BR112017007669A2 - composição farmacêutica com estabilidade melhorada - Google Patents

composição farmacêutica com estabilidade melhorada

Info

Publication number
BR112017007669A2
BR112017007669A2 BR112017007669A BR112017007669A BR112017007669A2 BR 112017007669 A2 BR112017007669 A2 BR 112017007669A2 BR 112017007669 A BR112017007669 A BR 112017007669A BR 112017007669 A BR112017007669 A BR 112017007669A BR 112017007669 A2 BR112017007669 A2 BR 112017007669A2
Authority
BR
Brazil
Prior art keywords
lactate
based polymer
pharmaceutical composition
improved stability
lactide monomer
Prior art date
Application number
BR112017007669A
Other languages
English (en)
Inventor
J Guarino Andrew
Li Yuhua
Original Assignee
J Guarino Andrew
Foresee Pharmaceuticals Co Ltd
Li Yuhua
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 J Guarino Andrew, Foresee Pharmaceuticals Co Ltd, Li Yuhua filed Critical J Guarino Andrew
Publication of BR112017007669A2 publication Critical patent/BR112017007669A2/pt

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/04—Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08—Peptides having 5 to 11 amino acids
    • A61K38/09—Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • 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
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/593—Polyesters, e.g. PLGA or polylactide-co-glycolide
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P13/00—Preparation of nitrogen-containing organic compounds
    • C12P13/04—Alpha- or beta- amino acids

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Reproductive Health (AREA)
  • Endocrinology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Immunology (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Wood Science & Technology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Microbiology (AREA)
  • Pregnancy & Childbirth (AREA)
  • Biotechnology (AREA)
  • Gynecology & Obstetrics (AREA)
  • Biochemistry (AREA)
  • General Engineering & Computer Science (AREA)
  • Genetics & Genomics (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

a presente invenção fornece uma composição injetável para entrega de fármaco de liberação controlada e o processo de fazer a mesma, em que a composição compreende: um polímero à base de lactato que tem um peso molecular ponderal médio entre 5.000 e 50.000 dáltons, um número de acidez menor que 3 mgkoh/g e o teor de monômeros de lactídeo residual no polímero à base de lactato menor que cerca de 0,3% em peso; um solvente orgânico farmaceuticamente aceitável; e uma substância bioativa ou um sal da mesma que contém uma serina de aminoácido na estrutura molecular que tem capacidade de reagir com o monômero de lactídeo para formar um conjugado; e em que a composição reduz a formação do conjugado.
BR112017007669A 2014-10-15 2015-10-15 composição farmacêutica com estabilidade melhorada BR112017007669A2 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201462064008P 2014-10-15 2014-10-15
PCT/US2015/055634 WO2016061296A1 (en) 2014-10-15 2015-10-15 Pharmaceutical composition with improved stability

Publications (1)

Publication Number Publication Date
BR112017007669A2 true BR112017007669A2 (pt) 2017-12-19

Family

ID=55747307

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112017007669A BR112017007669A2 (pt) 2014-10-15 2015-10-15 composição farmacêutica com estabilidade melhorada

Country Status (20)

Country Link
US (2) US20160106804A1 (pt)
EP (1) EP3207149B1 (pt)
JP (2) JP6717839B2 (pt)
KR (2) KR102274420B1 (pt)
CN (2) CN107075541B (pt)
AU (2) AU2015332456A1 (pt)
BR (1) BR112017007669A2 (pt)
CA (1) CA2964475C (pt)
ES (1) ES2949827T3 (pt)
HR (1) HRP20230716T1 (pt)
HU (1) HUE062326T2 (pt)
IL (1) IL251703B (pt)
MX (2) MX2017005235A (pt)
NZ (1) NZ730538A (pt)
PL (1) PL3207149T3 (pt)
RS (1) RS64339B1 (pt)
RU (1) RU2728786C2 (pt)
SA (1) SA517381298B1 (pt)
SG (1) SG11201702535QA (pt)
WO (1) WO2016061296A1 (pt)

