[go: up one dir, main page]

AR079896A1 - Proceso para preparar composiciones farmaceuticas para la liberacion sostenida de analogos de somatostatina - Google Patents

Proceso para preparar composiciones farmaceuticas para la liberacion sostenida de analogos de somatostatina

Info

Publication number
AR079896A1
AR079896A1 ARP110100112A ARP110100112A AR079896A1 AR 079896 A1 AR079896 A1 AR 079896A1 AR P110100112 A ARP110100112 A AR P110100112A AR P110100112 A ARP110100112 A AR P110100112A AR 079896 A1 AR079896 A1 AR 079896A1
Authority
AR
Argentina
Prior art keywords
composition
weight
acetic acid
lanreotide
pharmaceutical compositions
Prior art date
Application number
ARP110100112A
Other languages
English (en)
Inventor
Thomas Ciaran Loughman
Chantal Roume
Roland Cherif-Cheikh
Martin Montes
Original Assignee
Ipsen Pharma Sas
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 Ipsen Pharma Sas filed Critical Ipsen Pharma Sas
Publication of AR079896A1 publication Critical patent/AR079896A1/es

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/08Peptides having 5 to 11 amino acids
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/04Peptides having up to 20 amino acids in a fully defined sequence; Derivatives thereof
    • A61K38/12Cyclic peptides, e.g. bacitracins; Polymyxins; Gramicidins S, C; Tyrocidins A, B or C
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22Hormones
    • A61K38/31Somatostatins
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/02Drugs for disorders of the endocrine system of the hypothalamic hormones, e.g. TRH, GnRH, CRH, GRH, somatostatin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/06Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
    • A61P5/08Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH for decreasing, blocking or antagonising the activity of the anterior pituitary hormones
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K7/00Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04Linear peptides containing only normal peptide links
    • C07K7/06Linear peptides containing only normal peptide links having 5 to 11 amino acids

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Zoology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)

Abstract

Proceso para preparar composiciones farmacéuticas inyectables para la liberacion sostenida de análogos de somatostatina y composiciones farmacéuticas preparadas de acuerdo con el proceso. En un aspecto preferido, el proceso comprende los pasos de combinar acetato de lanreotido y ácido acético, liofilizar la mezcla resultante una sola vez e hidratar el liofilizado. Puede agregarse ácido acético hasta alcanzar el pH deseado durante el paso final del proceso. Reivindicacion 3: El proceso de la reivindicacion 1, caracterizado porque el ácido es el ácido acético. Reivindicacion 4: El proceso de la reivindicacion 1, caracterizado porque el pH final de la composicion varía entre 5,8 y 6,4. Reivindicacion 7: El proceso de la reivindicacion 1, caracterizado porque en el primer paso se combinan 25 +- 2 g/l de lanreotido y 15 +- 2% en peso de ácido acético. Reivindicacion 12: El proceso de acuerdo con cualquiera de las reivindicaciones 1 a 10, caracterizado porque la cantidad de agua en la que se disuelve el liofilizado es menor que 50%, preferiblemente menor que 30%, más preferiblemente menor que 10% de la cantidad necesaria para disolver completamente la sal de lanreotido, y está adaptada para conferirle a la composicion una consistencia semisolida. Reivindicacion 14: La composicion de la reivindicacion 12, caracterizada porque puede liberar el lanreotido in vivo durante un período de al menos 15 días, preferiblemente de 1 mes, y más preferiblemente de 2 meses. Reivindicacion 15: La composicion de las reivindicaciones 12 o 13, caracterizada porque comprende entre 15 y 35% en peso, preferiblemente 25 +- 5% en peso, y más preferiblemente aproximadamente 24,6 +- 2,5% en peso de lanreotido en forma de base. Reivindicacion 16: La composicion de cualquiera de las reivindicaciones 12 a 14, caracterizada porque es apropiada para usarla después de almacenarla a entre 2 y 8°C durante más de 12 meses, preferiblemente durante más de 24 meses.
ARP110100112A 2010-01-13 2011-01-13 Proceso para preparar composiciones farmaceuticas para la liberacion sostenida de analogos de somatostatina AR079896A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US29464410P 2010-01-13 2010-01-13

