HUE032387T2 - Nagyon alacsony molekulatömegû polimereket tartalmazó nyújtott felszabadulású készítmények - Google Patents

Nagyon alacsony molekulatömegû polimereket tartalmazó nyújtott felszabadulású készítmények Download PDF

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Publication number
HUE032387T2
HUE032387T2 HUE07819363A HUE07819363A HUE032387T2 HU E032387 T2 HUE032387 T2 HU E032387T2 HU E07819363 A HUE07819363 A HU E07819363A HU E07819363 A HUE07819363 A HU E07819363A HU E032387 T2 HUE032387 T2 HU E032387T2
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mon mon
inu
formulation
semi
polymer
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HUE07819363A
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English (en)
Inventor
Roland Cherif-Cheikh
Sousa Delgado Anne-Paula De
Frederic Lacombe
Laurence Lachamp
Didier Bourissou
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Ipsen Pharma Sas
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Publication of HUE032387T2 publication Critical patent/HUE032387T2/hu

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    • 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
    • A61K38/30Insulin-like growth factors, i.e. somatomedins, e.g. IGF-1, IGF-2
    • 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
    • A61K38/09Luteinising hormone-releasing hormone [LHRH], i.e. Gonadotropin-releasing hormone [GnRH]; Related peptides
    • 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
    • A61K38/25Growth hormone-releasing factor [GH-RF], i.e. somatoliberin
    • 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
    • A61K38/26Glucagons
    • 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
    • A61K38/27Growth hormone [GH], i.e. somatotropin
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00Anaesthetics
    • A61P23/02Local anaesthetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00Drugs for disorders of the senses
    • A61P27/02Ophthalmic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/08Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/10Antimycotics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/10Drugs for disorders of the endocrine system of the posterior pituitary hormones, e.g. oxytocin, ADH
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00Drugs for disorders of the endocrine system
    • A61P5/24Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/34Gestagens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Endocrinology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Neurosurgery (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Reproductive Health (AREA)
  • Oncology (AREA)
  • Anesthesiology (AREA)
  • Communicable Diseases (AREA)
  • Hematology (AREA)
  • Ophthalmology & Optometry (AREA)
  • Emergency Medicine (AREA)
  • Obesity (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Claims (4)

