WO2020130502A1 - Composition pharmaceutique comprenant l'empagliflozine et la sitagliptine - Google Patents

Composition pharmaceutique comprenant l'empagliflozine et la sitagliptine Download PDF

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WO2020130502A1
WO2020130502A1 PCT/KR2019/017680 KR2019017680W WO2020130502A1 WO 2020130502 A1 WO2020130502 A1 WO 2020130502A1 KR 2019017680 W KR2019017680 W KR 2019017680W WO 2020130502 A1 WO2020130502 A1 WO 2020130502A1
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sitagliptin
empagliflozin
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weight
related substances
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English (en)
Korean (ko)
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임윤진
이동일
김지혜
최윤석
조재민
오준교
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Huons Co Ltd
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    • 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
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7048—Compounds having saccharide radicals and heterocyclic rings having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin, digitoxin or digoxin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00

Definitions

  • the present invention relates to an oral combination preparation comprising empagliflozin and sitagliptin as active ingredients.
  • Diabetes is one of the leading causes of adult death worldwide, and the number of diabetic patients is rapidly increasing with the increase in the obese population, which is characterized by hyperglycemia due to excessive glucose production and peripheral insulin resistance.
  • Plasma glucose is usually filtered in the kidney glomerulus and is actively reabsorbed in the proximal tubule.
  • SGLT-2 is believed to be the major transporter involved in the reuptake of glucose at this site.
  • SGLT-2 Sodium-Glucose linked transporter 2
  • SGLT-2 inhibitors have attracted attention as a preventive or therapeutic agent for diabetes, diabetes-related diseases and diabetic complications.
  • Empagliflozin one of the SGLT-2 inhibitors, is commercially available under the trade name JardianceTM, and the chemical name is 1-chloro-4-( ⁇ -D-glucopyranos-1-yl)- 2-[4-((S)-tetrahydrofuran-3-yloxy)-benzyl]-benzene, has the structure of Formula 1 below, and is disclosed in WO 2005/092877.
  • Sitagliptin is a dipeptidyl peptidase-IV (DPP-4) inhibitor, a drug developed for the treatment of type 2 diabetes or improving blood sugar control, and cytagliptin in type 2 diabetes patients
  • DPP-4 dipeptidyl peptidase-IV
  • HbA1 c level is significantly decreased, and it is known that blood sugar and post-prandial blood sugar secretion decrease upon fasting.
  • the present inventors selected empagliflozin and sitagliptin as active ingredients of a diabetes complex agent having a synergistic therapeutic effect compared to administration of a single agent, and prepared a complex formulation therefrom, and showed that the stability and content uniformity of each active ingredient are excellent. Upon confirmation, the present invention was completed.
  • An object of the present invention is to provide an oral combination preparation of empagliflozin and sitagliptin, which is capable of obtaining an immediate and sustained release of empagliflozin and sitagliptin while having high stability and content uniformity of the active ingredient. Is doing.
  • Another object of the present invention is to provide a method for producing a combination preparation of empagliflozin and sitagliptin.
  • the present invention empagliflozin or a pharmaceutically acceptable salt thereof; And sitagliptin or a pharmaceutically acceptable salt thereof.
  • the oral combination formulation is characterized in that it exhibits the following dissolution profile when measured in pH1.2, pH4.0, pH6.8 or water according to the second method (paddle method) of the Korean Pharmacopoeia (KP) dissolution test :
  • the release rate of both drugs at a time point of 15 minutes or more is 75 to 100% (preferably, the release rate of empagliflozin or a pharmaceutically acceptable salt thereof is 90 to 100%, and sitagliptin or a pharmaceutically acceptable thereof
  • the release rate of salt is 80 to 100%).
  • the oral composite agent may be in the form of a monolayer tablet.
  • the monolayer tablet is empagliflozin or a pharmaceutically acceptable salt thereof; And sitagliptin or a pharmaceutically acceptable salt thereof.
  • the pharmaceutically acceptable salt of empagliflozin or the pharmaceutically acceptable salt of sitagliptin includes an acid addition salt, for example, but is not limited to, hydrochloride, succinate, or fumarate.
  • the pharmaceutically acceptable salt of sitagliptin is sitagliptin phosphate.
  • the combination preparation may contain 10 to 25 mg of empagliflozin per unit dosage form, for example, 10 mg, 15 mg, 20 mg or 25 mg per unit dosage form.
  • the combination preparation may also contain 50 to 100 mg of sitagliptin per unit dosage form, for example, 50 mg, 75 mg, 85 mg or 100 mg.
