AR114006A1 - PHARMACEUTICAL COMBINATION IN THE FORM OF TWO-LAYER TABLETS THAT INCLUDE KETOROLACO TROMETAMINE AND TRAMADOL HYDROCHLORIDE, AND ITS USE FOR THE TREATMENT OF PAIN - Google Patents
PHARMACEUTICAL COMBINATION IN THE FORM OF TWO-LAYER TABLETS THAT INCLUDE KETOROLACO TROMETAMINE AND TRAMADOL HYDROCHLORIDE, AND ITS USE FOR THE TREATMENT OF PAINInfo
- Publication number
- AR114006A1 AR114006A1 ARP180103777A ARP180103777A AR114006A1 AR 114006 A1 AR114006 A1 AR 114006A1 AR P180103777 A ARP180103777 A AR P180103777A AR P180103777 A ARP180103777 A AR P180103777A AR 114006 A1 AR114006 A1 AR 114006A1
- Authority
- AR
- Argentina
- Prior art keywords
- layer containing
- combination
- tramadol hydrochloride
- pharmaceutical combination
- pain
- Prior art date
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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
-
- 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
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/407—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with other heterocyclic ring systems, e.g. ketorolac, physostigmine
-
- 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)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Una combinación farmacéutica en la forma de comprimido en bicapa de liberación inmediata que comprende: i) una primera capa que contiene entre 1,0% y 6,0% p/p de ketorolaco trometamina; ii) una segunda capa que contiene entre 4,0% y 11,0% p/p de tramadol clorhidrato; y iii) un recubrimiento opcional que no modifica la liberación de los ingredientes farmacéuticamente activos. La presente proporciona métodos para prevenir y tratar el dolor, tal como el dolor agudo, y el uso de la combinación farmacéutica para la prevención y el tratamiento del dolor, tal como el dolor agudo. Reivindicación 1: Una combinación farmacéutica que contiene ketorolaco trometamina y tramadol clorhidrato caracterizada porque se encuentra en la forma de comprimido en bicapa que comprende: a) una primera capa que contiene entre 1,0% y 6,0% p/p de ketorolaco trometamina como el primer ingrediente farmacéuticamente activo y entre 44,0% y 52,0% p/p de excipientes farmacéuticamente aceptables; b) una segunda capa que contiene entre 4,0% y 11,0% p/p de tramadol clorhidrato como el segundo ingrediente farmacéuticamente activo y entre 39,0% y 43,0% p/p de excipientes farmacéuticamente aceptables; y c) un recubrimiento opcional; donde el comprimido en bicapa tiene una liberación inmediata de ambos ingredientes farmacéuticamente activos, siendo el porcentaje en peso, % p/p, referido al peso total de la combinación, y donde el recubrimiento opcional no está incluido en el peso total de la combinación y no modifica la liberación de los ingredientes farmacéuticamente activos. Reivindicación 4: Una combinación farmacéutica de acuerdo con la reivindicación 1 caracterizada porque el comprimido en bicapa incluye: c) una primera capa que contiene desde 1,0% a 6,0% p/p de ketorolaco trometamina; y, 4,0% a 6,5% p/p de lactosa, 39,5% a 42,0% p/p de celulosa microcristalina, 0,3% a 1,5% p/p de croscarmelosa de sodio, y 0,1% a 1,5% p/p de estearato de magnesio, 0,1% a 0,5% p/p de un colorante farmacéuticamente aceptable; d) una segunda capa que contiene desde 4,0% a 11,0% p/p de tramadol clorhidrato; y, 2,0% a 2,5% p/p de lactosa, 36,3% a 38,5% p/p de celulosa microcristalina, 0,5% a 0,9% p/p de croscarmelosa de sodio, y 0,2% a 1,1% p/p de estearato de magnesio; donde el porcentaje en peso, % p/p, de cada uno de los ingredientes en la primera y segunda capa está referido al peso total de la combinación; y e) un recubrimiento opcional que contiene desde 0,4 a 1,6% p/p de uno o más excipientes farmacéuticamente aceptables; donde el peso del recubrimiento opcional no está incluido en el porcentaje del peso total de la combinación.A pharmaceutical combination in the form of an immediate release bilayer tablet comprising: i) a first layer containing between 1.0% and 6.0% w / w ketorolac tromethamine; ii) a second layer containing between 4.0% and 11.0% w / w of tramadol hydrochloride; and iii) an optional coating that does not modify the release of the pharmaceutically active ingredients. The present provides