PE20210047A1 - Composicion inyectable - Google Patents
Composicion inyectableInfo
- Publication number
- PE20210047A1 PE20210047A1 PE2020001597A PE2020001597A PE20210047A1 PE 20210047 A1 PE20210047 A1 PE 20210047A1 PE 2020001597 A PE2020001597 A PE 2020001597A PE 2020001597 A PE2020001597 A PE 2020001597A PE 20210047 A1 PE20210047 A1 PE 20210047A1
- Authority
- PE
- Peru
- Prior art keywords
- composition
- letrozole
- active agent
- intramuscular
- milligrams
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4196—1,2,4-Triazoles
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/426—1,3-Thiazoles
-
- 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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0017—Filtration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/0005—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
- A61L2/0011—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts using physical methods
- A61L2/0029—Radiation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Molecular Biology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Se refiere a una composicion de letrozol de liberacion mantenida estable para administracion por via intramuscular adecuada para formar un implante intramuscular in situ que comprende de 10 a 500 mg de letrozol y un polimero termoplastico biodegradable esteril de poli (acido lactico) (PLA), donde dicho PLA esta molido y/o tiene una distribucion masica del tamano de las particulas con como maximo 10 % superior a 300 micrometros, preferiblemente no superior a 250 micrometros, cuando se mide mediante tamizado analitico segun USP<786>; y donde la liberacion del agente activo desde el implante es entre 2 y 30 % del agente activo cada 28 dias, preferiblemente es entre 5 y 25 % del agente activo cada 28 dias; y/o donde la composicion libera de 0,1 a 2 miligramos de letrozol al dia, preferiblemente de 0,13 a 0,80 miligramos de letrozol al dia. Dicha composicion libera el farmaco con un comienzo inmediato de la accion y de manera continua entre 3 y 6 meses. La composicion intramuscular inyectable es de absorcion lenta y esteril. Tambien se refiere a un procedimiento para preparar dicha composicion y a un kit adecuado para la preparacion in situ.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP18382413 | 2018-06-12 | ||
| PCT/EP2019/065318 WO2019238740A1 (en) | 2018-06-12 | 2019-06-12 | Injectable composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20210047A1 true PE20210047A1 (es) | 2021-01-08 |
Family
ID=62716017
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2020001597A PE20210047A1 (es) | 2018-06-12 | 2019-06-06 | Composicion inyectable |
Country Status (32)
| Country | Link |
|---|---|
| US (1) | US20210154302A1 (es) |
| EP (1) | EP3746047B1 (es) |
| JP (1) | JP7420735B2 (es) |
| KR (1) | KR20210019402A (es) |
| CN (1) | CN112004525B (es) |
| AU (1) | AU2019286572A1 (es) |
| BR (1) | BR112020020415A2 (es) |
| CA (1) | CA3096918A1 (es) |
| CL (1) | CL2020002844A1 (es) |
| CO (1) | CO2020012526A2 (es) |
| CY (1) | CY1124772T1 (es) |
| DK (1) | DK3746047T3 (es) |
| EA (1) | EA202092021A1 (es) |
| ES (1) | ES2900171T3 (es) |
| GE (1) | GEP20237501B (es) |
| HR (1) | HRP20211874T1 (es) |
| HU (1) | HUE057269T2 (es) |
| IL (1) | IL277802B2 (es) |
| LT (1) | LT3746047T (es) |
| MA (1) | MA52502B1 (es) |
| MD (1) | MD3746047T2 (es) |
| MX (1) | MX2020011732A (es) |
| PE (1) | PE20210047A1 (es) |
| PH (1) | PH12020551740A1 (es) |
| PL (1) | PL3746047T3 (es) |
| PT (1) | PT3746047T (es) |
| RS (1) | RS62681B1 (es) |
| SG (1) | SG11202008744VA (es) |
| SI (1) | SI3746047T1 (es) |
| UA (1) | UA127087C2 (es) |
| WO (1) | WO2019238740A1 (es) |
