HRP20210961T1 - Jedinica lijek-uređaj koja sadrži hinagolid - Google Patents
Jedinica lijek-uređaj koja sadrži hinagolid Download PDFInfo
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- HRP20210961T1 HRP20210961T1 HRP20210961TT HRP20210961T HRP20210961T1 HR P20210961 T1 HRP20210961 T1 HR P20210961T1 HR P20210961T T HRP20210961T T HR P20210961TT HR P20210961 T HRP20210961 T HR P20210961T HR P20210961 T1 HRP20210961 T1 HR P20210961T1
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- GDFGTRDCCWFXTG-SCTDSRPQSA-N (3r,4ar,10as)-3-(diethylsulfamoylamino)-6-hydroxy-1-propyl-3,4,4a,5,10,10a-hexahydro-2h-benzo[g]quinoline Chemical compound C1=CC=C2C[C@@H]3N(CCC)C[C@H](NS(=O)(=O)N(CC)CC)C[C@H]3CC2=C1O GDFGTRDCCWFXTG-SCTDSRPQSA-N 0.000 title claims 4
- 229960000924 quinagolide Drugs 0.000 title claims 2
- 229920000642 polymer Polymers 0.000 claims 27
- 239000013543 active substance Substances 0.000 claims 20
- 229920001400 block copolymer Polymers 0.000 claims 12
- 238000000034 method Methods 0.000 claims 10
- 229920000233 poly(alkylene oxides) Polymers 0.000 claims 8
- 239000004814 polyurethane Substances 0.000 claims 8
- 229920002635 polyurethane Polymers 0.000 claims 8
- 150000001875 compounds Chemical class 0.000 claims 5
- 239000012948 isocyanate Substances 0.000 claims 5
- 150000002513 isocyanates Chemical class 0.000 claims 5
- 239000002202 Polyethylene glycol Substances 0.000 claims 3
- 239000003054 catalyst Substances 0.000 claims 3
- 229920001223 polyethylene glycol Polymers 0.000 claims 3
- 229920001451 polypropylene glycol Polymers 0.000 claims 3
- 150000003839 salts Chemical class 0.000 claims 3
- 201000009273 Endometriosis Diseases 0.000 claims 2
- 239000005057 Hexamethylene diisocyanate Substances 0.000 claims 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 2
- 239000000654 additive Substances 0.000 claims 2
- 230000000996 additive effect Effects 0.000 claims 2
- WERYXYBDKMZEQL-UHFFFAOYSA-N butane-1,4-diol Chemical compound OCCCCO WERYXYBDKMZEQL-UHFFFAOYSA-N 0.000 claims 2
- 239000011248 coating agent Substances 0.000 claims 2
- 238000000576 coating method Methods 0.000 claims 2
- KORSJDCBLAPZEQ-UHFFFAOYSA-N dicyclohexylmethane-4,4'-diisocyanate Chemical compound C1CC(N=C=O)CCC1CC1CCC(N=C=O)CC1 KORSJDCBLAPZEQ-UHFFFAOYSA-N 0.000 claims 2
- 150000002009 diols Chemical class 0.000 claims 2
- GHLKSLMMWAKNBM-UHFFFAOYSA-N dodecane-1,12-diol Chemical compound OCCCCCCCCCCCCO GHLKSLMMWAKNBM-UHFFFAOYSA-N 0.000 claims 2
- 238000009472 formulation Methods 0.000 claims 2
- GJBXIPOYHVMPQJ-UHFFFAOYSA-N hexadecane-1,16-diol Chemical compound OCCCCCCCCCCCCCCCCO GJBXIPOYHVMPQJ-UHFFFAOYSA-N 0.000 claims 2
- RRAMGCGOFNQTLD-UHFFFAOYSA-N hexamethylene diisocyanate Chemical compound O=C=NCCCCCCN=C=O RRAMGCGOFNQTLD-UHFFFAOYSA-N 0.000 claims 2
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 2
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 2
- 238000003780 insertion Methods 0.000 claims 2
- 230000037431 insertion Effects 0.000 claims 2
- 239000002207 metabolite Substances 0.000 claims 2
- 239000000203 mixture Substances 0.000 claims 2
- 230000027758 ovulation cycle Effects 0.000 claims 2
- 239000000546 pharmaceutical excipient Substances 0.000 claims 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 2
- 230000002265 prevention Effects 0.000 claims 2
- VOJUXHHACRXLTD-UHFFFAOYSA-N 1,4-dihydroxy-2-naphthoic acid Chemical compound C1=CC=CC2=C(O)C(C(=O)O)=CC(O)=C21 VOJUXHHACRXLTD-UHFFFAOYSA-N 0.000 claims 1
