PE20231943A1 - Formulacion combinada oral que incluye gemigliptina y dapagliflozina y metodo de preparacion para la misma - Google Patents
Formulacion combinada oral que incluye gemigliptina y dapagliflozina y metodo de preparacion para la mismaInfo
- Publication number
- PE20231943A1 PE20231943A1 PE2023001386A PE2023001386A PE20231943A1 PE 20231943 A1 PE20231943 A1 PE 20231943A1 PE 2023001386 A PE2023001386 A PE 2023001386A PE 2023001386 A PE2023001386 A PE 2023001386A PE 20231943 A1 PE20231943 A1 PE 20231943A1
- Authority
- PE
- Peru
- Prior art keywords
- preparation
- weight
- gemigliptin
- dapagliflozin
- pharmaceutically acceptable
- Prior art date
Links
- 238000002360 preparation method Methods 0.000 title abstract 5
- 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 title abstract 3
- ZWPRRQZNBDYKLH-VIFPVBQESA-N Gemigliptin Chemical compound C([C@@H](N)CC(=O)N1CC2=C(C(=NC(=N2)C(F)(F)F)C(F)(F)F)CC1)N1CC(F)(F)CCC1=O ZWPRRQZNBDYKLH-VIFPVBQESA-N 0.000 title abstract 3
- 229960003834 dapagliflozin Drugs 0.000 title abstract 3
- 229960002458 gemigliptin Drugs 0.000 title abstract 3
- 238000009472 formulation Methods 0.000 title 1
- 238000000034 method Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 239000004480 active ingredient Substances 0.000 abstract 4
- 150000003839 salts Chemical class 0.000 abstract 4
- 239000003085 diluting agent Substances 0.000 abstract 2
- 239000007884 disintegrant Substances 0.000 abstract 2
- 239000000314 lubricant Substances 0.000 abstract 2
- 229920002785 Croscarmellose sodium Polymers 0.000 abstract 1
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 abstract 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 abstract 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 abstract 1
- 229960001681 croscarmellose sodium Drugs 0.000 abstract 1
- 229960000913 crospovidone Drugs 0.000 abstract 1
- 235000010947 crosslinked sodium carboxy methyl cellulose Nutrition 0.000 abstract 1
- MVPICKVDHDWCJQ-UHFFFAOYSA-N ethyl 3-pyrrolidin-1-ylpropanoate Chemical compound CCOC(=O)CCN1CCCC1 MVPICKVDHDWCJQ-UHFFFAOYSA-N 0.000 abstract 1
- 239000008101 lactose Substances 0.000 abstract 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 abstract 1
- 239000008108 microcrystalline cellulose Substances 0.000 abstract 1
- 229940016286 microcrystalline cellulose Drugs 0.000 abstract 1
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 abstract 1
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 abstract 1
- 229940045902 sodium stearyl fumarate Drugs 0.000 abstract 1
- 239000011885 synergistic combination Substances 0.000 abstract 1
- 208000001072 type 2 diabetes mellitus Diseases 0.000 abstract 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—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
-
- 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
- A61K31/7028—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages
- A61K31/7034—Compounds having saccharide radicals attached to non-saccharide compounds by glycosidic linkages attached to a carbocyclic compound, e.g. phloridzin
-
- 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
- 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
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Diabetes (AREA)
- Molecular Biology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Endocrinology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Hematology (AREA)
- Emergency Medicine (AREA)
- Organic Chemistry (AREA)
- Obesity (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biophysics (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Medicinal Preparation (AREA)