methods for preventing and treating pain, such as acute pain, and the use of the pharmaceutical combination for the prevention and treatment of pain, such as acute pain. Claim 1: A pharmaceutical combination containing ketorolac tromethamine and tramadol hydrochloride characterized in that it is in the form of a bilayer tablet comprising: a) a first layer containing between 1.0% and 6.0% w / w of ketorolac tromethamine as the first pharmaceutically active ingredient and between 44.0% and 52.0% w / w of pharmaceutically acceptable excipients; b) a second layer containing between 4.0% and 11.0% w / w of tramadol hydrochloride as the second pharmaceutically active ingredient and between 39.0% and 43.0% w / w of pharmaceutically acceptable excipients; and c) an optional coating; where the bilayer tablet has an immediate release of both pharmaceutically active ingredients, the percentage by weight,% w / w, referring to the total weight of the combination, and where the optional coating is not included in the total weight of the combination and it does not modify the release of the pharmaceutically active ingredients. Claim 4: A pharmaceutical combination according to claim 1 characterized in that the bilayer tablet includes: c) a first layer containing from 1.0% to 6.0% w / w of ketorolac tromethamine; and, 4.0% to 6.5% w / w of lactose, 39.5% to 42.0% w / w of microcrystalline cellulose, 0.3% to 1.5% w / w of croscarmellose sodium, and 0.1% to 1.5% w / w of magnesium stearate, 0.1% to 0.5% w / w of a pharmaceutically acceptable colorant; d) a second layer containing from 4.0% to 11.0% w / w of tramadol hydrochloride; and, 2.0% to 2.5% w / w of lactose, 36.3% to 38.5% w / w of microcrystalline cellulose, 0.5% to 0.9% w / w of croscarmellose sodium, and 0.2% to 1.1% w / w magnesium stearate; where the percentage by weight,% w / w, of each of the ingredients in the first and second layers is related to the total weight of the combination; and e) an optional coating containing from 0.4 to 1.6% w / w of one or more pharmaceutically acceptable excipients; where the weight of the optional coating is not included in the percentage of the total weight of the combination.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/IB2017/058310 WO2019122982A1 (en) | 2017-12-21 | 2017-12-21 | Pharmaceutical combination in a bilayer tablet form comprising ketorolac tromethamine and tramadol hydrochloride, and its use in pain treatment |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR114006A1 true AR114006A1 (en) | 2020-07-08 |
Family
ID=61148269
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP180103777A AR114006A1 (en) | 2017-12-21 | 2018-12-20 | PHARMACEUTICAL COMBINATION IN THE FORM OF TWO-LAYER TABLETS THAT INCLUDE KETOROLACO TROMETAMINE AND TRAMADOL HYDROCHLORIDE, AND ITS USE FOR THE TREATMENT OF PAIN |
Country Status (4)
| Country | Link |
|---|---|
| AR (1) | AR114006A1 (en) |
| MX (1) | MX2018003456A (en) |
| UY (1) | UY38028A (en) |
| WO (1) | WO2019122982A1 (en) |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5516803A (en) | 1991-10-30 | 1996-05-14 | Mcneilab, Inc. | Composition comprising a tramadol material and a non-steroidal anti-inflammatory drug |
| MXPA02010828A (en) * | 2002-11-04 | 2004-07-16 | Leopoldo Espinosa Abdala | Pharmaceutical composition in capsules comprising a non-steroidal anti-inflammatory and an opiate analgesic for handling pain. |
| BRPI0700133A (en) | 2007-01-29 | 2008-09-16 | Incrementha P D & I Pesquisa D | pharmaceutical composition comprising tramadol and ketoprofen in combination |
| MX2007003948A (en) | 2007-04-02 | 2009-02-25 | World Trade Imp Export Wtie Ag | Pharmaceutical composition in the form of a sublingual tablet consisting of a non-steroidal anti-inflammatory agent and an opiate analgesic for pain management. |
| WO2009087658A2 (en) | 2007-11-07 | 2009-07-16 | Sun Pharma Advanced Research Company Limited | Composition suitable for parenteral administration |
| EP3170494A3 (en) | 2007-11-23 | 2017-09-06 | Grünenthal GmbH | Tapentadol compositions |
| EP2177215A1 (en) | 2008-10-17 | 2010-04-21 | Laboratorios Del. Dr. Esteve, S.A. | Co-crystals of tramadol and NSAIDs |
