO2020098904A1 PCT/EP2018/080945 EP2018080945W WO2020098904A1 WO 2020098904 A1 WO2020098904 A1 WO 2020098904A1 EP 2018080945 W EP2018080945 W EP 2018080945W WO 2020098904 A1 WO2020098904 A1 WO 2020098904A1
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WO
WIPO (PCT)
Prior art keywords
dosage form
unit dosage
solid unit
pharmaceutical excipient
inhibitor
Prior art date
Application number
PCT/EP2018/080945
Other languages
English (en)
Inventor
Panagiotis PANAGOPOULOS
Konstantinos-Emmanouil PANITSAS
Pandora Alexaki
Christina KATAKALOU
Dimitris BELEKOS
Georgia KATHIOTOU
Original Assignee
Pharmaceutical Oriented Services Ltd
Rontis Hellas S.A.
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 Pharmaceutical Oriented Services Ltd, Rontis Hellas S.A. filed Critical Pharmaceutical Oriented Services Ltd
Priority to PCT/EP2018/080945 priority Critical patent/WO2020098904A1/fr
Publication of WO2020098904A1 publication Critical patent/WO2020098904A1/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
    • A61K9/14—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
    • A61K9/1635—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/13—Amines
    • A61K31/155—Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (N=C(OH)—NH2), isothiourea (—N=C(SH)—NH2)
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/4985—Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
    • 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
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • 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
    • A61K9/2027—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
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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