- UPMLOUAZCHDJJD-UHFFFAOYSA-N 4,4'-Diphenylmethane Diisocyanate Chemical group C1=CC(N=C=O)=CC=C1CC1=CC=C(N=C=O)C=C1 UPMLOUAZCHDJJD-UHFFFAOYSA-N 0.000 claims 1
- -1 C20 diol Chemical class 0.000 claims 1
- PTHCMJGKKRQCBF-UHFFFAOYSA-N Cellulose, microcrystalline Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC)C(CO)O1 PTHCMJGKKRQCBF-UHFFFAOYSA-N 0.000 claims 1
- 239000001856 Ethyl cellulose Substances 0.000 claims 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 claims 1
- 229910021578 Iron(III) chloride Inorganic materials 0.000 claims 1
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims 1
- 229920000881 Modified starch Polymers 0.000 claims 1
- ALQSHHUCVQOPAS-UHFFFAOYSA-N Pentane-1,5-diol Chemical compound OCCCCCO ALQSHHUCVQOPAS-UHFFFAOYSA-N 0.000 claims 1
- 239000004373 Pullulan Substances 0.000 claims 1
- 229920001218 Pullulan Polymers 0.000 claims 1
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims 1
- 229920002494 Zein Polymers 0.000 claims 1
- 239000008186 active pharmaceutical agent Substances 0.000 claims 1
- 150000001414 amino alcohols Chemical class 0.000 claims 1
- 238000010923 batch production Methods 0.000 claims 1
- 229910052797 bismuth Inorganic materials 0.000 claims 1
- JCXGWMGPZLAOME-UHFFFAOYSA-N bismuth atom Chemical compound [Bi] JCXGWMGPZLAOME-UHFFFAOYSA-N 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 235000010980 cellulose Nutrition 0.000 claims 1
- FOTKYAAJKYLFFN-UHFFFAOYSA-N decane-1,10-diol Chemical compound OCCCCCCCCCCO FOTKYAAJKYLFFN-UHFFFAOYSA-N 0.000 claims 1
- 150000004985 diamines Chemical class 0.000 claims 1
- 229920001249 ethyl cellulose Polymers 0.000 claims 1
- 235000019325 ethyl cellulose Nutrition 0.000 claims 1
- 238000001125 extrusion Methods 0.000 claims 1
- 229910021485 fumed silica Inorganic materials 0.000 claims 1
- 150000004676 glycans Chemical class 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- XXMIOPMDWAUFGU-UHFFFAOYSA-N hexane-1,6-diol Chemical compound OCCCCCCO XXMIOPMDWAUFGU-UHFFFAOYSA-N 0.000 claims 1
- 238000009474 hot melt extrusion Methods 0.000 claims 1
- 150000003840 hydrochlorides Chemical class 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- RBTARNINKXHZNM-UHFFFAOYSA-K iron trichloride Chemical group Cl[Fe](Cl)Cl RBTARNINKXHZNM-UHFFFAOYSA-K 0.000 claims 1
- 239000011159 matrix material Substances 0.000 claims 1
- 239000008108 microcrystalline cellulose Substances 0.000 claims 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims 1
- 229940016286 microcrystalline cellulose Drugs 0.000 claims 1
- 229920001282 polysaccharide Polymers 0.000 claims 1
- 239000005017 polysaccharide Substances 0.000 claims 1
- 235000019423 pullulan Nutrition 0.000 claims 1
- 239000005019 zein Substances 0.000 claims 1
- 229940093612 zein Drugs 0.000 claims 1
Classifications
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- 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
- A61K9/0034—Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
- A61K9/0036—Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/473—Quinolines; Isoquinolines ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
-
- 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
- A61P15/02—Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
-
- 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C48/00—Extrusion moulding, i.e. expressing the moulding material through a die or nozzle which imparts the desired form; Apparatus therefor
