CA2474698A1 - Polymer-based compositions for sustained release - Google Patents
Polymer-based compositions for sustained release Download PDFInfo
- Publication number
- CA2474698A1 CA2474698A1 CA002474698A CA2474698A CA2474698A1 CA 2474698 A1 CA2474698 A1 CA 2474698A1 CA 002474698 A CA002474698 A CA 002474698A CA 2474698 A CA2474698 A CA 2474698A CA 2474698 A1 CA2474698 A1 CA 2474698A1
- Authority
- CA
- Canada
- Prior art keywords
- sustained release
- polymer
- fsh
- compositions
- stabilized
- Prior art date
- Legal status (The legal status 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 status listed.)
- Granted
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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
- A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/22—Hormones
- A61K38/24—Follicle-stimulating hormone [FSH]; Chorionic gonadotropins, e.g. HCG; Luteinising hormone [LH]; Thyroid-stimulating hormone [TSH]
-
- 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
- A61K47/02—Inorganic compounds
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
-
- 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
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/06—Drugs for disorders of the endocrine system of the anterior pituitary hormones, e.g. TSH, ACTH, FSH, LH, PRL, GH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P5/00—Drugs for disorders of the endocrine system
- A61P5/10—Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1611—Inorganic compounds
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1617—Organic compounds, e.g. phospholipids, fats
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1682—Processes
- A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate 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
Abstract
This invention relates to sustained release compositions, and methods of forming and using said compositions, in particular for the sustained release of Follicle Stimulating Hormone (FSH). The sustained release compositions comprise a polymeric matrix of a biodegradable biocompatible polymer and stabilized FSH. The method of the invention for forming a sustained release composition includes, dissolving a biodegradable biocompatible polymer in a polymer solvent to form a polymer solution; adding biologically active stabilized FSH; removing the solvent; and solidifying the polymer to form a polymer matrix containing stabilized FSH dispersed therein. Also described is a method for providing a therapeutically effective amount of stabilized FSH in a patient in need of for a sustained period comprising administering to the patient a dose of the sustained release compositions of the invention. The sustained release composition of FSH can be used to promote maturation of follicles, promote spermatogenesis and to treat fertility disorders.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US35515902P | 2002-02-08 | 2002-02-08 | |
US60/355,159 | 2002-02-08 | ||
PCT/US2003/003981 WO2003066585A2 (en) | 2002-02-08 | 2003-02-07 | Polymer-based compositions for sustained release |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2474698A1 true CA2474698A1 (en) | 2003-08-14 |
CA2474698C CA2474698C (en) | 2009-07-21 |
Family
ID=27734472
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002474698A Expired - Fee Related CA2474698C (en) | 2002-02-08 | 2003-02-07 | Polymer-based compositions for sustained release |
Country Status (9)
