PE20230105A1 - DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALT - Google Patents
DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALTInfo
- Publication number
- PE20230105A1 PE20230105A1 PE2022001894A PE2022001894A PE20230105A1 PE 20230105 A1 PE20230105 A1 PE 20230105A1 PE 2022001894 A PE2022001894 A PE 2022001894A PE 2022001894 A PE2022001894 A PE 2022001894A PE 20230105 A1 PE20230105 A1 PE 20230105A1
- Authority
- PE
- Peru
- Prior art keywords
- tapentadol
- dosage form
- phosphoric acid
- acid salt
- form providing
- Prior art date
Links
- 229960005126 tapentadol Drugs 0.000 title abstract 7
- 239000002552 dosage form Substances 0.000 title abstract 3
- -1 TAPENTADOL PHOSPHORIC ACID SALT Chemical class 0.000 title 1
- KWTWDQCKEHXFFR-SMDDNHRTSA-N tapentadol Chemical compound CN(C)C[C@H](C)[C@@H](CC)C1=CC=CC(O)=C1 KWTWDQCKEHXFFR-SMDDNHRTSA-N 0.000 abstract 6
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 abstract 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 abstract 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 abstract 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract 2
- 229920000168 Microcrystalline cellulose Polymers 0.000 abstract 1
- 239000001913 cellulose Substances 0.000 abstract 1
- 229920002678 cellulose Polymers 0.000 abstract 1
- 235000010980 cellulose Nutrition 0.000 abstract 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-M dihydrogenphosphate Chemical compound OP(O)([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-M 0.000 abstract 1
- 239000012458 free base Substances 0.000 abstract 1
- 239000011159 matrix material 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
- 150000003016 phosphoric acids Chemical class 0.000 abstract 1
- 230000002035 prolonged effect Effects 0.000 abstract 1
Classifications
-
- 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
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
-
- 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
- A61K9/167—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface
- A61K9/1676—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction with an outer layer or coating comprising drug; with chemically bound drugs or non-active substances on their surface having a drug-free core with discrete complete coating layer containing drug
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
- A61K9/5073—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings
- A61K9/5078—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals having two or more different coatings optionally including drug-containing subcoatings with drug-free core
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/04—Centrally acting analgesics, e.g. opioids
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Emergency Medicine (AREA)
- Pain & Pain Management (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
REFERIDO A UNA FORMA DE DOSIFICACION FARMACEUTICA DE LIBERACION PROLONGADA QUE COMPRENDE TAPENTADOL PARA SU ADMINISTRACION ORAL DOS VECES AL DIA, EN DONDE EL TAPENTADOL ESTA PRESENTE COMO UNA SAL CON ACIDO FOSFORICO TAL COMO DIHIDROGENOFOSFATO DE TAPENTADOL, Y EN DONDE EL TAPENTADOL SE INCORPORA A UNA MATRIZ DE LIBERACION PROLONGADA QUE CONSISTE EN HIDROXIPROPILMETILCELULOSA (HPMC), HIDROXIPROPILCELULOSA (HPC), HIDROXIETILCELULOSA (HEC), CELULOSA MICROCRISTALINA, ENTRE OTROS. LA DOSIS EQUIVALENTE EN PESO DE TAPENTADOL CONTENIDA EN LA FORMA DE DOSIFICACION FARMACEUTICA SE ENCUENTRA DENTRO DEL INTERVALO DE 10 A 300 MG EN BASE A LA BASE LIBRE DE TAPENTADOL.REFERRING TO A SUPPORTED RELEASE PHARMACEUTICAL DOSAGE FORM COMPRISING TAPENTADOL FOR TWICE DAILY ORAL ADMINISTRATION, WHEREIN TAPENTADOL IS PRESENT AS A PHOSPHORIC ACID SALT SUCH AS TAPENTADOL DIHYDROGEN PHOSPHATE, AND WHEREIN TAPENTADOL IS INCORPORATED INTO A MATRIX OF PROLONGED RELEASE CONSISTING OF HYDROXYPROPYL METHYLCELLULOSE (HPMC), HYDROXYPROPYL CELLULOSE (HPC), HYDROXYYTHYL CELLULOSE (HEC), MICROCRYSTALLINE CELLULOSE, AMONG OTHERS. THE EQUIVALENT DOSE BY WEIGHT OF TAPENTADOL CONTAINED IN THE PHARMACEUTICAL DOSAGE FORM IS WITHIN THE RANGE OF 10 TO 300 MG ON A TAPENTADOL FREE BASE BASIS.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20160419.6A EP3875077B1 (en) | 2020-03-02 | 2020-03-02 | Dosage form providing prolonged release of tapentadol phosphoric acid salt |