Definitions

  • the present invention relates to a solid unit dosage form such as a tablet containing metformin and a dipeptidyl peptidase IV (DPP-IV) inhibitor and to a process for preparing the tablet.
  • a solid unit dosage form such as a tablet containing metformin and a dipeptidyl peptidase IV (DPP-IV) inhibitor and to a process for preparing the tablet.
  • DPP-IV dipeptidyl peptidase IV
  • metformin hydrochloride Tablets containing 500, 850 or 1000 mg metformin hydrochloride are commercially available under the tradename Glucophage ® for the treatment of non-insulin- dependent diabetes mellitus (NIDDM), i.e. type 2 diabetes mellitus.
  • NIDDM non-insulin- dependent diabetes mellitus
  • Metformin- containing tablets have a high drug load, and they are typically produced by wet- granulation.
  • Tablets containing metformin hydrochloride and a DPP-TV inhibitor are marketed for the treatment of diabetes type 2 under the tradenames Eucreas ® (vildagliptin), Janumet ® (sitagliptin phosphate), Jentadueto ® (linagliptin), Komboglyze ® (saxa- gliptin hydrochloride) and Vipdomet ® (alogliptin benzoate).
  • the DPP-IV inhibitors in particular vildagliptin, are sensitive to moisture, which may cause stability problems.
  • the challenges in the development of a tablet containing metformin and a DPP-IV inhibitor are the high metformin load that results in relatively large tablets, the poor processability of metformin and the wet-granulation process that is typically used for formulating metformin, while the DPP-IV inhibitor is sensitive to moisture.
  • WO 2007/041053 relates to the Eucreas ® tablet.
  • This application describes a tablet in which metformin is contained as intragranular component and vildagliptm is present as extragranular component.
  • the metformin-containing granules may be prepared by wet-granulation or melt-granulation.
  • Komboglyze ® tablet is protected by WO 2005/117841.
  • Komboglyze ® consists of a metformin hydrochloride, povidone and magnesium stearate-containing tablet core covered by a number of film-coat layers, whereby the drag saxagliptin hydrochloride is embedded within the middle layer, which is a film-coat of Opadry ® .
  • the Vipdomet ® tablet is covered by WO 2009/011451.
  • a mixture of alogliptin benzoate, mannitol and microcrystalline cellulose is subjected to wet-granulation using an aqueous povidone solution.
  • a mixture of metformin hydrochloride and microcrystalline cellulose is subjected to wet-granulation with an aqueous povidone solution.
  • the above granules are mixed with crospovidone and magnesium stearate, and the blend is compressed into a tablet.
  • WO 2007/078726 relates to the Janumet ® tablet.
  • sitagliptin phosphate and metformin hydrochloride are subjected to a wet-granulation process using an aqueous povidone solution (optionally containing a surfactant) as a granulation liquid.
  • aqueous povidone solution optionally containing a surfactant
  • the obtained granules, a filler and a lubricant are mixed, and the obtained blend is subjected to compression.
  • WO 2009/121945 relates to the Jentadueto ® tablet
  • This application describes the preparation of a tablet by subjecting metformin hydrochloride, linagliptin and starch to wet-granulation with an aqueous solution containing L-arginine and copovidone.
  • the manufacturing method used for preparing the metformin and DPP-IV inhibitor-containing tablet depends on the moisture sensitivity of the DPP-IV inhibitor.
  • DPP-IV inhibitors such as vildagliptin and saxagliptin
  • DPP-IV inhibitors which are moisture-sensitive in the presence of metformin such as alogliptin, metformin and the DPP-IV inhibitor cannot be subjected together to a wet-granulation process.
  • moisture-sensitive DPP-IV inhibitors such as sitagliptin and linagliptin, are typically subjected together with metformin to wet-granulation, because this technique is most suitable for formulating metformin.
  • the process of the present invention is a dry-granulation process in which metformin or a pharmaceutically acceptable salt thereof, a DPP-IV inhibitor and a binder are subjected to compaction, and the compacted material is subjected to a milling process to obtain granules, whereby the granules are preferably compressed into a tablet.
  • the present invention thus relates to a process for preparing a solid unit dosage form for oral administration containing metformin or a pharmaceutically acceptable salt thereof and a dipeptidyl peptidase IV (DPP-IV) inhibitor as active ingredients, wherein the process comprises the steps: a) mixing the active ingredients and a first pharmaceutical excipient, wherein the first pharmaceutical excipient comprises a binder,
  • DPP-IV dipeptidyl peptidase IV
  • step (a) subjecting the blend obtained in step (a) to compaction
  • step (c) milling the compacted blend obtained in step (b) to obtain granules, and d) optionally mixing the granules obtained in step (c) with a second pharmaceutical excipient.
  • the granules are converted into a tablet by: e) subjecting the granules obtained in step (c) or the blend obtained in step (d) to compression to obtain a tablet, and
  • step (e) optionally subjecting the tablet obtained in step (e) to film-coating.
  • the compaction in method step (b) may be a slugging process; however, roller compaction is preferred. It was found that sufficiently hard granules can be obtained if the active ingredients are compacted in the presence of a binder. Hence, it is preferred that the first pharmaceutical excipient consists of a binder and optionally a lubricant.
  • the granules obtained in step (c) are optionally mixed with a second pharmaceutical excipient and subjected to compression to obtain a tablet. Alternatively, the blend obtained in step (d) may be filled into a capsule.
  • the second pharmaceutical excipient i.e. the extragranular pharmaceutical excipient
  • the second pharmaceutical excipient comprises a filler and a lubricant
  • the second pharmaceutical excipient consists of a filler and a lubricant.
  • the first pharmaceutical excipient consists of a binder and a lubricant
  • the second pharmaceutical excipient consists of a filler and a lubricant.
  • binders include hydroxypropyl cellulose (HPC), hydroxypropyl methyl- cellulose (HPMC), polyethylene glycol and copovidone, whereby HPC is preferably contained.
  • lubricants include magnesium stearate, calcium stearate, stearic acid, sodium stearyl fumarate and glycerol dibehenate, whereby magnesium stearate is preferably used as lubricant, both as lubricant of the first pharmaceutical excipient and as lubricant of the second pharmaceutical excipient
  • fillers include microcrystalline cellulose, calcium hydrogen phosphate, mannitol, starch, partially pregelatinized starch (starch 1500), silicified microcrystalline cellulose, sorbitol and xylitol, whereby mannitol or starch 1500 is preferably contained.
  • the present invention further relates to a solid unit dosage form for oral administration containing metformin or a pharmaceutically acceptable salt thereof and a DPP-IV inhibitor, whereby the solid unit dosage form is prepared by using the dry-granulation process of the present invention.
  • the solid unit dosage form is an optionally film-coated tablet.
  • Commercially available film-coating systems containing polyvinyl alcohol as coating polymer, which are marketed under the tradename Opadry ® may be used.
  • the DPP-IV inhibitor may be selected from vildagliptin, saxagliptin, alogliptin, sitagliptin and linagliptin, and pharmaceutically acceptable salts thereof.
  • the process of the present invention is particularly suitable for moisture-sensitive DPP-IV inhibitors, such as vildagliptin, saxagliptin and alogliptin, and pharmaceutically acceptable salts thereof.
  • the solid unit dosage form of the present invention contains vildagliptin, more preferably metformin hydrochloride and vildagliptin.
  • the solid unit dosage form according to the present invention typically contains, in the granules obtained in step (c), metformin or a pharmaceutically acceptable salt thereof in an amount of at least 60 % by weight, preferably at least 65 % by weight, more preferred at least 70 % by weight, and most preferred at least 73 % by weight, based on the total weight of the granules.
  • the solid unit dosage form preferably contains 850 mg or 1000 mg metformin hydrochloride.
  • the granules obtained in step (c) contain the binder in an amount of 20-30 % by weight, preferably 22-26 % by weight.
  • the granules of the present invention may be compressed into a tablet, it was found that the compressibility can be improved by the addition of a small amount of filler.
  • the tablet of the present invention typically contains a filler as extragranular component in an amount of 1-2 % by weight, based on the total weight of the tablet or, if film-coated, on the total weight of the tablet core.
  • the solid unit dosage form of the present invention is suitable for the treatment of type 2 diabetes.
  • step lc The powder mixture of step lc is compacted with the roller compactor and the produced ribbons are sized through appropriate sieve.
  • the required quantity of Mannitol or starch 1500 is blended with the granules of step 3 for appropriate time.
  • the lubricated blend of step 5 is compressed with a suitable compressing machine using oval shaped punches required for each strength.
  • the tablets are collected in polyethylene bags and placed into plastic containers.
  • the required quantity of coating material is dissolved in water.
  • the compressed tablets of step 6 are coated with the film coating dispersion.

