PE20210047A1 - Composicion inyectable - Google Patents

Composicion inyectable

Info

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
Application number
PE2020001597A
Other languages
English (en)
Inventor
Rodriguez Guillermo Franco
Aduriz Ibon Gutierro
Original Assignee
Farm Rovi Lab Sa
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Farm Rovi Lab Sa filed Critical Farm Rovi Lab Sa
Publication of PE20210047A1 publication Critical patent/PE20210047A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/41961,2,4-Triazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41Heterocyclic 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
    • A61K31/425Thiazoles
    • A61K31/4261,3-Thiazoles
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods 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
    • A61L2/0017Filtration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L2/00Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
    • A61L2/0005Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor for pharmaceuticals, biologicals or living parts
    • A61L2/0011Methods 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
    • A61L2/0029Radiation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic 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.
PE2020001597A 2018-06-12 2019-06-06 Composicion inyectable PE20210047A1 (es)

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) CN112004525A (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)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP4203917A1 (en) * 2020-08-25 2023-07-05 Merck Sharp & Dohme LLC Injectable depot compositions for the delivery of antiviral agents

Family Cites Families (11)

* Cited by examiner, † Cited by third party
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
US20120225033A1 (en) 2010-11-24 2012-09-06 Durect Corporation Biodegradable Drug Delivery Composition
GB0517673D0 (en) 2005-08-31 2005-10-05 Astrazeneca Ab Formulation
ZA200804207B (en) * 2005-10-21 2009-10-28 Panacea Biotec Ltd Pharmaceutical composition comprising at least one anticancer drug and at least one polymer
MX2009003737A (es) 2006-10-05 2009-06-16 Panacea Biotec Ltd Composicion inyectable en deposito y su procedimiento de preparacion.
WO2009060473A2 (en) 2007-11-06 2009-05-14 Panacea Biotec Limited Injectable compositions, processes and uses thereof
US20100144687A1 (en) 2008-12-05 2010-06-10 Glaser Rebecca L Pharmaceutical compositions containing testosterone and an aromatase inhibitor
US10285936B2 (en) * 2010-05-31 2019-05-14 Laboratorios Farmacéuticos Rovi, S.A. Injectable composition with aromatase inhibitor
ES2390439B1 (es) * 2012-08-03 2013-09-27 Laboratorios Farmacéuticos Rovi, S.A. Composición inyectable
PT2394663T (pt) * 2010-05-31 2021-11-26 Farm Rovi Lab Sa Composições para implantes biodegradáveis injectáveis
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

Also Published As

Publication number Publication date
AU2019286572A1 (en) 2020-10-01
HUE057269T2 (hu) 2022-05-28
RS62681B1 (sr) 2021-12-31
CA3096918A1 (en) 2019-12-19
IL277802B2 (en) 2024-04-01
MA52502A (fr) 2020-12-09
JP7420735B2 (ja) 2024-01-23
WO2019238740A1 (en) 2019-12-19
IL277802B1 (en) 2023-12-01
BR112020020415A2 (pt) 2021-03-02
MX2020011732A (es) 2021-01-08
CL2020002844A1 (es) 2021-03-05
GEP20237501B (en) 2023-04-25
SG11202008744VA (en) 2020-10-29
SI3746047T1 (sl) 2022-02-28
EA202092021A1 (ru) 2021-03-23
JP2021527627A (ja) 2021-10-14
UA127087C2 (uk) 2023-04-05
MD3746047T2 (ro) 2022-02-28
PT3746047T (pt) 2021-11-26
EP3746047B1 (en) 2021-10-13
PL3746047T3 (pl) 2022-02-07
ZA202006113B (en) 2022-12-21
CY1124772T1 (el) 2022-11-25
CN112004525A (zh) 2020-11-27
US20210154302A1 (en) 2021-05-27
HRP20211874T1 (hr) 2022-03-04
CO2020012526A2 (es) 2020-12-10
PH12020551740A1 (en) 2021-06-07
ES2900171T3 (es) 2022-03-16
IL277802A (en) 2020-11-30
DK3746047T3 (da) 2021-12-06
EP3746047A1 (en) 2020-12-09
LT3746047T (lt) 2022-01-10
KR20210019402A (ko) 2021-02-22
MA52502B1 (fr) 2021-12-31

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