| MX2010011193A (en) | 2010-10-12 | 2012-04-18 | World Trade Imp Exp Wtie Ag | Liquid pharmaceutical composition for pain treatment and prevention. |
| CA2869280C (en) | 2011-04-05 | 2020-03-10 | Optosolve Llp | Ophthalmic treatments |
| WO2013163142A1 (en) | 2012-04-25 | 2013-10-31 | Yung Shin Pharm. Ind. Co., Ltd. | Liquid pharmaceutical formulation containing ketorolac and tramadol |
| MX2014005153A (en) | 2014-04-29 | 2015-10-28 | Liomont S A De C V Lab | Production method and sublingual pharmaceutical composition of ketorolac tromethamine and tramadol hydrochloride used for pain. |
| MX2014005152A (en) | 2014-04-29 | 2015-10-28 | Liomont S A De C V Lab | Pharmaceutical composition for the treatment of allopathic pain, using ketorolac tromethamine and tramadol hydrochloride as an active ingredient. |
-
2017
- 2017-12-21 MX MX2018003456A patent/MX2018003456A/en unknown
- 2017-12-21 WO PCT/IB2017/058310 patent/WO2019122982A1/en active Application Filing
-
2018
- 2018-12-20 AR ARP180103777A patent/AR114006A1/en unknown
- 2018-12-20 UY UY0001038028A patent/UY38028A/en not_active Application Discontinuation
Also Published As
| Publication number | Publication date |
|---|---|
| UY38028A (en) | 2019-07-31 |
| MX2018003456A (en) | 2019-09-06 |
| WO2019122982A1 (en) | 2019-06-27 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| JP2015523407A5 (en) | ||
| AR107871A1 (en) | COMBINATIONS OF LSD1 INHIBITORS FOR USE IN THE TREATMENT OF SOLID TUMORS | |
| ES2916649T1 (en) | Compositions and uses for the treatment of multiple sclerosis | |
| HRP20150644T1 (en) | Method of treating atrial fibrillation | |
| AR077546A1 (en) | FORMULATIONS OF TABLETS OF 3-CYANOQUINOLINE AND USES OF THE SAME | |
| MX2021002321A (en) | Novel methods. | |
| AR100369A1 (en) | COMPOSITION OF FIXED DOSE OF FORMOTEROL AND BUDESONIDE | |
| AR115913A1 (en) | BIO AVAILABLE ORAL DOSAGE FORMS, USE, METHODS | |
| DK1711169T3 (en) | Coated microdeposition tablets with venlafaxine hydrochloride | |
| JP2014507475A5 (en) | ||
| CO2024002256A2 (en) | 5-Hydroxytryptophan Gastroretentive Dosage Forms | |
| MX2019014687A (en) | Oral pharmaceutical formulations of remogliflozin. | |
| AR072954A1 (en) | USE OF DRONEDARONA TO PREPARE A MEDICINAL PRODUCT FOR THE TREATMENT OF PATIENTS WITH ARRITMIA AND THAT HAVE AN INCREASE OF THE CREATININE LEVEL DUE TO THE ADMINISTRATION OF DRONEDARONA, MANUFACTURING PRODUCT AND PACKAGING | |
| AR114006A1 (en) | PHARMACEUTICAL COMBINATION IN THE FORM OF TWO-LAYER TABLETS THAT INCLUDE KETOROLACO TROMETAMINE AND TRAMADOL HYDROCHLORIDE, AND ITS USE FOR THE TREATMENT OF PAIN | |
| CR20190145A (en) | Indazole compounds for use in tendon and/or ligament injuries | |
| ES2526359T3 (en) | Oral galenic formulation comprising ketorolac and B vitamins, in which vitamin B6 is in an external layer separated from the rest of active ingredients | |
| CO2018009543A2 (en) | Extended release pharmaceutical composition comprising cysteamine or salt thereof | |
| CO2018002046A2 (en) | New oral delayed dual dexlansoprazole oral composition | |
| HRP20230735T1 (en) | Betahistine, or a pharmaceutically acceptable salt thereof, and a monoamine oxidase inhibitor, for use in the treatment or prevention of one or more symptoms of vertigo in a subject | |
| ECSP16005208A (en) | STABLE ANTI-TUBERCULOSIS PHARMACEUTICAL COMPOSITION IN A FORM OF A COATED TABLET INCLUDING ISONIAZID GRANULES AND RIFAPENTINE GRANULES AND THEIR PREPARATION PROCESS | |
| BR112018008835A2 (en) | oral pharmaceutical composition, oral pulsatile release pharmaceutical composition, method for treating a disease condition requiring dimethyl fumarate therapy and method for treating multiple sclerosis | |
| DOP2021000052A (en) | PROCEDURE FOR THE PREPARATION OF AN ORAL DOSAGE FORM OF MULTIPLE UNITS OF MODIFIED RELEASE OF DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE | |
| CO2019008347A2 (en) | Quick release composition of cinitapride and simethicone and process to prepare it | |
| UY38043A (en) | PHARMACEUTICAL COMBINATION THAT INCLUDES TRAMADOL EXTENDED RELEASE CHLORIDE HYDROXYLOR AND IMMEDIATE RELEASE, AND ITS USE FOR PAIN TREATMENT | |
| JP2017515849A5 (en) |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FB | Suspension of granting procedure |