- B29C48/001—Combinations of extrusion moulding with other shaping operations
- B29C48/0021—Combinations of extrusion moulding with other shaping operations combined with joining, lining or laminating
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2033/00—Use of polymers of unsaturated acids or derivatives thereof as moulding material
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2105/00—Condition, form or state of moulded material or of the material to be shaped
- B29K2105/0005—Condition, form or state of moulded material or of the material to be shaped containing compounding ingredients
- B29K2105/0035—Medical or pharmaceutical agents
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/754—Pessaries
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- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Reproductive Health (AREA)
- Inorganic Chemistry (AREA)
- Gynecology & Obstetrics (AREA)
- Engineering & Computer Science (AREA)
- Urology & Nephrology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Endocrinology (AREA)
- Organic Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Diabetes (AREA)
- Mechanical Engineering (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Materials For Medical Uses (AREA)
Claims (16)
1. Polimerna jedinica lijek-uređaj koja obuhvaća:
(i) poliuretanski blok kopolimer koji se može dobiti reagiranjem zajedno:
(a) poli(alkilen oksida);
(b) difunkcionalnog spoja;
(c) difunkcionalnog izocijanata; i
(d) opcionalno blok kopolimera koji obuhvaća poli(alkilen oksid) blokove; i
(ii) farmaceutski aktivno sredstvo, pri čemu farmaceutski aktivno sredstvo je odabrano iz grupe koja se sastoji od hinagolida, N-desetila metabolita hinagolida i N,N-didesetila metabolita hinagolida, ili njihove farmaceutski prihvatljive soli.
2. Polimerna jedinica lijek-uređaj prema patentnom zahtjevu 1, pri čemu poli(alkilen oksid) je:
polietilen glikol (PEG), koji opcionalno ima molekulsku težinu od 200 do 35,000 g/mol ili molekulsku težinu približno 2,000 g/mol; ili
polipropilen glikol (PPG), koji opcionalno ima molekulsku težinu od 200 do 35,000 g/mol ili približno 2,000 g/mol.
3. Polimerna jedinica lijek-uređaj prema bilo kojem prethodnom patentnom zahtjevu, pri čemu:
(a) poli(alkilen oksid) blok kopolimer obuhvaća blokove polietilen glikola i polipropilen glikola;
(b) difunkcionalni spoj je odabrano iz grupe koja se sastoji od diola; diamina; i amino alkohola; opcionalno, pri čemu diol je C3 do C20 diol ili difunkcionalni spoj je odabrano iz grupe koja se sastoji od: 1,4-butandiola; 1,5-pentandiola; 1,6-heksandiola; 1,10-dekandiola; 1,12-dodekandiola; i 1,16-heksadekandiola; i/ili
(c) difunkcionalni izocijanat je aromatični diizocijanat ili alifatični diizocijanat; opcionalno, pri čemu difunkcionalni izocijanat je difenilmetan-4,4'-diizocijanat, dicikloheksilmetan-4,4'-diizocijanat (DMDI) ili heksametilen diizocijanat (HMDI).
4. Polimerna jedinica lijek-uređaj prema bilo kojem prethodnom patentnom zahtjevu, pri čemu molarni odnos komponenata (a) prema (b) prema (c) je u opsegu 0.05-0.75 prema 1 prema 1.00-2.00, ili pri čemu odnos komponenata (a) prema (b) prema (c) prema (d) je u opsegu 0.05-0.75 prema 1 prema 1.00-2.00 prema 0.01-0.50, ili pri čemu odnos komponenata (a) prema (b) prema (c) prema (d) je u opsegu 0.05-0.20 prema 1 prema 1.1-1.4 prema 0.03-0.25.