Country | Link |
---|---|
US (1) | US20040028733A1 (en) |
EP (1) | EP1471891A4 (en) |
JP (1) | JP2005517012A (en) |
AU (1) | AU2003217367B2 (en) |
CA (1) | CA2474698C (en) |
IL (1) | IL163218A (en) |
NZ (1) | NZ535008A (en) |
WO (1) | WO2003066585A2 (en) |
ZA (1) | ZA200405852B (en) |
Families Citing this family (42)
Publication number | Priority date | Publication date | Assignee | Title |
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US20040234602A1 (en) * | 2001-09-21 | 2004-11-25 | Gina Fischer | Polymer release system |
US20040253310A1 (en) | 2001-09-21 | 2004-12-16 | Gina Fischer | Morphine polymer release system |
US20050019380A1 (en) * | 2002-04-26 | 2005-01-27 | Xylos Corporation | Microbial cellulose wound dressing for treating chronic wounds |
AU2003277446A1 (en) | 2002-10-17 | 2004-05-04 | Alkermes Controlled Therapeutics, Inc. Ii | Microencapsulation and sustained release of biologically active polypeptides |
ES2360102T3 (en) | 2003-03-26 | 2011-05-31 | Egalet A/S | SYSTEM FOR CONTROLLED RELEASE OF MORPHINE. |
KR101105486B1 (en) | 2003-04-02 | 2012-01-13 | 아레스 트레이딩 에스.에이. | Liquid pharmaceutical formulations of FSH and LH together with a non-ionic surfactant |
US7090433B2 (en) * | 2003-10-07 | 2006-08-15 | Steve Searby | Underground cable laying apparatus |
MXPA06011924A (en) | 2004-04-15 | 2007-06-11 | Alkermes Inc | Polymer-based sustained release device. |
US7456254B2 (en) | 2004-04-15 | 2008-11-25 | Alkermes, Inc. | Polymer-based sustained release device |
NZ550926A (en) | 2004-05-17 | 2010-01-29 | Ares Trading Sa | Hydrogel interferon formulations |
UA92146C2 (en) | 2004-06-01 | 2010-10-11 | Эйрэс Трейдинг С.А. | Stabilized interferon liquid formulations |
US7238974B2 (en) * | 2004-10-29 | 2007-07-03 | Infineon Technologies Ag | Semiconductor device and method of producing a semiconductor device |
US11246913B2 (en) | 2005-02-03 | 2022-02-15 | Intarcia Therapeutics, Inc. | Suspension formulation comprising an insulinotropic peptide |
CA2611081C (en) * | 2005-06-03 | 2016-05-31 | Egalet A/S | A drug delivery system for delivering active substances dispersed in a dispersion medium |
KR101105871B1 (en) * | 2005-09-27 | 2012-01-16 | 주식회사 엘지생명과학 | hFSF Aqueous Formulation |
ES2422864T3 (en) | 2006-08-09 | 2013-09-16 | Intarcia Therapeutics, Inc | Osmotic release systems and piston units |
AU2007234612B2 (en) * | 2006-12-14 | 2013-06-27 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein stabilization formulations |
NZ577560A (en) * | 2007-01-16 | 2012-01-12 | Egalet Ltd | Use of i) a polyglycol and ii) an active drug substance for the preparation of a pharmaceutical composition for i) mitigating the risk of alcohol induced dose dumping and/or ii) reducing the risk of drug abuse |
RU2440097C2 (en) | 2007-04-23 | 2012-01-20 | Интарсия Терапьютикс, Инк. | Method of treating insulin-independent diabetes and obesity, osmotic delivery system and method for making it |
AU2008258596B2 (en) | 2007-06-04 | 2013-02-14 | Egalet Ltd | Controlled release pharmaceutical compositions for prolonged effect |
US7678764B2 (en) | 2007-06-29 | 2010-03-16 | Johnson & Johnson Regenerative Therapeutics, Llc | Protein formulations for use at elevated temperatures |
CA2695697A1 (en) | 2007-08-07 | 2009-02-12 | Advanced Technologies And Regenerative Medicine, Llc | Protein formulations comprising gdf-5 in aqueous acidic solution |
WO2009043843A1 (en) * | 2007-10-01 | 2009-04-09 | Universite Catholique De Louvain | Scaffolds for follicle transplantation |
