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EP4031122A1 - Formulations de comprimés effervescents comprenant de la dapagliflozine et de la metformine - Google Patents

Formulations de comprimés effervescents comprenant de la dapagliflozine et de la metformine

Info

Publication number
EP4031122A1
EP4031122A1 EP20866500.0A EP20866500A EP4031122A1 EP 4031122 A1 EP4031122 A1 EP 4031122A1 EP 20866500 A EP20866500 A EP 20866500A EP 4031122 A1 EP4031122 A1 EP 4031122A1
Authority
EP
European Patent Office
Prior art keywords
weight
effervescent tablet
composition according
sodium
acid
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.)
Pending
Application number
EP20866500.0A
Other languages
German (de)
English (en)
Other versions
EP4031122A4 (fr
Inventor
Abdullah TASKIN
Yavuz Dedeoglu
Muge ULUSOY BOZYEL
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.)
Sanovel Ilac Sanayi ve Ticaret AS
Original Assignee
Sanovel Ilac Sanayi ve Ticaret AS
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 Sanovel Ilac Sanayi ve Ticaret AS filed Critical Sanovel Ilac Sanayi ve Ticaret AS
Publication of EP4031122A1 publication Critical patent/EP4031122A1/fr
Publication of EP4031122A4 publication Critical patent/EP4031122A4/fr
Pending 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
    • A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
    • A61K9/0007—Effervescent
    • 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
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • 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
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers

