EP4125824A1 - Beutelformulierung mit metformin und dapagliflozin - Google Patents
Beutelformulierung mit metformin und dapagliflozinInfo
- Publication number
- EP4125824A1 EP4125824A1 EP21776477.8A EP21776477A EP4125824A1 EP 4125824 A1 EP4125824 A1 EP 4125824A1 EP 21776477 A EP21776477 A EP 21776477A EP 4125824 A1 EP4125824 A1 EP 4125824A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- weight
- metformin
- sodium
- sachet
- dapagliflozin
- 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
Links
- 239000000203 mixture Substances 0.000 title claims abstract description 63
- 238000009472 formulation Methods 0.000 title claims abstract description 46
- 229940036941 metformin and dapagliflozin Drugs 0.000 title description 9
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 claims abstract description 27
- 229960003105 metformin Drugs 0.000 claims abstract description 23
- JVHXJTBJCFBINQ-ADAARDCZSA-N Dapagliflozin Chemical compound C1=CC(OCC)=CC=C1CC1=CC([C@H]2[C@@H]([C@@H](O)[C@H](O)[C@@H](CO)O2)O)=CC=C1Cl JVHXJTBJCFBINQ-ADAARDCZSA-N 0.000 claims abstract description 19
- 229960003834 dapagliflozin Drugs 0.000 claims abstract description 18
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 7
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 claims description 18
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- 235000019568 aromas Nutrition 0.000 claims description 8
- 239000000945 filler Substances 0.000 claims description 8
- 239000000796 flavoring agent Substances 0.000 claims description 7
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 6
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- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 5
- 235000000346 sugar Nutrition 0.000 claims description 5
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 4
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 claims description 4
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- CDBYLPFSWZWCQE-UHFFFAOYSA-L Sodium Carbonate Chemical compound [Na+].[Na+].[O-]C([O-])=O CDBYLPFSWZWCQE-UHFFFAOYSA-L 0.000 claims description 4
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- CBOQJANXLMLOSS-UHFFFAOYSA-N ethyl vanillin Chemical compound CCOC1=CC(C=O)=CC=C1O CBOQJANXLMLOSS-UHFFFAOYSA-N 0.000 claims description 4
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- 206010012601 diabetes mellitus Diseases 0.000 description 6
- 239000002775 capsule Substances 0.000 description 4
- 239000008103 glucose Substances 0.000 description 4
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 239000003814 drug Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000008187 granular material Substances 0.000 description 3
- OETHQSJEHLVLGH-UHFFFAOYSA-N metformin hydrochloride Chemical compound Cl.CN(C)C(=N)N=C(N)N OETHQSJEHLVLGH-UHFFFAOYSA-N 0.000 description 3
- 229960004329 metformin hydrochloride Drugs 0.000 description 3
- 210000000496 pancreas Anatomy 0.000 description 3
- 239000002245 particle Substances 0.000 description 3
- 208000001072 type 2 diabetes mellitus Diseases 0.000 description 3
- HBAQYPYDRFILMT-UHFFFAOYSA-N 8-[3-(1-cyclopropylpyrazol-4-yl)-1H-pyrazolo[4,3-d]pyrimidin-5-yl]-3-methyl-3,8-diazabicyclo[3.2.1]octan-2-one Chemical class C1(CC1)N1N=CC(=C1)C1=NNC2=C1N=C(N=C2)N1C2C(N(CC1CC2)C)=O HBAQYPYDRFILMT-UHFFFAOYSA-N 0.000 description 2
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- 229940123518 Sodium/glucose cotransporter 2 inhibitor Drugs 0.000 description 2
- 230000002411 adverse Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 210000004027 cell Anatomy 0.000 description 2
- 229940079593 drug Drugs 0.000 description 2
- 238000012395 formulation development Methods 0.000 description 2
- 150000004677 hydrates Chemical class 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 238000002360 preparation method Methods 0.000 description 2
- 239000000651 prodrug Substances 0.000 description 2
- 229940002612 prodrug Drugs 0.000 description 2
- 239000012453 solvate Substances 0.000 description 2
- 238000010561 standard procedure Methods 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 238000002560 therapeutic procedure Methods 0.000 description 2