| ZA (1) | ZA202006113B (es) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2022046578A1 (en) * | 2020-08-25 | 2022-03-03 | Merck Sharp & Dohme Corp. | Injectable depot compositions for the delivery of antiviral agents |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2670680B2 (ja) * | 1988-02-24 | 1997-10-29 | 株式会社ビーエムジー | 生理活性物質含有ポリ乳酸系微小球およびその製造法 |
| GB0517673D0 (en) | 2005-08-31 | 2005-10-05 | Astrazeneca Ab | Formulation |
| CN101495148B (zh) * | 2005-10-21 | 2012-12-19 | 万能药生物有限公司 | 包括至少一种抗癌药和至少一种聚合物的药物组合物 |
| CA2665105A1 (en) | 2006-10-05 | 2008-04-10 | Panacea Biotec Ltd. | Injectable depot composition and its' process of preparation |
| CL2008003305A1 (es) * | 2007-11-06 | 2009-06-05 | M/S Panacea Biotec Ltd | Composicion inyectable que comprende un agente activo seleccionado de un grupo definido; al menos un polimero bioerosionable, al menos un solvente no toxico y opcionalmente uno o mas excipientes; proceso de preparacion; uso para tratar enfermedades mentales o cancer. |
| US20100144687A1 (en) | 2008-12-05 | 2010-06-10 | Glaser Rebecca L | Pharmaceutical compositions containing testosterone and an aromatase inhibitor |
| ES2390439B1 (es) * | 2012-08-03 | 2013-09-27 | Laboratorios Farmacéuticos Rovi, S.A. | Composición inyectable |
| US10285936B2 (en) * | 2010-05-31 | 2019-05-14 | Laboratorios Farmacéuticos Rovi, S.A. | Injectable composition with aromatase inhibitor |
| PL2394663T3 (pl) * | 2010-05-31 | 2022-02-21 | Laboratorios Farmaceuticos Rovi, S.A. | Kompozycje do wstrzykiwania implantów biodegradowalnych in-situ |
| MX347014B (es) | 2010-11-24 | 2017-04-07 | Durect Corp | Composición para administración de fármaco biodegradable. |
| CN102512399B (zh) * | 2011-12-31 | 2013-05-01 | 湖南赛沃药业股份有限公司 | 一种长效纳曲酮植入剂及其制备方法 |
-
2019
- 2019-06-06 PE PE2020001597A patent/PE20210047A1/es unknown
- 2019-06-12 MD MDE20201233T patent/MD3746047T2/ro unknown
- 2019-06-12 GE GEAP201915469A patent/GEP20237501B/en unknown
- 2019-06-12 RS RS20211463A patent/RS62681B1/sr unknown
- 2019-06-12 BR BR112020020415-3A patent/BR112020020415A2/pt unknown
- 2019-06-12 PL PL19733972T patent/PL3746047T3/pl unknown
- 2019-06-12 MA MA52502A patent/MA52502B1/fr unknown
- 2019-06-12 CN CN201980027406.XA patent/CN112004525B/zh active Active
- 2019-06-12 SI SI201930141T patent/SI3746047T1/sl unknown
- 2019-06-12 WO PCT/EP2019/065318 patent/WO2019238740A1/en active Application Filing
- 2019-06-12 PT PT197339724T patent/PT3746047T/pt unknown
- 2019-06-12 CA CA3096918A patent/CA3096918A1/en active Pending
- 2019-06-12 EA EA202092021A patent/EA202092021A1/ru unknown
- 2019-06-12 MX MX2020011732A patent/MX2020011732A/es unknown
- 2019-06-12 LT LTEPPCT/EP2019/065318T patent/LT3746047T/lt unknown
- 2019-06-12 KR KR1020207028732A patent/KR20210019402A/ko unknown
- 2019-06-12 AU AU2019286572A patent/AU2019286572A1/en active Pending
- 2019-06-12 ES ES19733972T patent/ES2900171T3/es active Active
- 2019-06-12 DK DK19733972.4T patent/DK3746047T3/da active
- 2019-06-12 HR HRP20211874TT patent/HRP20211874T1/hr unknown
- 2019-06-12 EP EP19733972.4A patent/EP3746047B1/en active Active
- 2019-06-12 HU HUE19733972A patent/HUE057269T2/hu unknown
- 2019-06-12 UA UAA202005782A patent/UA127087C2/uk unknown
- 2019-06-12 IL IL277802A patent/IL277802B2/en unknown
- 2019-06-12 SG SG11202008744VA patent/SG11202008744VA/en unknown
- 2019-06-12 JP JP2020557943A patent/JP7420735B2/ja active Active
-
2020
- 2020-10-02 ZA ZA2020/06113A patent/ZA202006113B/en unknown
- 2020-10-07 CO CONC2020/0012526A patent/CO2020012526A2/es unknown
- 2020-10-20 PH PH12020551740A patent/PH12020551740A1/en unknown
- 2020-11-03 CL CL2020002844A patent/CL2020002844A1/es unknown
- 2020-11-23 US US17/101,585 patent/US20210154302A1/en active Pending
-
2021
- 2021-11-29 CY CY20211101043T patent/CY1124772T1/el unknown
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