Abstract
La presente invencion se refiere a una preparacion de combinacion oral que comprende gemigliptina o una sal farmaceuticamente aceptable de la misma y dapagliflozina o una sal farmaceuticamente aceptable de la misma como ingredientes activos; lactosa y/o celulosa microcristalina como diluyente; un desintegrante tal como croscarmelosa sodica o crospovidona y un lubricante tal como estearil fumarato de sodio. La preparacion comprende 20 a 60% en peso de ingredientes activos, 20 a 70% en peso del diluyente, 0.5 a 15% en peso del desintegrante y 0.2 a 15% en peso del lubricante; y ademas, la gemigliptina o su sal farmaceuticamente aceptable y la dapagliflozina o su sal farmaceuticamente aceptable se encuentran en una relacion de peso de 5:1 con base en las formas libres. Tambien se refiere a un metodo de preparacion. La preparacion combinada tiene una biodisponibilidad y estabilidad incrementada de los principios activos, asi como tambien una combinacion sinergica de los ingredientes activos, siendo util en el tratamiento de la diabetes mellitus tipo 2.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR20200131868 | 2020-10-13 | ||
| PCT/KR2021/014013 WO2022080815A1 (ko) | 2020-10-13 | 2021-10-12 | 제미글립틴 및 다파글리플로진을 포함하는 경구용 복합제제, 및 이의 제조 방법 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20231943A1 true PE20231943A1 (es) | 2023-12-05 |
Family
ID=81208465
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2023001386A PE20231943A1 (es) | 2020-10-13 | 2021-10-12 | Formulacion combinada oral que incluye gemigliptina y dapagliflozina y metodo de preparacion para la misma |
Country Status (10)
| Country | Link |
|---|---|
| KR (1) | KR20220048952A (es) |
| CL (1) | CL2023001014A1 (es) |
| CO (1) | CO2023006028A2 (es) |
| CR (1) | CR20230161A (es) |
| DO (1) | DOP2023000071A (es) |
| EC (1) | ECSP23027106A (es) |
| MX (1) | MX2023004218A (es) |
| PE (1) | PE20231943A1 (es) |
| TW (1) | TWI826841B (es) |
| WO (1) | WO2022080815A1 (es) |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20180058510A (ko) * | 2016-11-24 | 2018-06-01 | 한미약품 주식회사 | 다파글리플로진 l-프롤린을 포함하는 약제학적 제제 |
| WO2018124497A1 (ko) * | 2016-12-30 | 2018-07-05 | 한미약품 주식회사 | 다파글리플로진 l-프롤린과 항당뇨병제를 포함하는 약제학적 복합 제제 |
| KR20180078762A (ko) * | 2016-12-30 | 2018-07-10 | 한미약품 주식회사 | 다파글리플로진 l-프롤린을 포함하는 당뇨병 질환의 예방 또는 치료용 약제학적 조성물 |
| KR102204439B1 (ko) | 2018-05-14 | 2021-01-18 | 에이치케이이노엔 주식회사 | Sglt-2 억제제 및 dpp-iv 억제제를 포함하는 약제학적 조성물 |
-
2021
- 2021-10-12 WO PCT/KR2021/014013 patent/WO2022080815A1/ko active Application Filing
- 2021-10-12 KR KR1020210134776A patent/KR20220048952A/ko not_active Application Discontinuation
- 2021-10-12 PE PE2023001386A patent/PE20231943A1/es unknown
- 2021-10-12 CR CR20230161A patent/CR20230161A/es unknown
- 2021-10-12 MX MX2023004218A patent/MX2023004218A/es unknown
- 2021-10-13 TW TW110138009A patent/TWI826841B/zh active
-
2023
- 2023-04-06 CL CL2023001014A patent/CL2023001014A1/es unknown
- 2023-04-12 DO DO2023000071A patent/DOP2023000071A/es unknown
- 2023-04-13 EC ECSENADI202327106A patent/ECSP23027106A/es unknown
- 2023-05-11 CO CONC2023/0006028A patent/CO2023006028A2/es unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CL2023001014A1 (es) | 2023-12-11 |
| KR20220048952A (ko) | 2022-04-20 |
| MX2023004218A (es) | 2023-04-21 |
| ECSP23027106A (es) | 2023-05-31 |
| DOP2023000071A (es) | 2023-07-09 |
| TWI826841B (zh) | 2023-12-21 |
| CR20230161A (es) | 2023-09-21 |
| CO2023006028A2 (es) | 2023-07-10 |
| TW202228701A (zh) | 2022-08-01 |
| WO2022080815A1 (ko) | 2022-04-21 |
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