5. Polimerna jedinica lijek-uređaj prema bilo kojem prethodnom patentnom zahtjevu, pri čemu polimerna jedinica lijek-uređaj obuhvaća više od jednog poliuretanskog blok kopolimera, pri čemu svaki poliuretanski blok kopolimer se može dobiti reagiranjem zajedno:
(a) poli(alkilen oksida);
(b) difunkcionalnog spoja;
(c) difunkcionalnog izocijanata; i
(d) opcionalno blok kopolimera koji obuhvaća poli(alkilen oksid) blokove.
6. Polimerna jedinica lijek-uređaj prema patentnom zahtjevu 5, pri čemu polimerna jedinica lijek-uređaj obuhvaća polimernu strukturu monolitnog tipa ili jednu matričnog tipa; strukturu tipa rezervoara; slojevitu strukturu, pri čemu svaki sloj obuhvaća jedan ili više poliuretanskih blok kopolimera; ili unutrašnju strukturu jezgra ili sloj i vanjski sloj, poklopac, omotač, ili oblogu, opcionalno pri čemu unutrašnja struktura jezgra ili sloj su opterećeni farmaceutski aktivnim sredstvom, ili pri čemu farmaceutski aktivno sredstvo je odsutno iz vanjskog sloja ili obloge.
7. Polimerna jedinica lijek-uređaj prema bilo kojem prethodnom patentnom zahtjevu, pri čemu:
(a) polimerna jedinica lijek-uređaj obuhvaća elastični, deformabilni/fleksibilni i/ili meki polimer;
(b) polimerna jedinica lijek-uređaj ima modul elastičnosti između oko 5 i 100 MPa; opcionalno pri čemu modul elastičnosti između oko 5 i 30 MPa, između 10 i 20 MPa ili između oko 10 i 20 MPa kada je u hidratiziranom stanju; i/ili
(c) polimerna jedinica lijek-uređaj ima oblik prstena za umetanje i/ili postavljanje u vaginalnu šupljinu.
8. Polimerna jedinica lijek-uređaj prema bilo kojem prethodnom patentnom zahtjevu, pri čemu:
(a) polimerna jedinica lijek-uređaj obuhvaća farmaceutski aktivno sredstvo u dozi od oko 25 do oko 15000 mikrograma µg; opcionalno pri čemu polimerna jedinica lijek-uređaj obuhvaća farmaceutski aktivno sredstvo u dozi od oko 200 do 5000 µg, oko 400-1500 µg, oko 200 µg, oko 400 µg, oko 800 µg, oko 1200 µg, oko 2400 µg ili oko 3000 µg farmaceutski aktivnog sredstva; i/ili
(b) hinagolid je odabran iz grupe koja se sastoji od hinagolida, farmaceutski prihvatljive soli hinagolida, hinagolid hidroklorida, bilo kog aktivnog enantiomera i enantiomera hinagolid hidroklorida apsolutne konfiguracije 3S, 4aS, 10aR.
9. Polimerna jedinica lijek-uređaj prema bilo kojem prethodnom patentnom zahtjevu, pri čemu:
(a) u primjeni, početno oslobađanje farmaceutski aktivnog sredstva odgovara količniku oslobađanja između 0.05 i 10, pri čemu se količnik oslobađanja izračunava kao postotak oslobađanja tokom početnog perioda od 24 sata podijeljen postotkom oslobađanja farmaceutski aktivnog sredstva tokom perioda od 7-14 dana nakon administracije;
(b) polimerna jedinica lijek-uređaj osigurava kontinuirano oslobađanje farmaceutski aktivnog sredstva u vaginalna tkiva; opcionalno, pri čemu polimerna jedinica lijek-uređaj kontinuirano oslobađa farmaceutski aktivno sredstvo tokom perioda od oko 21, 28 ili 35 dana; i/ili
(c) u primjeni, polimerna jedinica lijek-uređaj oslobađa između oko 1 i oko 150 µg ili 300 µg ili između oko 1 i oko 50 µg farmaceutski aktivnog sredstva /dan; opcionalno, pri čemu polimerna jedinica lijek-uređaj oslobađa oko 5, oko 10, oko 15, oko 20 ili oko 30 µg farmaceutski aktivnog sredstva /dan.