- 238000005550 wet granulation Methods 0.000 description 2
- 229940077274 Alpha glucosidase inhibitor Drugs 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 206010028813 Nausea Diseases 0.000 description 1
- 102100020888 Sodium/glucose cotransporter 2 Human genes 0.000 description 1
- 229940100389 Sulfonylurea Drugs 0.000 description 1
- 239000003888 alpha glucosidase inhibitor Substances 0.000 description 1
- 230000003178 anti-diabetic effect Effects 0.000 description 1
- 210000000227 basophil cell of anterior lobe of hypophysis Anatomy 0.000 description 1
- 150000004283 biguanides Chemical group 0.000 description 1
- XAAHAAMILDNBPS-UHFFFAOYSA-L calcium hydrogenphosphate dihydrate Chemical compound O.O.[Ca+2].OP([O-])([O-])=O XAAHAAMILDNBPS-UHFFFAOYSA-L 0.000 description 1
- 239000007963 capsule composition Substances 0.000 description 1
- 230000023852 carbohydrate metabolic process Effects 0.000 description 1
- 235000021256 carbohydrate metabolism Nutrition 0.000 description 1
- 238000005056 compaction Methods 0.000 description 1
- 238000007906 compression Methods 0.000 description 1
- 230000006835 compression Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000037213 diet Effects 0.000 description 1
- 230000003292 diminished effect Effects 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 238000001125 extrusion Methods 0.000 description 1
- 239000012458 free base Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 230000010030 glucose lowering effect Effects 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 208000035474 group of disease Diseases 0.000 description 1
- 239000008240 homogeneous mixture Substances 0.000 description 1
- 238000009474 hot melt extrusion Methods 0.000 description 1
- 239000012943 hotmelt Substances 0.000 description 1
- 239000012729 immediate-release (IR) formulation Substances 0.000 description 1
- 210000003734 kidney Anatomy 0.000 description 1
- 238000002483 medication Methods 0.000 description 1
- 238000007909 melt granulation Methods 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 230000008693 nausea Effects 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 230000000704 physical effect Effects 0.000 description 1
- QMYDVDBERNLWKB-UHFFFAOYSA-N propane-1,2-diol;hydrate Chemical compound O.CC(O)CO QMYDVDBERNLWKB-UHFFFAOYSA-N 0.000 description 1
- 230000009103 reabsorption Effects 0.000 description 1
- 230000028327 secretion Effects 0.000 description 1
- 238000007493 shaping process Methods 0.000 description 1
- 238000009491 slugging Methods 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 239000007909 solid dosage form Substances 0.000 description 1
- 238000000935 solvent evaporation Methods 0.000 description 1
- 238000005563 spheronization Methods 0.000 description 1
- 238000001694 spray drying Methods 0.000 description 1
- 229960004793 sucrose Drugs 0.000 description 1
- 230000009747 swallowing Effects 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 1
- 210000002700 urine Anatomy 0.000 description 1
- 230000037221 weight management Effects 0.000 description 1
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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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
- 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
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
Definitions
- the present invention relates to a sachet formulation comprising metformin, dapagliflozin and at least one pharmaceutically acceptable excipient.
- Diabetes mellitus is a group of disorders of carbohydrate metabolism in which the action of insulin is diminished or absent through altered secretion, decreased insulin activity or a combination of both factors.
- Type 1 and Type 2 There are two main types of diabetes; Type 1 and Type 2:
- Type 1 diabetes occurs because the insulin-producing cells of the pancreas (beta cells) are damaged. In Type 1 diabetes, the pancreas makes little or no insulin, so sugar cannot get into the body's cells for use as energy. People with Type 1 diabetes must use insulin injections to control their blood glucose.