US20100323441A1 (en) * | 2007-12-13 | 2010-12-23 | Biocell Center S.P.A. | Method of collection and preservation of fluids and/or materials, in particular of organic fluids and/or materials containing stem cells, and device employable in such method |
WO2009080699A2 (en) | 2007-12-20 | 2009-07-02 | Merck Serono S.A. | Peg-interferon-beta formulations |
EP2240155B1 (en) | 2008-02-13 | 2012-06-06 | Intarcia Therapeutics, Inc | Devices, formulations, and methods for delivery of multiple beneficial agents |
AU2009236459B2 (en) * | 2008-04-14 | 2013-07-25 | Advanced Technologies And Regenerative Medicine, Llc | Liquid buffered GDF-5 formulations |
CN101269215B (en) * | 2008-05-15 | 2011-03-23 | 上海天伟生物制药有限公司 | Glucoprotein incretion composition |
NZ594207A (en) | 2009-02-06 | 2013-03-28 | Egalet Ltd | Immediate release composition resistant to abuse by intake of alcohol |
EP2445487A2 (en) | 2009-06-24 | 2012-05-02 | Egalet Ltd. | Controlled release formulations |
EP3323423B1 (en) | 2009-09-28 | 2020-06-17 | Intarcia Therapeutics, Inc | Rapid establishment and/or termination of substantial steady-state drug delivery |
KR101042302B1 (en) * | 2010-12-27 | 2011-06-17 | 위재영 | The housing for exterior imaging device of the vehicle |
US20120208755A1 (en) | 2011-02-16 | 2012-08-16 | Intarcia Therapeutics, Inc. | Compositions, Devices and Methods of Use Thereof for the Treatment of Cancers |
IN2014DN06817A (en) * | 2012-01-19 | 2015-05-22 | Natrix Separations Inc | |
EP2877161A1 (en) | 2012-07-06 | 2015-06-03 | Egalet Ltd. | Abuse deterrent pharmaceutical compositions for controlled release |
US9889085B1 (en) | 2014-09-30 | 2018-02-13 | Intarcia Therapeutics, Inc. | Therapeutic methods for the treatment of diabetes and related conditions for patients with high baseline HbA1c |
EP3302354B1 (en) | 2015-06-03 | 2023-10-04 | i2o Therapeutics, Inc. | Implant placement systems |
WO2017200943A1 (en) | 2016-05-16 | 2017-11-23 | Intarcia Therapeutics, Inc. | Glucagon-receptor selective polypeptides and methods of use thereof |
USD860451S1 (en) | 2016-06-02 | 2019-09-17 | Intarcia Therapeutics, Inc. | Implant removal tool |
USD840030S1 (en) | 2016-06-02 | 2019-02-05 | Intarcia Therapeutics, Inc. | Implant placement guide |
KR20190104039A (en) | 2017-01-03 | 2019-09-05 | 인타르시아 세라퓨틱스 인코포레이티드 | Methods Including Continuous Administration of GLP-1 Receptor Agonists and Co-administration of Drugs |
US11376220B2 (en) * | 2017-06-30 | 2022-07-05 | Therio, LLC | Single-injection methods and formulations to induce and control multiple ovarian follicles in bovine, caprine, ovine, camelid and other female animals |
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BE634668A (en) * | 1962-07-11 | |||
BE744162A (en) * | 1969-01-16 | 1970-06-15 | Fuji Photo Film Co Ltd | ENCAPSULATION PROCESS |
DE2010115A1 (en) * | 1970-03-04 | 1971-09-16 | Farbenfabriken Bayer Ag, 5090 Leverkusen | Process for the production of micro-granules |
JPS523342B2 (en) * | 1972-01-26 | 1977-01-27 | ||
GB1413186A (en) * | 1973-06-27 | 1975-11-12 | Toyo Jozo Kk | Process for encapsulation of medicaments |
US4389330A (en) * | 1980-10-06 | 1983-06-21 | Stolle Research And Development Corporation | Microencapsulation process |
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US4923805A (en) * | 1983-11-02 | 1990-05-08 | Integrated Genetics, Inc. | Fsh |