Publications (1)

Publication Number Publication Date
AR079896A1 true AR079896A1 (es) 2012-02-29

Family

ID=43743499

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP110100112A AR079896A1 (es) 2010-01-13 2011-01-13 Proceso para preparar composiciones farmaceuticas para la liberacion sostenida de analogos de somatostatina

Country Status (24)

Country Link
US (3) US9352012B2 (es)
EP (2) EP2523653B1 (es)
JP (1) JP6029472B2 (es)
KR (1) KR101915820B1 (es)
CN (2) CN105456206B (es)
AR (1) AR079896A1 (es)
AU (1) AU2011206728B2 (es)
BR (1) BR112012017435A2 (es)
CA (1) CA2786181C (es)
DK (1) DK2523653T3 (es)
EA (1) EA023128B1 (es)
ES (1) ES2677012T3 (es)
HU (1) HUE038200T2 (es)
IL (2) IL220538A (es)
MX (1) MX343112B (es)
NZ (1) NZ600891A (es)
PL (1) PL2523653T3 (es)
PT (1) PT2523653T (es)
SG (1) SG182548A1 (es)
TR (1) TR201809874T4 (es)
TW (2) TW201600108A (es)
UA (1) UA108872C2 (es)
WO (1) WO2011085957A2 (es)
ZA (1) ZA201205160B (es)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6029472B2 (ja) 2010-01-13 2016-11-24 イプセン ファルマ ソシエテ パール アクシオン サンプリフィエIpsen Pharma S.A.S. ソマトスタチン類似体(アナログ)の持続的放出のための医薬組成物の製造方法
EP2823808A1 (en) * 2013-07-09 2015-01-14 Ipsen Pharma S.A.S. Pharmaceutical composition for a sustained release of lanreotide
TW201605488A (zh) 2013-10-15 2016-02-16 大塚製藥股份有限公司 用以預防及/或治療多囊腎病之藥物
EP3060230A4 (en) 2013-10-22 2017-06-14 Prolynx LLC Conjugates of somatostatin and its analogs
FR3079421B1 (fr) * 2018-03-28 2024-11-15 Edix Sa Presentations injectables, seringues et compositions a liberation prolongee et/ou controlee de lanreotide
GR1009814B (el) * 2019-07-29 2020-09-11 Φαρματεν Α.Β.Ε.Ε. Φαρμακευτικο σκευασμα που περιλαμβανει ενα πεπτιδιο αναλογο σωματοστατινης
RU2742196C1 (ru) * 2019-09-11 2021-02-03 Общество с ограниченной ответственностью "Медицинские нанотехнологии" Фармацевтическая композиция для приготовления инъекционного раствора при использовании в лечении магнитной гипертермии и способ ее получения
CN112791177B (zh) * 2019-10-28 2023-06-20 深圳翰宇药业股份有限公司 注射用生长抑素冻干组合物及其制备方法
LU101974B1 (en) 2020-08-07 2022-02-07 Pharmathen Sa Process and apparatus for preparing viscous pharmaceutical formulations
EP4445950A3 (en) 2020-08-07 2024-12-11 Pharmathen S.A. Process and apparatus for preparing viscous pharmaceutical formulations
GR1010059B (el) * 2020-08-10 2021-08-13 Φαρματεν Α.Β.Ε.Ε. Διαδικασια και συσκευη για την παρασκευη παχυρευστων φαρμακοτεχνικων μορφων
WO2023092148A1 (en) * 2021-11-22 2023-05-25 SpecGx LLC Injectable sustained release pharmaceutical composition