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20160106804A1 (en) * 2014-10-15 2016-04-21 Yuhua Li Pharmaceutical composition with improved stability
US11046810B2 (en) * 2017-01-04 2021-06-29 Pharmathen S.A. Process for preparing biodegradable polymers of high molecular weight
US20200282008A1 (en) * 2017-01-31 2020-09-10 Veru Inc. COMPOSITIONS AND METHODS FOR LONG TERM RELEASE OF GONADOTROPIN-RELEASING HORMONE (GnRH) ANTAGONISTS
HUE058207T2 (hu) * 2017-01-31 2022-07-28 Veru Inc Készítmények és módszerek gonadotropin felszabadító hormon (GNRH) antagonisták elnyújtott idejû felszabadítására
CN111511385B (zh) * 2017-12-18 2024-05-03 逸达生物科技股份有限公司 具有选定的释放持续时间的药物组合物
BR112024002231A2 (pt) 2021-08-05 2024-04-30 Medincell S A Composição farmacêutica

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JPS60100516A (ja) * 1983-11-04 1985-06-04 Takeda Chem Ind Ltd 徐放型マイクロカプセルの製造法
DE3708916A1 (de) 1987-03-19 1988-09-29 Boehringer Ingelheim Kg Verfahren zur reinigung resorbierbarer polyester
US5702716A (en) 1988-10-03 1997-12-30 Atrix Laboratories, Inc. Polymeric compositions useful as controlled release implants
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JP5242415B2 (ja) * 2006-01-18 2013-07-24 フォアシーエイサー ファーマシューティカルズ インコーポレイテッド 高い安定性を持つ薬理組成物
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Also Published As

Publication number Publication date
MX2017005235A (es) 2019-12-11
CN107075541B (zh) 2021-06-25
NZ730538A (en) 2024-01-26
RS64339B1 (sr) 2023-08-31
AU2015332456A1 (en) 2017-04-13
EP3207149B1 (en) 2023-06-07
ES2949827T3 (es) 2023-10-03
RU2728786C2 (ru) 2020-07-31
AU2019279929A1 (en) 2020-01-16
EP3207149A4 (en) 2018-06-13
RU2017111079A (ru) 2018-11-15
HRP20230716T1 (hr) 2023-10-13
EP3207149C0 (en) 2023-06-07
SG11201702535QA (en) 2017-04-27
KR20190029783A (ko) 2019-03-20
IL251703B (en) 2021-03-25
JP6928695B2 (ja) 2021-09-01
JP2017531697A (ja) 2017-10-26
RU2017111079A3 (pt) 2019-05-17
PL3207149T3 (pl) 2023-08-21
KR20170070176A (ko) 2017-06-21
KR102134873B1 (ko) 2020-07-17
IL251703A0 (en) 2017-06-29
CN113209009A (zh) 2021-08-06
WO2016061296A1 (en) 2016-04-21
KR102274420B1 (ko) 2021-07-08
CN107075541A (zh) 2017-08-18
HUE062326T2 (hu) 2023-10-28
US20160106804A1 (en) 2016-04-21
SA517381298B1 (ar) 2021-12-18
EP3207149A1 (en) 2017-08-23
CA2964475A1 (en) 2016-04-21
AU2019279929B2 (en) 2021-02-25
JP2020147595A (ja) 2020-09-17
JP6717839B2 (ja) 2020-07-08
CA2964475C (en) 2020-03-24
MX2022003939A (es) 2022-04-25
US20220160817A1 (en) 2022-05-26

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Legal Events

Date Code Title Description
B15I Others concerning applications: loss of priority

Free format text: PERDA DA PRIORIDADE US 62/064,008, DE 15/10/2014, CONFORME AS DISPOSICOES PREVISTAS NA LEI 9.279 DE 14/05/1996 (LPI) ART. 16 7O E NO ART. 29 DA RESOLUCAO INPI-PR 77/2013, POR NAO ATENDER AO DISPOSTO NO ART. 2 DA RESOLUCAO INPI-PR 179/2017, POIS NAO FOI APRESENTADA CESSAO DA REFERIDA PRIORIDADE, QUE POSSUI DEPOSITANTE DIFERENTE DO DEPOSITANTE DA FASE NACIONAL.

B151 Others concerning applications: resolution cancelled [chapter 15.31 patent gazette]
B11A Dismissal acc. art.33 of ipl - examination not requested within 36 months of filing
B11Y Definitive dismissal - extension of time limit for request of examination expired [chapter 11.1.1 patent gazette]