- Type 2 diabetes the pancreas makes insulin, but it either doesn't produce enough, or the insulin does not work properly. This diabetes occurs most often in people who are over 40 years old and overweight. Type 2 diabetes may sometimes be controlled with a combination of diet, weight management, and exercise. However, treatment also may include oral glucose-lowering medications or insulin injections.
- Dapagliflozin is a sodium-glucose cotransporter 2 inhibitor (SGLT2) indicated in the treatment of diabetes mellitus, in particular type 2 diabetes. It prevents reabsorption of at least 90% of the glucose in the kidney and facilitates elimination of the glucose through the urine.
- SGLT2 sodium-glucose cotransporter 2 inhibitor
- Dapagliflozin also known as (1 S)-1 ,5-Anhydro-1 -C-[4-chloro-3-[(4-ethoxyphenyl)methyl] phenyl]-D-glucitol, is represented by the structure of Formula I.
- Metformin is antidiabetics having an orally-administrated biguanide structure. Oral doses of metformin are generally recommended in the range of 500 to 2500 mg a day and a single dose may vary from 250 to 1000 mg. It is used singly or in combination with sulfonylureas, alpha-glucosidase inhibitors, or insulin.
- metformin is 1 ,1 -dimethyl biguanide, has the following chemical structure of Formula II.
- metformin Although metformin is effective at lowering blood glucose levels, its use is associated with gastrointestinal (Gl) adverse effects, particularly diarrhea and nausea. These adverse effects may limit the tolerated dose of metformin and cause patients to discontinue the therapy.
- Gl gastrointestinal
- IN2012DN4094A application discloses an immediate release pharmaceutical formulation which includes a tablet or capsule formulation comprising metformin and the dapagliflozin or its propylene glycol hydrate.
- CN109528706A application discloses a medicine composition for treatment of diabetes, which includes dapagliflozin and metformin hydrochloride according to mass ratio of 1 :50 to 1 :200.
- a medicine composition for treatment of diabetes which includes dapagliflozin and metformin hydrochloride according to mass ratio of 1 :50 to 1 :200.
- the method by control the amount of both the metformin hydrochloride amount and the dapagliflozin, mixing uniformity of the two active components is guaranteed, and flowability and tabletability of the particles are ensured.
- Tablet and capsule forms comprising metformin and dapagliflozin are known in the prior art. But, the compressibility of metformin is poor, and how to obtain a tablet or a capsule having an acceptable mechanical strength is an important problem in formulation development.
- the formulation is present in the form of a sachet, also the formulation provides desired dissolution profile.
- the formulation has been developed by using standard techniques which is simple and cost-effective method.
- the main object of the present invention is to provide a sachet formulation comprising metformin, dapagliflozin and at least one pharmaceutically acceptable excipient.
- Another object of the present invention is to provide pharmacotechnical properties such as flowability and homogeneity and the desired dissolution profile.
- Another object of the present invention is to provide a sachet formulation comprising metformin and dapagliflozin for increasing patient compliance.
- metalformin refers to not only metformin, but also its other pharmaceutically acceptable salt, pharmaceutically acceptable solvates, pharmaceutically acceptable hydrates, pharmaceutically acceptable enantiomers, pharmaceutically acceptable derivatives, pharmaceutically acceptable polymorphs or pharmaceutically acceptable prodrugs thereof.
- metformin can present in the invention as metformin free base or metformin hydrochloride.
- dapagliflozin refers to not only dapagliflozin, but also its other pharmaceutically acceptable salt, pharmaceutically acceptable solvates, pharmaceutically acceptable hydrates, pharmaceutically acceptable enantiomers, pharmaceutically acceptable derivatives, pharmaceutically acceptable polymorphs or pharmaceutically acceptable prodrugs thereof.
- sachet formulations have become an issue with increasing importance in terms of patient compliance as compared to conventional solid dosage forms such as capsules and tablets. This issue is more important in terms of patients having difficulty in swallowing.