10. Polimerna jedinica lijek-uređaj prema bilo kojem prethodnom patentnom zahtjevu, pri čemu:
(a) uređaj se može dobiti reagiranjem zajedno komponenata (a), (b), (c) i opcionalno (d) u prisustvu katalizatora; opcionalno, pri čemu katalizator je željezni klorid i/ili katalizatori na bazi bizmuta; i/ili
(b) farmaceutski aktivno sredstvo se puni u polimernu jedinicu lijek-uređaj kao granulirana formulacija, npr. vlažno granulirana formulacija.
11. Polimerna jedinica lijek-uređaj prema bilo kojem prethodnom patentnom zahtjevu, pri čemu:
(a) farmaceutski aktivno sredstvo je formulirano sa jednim ili više ekscipijenasa; opcionalno, pri čemu ekscipijensi su odabrani iz grupe koja se sastoji od celuloze, mikrokristalne celuloze, derivata celuloze, etil celuloze, (hidroksipropil)metil celuloze (HPMC) i hidroksipropil celuloze (HPC)), polisaharida, preželatiniziranog škroba i pululana, zeina i polivinilpirolidona (PVP); i/ili
(b) farmaceutski aktivno sredstvo se puni u uređaj primjenom antistatičkog aditiva; opcionalno, pri čemu antistatički aditiv je pirogeni silicij dioksid.
12. Postupak izrade polimerne jedinice lijek-uređaj za intravaginalnu administraciju farmaceutski aktivnog sredstva, pri čemu spomenuti postupak obuhvaća reagiranje zajedno:
(a) poli(alkilen oksida);
(b) difunkcionalnog spoja;
(c) difunkcionalnog izocijanata; i
(d) opcionalno blok kopolimera koji obuhvaća poli(alkilen oksid) blokove;
da se osigura poliuretanski blok kopolimer; i
punjenje farmaceutski aktivnog sredstva u poliuretanski blok kopolimer,
pri čemu farmaceutski aktivno sredstvo je odabrano iz grupe koja se sastoji od hinagolida, N-desetila metabolita hinagolida i N,N-didesetila metabolita hinagolida, ili njihove farmaceutski prihvatljive soli.
13. Postupak prema patentnom zahtjevu 12, pri čemu postupak obuhvaća najmanje jedno od sljedećeg:
(a) poliuretanski blok kopolimer koji je pripremljen procesom reaktivnog istiskivanja ili šaržnim procesom;
(b) farmaceutski aktivno sredstvo koje je inkorporirano u poliuretanski blok kopolimer putem procesa istiskivanja vrućim topljenjem; i
(c) farmaceutski aktivno sredstvo koje je formulirano u granule prije punjenja.
14. Polimerna jedinica lijek-uređaj prema bilo kojem patentnom zahtjevu 1-11 ili pripremljena postupkom prema bilo kojem od patentnih zahtjeva 12-13, za primjenu u liječenju i/ili prevenciji endometrioze.
15. Polimerna jedinica lijek-uređaj prema patentnim zahtjevima 14, za primjenu prema patentnom zahtjevu 14, pri čemu liječenje i/ili prevencija endometrioze obuhvaća najmanje jedno od:
postupka u kojem jedinica lijek-uređaja se nosi intravaginalno tokom cijelog ili dijela menstrualnog ciklusa; i
postupka u kojem nova jedinica lijek-uređaj se administrira na početku svakog novog menstrualnog ciklusa.