Family Cites Families (20)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH085913B2 (ja) 1985-09-12 1996-01-24 ザ・アドミニストレ−タ−ズ・オブ・ザ・ツ−レイン・エデユケイシヨナル・フアンド 治療用ソマトスタチン同族体
PT1288223E (pt) 1993-08-09 2005-03-31 Sod Conseils Rech Applic Derivados de peptidos terapeuticos
US5595760A (en) 1994-09-02 1997-01-21 Delab Sustained release of peptides from pharmaceutical compositions
FR2762319A1 (fr) * 1997-04-18 1998-10-23 Pharma Biotech Microcapsules presentant une liberation prolongee et leur procede de preparation
FR2776520B1 (fr) * 1998-03-25 2000-05-05 Sod Conseils Rech Applic Nouvelles compositions pharmaceutiques destinees a la liberation prolongee de peptides et leur procede de preparation
TWI294991B (en) * 1999-09-02 2008-03-21 Fujitsu Ltd Negative resist composition, method for the formation of resist patterns and process for the production of electronic devices
IT1318539B1 (it) 2000-05-26 2003-08-27 Italfarmaco Spa Composizioni farmaceutiche a rilascio prolungato per lasomministrazione parenterale di sostanze idrofile biologicamente
US7098305B2 (en) 2001-09-06 2006-08-29 Ardana Bioscience Limited Sustained release of microcrystalline peptide suspensions
DK1565160T3 (da) 2002-09-27 2014-04-28 Terna Zentaris Gmbh Administrationsform til farmaceutisk aktive peptider med vedvarende frigivelse og en fremgangsmåde til fremstilling deraf
CN1415378A (zh) * 2002-10-22 2003-05-07 南京长澳医药科技有限公司 生长抑素冻干粉针及其制备工艺
US6953447B2 (en) 2002-10-22 2005-10-11 Societe De Conseils De Recherches Et D'applications Scientifiques (S.C.R.A.S) Pre-filled safety injection device with integrated waste collector
GB0428151D0 (en) 2004-12-22 2005-01-26 Novartis Ag Organic compounds
US8158152B2 (en) * 2005-11-18 2012-04-17 Scidose Llc Lyophilization process and products obtained thereby
GB0711656D0 (en) 2007-06-15 2007-07-25 Camurus Ab Formulations
WO2009033741A2 (en) * 2007-09-11 2009-03-19 Mondobiotech Laboratories Ag Use of lvv-hemorphin-6 and optionally af12198 as therapeutic agent(s)
US20090181068A1 (en) 2008-01-14 2009-07-16 Dunn Richard L Low Viscosity Liquid Polymeric Delivery System
RU2504360C2 (ru) 2008-08-12 2014-01-20 Новартис Аг Фармацевтические композиции
EP2168983A1 (fr) 2008-09-30 2010-03-31 Ipsen Pharma Nouveaux composés octapeptidiques et leur utilisation thérapeutique
US20110250243A1 (en) 2008-12-15 2011-10-13 Thomas Kissel Nanoparticle compositions
JP6029472B2 (ja) * 2010-01-13 2016-11-24 イプセン ファルマ ソシエテ パール アクシオン サンプリフィエIpsen Pharma S.A.S. ソマトスタチン類似体(アナログ)の持続的放出のための医薬組成物の製造方法