Definitions

  • the invention relates to formulations comprising dapagliflozin or a pharmaceutically acceptable salt thereof combined with metformin or a pharmaceutically acceptable salt thereof. More particularly, the present invention relates to the effervescent formulation of dapagliflozin and metformin with the desired properties.
  • Diabetes mellitus is a lifelong chronic disease resulting from the pancreas's inability to produce enough insulin or the body's ability to use insulin effectively and it continues with the reduction of insulin-producing cells. Blood glucose rises with absent or non-functioning insulin hormone. The resulting high blood sugar causes classical symptoms such as polyuria (frequent urination), polydipsia (increased thirst) and polyphagia (increased hunger).
  • type 1 diabetes type 1
  • type 2 diabetes type 2 diabetes
  • gestational diabetes is seen in pregnant women who develop high blood sugar levels.
  • Type 1 diabetes is caused by the body's inability to produce insulin, requiring insulin injection.
  • type 2 diabetes the body either resists the effects of insulin or does not produce enough insulin to maintain a normal glucose level.
  • type 2 diabetes is the most common type, affecting more than 171 million people worldwide.
  • Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor (SGLT2).
  • SGLT2 is a carrier responsible for the reabsorption of most of the glucose from the lumen of the renal tubule.
  • SGLT2 is expressed in proximal renal tubules.
  • dapagliflozin reduces the reabsorption of the filtered glucose and lowers the renal threshold for glucose. This improves urinary glucose excretion and blood glucose control.
  • Dapagliflozin also known as (1S)-1 ,5-Anhydro-1-C-[4-chloro-3-[(4- ethoxyphenyl)methyl]phenyl]-D-glucitol or (2S,3R,4R,5S,6R)-2-(3-(4-etoxybenzyl)-4- chlorophenyl)-6-hydroxymethyltetrahydro-2FI-pyran-3,4,5-triol is represented by the structure of Formula I.
  • Dapagliflozin was first disclosed in patent US 6515117 (2003, Bristol-Myers Squibb).
  • Metformin is an antihyperglycemic agent that improves glucose tolerance and lowers both basal and postprandial plasma glucose levels by different mechanisms than other oral antidiabetic agents. Metformin decreases hepatic gluconeogenesis, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. With metformin therapy, insulin secretion remains unchanged while fasting insulin levels and day-long plasma insulin response may actually decrease.
  • Metformin also known as N, N- dimethylimidodicarbonimidic diamide or 1 ,1 -Dimethylbiguanide or N, N- dimethyldiguanide or N, N-Dimethylguanylguanidine, is represented by the chemical structure in Formula II.
  • EP2498758B1 discloses bilayer tablets comprising metformin and dapagliflozin.
  • EP2498759B1 discloses a process for the preparation of an immediate release formulation comprising a combination of dapagliflozin and metformin.
  • WO 2017/098481 discloses an effervescent combination comprising metformin with retained carbon dioxide content of at least 90% of the input blend and a different antidiabetic agent.
  • Unexamined patent TR2012/02948 discloses a tablet form comprising a combination of metformin hydrochloride and dapagliflozin and a core tablet coated with a coating solution containing extended release metformin and dapagliflozin.
  • the main object of effervescent tablet formulations comprising dapagliflozin or a pharmaceutically acceptable salt thereof with metformin or a pharmaceutically acceptable salt thereof is to obtain a stable formulation with good flowability and that does not adhere to the manufacturing apparatus. Another object is to obtain an effervescent formulation that is well dispersed and dissolved in water, thereby having high bioavailability. Effervescent tablet formulations with good solubility provide a homogeneous mixture, which increases patient compliance.
  • effervescent tablet formulations are becoming an increasingly important issue in patient compliance, compared to traditional solid dosage forms such as capsules and tablets for oral administration. Compliance is even more important, especially in patients having difficulty in swallowing.
  • effervescent tablet formulations are one of the advantageous ways of delivering drugs comprising dapagliflozin and metformin, providing better patient compliance along with the recommended pharmaceutical treatments. It is known that it is difficult to develop effervescent tablet formulations for several different reasons. First, it can cause non-compliance problems if it leaves an unpleasant and bitter taste when dispersed in water. Moreover, these tablets should be very porous and not too hard.
  • Effervescent tablets should ensure rapid dissolution of the drug to provide a neutral, clear solution with a pleasant taste, without leaving any residues or precipitates behind. Therefore, there is a need for the development of an effervescent formulation that has a desired dissolution time and a desired solubility without leaving any residues and precipitates after dissolution and has an acceptable taste for patients. Dissolution problems of the drug and formulation, unpleasant and bitter taste arising from water dissolution are problems that need to be overcome. Finally, any effervescent tablet with appropriate organoleptic and pharmacokinetic properties should also be produced in commercially appropriate quantities and yields and simpler methods. When evaluated within the framework of the mentioned problem, it is clear that an innovation in the art is needed for effervescent formulations comprising dapagliflozin and metformin.
  • the object of the present invention is to provide an improved effervescent tablet formulation comprising dapagliflozin or a pharmaceutically acceptable salt thereof combined with metformin or a pharmaceutically acceptable salt thereof that overcomes the above mentioned problems and beneficial in the treatment of type 2 diabetes using suitable excipients.
  • the object of the present invention is to overcome the above-mentioned problems related to effervescent formulations such as obtaining the desired solubility of the drug or formulation without leaving any residues or precipitates after dissolution and providing a better flavor for patients, by using suitable excipients together and in specific proportions.
  • Another aim of the present invention is to increase flowability during manufacture and to eliminate the problem of adhesion to the manufacturing apparatus thanks to the formulation obtained.
  • another object is to provide effervescent tablet formulations that is water-soluble and remain stable throughout their shelf life.
  • Main difficulties when two or more molecules are combined in the same pharmaceutical dosage form are a) ensuring compatibility between different active substances and / or excipients used with active substances, (b) ensuring therapeutic compatibility between the active ingredients, taking into account the pharmacokinetic and / or biopharmaceutical properties, such as the posology of the combination, to obtain effective and safe plasma levels of both active ingredients. Therefore, the selection of the active ingredients and suitable excipients to be used together and the amounts at which they are used are very important.
  • a pharmaceutical formulation comprising a combination of dapagliflozin or a pharmaceutically acceptable salt thereof and metformin or a pharmaceutically acceptable salt thereof.
  • the effervescent tablet formulation comprising dapagliflozin and metformin that is stable and has very good dissolution and solubility rate, thereby high bioavailability is obtained by the present invention.
  • the present invention is an effervescent tablet formulation comprising dapagliflozin or a pharmaceutically acceptable salt thereof and metformin or a pharmaceutically acceptable salt thereof.