Abstract

La présente invention concerne une forme posologique unitaire solide destinée à une administration par voie orale, de préférence un comprimé, contenant de la metformine et un inhibiteur de la dipeptidyl peptidase IV, de préférence la vildagliptine. La forme posologique unitaire solide est destinée au traitement du diabète sucré de type 2.
PCT/EP2018/080945 2018-11-12 2018-11-12 Forme posologique contenant de la metformine et un inhibiteur de la dipeptidyl peptidase iv WO2020098904A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EP2018/080945 WO2020098904A1 (fr) 2018-11-12 2018-11-12 Forme posologique contenant de la metformine et un inhibiteur de la dipeptidyl peptidase iv

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EP2018/080945 WO2020098904A1 (fr) 2018-11-12 2018-11-12 Forme posologique contenant de la metformine et un inhibiteur de la dipeptidyl peptidase iv

Publications (1)

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WO2020098904A1 true WO2020098904A1 (fr) 2020-05-22

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022211762A1 (fr) * 2021-03-29 2022-10-06 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Comprimé pelliculé à base de vildagliptine et de chlorhydrate de metformine
KR20230051096A (ko) 2021-10-08 2023-04-17 (주)셀트리온 안정성이 개선된 당뇨병 치료용 약학 조성물

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005117841A1 (fr) 2004-05-28 2005-12-15 Bristol-Myers Squibb Company Formulation de comprime revetu et procede correspondant
WO2007041053A2 (fr) 2005-09-29 2007-04-12 Novartis Ag Nouvelle formulation
WO2007078726A2 (fr) 2005-12-16 2007-07-12 Merck & Co., Inc. Compositions pharmaceutiques contenant des combinaisons d'inhibiteurs de la dipeptidylpeptidase 4 avec de la métformine
WO2009011451A1 (fr) 2007-07-19 2009-01-22 Takeda Pharmaceutical Company Limited Preparation solide
WO2009121945A2 (fr) 2008-04-03 2009-10-08 Boehringer Ingelheim International Gmbh Nouvelles formulations, comprimés comprenant de telles formulations, leur utilisation et leur procédé de préparation
EP2295083A1 (fr) * 2009-09-15 2011-03-16 Ratiopharm GmbH Composition pharmaceutique renfermant les agents actifs metformine et sitagliptine ou vildagliptine
WO2014101986A1 (fr) * 2012-12-27 2014-07-03 Zentiva Sağlik Ürünleri San. Ve Tic. A.Ş. Procédé de granulation à sec pour la production de compositions de comprimés de metformine et compositions associées
CN106580960A (zh) * 2015-10-19 2017-04-26 南京优科制药有限公司 一种维格列汀和盐酸二甲双胍复方制剂的制备方法

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005117841A1 (fr) 2004-05-28 2005-12-15 Bristol-Myers Squibb Company Formulation de comprime revetu et procede correspondant
WO2007041053A2 (fr) 2005-09-29 2007-04-12 Novartis Ag Nouvelle formulation
WO2007078726A2 (fr) 2005-12-16 2007-07-12 Merck & Co., Inc. Compositions pharmaceutiques contenant des combinaisons d'inhibiteurs de la dipeptidylpeptidase 4 avec de la métformine
WO2009011451A1 (fr) 2007-07-19 2009-01-22 Takeda Pharmaceutical Company Limited Preparation solide
WO2009121945A2 (fr) 2008-04-03 2009-10-08 Boehringer Ingelheim International Gmbh Nouvelles formulations, comprimés comprenant de telles formulations, leur utilisation et leur procédé de préparation
EP2295083A1 (fr) * 2009-09-15 2011-03-16 Ratiopharm GmbH Composition pharmaceutique renfermant les agents actifs metformine et sitagliptine ou vildagliptine
WO2014101986A1 (fr) * 2012-12-27 2014-07-03 Zentiva Sağlik Ürünleri San. Ve Tic. A.Ş. Procédé de granulation à sec pour la production de compositions de comprimés de metformine et compositions associées
CN106580960A (zh) * 2015-10-19 2017-04-26 南京优科制药有限公司 一种维格列汀和盐酸二甲双胍复方制剂的制备方法

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022211762A1 (fr) * 2021-03-29 2022-10-06 Sanovel Ilac Sanayi Ve Ticaret Anonim Sirketi Comprimé pelliculé à base de vildagliptine et de chlorhydrate de metformine
KR20230051096A (ko) 2021-10-08 2023-04-17 (주)셀트리온 안정성이 개선된 당뇨병 치료용 약학 조성물

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