- sachet formulations are one of the advantageous routes for administering the drugs comprising metformin and dapagliflozin and provide a higher patient compliance along with recommended pharmaceutical therapies.
- the term “sachet” will refer to an envelope or bag for a granulate, while “granulate” refers to particles, granulate or spheronised particles.
- the sachets require no special shaping or molding operations. Thus, the compaction, compression or tamping steps used with other dosage forms are not needed.
- a sachet formulation comprises metformin, dapagliflozin and at least one pharmaceutically acceptable excipient.
- the amount of metformin is 10.0% to 20.0% by weight of the total formulation.
- the amount of dapagliflozin is 0.05% to 5.0% or 0.05% to 2.0% or 0.05% to 1.0% by weight of the total formulation.
- At least one pharmaceutically acceptable excipient is selected from the group comprising fillers, pH adjusters, flavouring agent, aromas or mixtures.
- Suitable fillers are selected from the group comprising mannitol, microcrystalline cellulose, sorbitol, sucrose, inorganic salts, calcium salts, spray-dried lactose, calcium silicate, polysaccharides, dextrose, sodium chloride, dextrates, lactitol, sugar pellet, lactose monohydrate, starch, maltodextrin, dibasic calcium phosphate, sucrose-maltodextrin mixtures, xylitol, trehalose, heavy magnesium carbonate, isomalt or mixtures thereof.
- the amount of the fillers is 5.0% to 60.0% by weight of the total formulation.
- the amount of the fillers is 8.0% to 50.0% or 10.0% to 40.0% or 12.0% to 35.0% by weight of the total formulation.
- the filler is mannitol.
- Suitable pH adjusters are selected from the group comprising citric acid, sodium bicarbonate, aluminum potassium sulfate, anhydrous disodium hydrogen phosphate, potassium carbonate, anhydrous sodium dihydrogen phosphate, dibasic potassium sulfate, calcium carbonate, nicotinic acid, dilute hydrochloric acid, glacial acetic acid, lactic acid, maleic acid, monobasic potassium phosphate, phosphoric acid, adipic acid, sodium acetate, sodium carbonate, sodium citrate, sodium dihydrogen phosphate dihydrate, tartaric acid, tribasic sodium phosphate or mixtures thereof.
- the amount of the pH adjusters is 4.0% to 80.0% by weight of the total formulation.
- the amount of the pH adjusters is 5.0% to 70.0% or 5.0% to 60.0% or 5.0% to 50.0% or 5.0% to 40.0% or 5.0% to 30.0% or 5.0% to 20.0% or 5.0% to 10.0% by weight of the total formulation.
- the pH adjuster is citric acid or sodium bicarbonate or mixtures thereof.
- Suitable flavourings are selected from the group comprising sucralose, sugar alcohols, sugars, liquid glucose, sucrose, saccharine sodium, xylitol, sorbitol, erythritol or mixtures thereof.
- the amount of the flavourings is 0.1% to 10.0% by weight of the total formulation.
- the amount of the flavourings is 0.1% to 5.0% or 1 .0% to 3.0% by weight of the total formulation.
- the flavouring is sucralose.
- Suitable aromas are selected from the group comprising menthol, peppermint, cinnamon, chocolate, vanillin, fruit essences, cherry, orange, strawberry, grape, black currant, raspberry, banana, red fruits, wild berries, cardamom, anise, ethyl vanillin or mixtures thereof.
- the amount of the aromas is 0.1% to 10.0% by weight of the total formulation.
- the amount of the aromas is 0.1% to 5.0% or 1.0% to 3.0% by weight of the total formulation.
- flavourings or aromas are used in the formulation, it is observed that the use of the formulation for the patient is very easy.
- the pharmaceutical composition of the present invention may be prepared, using standard techniques and manufacturing processes well known in the art, such as direct compression, wet or dry granulation, hot melt granulation, hot melt extrusion, fluidized bed granulation, extrusion/spheronization, slugging, spray drying and solvent evaporation.