  • the monolayer tablet may be formed into tablets of granules of a mixture containing empagliflozin and sitagliptin or a pharmaceutically acceptable salt thereof, and the granules include dry granules and wet granules.
  • the granules are preferably wet granules, and dry granules may exhibit a phenomenon in which elution decreases during tableting and a decrease in fluidity of the granules, and thus may adversely affect physical properties during tableting. .
  • the monolayer tablet may further contain, in addition to the active ingredient, any pharmaceutically acceptable additive known in the art for the preparation of the granules.
  • the pharmaceutically acceptable additive can be selected from the group consisting of plasticizers, dispersants, diluents, disintegrants, lubricants, and any combinations thereof.
  • the diluent may be selected from the group consisting of microcrystalline cellulose, calcium hydrogen phosphate anhydrous, mannitol, sucrose, lactose hydrate, sorbitol, xylitol, glucose, and mixtures thereof, but is not limited thereto.
  • the diluent is microcrystalline cellulose and lactose hydrate.
  • the diluent may be contained in an amount of 1 to 10 parts by weight based on 100 parts by weight of empagliflozin and sitagliptin or a pharmaceutically acceptable salt thereof.
  • the binder is low-substituted hydroxypropyl methyl cellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, methyl cellulose, ethyl cellulose, polyethylene oxide, guar gum, locust bean gum, xanthan gum, glyceryl distearate , Sodium carboxymethylcellulose, polyvinylpyrrolidone and mixtures thereof, but is not limited thereto.
  • the binder is a low-substituted hydroxypropyl cellulose.
  • the diluent may be contained in an amount of 1 to 10 parts by weight based on 100 parts by weight of empagliflozin and sitagliptin or a pharmaceutically acceptable salt thereof.
  • the disintegrant may be selected from the group consisting of alginic acid, sodium alginate, sodium carboxymethylcellulose, microcrystalline cellulose, powdered cellulose, croscarmellose sodium, crospovidone, pregelatinized starch, sodium starch glycolate, starch and mixtures thereof. However, it is not limited thereto.
  • the disintegrant is croscarmellose sodium.
  • the binder may be contained in an amount of 3 to 10 parts by weight based on 100 parts by weight of empagliflozin and sitagliptin or a pharmaceutically acceptable salt thereof.
  • the lubricant is calcium stearate, glyceryl monostearate, glyceryl palmitostearate, magnesium stearate, sodium lauryl sulfate, sodium stearyl fumarate, zinc stearate, stearic acid, cured vegetable oil, polyethylene glycol, benzoic acid Sodium, talc, silicon dioxide, and mixtures thereof.
  • the lubricant is silicon dioxide and magnesium stearate.
  • the lubricant may be contained in an amount of 1 to 5 parts by weight based on 100 parts by weight of empagliflozin and sitagliptin or a pharmaceutically acceptable salt thereof.
  • the coating agent may be selected from the group consisting of a mixture of HPC and HPMC, or a mixture of polyvinyl alcohol (PVA) and PEG (polyethylene glycol) and mixtures thereof, but is not limited thereto.
  • the coating agent is a mixture of HPMC.
  • the coating agent may be contained in an amount of 1 to 10 parts by weight based on 100 parts by weight of empagliflozin and sitagliptin or a pharmaceutically acceptable salt thereof.
  • the film-coated tablet may be formed by tableting in the form of a monolayer tablet with a mixture containing the empagliflozin or sitagliptin or a pharmaceutically acceptable salt thereof.
  • the film-coated tablets may contain empagliflozin and sitagliptin in one tablet, thereby exhibiting blood sugar improving effects of empagliflozin and sitagliptin.
  • the single-layered tablet according to the present invention is a composite formulation, but can also secure the stability of empagliflozin and sitagliptin, but is a single-layered tablet, but forms a granular layer, respectively, to control the stability of the controlled release composite formulation. Excellent in terms of aspect.
  • the combination agent of the present invention has both immediate release properties of empagliflozin and sitagliptin, but has excellent stability of the active ingredient compared to the conventional combination agent.
  • the oral combination preparation is stored for 4 weeks at a long-term storage condition of 25 ⁇ 2°C/relative humidity of 60 ⁇ 5% and an accelerated condition of 40 ⁇ 2°C/relative humidity of 75 ⁇ 5%. It can be confirmed that the city content and related substances are suitable for the standard. Specifically, when the oral combination preparation is stored for 4 weeks under conditions of 25 ⁇ 2° C.
  • the individual related substances of empagliflozin are 0.2% by weight or less (preferably, 0.1% by weight or less), Total related substances are 0.6% by weight or less (preferably, 0.2% by weight or less), and individual related substances of sitagliptin are 0.2% by weight or less (preferably, 0.1% by weight or less), and total related substances are 0.6% by weight or less ( Preferably, 0.2% by weight or less).