Also Published As

Publication number Publication date
TR201809874T4 (tr) 2018-07-23
EP2523653B1 (en) 2018-04-11
KR101915820B1 (ko) 2018-11-06
NZ600891A (en) 2014-05-30
EA201290637A1 (ru) 2013-01-30
CA2786181A1 (en) 2011-07-21
CN102711728A (zh) 2012-10-03
ES2677012T3 (es) 2018-07-27
WO2011085957A2 (en) 2011-07-21
DK2523653T3 (en) 2018-07-16
HK1222807A1 (zh) 2017-07-14
CN102711728B (zh) 2016-01-20
EP3378468A1 (en) 2018-09-26
EP2523653A2 (en) 2012-11-21
US20190167754A1 (en) 2019-06-06
BR112012017435A2 (pt) 2020-08-25
SG182548A1 (en) 2012-08-30
JP2013517228A (ja) 2013-05-16
HUE038200T2 (hu) 2018-09-28
CN105456206B (zh) 2018-12-14
AU2011206728A1 (en) 2012-08-30
TW201600108A (zh) 2016-01-01
WO2011085957A3 (en) 2012-05-03
MX343112B (es) 2016-10-25
US20160339075A1 (en) 2016-11-24
JP6029472B2 (ja) 2016-11-24
TWI536999B (zh) 2016-06-11
PL2523653T3 (pl) 2018-09-28
IL220538A (en) 2016-12-29
CN105456206A (zh) 2016-04-06
PT2523653T (pt) 2018-06-28
US9352012B2 (en) 2016-05-31
MX2012007802A (es) 2012-08-31
US10206968B2 (en) 2019-02-19
IL248510A0 (en) 2016-12-29
US20130079282A1 (en) 2013-03-28
ZA201205160B (en) 2013-03-27
UA108872C2 (uk) 2015-06-25
EA023128B1 (ru) 2016-04-29
AU2011206728B2 (en) 2016-02-04
CA2786181C (en) 2017-12-12
KR20120125576A (ko) 2012-11-15
TW201129371A (en) 2011-09-01
IL220538A0 (en) 2012-08-30

Similar Documents

Publication Publication Date Title
AR079896A1 (es) Proceso para preparar composiciones farmaceuticas para la liberacion sostenida de analogos de somatostatina
ES2656901T3 (es) Una formulación estabilizada de pemetrexed
ECSP15039103A (es) Formulación de liberación sostenida de mosapride que proporciona efectos farmacológicos y clínicos con administración una vez al día
PE20130511A1 (es) Formulaciones de insulina de accion prolongada
PE20200698A1 (es) Gel que comprende clorhexidina
PE20120204A1 (es) Metodo y formulacion para reducir la agregacion de una macromolecula bajo condiciones fisiologicas
AR081364A1 (es) Composiciones farmaceuticas de pazopanib y metodos para su elaboracion
RU2015137145A (ru) Новые жидкие композиции с повышенной стабильностью
BR112014009087A2 (pt) formulações de etanercept estabilizadas com xilitol
PE20121405A1 (es) Excipiente solubilizante para vacunas de virus completo inactivado
AR087857A1 (es) Composiciones de yodo-povidona estable
CO6270302A2 (es) Formulaciones solidas de liberacion rapida que incluyen florfenicol y sales farmaceuticamente aceptables del mismo.
JP2015506989A5 (es)
PE20151205A1 (es) Formulaciones que contienen linaclotida para administracion oral
HRP20201948T1 (hr) Pripravci inhibitora dopa-dekarbokilaze
AR077384A1 (es) Una formulacion farmaceutica inyectable de melfalano.
RU2013133082A (ru) Композиции тестостерона
AR081870A1 (es) Composicion farmaceutica que comprende un derivado de amida o sal farmaceuticamente aceptable del mismo
AR082049A1 (es) Formulaciones liquidas de rupatadina fumarato
PE20140636A1 (es) Conjugado de naloxol-peg cristalino
AR096854A1 (es) Composición farmacéutica para una liberación sostenida de lanreotide
PH12015500864A1 (en) Liquid formulation comprising gm-csf neutralizing compound
PH12013500552A1 (en) Enhanced transbuccal drug delivery system and compositions
HRP20140676T1 (hr) Formulacije deoksikolne kiseline i njezinih soli
PE20190707A1 (es) Formulaciones de buprenorfina de liberacion sostenida

Legal Events

Date Code Title Description
FA Abandonment or withdrawal
FC Refusal