  1. Saahadaimi igénypontok \ni ** t e* «aaeftntei tiVah vita**.\· e g-siiüoKee no e''"· a ' ok 'a tali' *z a) egy Je?J&amp;k!M£$^:-nagyon alaesorty moiekutemegâ bkidegs-adàih&amp;iô polimer* «Ä keverékét* amelynek tftrneg. «zerfati teopes osniekviaibnisge SüiMbbÛ Date» b) legalább :egy· hidnsnyagot vagy-eæek keverékét s. következő listából kiválasztva; ^^tidv pöb^gptid, protein., például imeinlaàlê homion (LHRH). p»jzsmsig> Ahrnilâlô hormon fïSRk kksxô sisfoulâlô hormon (FSH), pæratÎroid hormon (P?V%. 'tofc. '»övékedé·*» temm* növekedés! hpmxmt fôîssÂdtM kormon (QHRftk növekedési hormont teísxnbadiió pepiid, katotem és.«««« vegystleiek gyágyszerésxetiíeg elfogadható sói vagy ezek frognieosd, amely készítmény hozzáadott Mgitósxerek, lâgvhôsxerek, oidásxerefc vagy adalékanyagok nélkül vas éibálihva; és a lázárt lásycvégő hagytm slaesony taoieMattiis*# !>h>áspa#Ö«»ó· pföHa^í^iík^elim^ Ct-C'ss alkiksopomai vsa lezárva esnek karbonsav IÉíí««égzóddse bolyét*» és pohi laktid-ke-ghk:oliid)ok peliíejsav&amp;k, po!l(giikoísavák) és exbk&amp;vsrékes Rbxaí -«lifcm 2 A? L igénypont szerinti nyújtott feh.ssbadniású íeiig-sziklrd készkény, ahol &amp;?. alkiksoporí egy 5-12 svêbîfosîoî tartalmazd á%lf#öp*fc 4 A,·· 1 s.*g\ ' s..,eí-'<p<'. ni mt-nis nvnjîoti félszabadulásó leiig-sztlárd készitény, ahol &amp;;< sikiiesopott egy s sv..>; ü >mot tartatra» alknem \«s
  2. 4. Az l·? igénypontok bármelyike· Retint» nymimt: fclvahadttlátts féUg-a/ilatd kesxíiény, simbysllligy -szilárd késxiunens előállításánál a meglelde aihdmazoisi InkktiUs* hőmérséklet l>>0:'€ kbzöti van, 5. Λ 4. igénypont szerinu nyújtói; felvahadttüssö iekg-srilsrd ké*x:hény, amely·kásgítmátiy s:ioa *m ntl * nvetek ><. < L- s, ,.-= « - ! i s. o v, fi R tó > wxoíi sut 4 be í igénypont mono nsmtotí tets»\ät\5dnkkm tehg-s-xílúKi ksseneny- aboi a poim\i \agv I oponme; n i>k4 okbOiiKgr 740- 'Ogp lomon Won saa, előnyösen bob-ioon Halton kO,o't van. \ Λ* i igénypont ?*e««t} g>egy ^/etkészitnam^ nmek kvsrmnény nab>a»yap::r^öÄi»Äs.|j^8teÄ' vefcedást Hotmon t'tfcOH) vagy növekedési hormont tetebadhö bonbon (<GHRRt, srnmfinsxeró növekedési faktorok:{RïF-ekl, példán! lölAÍ, és kiíeinieiki bortnon (UiilH). 4 A -^:¾^ niniy tisgibÄy bstbspyap: imkontbbilbs teÄRPäf: nkii μ osnu hüo, vtys nbsek^eN, ·, no J.p i iou v ί I Ί1 ^ v \eOx'xO U ti \V\\ v. k'x \ \\ J'C \ x' tOV< X M'U! 1' I. V» $MvX &amp;>·>«> saerésaebleg elfogadható s4ja 10. A '?, igénvpooi izcrími gyôgyaxerk'hîJtmény, amelv kászitmám hatóanyaga intetdlgájNI' Joioort: (LMK.H î e? ennek gyôgy.TaerA>veîsleg elfogadhat sûps.
  3. 11. Ae 1-12.. îgènypom sxennti g>4igyar.eFkesxÈfmè»y< amely készihaeö) «: »&amp;·· m«g%, elönyíhen A.S-30 rbrnegA«. elbnyö&amp;ebhe« 2-20 tbinegH tartományba esô nietrft$fsf$b*8 tártál»®«« ' ' t b»** 1 ' *£«>»' ,v « s >".vi î>',' x/»L J >. va» x» o» kevmoin} eíőof Inasat«* «^-artfe- mrtm?- maxes .a kimeikexh lépésekéi: a) &amp; hatdaovagoi és a polimert bevsaetjbk kvd kulbnbözó fecskendőbe és hozzbUlesz^l^.a'SxsvÄdyöKÄ, bra kes megtöltött fecskendőt eg y 3 Irttpos rozsdamentes csatlakozóval csatlakoztatni:* » t « hato*» )¾ î. » tobsiut *.xkc tabol s akuto afett eltávolítjuk a levegőt, d) a ket komponenst &amp; két ieocketulô között keverési eíjftrássai összekeverj» 13. A \2 igénypont »rittst eljárés,,atzssl: jellemezve, hogy £#£&amp;&amp;-esÄ»; ^AtSf^klNôÂt 'Sbaiwvat ! eme, exlv en Jet vbsost xAthaKVitersexA'* ' ségwzok
  4. 14. Eljárás az 1. igénypont szerint; fellgAkilárd gyóg^Z^|ssáitósyidl«álíllá^^:í^g^í.latóySl«^''a: következő kipèsekei; a) a polimert egy követőben ősszékevesjllfe b,î hatóanyagot adónk hozzá, e) a koo>pöoeHsek#k«sob&amp;hömdfeskjei«», φφ esegjeR S*C és *P?£'kőZÖtó· ssÄlpaitMm#s&amp;Äö' összekeverjek; 15 A 14. igénypont szerinti eljárás, azzal jellemezve* begy a hatóanyag por tormában van, Sé Gÿôgyszeïkeszionény,amely elMilíihatőa t-4 IS. igénypontok bármelyik« szerinti eljárással. iÊJm I. igénypont szÂI'ftyg^ista&amp;dàte. M^ÍEÍiyi:%teíMayr *a»|rny$ti&amp; IM«kâ&amp; jg*,d Készítmény a festőanyagot legalább egy hèt âiaibJonyAscst legalább egy honsp alatt szsfeoltja fêlgamikor « fôijg-salâ«i kásztaaényt viz^Âl^iàS'Â^s^te^dc be.
HUE07819363A 2006-10-27 2007-10-26 Nagyon alacsony molekulatömegû polimereket tartalmazó nyújtott felszabadulású készítmények HUE032387T2 (hu)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP06291679A EP1917971A1 (en) 2006-10-27 2006-10-27 Substained release formulations comprising very low molecular weight polymers

Publications (1)

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HUE032387T2 true HUE032387T2 (hu) 2017-09-28

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Country Status (14)

Country Link
US (1) US9724397B2 (hu)
EP (3) EP1917971A1 (hu)
JP (2) JP5410980B2 (hu)
CN (1) CN101528249B (hu)
BR (1) BRPI0718176B8 (hu)
CA (1) CA2667424C (hu)
DK (1) DK2086567T3 (hu)
ES (1) ES2610400T3 (hu)
HU (1) HUE032387T2 (hu)
MX (1) MX2009004332A (hu)
PL (1) PL2086567T3 (hu)
PT (1) PT2086567T (hu)
RU (1) RU2453329C2 (hu)
WO (1) WO2008049631A1 (hu)

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Publication number Publication date
CA2667424C (en) 2018-05-22
CA2667424A1 (en) 2008-05-02
JP2014015488A (ja) 2014-01-30
EP2086567B1 (en) 2016-10-19
EP3141257A1 (en) 2017-03-15
CN101528249B (zh) 2013-04-17
WO2008049631A1 (en) 2008-05-02
US9724397B2 (en) 2017-08-08
US20100209384A1 (en) 2010-08-19
EP2086567A1 (en) 2009-08-12
MX2009004332A (es) 2009-06-16
RU2009120005A (ru) 2010-12-10
JP5778741B2 (ja) 2015-09-16
EP1917971A1 (en) 2008-05-07
DK2086567T3 (en) 2017-01-23
JP5410980B2 (ja) 2014-02-05
BRPI0718176B8 (pt) 2021-05-25
JP2010507612A (ja) 2010-03-11
PL2086567T3 (pl) 2017-05-31
RU2453329C2 (ru) 2012-06-20
BRPI0718176A2 (pt) 2013-12-17
ES2610400T3 (es) 2017-04-27
PT2086567T (pt) 2017-01-17
BRPI0718176B1 (pt) 2018-06-05
CN101528249A (zh) 2009-09-09

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