  • the individual related substances of empagliflozin are 0.2% by weight or less (preferably 0.1% by weight) or less.
  • the related substance is 0.6% by weight or less (preferably, 0.3% by weight or less), the individual related substances of sitagliptin are 0.2% by weight or less (preferably, 0.1% by weight or less), and the total related substances are 0.6% by weight or less (preferably It can be maintained at 0.3% by weight or less).
  • the oral combination preparation may be administered as an adjunct to diet therapy and exercise therapy to improve blood sugar control in adult type 2 diabetes patients.
  • a method for preparing an oral composite preparation including a wet granulation step.
  • the present invention provides a use for use in a pharmaceutical composition for preventing or treating diabetes, including the oral combination preparation.
  • the present invention provides a use for use in a health functional food composition for preventing or improving diabetes comprising the oral combination preparation.
  • the present invention provides a method for preventing or treating diabetes, comprising orally administering the oral combination preparation to an individual.
  • “individual” refers to a subject in need of treatment of a disease, and more specifically, a human or non-human primate, mouse, rat, dog, cat, horse, and cow, etc. Means mammal.
  • these drugs are included in a single layer to exhibit an immediate and sustained improvement of blood sugar, and storage stability of the active ingredient And the improved content uniformity has an advantage in terms of pharmaceuticals.
  • Figure 1 shows the dissolution rate of empagliflozin over time with 50 rpm dissolution test results, performance results, and time in 4 solutions of water, pH 1.2, 4.0, and 6.8 using the eluator for the formulations of Example 1 and Comparative Example 1. It is a graph showing the measured results.
  • Figure 2 shows the results of the dissolution test for 50 rpm in 4 solutions of water, pH 1.2, 4.0, 6.8 using the eluator for the formulations of Example 1 and Comparative Example 2, the results of the test, and the dissolution rate of cytagliptin over time It is a graph showing the results.
  • a monolayer tablet of a mixture of empagliflozin and sitagliptin was prepared according to the composition of Table 1 below. Specifically, empagliflozin, sitagliptin, lactose hydrate, low-substituted hydroxypropylcellulose, microcrystalline cellulose, and croscarmellose sodium (half injection) are used as high-speed mixers (PKM-20, Pharmatech Korea) After wet granulation with ), dried with a plate or fluidized bed dryer, and then sized with a sizing machine. Then, croscarmellose sodium (the other half input) and silicon dioxide were added, followed by post-mixing with a high-speed mixer. Finally, magnesium stearate was added and mixed, followed by tableting with a tableting machine (TPR-1002, Yenchen).
  • Molded empagliflozin and sitagliptin phosphate tablets were coated with the composition of [Table 1] to prepare a film coated tablet.
  • a film coating tablet was prepared by dissolving an HPMC-based coating agent in ethanol with a coater.
  • Example 1 Purpose of blending Raw material name Example 1 (mg) Example 1 (%) chief ingredient Empagliflozin 25.00 7.23 chief ingredient Sitagliptin 100.00 28.90 diluent Lactose hydrate 150.00 43.35 diluent Microcrystalline cellulose 25.00 7.23 Binder Low substitution high profile cellulose 7.00 2.02 Disintegrant Croscarmellose sodium 18.00 5.20 Lubricant Silicon dioxide 5.00 1.45 Lubricant Sodium stearate 5.00 1.45 Coating Opadry (03B620011) 11.00 3.18 Sum 346.00 100.00
  • Jadiang tablets (Berlinger Ingelheim Korea) tablets containing 25 mg of empagliflozin and Januvia tablets (MSD Korea) tablets containing 100 mg of sitagliptin were purchased.
  • Comparative Example 1 Comparative Example 2 Jadiangjung 25mg (Empagliflozin) Januvia Tablet 100mg (Citagliptin) Boehringer Ingelheim Korea MSD Korea
  • the dissolution rate was measured at 50 rpm in the 4th solution according to the Paddle Method of the Dissolution Test Method 2 of the General Test Methods of the Korean Pharmacopoeia, and the results of measuring the dissolution rate were as follows [Table] 3].
  • Standard solution Approximately 20 mg of the standard product of sitagliptin phosphate is precisely weighed and placed in a 50 mL volumetric flask and marked with the dissolution test solution. Take 9 mL of this solution, put it in a 50 mL volumetric flask, add the dissolution test solution, mark it, and use the standard filtrate as a solution filtered with a 0.45 ⁇ m membrane filter.
  • Test Solution Test with 50 tablets per minute according to the Dissolution Test Method 2 (Paddle Method) of the General Test Methods of the Korean Pharmacopoeia using 1 tablet of dissolution and 900 mL of dissolution test solution. 30 minutes after the start of the dissolution test, 10 mL of the eluate is taken and filtered through a 0.45 ⁇ m membrane filter. Take 5 mL of this solution accurately, put it in a 10 mL volumetric flask, and use the solution selected as the dissolution test solution as the sample solution.