US5639639A (en) * | 1983-11-02 | 1997-06-17 | Genzyme Corporation | Recombinant heterodimeric human fertility hormones, and methods, cells, vectors and DNA for the production thereof |
US4840896A (en) * | 1983-11-02 | 1989-06-20 | Integrated Genetics, Inc. | Heteropolymeric protein |
US6217911B1 (en) * | 1995-05-22 | 2001-04-17 | The United States Of America As Represented By The Secretary Of The Army | sustained release non-steroidal, anti-inflammatory and lidocaine PLGA microspheres |
US5019400A (en) * | 1989-05-01 | 1991-05-28 | Enzytech, Inc. | Very low temperature casting of controlled release microspheres |
MY107937A (en) * | 1990-02-13 | 1996-06-29 | Takeda Chemical Industries Ltd | Prolonged release microcapsules. |
US5384132A (en) * | 1990-03-20 | 1995-01-24 | Akzo N.V. | Stabilized gonadotropin containing preparations |
IT1250075B (en) * | 1991-12-18 | 1995-03-30 | Serono Cesare Ist Ricerca | PHARMACEUTICAL COMPOSITIONS CONTAINING GONADOTROPINE. |
EP0674506B1 (en) * | 1992-12-02 | 2000-08-23 | Alkermes Controlled Therapeutics, Inc. | Controlled release growth hormone containing microspheres |
US6447796B1 (en) * | 1994-05-16 | 2002-09-10 | The United States Of America As Represented By The Secretary Of The Army | Sustained release hydrophobic bioactive PLGA microspheres |
US6117455A (en) * | 1994-09-30 | 2000-09-12 | Takeda Chemical Industries, Ltd. | Sustained-release microcapsule of amorphous water-soluble pharmaceutical active agent |
US5922253A (en) * | 1995-05-18 | 1999-07-13 | Alkermes Controlled Therapeutics, Inc. | Production scale method of forming microparticles |
FR2744367B1 (en) * | 1996-02-02 | 1999-07-09 | Emperaire Jean Claude | MEDICATIONS FOR OVULATION TRIGGERING |
JP2001522812A (en) * | 1997-11-07 | 2001-11-20 | カイロン コーポレイション | Methods of making IGF-1 sustained release formulations |
CA2335460A1 (en) * | 1998-06-18 | 1999-12-23 | Johns Hopkins University School Of Medicine | Polymers for delivery of nucleic acids |
JP2003501375A (en) * | 1999-06-04 | 2003-01-14 | アルザ・コーポレーション | Implantable gel composition and method of manufacture |
US6284283B1 (en) * | 1999-10-21 | 2001-09-04 | Alkermes Controlled Therapeutics, Inc. | Method of producing sub-micron particles of biologically active agents and uses thereof |
-
2003
- 2003-02-07 JP JP2003565960A patent/JP2005517012A/en active Pending
- 2003-02-07 US US10/361,797 patent/US20040028733A1/en not_active Abandoned
- 2003-02-07 CA CA002474698A patent/CA2474698C/en not_active Expired - Fee Related
- 2003-02-07 NZ NZ535008A patent/NZ535008A/en not_active IP Right Cessation
- 2003-02-07 EP EP03713410A patent/EP1471891A4/en not_active Withdrawn
- 2003-02-07 AU AU2003217367A patent/AU2003217367B2/en not_active Ceased
- 2003-02-07 WO PCT/US2003/003981 patent/WO2003066585A2/en active IP Right Grant
-
2004
- 2004-07-22 ZA ZA200405852A patent/ZA200405852B/en unknown
- 2004-07-26 IL IL163218A patent/IL163218A/en not_active IP Right Cessation
Also Published As
Publication number | Publication date |
---|---|
JP2005517012A (en) | 2005-06-09 |
WO2003066585A2 (en) | 2003-08-14 |
ZA200405852B (en) | 2005-01-24 |
AU2003217367B2 (en) | 2005-09-08 |
AU2003217367A1 (en) | 2003-09-02 |
EP1471891A4 (en) | 2007-04-11 |
IL163218A (en) | 2009-11-18 |
US20040028733A1 (en) | 2004-02-12 |
EP1471891A2 (en) | 2004-11-03 |
NZ535008A (en) | 2005-09-30 |
CA2474698C (en) | 2009-07-21 |
WO2003066585A3 (en) | 2004-03-11 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
MKLA | Lapsed |
Effective date: 20140207 |