16. Komplet koji sadrži najmanje jednu ili više polimernih jedinica lijek-uređaj prema bilo kojem od patentnih zahtjeva 1-11 ili pripremljenu postupkom prema bilo kojem od patentnih zahtjeva 12-13; opcionalno, pri čemu komplet dalje sadrži jedan ili više aplikatora i/ili uputa za primjenu;
dalje opcionalno pri čemu aplikator olakšava umetanje polimerne jedinice lijek-uređaj u vaginalnu šupljinu; opcionalno pri čemu polimerna jedinica lijek-uređaj kompleta je prethodno napunjena u ili na aplikator.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP14192372.2A EP3017809A1 (en) | 2014-11-07 | 2014-11-07 | Drug-device unit containing quinagolide |
| PCT/EP2015/075849 WO2016071466A1 (en) | 2014-11-07 | 2015-11-05 | Drug-device unit containing quinagolide |
| EP15790568.8A EP3215118B1 (en) | 2014-11-07 | 2015-11-05 | Drug-device unit containing quinagolide |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20210961T1 true HRP20210961T1 (hr) | 2021-09-17 |
Family
ID=51951583
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20210961TT HRP20210961T1 (hr) | 2014-11-07 | 2021-06-16 | Jedinica lijek-uređaj koja sadrži hinagolid |
Country Status (33)
| Country | Link |
|---|---|
| US (2) | US20180008535A1 (hr) |
| EP (3) | EP3017809A1 (hr) |
| JP (2) | JP6907120B2 (hr) |
| KR (1) | KR102612852B1 (hr) |
| CN (2) | CN116212032A (hr) |
| AR (1) | AR102571A1 (hr) |
| AU (2) | AU2015341734C1 (hr) |
| CA (1) | CA2966473A1 (hr) |
| CL (1) | CL2017001119A1 (hr) |
| CO (1) | CO2017005578A2 (hr) |
| DK (1) | DK3215118T3 (hr) |
| EA (2) | EA033806B9 (hr) |
| ES (1) | ES2877973T3 (hr) |
| HR (1) | HRP20210961T1 (hr) |
| HU (1) | HUE054951T2 (hr) |
| IL (1) | IL252088B (hr) |
| JO (1) | JO3561B1 (hr) |
| LT (1) | LT3215118T (hr) |
| MA (2) | MA40897B1 (hr) |
| MD (1) | MD3215118T2 (hr) |
| MX (1) | MX2017005828A (hr) |
| MY (1) | MY193638A (hr) |
| PH (1) | PH12017550005A1 (hr) |
| PL (1) | PL3215118T3 (hr) |
| PT (1) | PT3215118T (hr) |
| RS (1) | RS62018B1 (hr) |
| SA (1) | SA517381471B1 (hr) |
| SG (1) | SG11201703596SA (hr) |
| SI (1) | SI3215118T1 (hr) |
| TN (1) | TN2017000175A1 (hr) |
| TW (1) | TWI685339B (hr) |
| UA (1) | UA122329C2 (hr) |
| WO (1) | WO2016071466A1 (hr) |
Families Citing this family (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US11896685B2 (en) | 2018-10-31 | 2024-02-13 | Amorepacific Corporation | Core-shell network structure comprising biopolymer and composition comprising same |
| KR20210069344A (ko) | 2019-12-03 | 2021-06-11 | (주)아모레퍼시픽 | 바이오 폴리머를 포함하는 효능물질 전달체 |
| WO2023031218A1 (en) | 2021-08-31 | 2023-03-09 | Ferring B.V. | Diagnosis and treatment of ectopic endometriosis |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4235988A (en) | 1976-12-13 | 1980-11-25 | Imperial Chemical Industries Limited | Delivery means for biologically active agents |
| JP4898431B2 (ja) | 2003-04-29 | 2012-03-14 | ザ ジェネラル ホスピタル コーポレイション | 複数薬物の持続放出のための方法およびデバイス |
| WO2005004837A1 (en) | 2003-07-10 | 2005-01-20 | Galen (Chemicals) Limited | Intravaginal drug delivery devices |
| EP1682102A2 (en) * | 2003-09-10 | 2006-07-26 | Noven Pharmaceuticals, Inc. | Multi-layer transdermal drug delivery device |