  • Standard solution Accurately weigh about 14 mg of empagliflozin standard, put it in a 250 mL volumetric flask, add 3 mL of methanol to dissolve it, dissolve it, and align the mark with the dissolution test solution. Take 4 mL of this solution accurately, put it in a 20 mL volumetric flask, add the dissolution test solution, mark it, and use the solution filtered with a 0.45 ⁇ m membrane filter as a standard solution.
  • Test Solution Take 900 tablets of dissolution test with 1 tablet of this drug and test at 50 revolutions per minute according to the Dissolution Test Method 2 (Paddle Method) of the General Test Methods of the Korean Pharmacopoeia. 30 minutes after the start of the dissolution test, 10 mL of the eluate is taken and filtered through a 0.45 ⁇ m membrane filter. Take 5 mL of this solution accurately, put it in a 10 mL volumetric flask, and use the solution selected as the dissolution test solution as the sample solution.
  • Dissolution rate of empagliflozin (%) AT/AS ⁇ WS/DS ⁇ DT/L ⁇ P
  • Dissolution test method Korean Pharmacopoeia dissolution test method 2 (paddle method)
  • Example 1 proved to be equivalent to Comparative Examples 1 and 2 through the dissolution test.
  • Example 1 and 2 are equivalent to ⁇ 15% of Comparative Examples 1 and 2 at two time points in which the dissolution rates of Comparative Examples 1 and 2 are around 40% and 85%.
  • Standard solution Precisely weigh approximately 10 mg of the standard product of sitagliptin phosphate monohydrate, put it in a 100 mL volumetric flask, dissolve the solution, sonicate it, dissolve it, and dissolve it, and align the mark with dilution solution Note 4).
  • Test Solution Take 10 tablets of this drug, put it in a 1 L volumetric flask, add diluent Note 4) and stir for 1 hour. Take 8 mL of this solution accurately, place it in a 100 mL volumetric flask, align the mark with diluent Note 4) and filter with a 0.45 ⁇ m membrane filter. This solution is used as the sample solution.
  • the tailing coefficient of the main peak is 2.0 or less when the standard solution is repeatedly injected 6 times, and the relative standard deviation of the peak area is 2.0% or less.
  • Standard solution About 25 mg of empagliflozin standard is precisely weighed, placed in a 50 mL volumetric flask, and diluted 3) and sonicated to dissolve. Align the mark with diluent Note 3), and the solution filtered with a 0.45 ⁇ m membrane filter is used as the standard solution.
  • Test Solution Take 10 tablets of this drug, place it in a 500 mL volumetric flask, add diluent Note 3) and dissolve by ultrasonic treatment. Align the mark with diluent Note 3) and use the solution filtered with a 0.45 ⁇ m membrane filter as the sample solution.
  • the tailing coefficient of the main peak is 2.0 or less when the standard solution is repeatedly injected 6 times, and the relative standard deviation of the peak area is 2.0% or less.
  • Example 1 showed less change in content than the formulations of Comparative Examples 1 and 2, indicating that storage stability was better.
  • Standard solution About 10 mg of sitagliptin phosphate monohydrate standard is precisely weighed, placed in a 100 mL volumetric flask, diluted with ultrasonic solution, dissolved, filtered with a 0.45 ⁇ m membrane filter as a standard solution.
  • Test Solution Take 2 tablets of this drug, put it in a 250 mL volumetric flask, add diluent Note 1) and stir for 1 hour. After marking with dilution solution Note 1), 10 mL of this solution is accurately taken, placed in a 100 mL volumetric flask, and the solution selected with Dilution Note 1) is filtered with a 0.45 ⁇ m membrane filter. This solution is used as the sample solution.
  • the relative standard deviation of the peak area when repeated injection of the standard solution 6 times is 2.0% or less.
  • Amount of analog (%) AT/AS ⁇ WS/DS ⁇ DT/L ⁇ F/RRF ⁇ P/N
  • Standard solution About 25 mg of empagliflozin standard is precisely weighed, placed in a 50 mL volumetric flask, diluted with a diluent and sonicated to dissolve, and the solution aligned with the diluent note 3) is filtered through a 0.45 ⁇ m membrane filter. Let this solution be the standard solution.
  • Test Solution Take 10 tablets of this drug, put it in a 250 mL volumetric flask, add diluent solution 3), dissolve by ultrasonic treatment, and align the mark with diluent solution 3). Take 10 mL of this solution, put it in a 20 mL volumetric flask, and filter the lined solution with diluent Note 3) with a 0.45 ⁇ m membrane filter. This solution is used as the sample solution.
  • Phase A-0.1% phosphoric acid aqueous solution
  • the tailing coefficient of the main peak is 2.0 or less when the standard solution is repeatedly injected 6 times, and the relative standard deviation of the peak area is 2.0% or less.
  • Amount of analog (%) AT/AS ⁇ WS/DS ⁇ DT/L ⁇ P/N ⁇ 1/RRF
  • Example 1 Substance name Relative holding time (RRT) 1 week (%) 2 weeks(%) 3 weeks (%) 4 weeks (%) EGS 0 0 0 0 0 0 TMF One 0 0 0 0 DGF 2 0 0 0 0 MAE impurity 2 0 0 0 0 EAP 3 0 0 0 0 CHA 3 0 0 0 0 DGF-IV 4 0 0 0 0 0 0 Other flexible substances - 0 0 0 0 0 0 0 0 0 0