- the sachet formulation is obtained by using a wet granulation method therefore, a simple and low-cost production method was employed.
- the sachet formulation can be used for treatment on the diabetes type II.
- Example 1 The sachet formulation comprising metformin and dapagliflozin
- the sachet content is adjusted so that the sachet weight is 4-5 grams.
- Process for example 1 The process for the preparation of the sachet formulation comprises the following steps: a) Granulating dapagliflozin, metformin and at least one filler with alcohol or alcohol/water, b) Then, drying and sieving, c) Then, adding pH adjusters, at least one flavouring and aromas and mixing, d) Filling the mixture into sachets under low humidity conditions.
- Example 2 The sachet formulation comprising metformin and dapagliflozin
- the sachet content is adjusted so that the sachet weight is 4-5 grams.
- Process for example 2 The process for the preparation of the sachet formulation comprises the following steps: a) Granulating dapagliflozin, metformin and mannitol with alcohol or alcohol/water, b) Then, drying and sieving, c) Then, adding sodium bicarbonate, citric acid, sucralose, aroma and mixing, d) Filling the mixture into sachets under low humidity conditions.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Molecular Biology (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)
- Biophysics (AREA)
- Emergency Medicine (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| TR2020/04809A TR202004809A2 (tr) | 2020-03-27 | 2020-03-27 | Metformi̇n ve dapagli̇flozi̇n i̇çeren bi̇r saşe formülasyonu |
| PCT/TR2021/050029 WO2021194446A1 (en) | 2020-03-27 | 2021-01-15 | A sachet formulation comprising metformin and dapagliflozin |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| EP4125824A1 true EP4125824A1 (de) | 2023-02-08 |
| EP4125824A4 EP4125824A4 (de) | 2023-12-27 |
Family
ID=77892783
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP21776477.8A Pending EP4125824A4 (de) | 2020-03-27 | 2021-01-15 | Beutelformulierung mit metformin und dapagliflozin |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP4125824A4 (de) |
| TR (1) | TR202004809A2 (de) |
| WO (1) | WO2021194446A1 (de) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4427742A1 (de) * | 2023-03-06 | 2024-09-11 | Galenicum Health S.L.U. | Pharmazeutische zusammensetzungen mit dapagliflozin und metformin |
Family Cites Families (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE10360924A1 (de) * | 2003-12-23 | 2005-07-28 | IIP - Institut für industrielle Pharmazie, Forschungs- und Entwicklungsgesellschaft mbH | Metformin-haltige pharmazeutische Zusammensetzung |
| JP5784623B2 (ja) * | 2009-11-13 | 2015-09-24 | アストラゼネカ・アクチエボラーグＡｓｔｒａｚｅｎｅｃａ Ａｋｔｉｅｂｏｌａｇ | 速放性錠剤製剤 |
| WO2013077822A1 (en) * | 2011-11-23 | 2013-05-30 | Mahmut Bilgic | New formulations for treatment of diabetes |
| WO2013077825A1 (en) * | 2011-11-23 | 2013-05-30 | Mahmut Bilgic | Preparation process for a formulation comprising metformin |
| CN103462900A (zh) * | 2013-09-02 | 2013-12-25 | 天津市聚星康华医药科技有限公司 | 一种盐酸二甲双胍干混悬剂及其制备方法 |
| JP2019512537A (ja) * | 2016-03-31 | 2019-05-16 | ルピン・リミテッド | ダパグリフロジンの医薬組成物 |
-
2020
- 2020-03-27 TR TR2020/04809A patent/TR202004809A2/tr unknown
-
2021
- 2021-01-15 EP EP21776477.8A patent/EP4125824A4/de active Pending
- 2021-01-15 WO PCT/TR2021/050029 patent/WO2021194446A1/en active Application Filing
Also Published As
| Publication number | Publication date |
|---|---|
| WO2021194446A1 (en) | 2021-09-30 |
| TR202004809A2 (tr) | 2021-10-21 |
| EP4125824A4 (de) | 2023-12-27 |
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