| EP20160420.4A EP3875079A1 (en) | 2020-03-02 | 2020-03-02 | Dosage form providing prolonged release of tapentadol phosphoric acid salt |
| PCT/EP2021/055025 WO2021175773A1 (en) | 2020-03-02 | 2021-03-01 | Dosage form providing prolonged release of tapentadol phosphoric acid salt |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20230105A1 true PE20230105A1 (en) | 2023-01-25 |
Family
ID=74701506
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2022001894A PE20230105A1 (en) | 2020-03-02 | 2021-03-01 | DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALT |
Country Status (7)
| Country | Link |
|---|---|
| EP (1) | EP4003318A1 (en) |
| BR (1) | BR112022017700A2 (en) |
| CO (1) | CO2022012567A2 (en) |
| DE (1) | DE202021003994U1 (en) |
| MX (1) | MX2022010780A (en) |
| PE (1) | PE20230105A1 (en) |
| WO (1) | WO2021175773A1 (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PE20230105A1 (en) | 2020-03-02 | 2023-01-25 | Gruenenthal Chemie | DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALT |
Family Cites Families (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| IL88083A (en) * | 1987-11-06 | 1992-11-15 | Tanabe Seiyaku Co | Controlled release pharmaceutical dosage form and its preparation |
| DE4426245A1 (en) | 1994-07-23 | 1996-02-22 | Gruenenthal Gmbh | 1-phenyl-3-dimethylamino-propane compounds with pharmacological activity |
| PE20030527A1 (en) | 2001-10-24 | 2003-07-26 | Gruenenthal Chemie | DELAYED-RELEASE PHARMACEUTICAL FORMULATION CONTAINING 3- (3-DIMETHYLAMINO-1-ETHYL-2-METHYL-PROPYL) PHENOL OR A PHARMACEUTICALLY ACCEPTABLE SALT OF THE SAME AND ORAL TABLETS CONTAINING IT |
| EP1484056B1 (en) * | 2002-02-21 | 2013-08-14 | Otsuka Pharmaceutical Co., Ltd. | Sustained release preparations and process for producing the same |
| PL1786403T3 (en) | 2004-07-01 | 2013-10-31 | Gruenenthal Gmbh | Oral dosage form safeguarded against abuse containing (1r, 2r)-3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol |
| CN101568329A (en) | 2006-10-27 | 2009-10-28 | 詹森药业有限公司 | Dry granulated pharmaceutical compositions and methods for producing same |
| JP5774853B2 (en) | 2008-01-25 | 2015-09-09 | グリュネンタール・ゲゼルシャフト・ミト・ベシュレンクテル・ハフツング | Pharmaceutical dosage form |
| NZ592437A (en) | 2008-10-30 | 2013-03-28 | Gruenenthal Chemie | A dosage form comprising tapentadol and an opioid antagonist |
| KR102146233B1 (en) | 2010-07-23 | 2020-08-21 | 그뤼넨탈 게엠베하 | Salts or co-crystals of 3-(3-dimethylamino-1-ethyl-2-methyl-propyl)-phenol |
| WO2012051246A1 (en) | 2010-10-12 | 2012-04-19 | Ratiopharm Gmbh | Tapentadol hydrobromide and crystalline forms thereof |
| KR20160031526A (en) | 2013-07-12 | 2016-03-22 | 그뤼넨탈 게엠베하 | Tamper-resistant dosage form containing ethylene-vinyl acetate polymer |
| US20160136112A1 (en) | 2013-08-02 | 2016-05-19 | Ratiopharm Gmbh | Composition comprising tapentadol in a dissolved form |
| EP2942054A1 (en) | 2014-05-09 | 2015-11-11 | G.L. Pharma GmbH | Slow-release pharmaceutical formulation |
| PL3653599T3 (en) | 2016-04-19 | 2023-03-20 | Ratiopharm Gmbh | Crystalline tapentadol phosphate |
| US20180369151A1 (en) | 2017-05-29 | 2018-12-27 | Grünenthal GmbH | Multiparticulate oral dosage form providing prolonged release of tapentadol |
| PE20230105A1 (en) | 2020-03-02 | 2023-01-25 | Gruenenthal Chemie | DOSAGE FORM PROVIDING SUPPORTED RELEASE OF TAPENTADOL PHOSPHORIC ACID SALT |
-
2021
- 2021-03-01 PE PE2022001894A patent/PE20230105A1/en unknown
- 2021-03-01 MX MX2022010780A patent/MX2022010780A/en unknown
- 2021-03-01 WO PCT/EP2021/055025 patent/WO2021175773A1/en active Application Filing
- 2021-03-01 DE DE202021003994.5U patent/DE202021003994U1/en active Active
- 2021-03-01 BR BR112022017700A patent/BR112022017700A2/en unknown
- 2021-03-01 EP EP21707730.4A patent/EP4003318A1/en active Pending
-
2022
- 2022-09-02 CO CONC2022/0012567A patent/CO2022012567A2/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| DE202021003994U1 (en) | 2022-04-12 |
| EP4003318A1 (en) | 2022-06-01 |
| WO2021175773A1 (en) | 2021-09-10 |
| BR112022017700A2 (en) | 2023-01-17 |
| CO2022012567A2 (en) | 2022-09-09 |
| MX2022010780A (en) | 2022-09-26 |
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