PE20240113A1 - SUSTAINED RELEASE DOSAGE FORMS OF A SALT OF TAPENTADOL WITH L-(+)-TARTARIC ACID - Google Patents
SUSTAINED RELEASE DOSAGE FORMS OF A SALT OF TAPENTADOL WITH L-(+)-TARTARIC ACIDInfo
- Publication number
- PE20240113A1 PE20240113A1 PE2023001584A PE2023001584A PE20240113A1 PE 20240113 A1 PE20240113 A1 PE 20240113A1 PE 2023001584 A PE2023001584 A PE 2023001584A PE 2023001584 A PE2023001584 A PE 2023001584A PE 20240113 A1 PE20240113 A1 PE 20240113A1
- Authority
- PE
- Peru
- Prior art keywords
- tapentadol
- salt
- tablet
- tartaric acid
- sustained release
- Prior art date
Links
- 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 title abstract 4
- 229960005126 tapentadol Drugs 0.000 title abstract 4
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 title abstract 2
- 235000011002 L(+)-tartaric acid Nutrition 0.000 title abstract 2
- 239000001358 L(+)-tartaric acid Substances 0.000 title abstract 2
- FEWJPZIEWOKRBE-LWMBPPNESA-N L-(+)-Tartaric acid Natural products OC(=O)[C@@H](O)[C@H](O)C(O)=O FEWJPZIEWOKRBE-LWMBPPNESA-N 0.000 title abstract 2
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 title abstract 2
- 239000002552 dosage form Substances 0.000 title abstract 2
- 150000003839 salts Chemical class 0.000 title abstract 2
- 238000013268 sustained release Methods 0.000 title abstract 2
- 239000012730 sustained-release form Substances 0.000 title abstract 2
- 229920002689 polyvinyl acetate Polymers 0.000 abstract 3
- 208000002193 Pain Diseases 0.000 abstract 2
- 239000001866 hydroxypropyl methyl cellulose Substances 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
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 2
- 208000000094 Chronic Pain Diseases 0.000 abstract 1
- 239000004349 Polyvinylpyrrolidone-vinyl acetate copolymer Substances 0.000 abstract 1
- 230000006835 compression Effects 0.000 abstract 1
- 238000007906 compression Methods 0.000 abstract 1
- 239000012458 free base Substances 0.000 abstract 1
- 239000011159 matrix material Substances 0.000 abstract 1
- 238000000034 method Methods 0.000 abstract 1
- 230000036470 plasma concentration Effects 0.000 abstract 1
- 239000011118 polyvinyl acetate Substances 0.000 abstract 1
- 235000019448 polyvinylpyrrolidone-vinyl acetate copolymer Nutrition 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
- A61K9/2022—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
- 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
- A61K9/20—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
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Emergency Medicine (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Refiere a una forma de dosificacion farmaceutica, especificamente a un comprimido monolitico que proporciona la liberacion sostenida de una sal de tapentadol con acido L-(+)-tartarico incorporado en una matriz de liberacion, como hidroxipropilmetilcelulosa (HPMC), acetato de polivinilo (PVAc) o un copolimero de polivinilpirrolidona-acetato de vinilo (PVP/PVAc). Dicho comprimido se administra dos veces al dia, presenta una dosis de tapentadol equivalente en peso de 25 mg, 50 mg o 100 mg en relacion con una base libre, y tiene propiedades mecanicas satisfactorias, por ejemplo, una resistencia a la rotura de al menos 100 N, y en terminos de friabilidad; ademas, se utiliza en el tratamiento de dolor cronico y proporciona niveles plasmaticos de tapentadol que proporcionan alivio del dolor durante un periodo de al menos 6 horas. Tambien, la presente reivindica un proceso para producir dicho comprimido en condiciones de compresion simplificadas, en particular, con una fuerza de prensado reducida no mayor que 20 kN.Refers to a pharmaceutical dosage form, specifically a monolithic tablet that provides sustained release of a salt of tapentadol with L-(+)-tartaric acid incorporated in a release matrix, such as hydroxypropylmethylcellulose (HPMC), polyvinyl acetate (PVAc ) or a polyvinylpyrrolidone-vinyl acetate copolymer (PVP/PVAc). Said tablet is administered twice a day, has a tapentadol dose equivalent by weight of 25 mg, 50 mg or 100 mg relative to a free base, and has satisfactory mechanical properties, for example, a breaking strength of at least 100 N, and in terms of friability; In addition, it is used in the treatment of chronic pain and provides plasma levels of tapentadol that provide pain relief for a period of at least 6 hours. Also, the present claims a process for producing said tablet under simplified compression conditions, in particular, with a reduced pressing force of no more than 20 kN.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP20206812 | 2020-11-10 | ||
| EP20206800.3A EP3995135B1 (en) | 2020-11-10 | 2020-11-10 | Prolonged release dosage form of tapentadol l-(+)- tartaric acid salt |
| PCT/EP2021/081197 WO2022101247A1 (en) | 2020-11-10 | 2021-11-10 | Sustained release dosage forms of a salt of tapentadol with l-(+)-tartaric acid |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20240113A1 true PE20240113A1 (en) | 2024-01-22 |
Family
ID=78536235
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2023001584A PE20240113A1 (en) | 2020-11-10 | 2021-11-10 | SUSTAINED RELEASE DOSAGE FORMS OF A SALT OF TAPENTADOL WITH L-(+)-TARTARIC ACID |
Country Status (4)
| Country | Link |
|---|---|
| CO (1) | CO2023005962A2 (en) |
| MX (1) | MX2023005472A (en) |
| PE (1) | PE20240113A1 (en) |
| WO (1) | WO2022101247A1 (en) |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| AU2009207796B2 (en) | 2008-01-25 | 2014-03-27 | Grunenthal Gmbh | Pharmaceutical dosage form |
| US20160136112A1 (en) | 2013-08-02 | 2016-05-19 | Ratiopharm Gmbh | Composition comprising tapentadol in a dissolved form |
| WO2015157138A1 (en) * | 2014-04-07 | 2015-10-15 | Banner Life Sciences Llc | Abuse-deterrent controlled release formulations |
| EP2942054A1 (en) | 2014-05-09 | 2015-11-11 | G.L. Pharma GmbH | Slow-release pharmaceutical formulation |
| DK3377049T3 (en) | 2015-11-17 | 2021-04-12 | Msn Laboratories Private Ltd | Crystalline forms of tapentadol salts and process for preparation thereof |
-
2021
- 2021-11-10 MX MX2023005472A patent/MX2023005472A/en unknown
- 2021-11-10 PE PE2023001584A patent/PE20240113A1/en unknown
- 2021-11-10 WO PCT/EP2021/081197 patent/WO2022101247A1/en not_active Ceased
-
2023
- 2023-05-09 CO CONC2023/0005962A patent/CO2023005962A2/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| MX2023005472A (en) | 2023-05-22 |
| WO2022101247A1 (en) | 2022-05-19 |
| CO2023005962A2 (en) | 2023-05-19 |
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