  • dapagliflozin or a pharmaceutically acceptable salt thereof being present in the ratio of 0,001 to 5%, preferably 0,01 to 1%, and more preferably 0,05 to 0,2% by weight of the total formulation and metformin or a pharmaceutically acceptable salt thereof being present in the ratio of 1 to 50%, preferably 5 to 30%, and more preferably 10 to 20% by weight of the total formulation has enabled both active substances to reach an effective and safe plasma level, ensured therapeutic compatibility between the active ingredients and compatibility between active ingredients and excipients.
  • Pharmaceutical formulations of the present invention may also comprise one or more pharmaceutically acceptable excipients.
  • Pharmaceutically acceptable excipients include, but are not limited to fillers, alkali agents, acidic agents, sweeteners, aromatic agents, disintegrants, lubricants, or mixtures thereof.
  • the amount of filler in the formulation according to the invention is 1 to 80%, preferably 3 to 70%, more preferably 5 to 60% by weight in the total composition.
  • the filler is sugars, mannitol, sorbitol, sucrose, inorganic salts, calcium salts, polysaccharides, dextrose, dicalcium phosphate, sodium chloride, dextrates, lactitol, maltodextrin, sucrose-maltodextrin mixtures, xylitol, trehalose or mixtures thereof.
  • mannitol is used in the invention.
  • the use of the total active ingredient to the filler at the ratio of 0,01 to 30, preferably 0,015 to 20, more preferably 0,05 to 10, and most preferably 0,1 to 5 allowed a more stable effervescent tablet formulation of dapagliflozin and metformin.
  • metformin active ingredient with low compressibility rate to the filler in the ratio of 0,01 - 30, preferably 0,05 - 20, more preferably 0,07 - 10 and most preferably 0,16 - 4 allowed a more stable effervescent tablet formulation of dapagliflozin and metformin.
  • effervescent formulations comprise acidic agents and alkali agents that react quickly in the presence of water by releasing carbon dioxide such as carbonates or bicarbonates.
  • the choice of acidic-alkali agent and their ratio to each other is important in terms of stability, disintegration time and water solubility.
  • the ratio of the acidic agent to the alkaline agent should be carefully determined to obtain a neutral solution that doesn’t leave any residues or precipitates after dissolution.
  • the high amount of acidic agent can adversely affect the gastrointestinal tract.
  • high amounts of alkaline agents (especially hydrophobic agents) lead to blurry and precipitated solution and damage the gastrointestinal tract.
  • the amount of alkali agent in the formulation of the invention is 0,5 to 60%, preferably 1 to 50%, more preferably 2 to 40% by weight in the total composition.
  • alkali agent is selected from sodium bicarbonate, sodium glycine carbonate, ammonia solution, ammonium carbonate, diethanolamine, diisopropanolamine, potassium hydroxide, sodium borate, sodium carbonate, sodium hydroxide, trolamine or mixtures thereof.
  • sodium bicarbonate is used in the invention.
  • the amount of acidic agent in the formulation of the invention is between 0,5 and 60% by weight, preferably between 1 and 50%, more preferably between 2 and 40% by weight in the total composition
  • the acidic agent is selected from the group comprising malic acid, fumaric acid, citric acid, adipic acid, acetic acid, hydrochloric acid, nitric acid, phosphoric acid, sulfuric acid, tartaric acid or mixtures thereof.
  • citric acid is used in the invention.
  • the amount of sweetener in the formulation of the invention is in the ratio of 0,01 to 30%, preferably 0,05 to 20%, more preferably 0,1 to 10% by weight of the total composition.
  • sweeteners comprise, but are not limited to, saccharin sodium, aspartame, sucralose, glucose, lactose, fructose and other sugars, or taumatin, mogroside, inulin, mannitol, sorbitol, xylitol, erythritol and other sugar alcohols or mixtures thereof.
  • sucralose is used in the invention.
  • the amount of the aroma in the formulation of the invention is in the ratio of 0,01 to 30%, preferably 0,05 to 20%, more preferably 0,1 to 10% by weight of the total composition.
  • aromatic agents of the invention comprise, but are not limited to, fruit flavors such as orange, banana, strawberry, cherry, bird cherry, lemon, and other flavors such as cardamom, anise, peppermint, menthol, vanillin and ethyl vanillin, and mixtures thereof.
  • disintegrant is selected from alginic acid and alginates, ion-exchange resins, magnesium aluminum silica, sodium dodecyl sulfate, sodium carboxymethyl cellulose, croscarmellose sodium, crospovidone, carboxymethyl cellulose calcium, doucat sodium, guar gum, low substitute hydroxypropyl cellulose, polyacrylene potassium, poloxamer, povidone, sodium alginate, sodium glycine carbonate, sodium lauryl sulfate or mixtures thereof.
  • crospovidone is used in the invention.
  • crospovidone as a disintegrant in the ratio of 0,1% to 15%, preferably 1% to 8%, more preferably 2% to 4% by weight in the total composition allowed for a formulation with the desired water solubility time and improved patient compliance.
  • the ratio of the active ingredient dapagliflozin with low solubility to the disintegrant in the range of 0,001 - 5, preferably 0,00125 - 1 , more preferably 0,01 - 0,5, more preferably 0,0125 - 0,1 by weight in the formulation allowed for an effervescent tablet formulation of dapagliflozin and metformin with very good dissolution and solubility ratio, thereby high bioavailability, forming a neutral and clear solution that doesn’t leave any residues or precipitates after dissolution.
  • Polyethylene glycol is a water-soluble lubricant and is stable. Polyethylene glycol also does not cause over-mixing problems and is not hygroscopic. Since it is not hygroscopic, it does not harm the manufacture apparatus. Furthermore, polyethylene glycol can perform more than one function in the formulation of the present invention. For example, it can function both as a lubricant and as a stabilizer. This helps the formulation to remain stable throughout its shelf life.
  • PEG 6000 is used in the invention.
  • the amount of lubricant is 0,1 to 30%, preferably 0,5 to 15%, more preferably 1 to 5% by weight in the total composition.
  • Another embodiment of the present invention is a method for the preparation of effervescent tablet formulation, comprising the following steps; a. Granulating, drying and sieving dapagliflozin, metformin and mannitol using alcohol b. Mixing the granules with sodium bicarbonate, citric acid, sucralose, aroma and crospovidone to obtain homogeneity c. Adding PEG 6000 and mixing further for a short period of time to obtain a homogeneous mixture. d. Finalising the mixture and pressing into the tablets under low humidity conditions adimlarini igermektedir.
  • the above-mentioned pharmaceutical formulation is prepared as follows:
  • the above-mentioned pharmaceutical formulation is prepared as follows:
  • the above-mentioned pharmaceutical formulation is prepared as follows:
  • this invention provides an effervescent tablet formulation of dapagliflozin and metformin that is stable and has very good dissolution and solubility ratio, thereby high bioavailability, that does not stick to the manufacture apparatus during production, creates a stable, neutral and clear solution against moisture, does not leave any residues or precipitates after dissolution and provides a delicious taste, does not leave an unpleasant and bitter taste.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Diabetes (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Molecular Biology (AREA)
  • Emergency Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne des formulations de comprimés effervescents comprenant de la dapagliflozine ou un sel pharmaceutiquement acceptable de celle-ci et de la metformine ou un sel pharmaceutiquement acceptable de celle-ci.
EP20866500.0A 2019-09-16 2020-08-05 Formulations de comprimés effervescents comprenant de la dapagliflozine et de la metformine Pending EP4031122A4 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
TR2019/14043A TR201914043A1 (tr) 2019-09-16 2019-09-16 Dapagli̇flozi̇n ve metformi̇n i̇çeren efervesan tablet formülasyonlari
PCT/TR2020/050687 WO2021054912A1 (fr) 2019-09-16 2020-08-05 Formulations de comprimés effervescents comprenant de la dapagliflozine et de la metformine