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Abstract

La présente invention concerne une préparation composite orale comprenant l'empagliflozine et la sitagliptine en tant qu'ingrédients efficaces. Selon la présente invention, la préparation est avantageuse selon des aspects pharmacologiques non seulement parce que les médicaments sont contenus dans une monocouche afin de présenter l'effet d'atténuation instantanée et durable du taux de glucose sanguin, mais aussi parce que la stabilité au stockage et l'uniformité de la teneur des principes actifs sont améliorées.
PCT/KR2019/017680 2018-12-21 2019-12-13 Composition pharmaceutique comprenant l'empagliflozine et la sitagliptine Ceased WO2020130502A1 (fr)

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CN114699378A (zh) * 2022-04-07 2022-07-05 北京福元医药股份有限公司 一种磷酸西格列汀药物制剂及制备方法
WO2023062648A1 (fr) * 2021-10-12 2023-04-20 Unison Pharmaceuticals Pvt. Ltd. Composition pharmaceutique comprenant une association de sitagliptine et d'empagliflozine
EP4442253A1 (fr) * 2023-04-04 2024-10-09 Sanovel Ilac Sanayi Ve Ticaret A.S. Comprimé enrobé d'un film comprenant de l'empagliflozine et un tensioactif
EP4442254A1 (fr) * 2023-04-04 2024-10-09 Sanovel Ilac Sanayi Ve Ticaret A.S. Comprimés enrobés d'un film comprenant de l'empagliflozine
EP4497434A1 (fr) * 2023-07-26 2025-01-29 Sanovel Ilac Sanayi ve Ticaret A.S. Formulation de comprimé pelliculé comprenant de l'empagliflozine

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KR102924036B1 (ko) * 2023-01-31 2026-02-09 주식회사 종근당 로베글리타존 및 시타글립틴을 포함하는 약제학적 복합제제
KR20250152341A (ko) * 2024-04-16 2025-10-23 주식회사 종근당 시타글립틴과 엠파글리플로진을 포함하는 약제학적 복합제제 및 이의 제조방법

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Cited By (6)

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Publication number Priority date Publication date Assignee Title
WO2023062648A1 (fr) * 2021-10-12 2023-04-20 Unison Pharmaceuticals Pvt. Ltd. Composition pharmaceutique comprenant une association de sitagliptine et d'empagliflozine
CN114699378A (zh) * 2022-04-07 2022-07-05 北京福元医药股份有限公司 一种磷酸西格列汀药物制剂及制备方法
CN114699378B (zh) * 2022-04-07 2023-09-26 北京福元医药股份有限公司 一种磷酸西格列汀药物制剂及制备方法
EP4442253A1 (fr) * 2023-04-04 2024-10-09 Sanovel Ilac Sanayi Ve Ticaret A.S. Comprimé enrobé d'un film comprenant de l'empagliflozine et un tensioactif
EP4442254A1 (fr) * 2023-04-04 2024-10-09 Sanovel Ilac Sanayi Ve Ticaret A.S. Comprimés enrobés d'un film comprenant de l'empagliflozine
EP4497434A1 (fr) * 2023-07-26 2025-01-29 Sanovel Ilac Sanayi ve Ticaret A.S. Formulation de comprimé pelliculé comprenant de l'empagliflozine

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