Publications (2)

Publication Number Publication Date
EP4031122A1 true EP4031122A1 (fr) 2022-07-27
EP4031122A4 EP4031122A4 (fr) 2023-08-30

Family

ID=74883168

Family Applications (1)

Application Number Title Priority Date Filing Date
EP20866500.0A Pending EP4031122A4 (fr) 2019-09-16 2020-08-05 Formulations de comprimés effervescents comprenant de la dapagliflozine et de la metformine

Country Status (3)

Country Link
EP (1) EP4031122A4 (fr)
TR (1) TR201914043A1 (fr)
WO (1) WO2021054912A1 (fr)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2599950A (en) * 2020-10-16 2022-04-20 Zentiva Ks Pharmaceutical compositions with low amounts of nitrosamine impurities and methods for producing the same
EP4079296A1 (fr) * 2021-04-21 2022-10-26 Sanovel Ilac Sanayi Ve Ticaret A.S. Formulation de comprimé bicouche comprenant de la dapagliflozine amorphe et de la metformine
CN118078745B (zh) * 2024-04-07 2025-01-24 安徽新世纪药业有限公司 一种盐酸二甲双胍口服溶液的制备方法

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1945190A1 (fr) * 2005-09-22 2008-07-23 Swissco Devcelopment AG Composition effervescente de metformine et comprimés et granules fabriqués à partir de cette composition
EP2498758B1 (fr) * 2009-11-13 2018-07-25 AstraZeneca AB Formulations de comprimé bicouche
EP2809311A1 (fr) * 2012-01-31 2014-12-10 Mahmut Bilgic Formulations de comprimés effervescents contenant la combinaison voglibose et metformine
US11219594B2 (en) * 2015-12-12 2022-01-11 Steerlife India Private Limited Effervescent compositions of metformin and processes for preparation thereof
WO2018185669A1 (fr) * 2017-04-07 2018-10-11 Zenvision Pharma Llp Compositions effervescentes comprenant de la saxagliptine ou un sel de celle-ci

Also Published As

Publication number Publication date
TR201914043A1 (tr) 2021-04-21
WO2021054912A1 (fr) 2021-03-25
EP4031122A4 (fr) 2023-08-30

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