| CA2605972C (en) | 2005-04-29 | 2011-08-02 | Ferring International Center S.A. | Treatment or prevention of ovarian hyperstimulation syndrome (ohss) using a dopamine agonist |
| GB0613638D0 (en) * | 2006-07-08 | 2006-08-16 | Controlled Therapeutics Sct | Polyurethane elastomers |
| SA08290041B1 (ar) | 2007-02-01 | 2012-06-05 | فيرينج انترناشونال سنتر اس آيه | أدوية من أجل معالجة بطانة الرحم |
| EP2249811A1 (en) * | 2008-01-25 | 2010-11-17 | Grünenthal GmbH | Pharmaceutical dosage form |
| WO2009094573A2 (en) | 2008-01-25 | 2009-07-30 | The University Of Utah Research Foundation | Linear order release polymer |
| US20100040671A1 (en) | 2008-08-12 | 2010-02-18 | Ahmed Salah U | Intravaginal Devices With a Rigid Support, Methods of Making, and Uses Thereof |
| US20100210600A1 (en) * | 2009-02-19 | 2010-08-19 | Prelief Inc. | Methods and Compositions for Treating Urogenital Disorders |
| TW201102066A (en) * | 2009-06-26 | 2011-01-16 | Ferring Int Ct Sa | Treatment of endometriosis |
| CA2795289A1 (en) * | 2010-04-08 | 2011-10-13 | Sanford-Burnham Medical Research Institute | Methods and compositions for enhanced delivery of compounds |
| US9393311B2 (en) | 2010-11-15 | 2016-07-19 | Dsm Ip Assets B.V. | Intravaginal ring comprising polyurethane composition for drug delivery |
| EP2734262B1 (en) * | 2011-07-20 | 2018-02-28 | Patrick F. Kiser | Intravaginal rings for drug delivery |
| US10137199B2 (en) * | 2013-05-14 | 2018-11-27 | Biotime, Inc. | Thiolated hyaluronan-based hydrogels cross-linked using oxidized glutathione |
| US10413504B2 (en) * | 2013-12-11 | 2019-09-17 | Merck Sharp & Dohme Corp. | Intravaginal ring drug delivery system |
-
2014
- 2014-11-07 EP EP14192372.2A patent/EP3017809A1/en not_active Withdrawn
-
2015
- 2015-11-05 SI SI201531573T patent/SI3215118T1/sl unknown
- 2015-11-05 JP JP2017542330A patent/JP6907120B2/ja active Active
- 2015-11-05 AU AU2015341734A patent/AU2015341734C1/en active Active
- 2015-11-05 PL PL15790568T patent/PL3215118T3/pl unknown
- 2015-11-05 MX MX2017005828A patent/MX2017005828A/es unknown
- 2015-11-05 MY MYPI2017000673A patent/MY193638A/en unknown
- 2015-11-05 HU HUE15790568A patent/HUE054951T2/hu unknown
- 2015-11-05 MD MDE20170069T patent/MD3215118T2/ro unknown
- 2015-11-05 UA UAA201705500A patent/UA122329C2/uk unknown
- 2015-11-05 CN CN202310079847.2A patent/CN116212032A/zh active Pending
- 2015-11-05 PT PT157905688T patent/PT3215118T/pt unknown
- 2015-11-05 US US15/524,792 patent/US20180008535A1/en not_active Abandoned
- 2015-11-05 EP EP21162634.6A patent/EP3892261A1/en active Pending
- 2015-11-05 EA EA201790898A patent/EA033806B9/ru not_active IP Right Cessation
- 2015-11-05 SG SG11201703596SA patent/SG11201703596SA/en unknown
- 2015-11-05 EA EA201991882A patent/EA201991882A2/ru unknown
- 2015-11-05 CN CN201580067303.8A patent/CN106999422A/zh active Pending
- 2015-11-05 TN TN2017000175A patent/TN2017000175A1/en unknown
- 2015-11-05 RS RS20210767A patent/RS62018B1/sr unknown
- 2015-11-05 KR KR1020177015238A patent/KR102612852B1/ko active IP Right Grant
- 2015-11-05 JO JOP/2015/0276A patent/JO3561B1/ar active
- 2015-11-05 DK DK15790568.8T patent/DK3215118T3/da active
- 2015-11-05 MA MA40897A patent/MA40897B1/fr unknown
- 2015-11-05 WO PCT/EP2015/075849 patent/WO2016071466A1/en active Application Filing
- 2015-11-05 ES ES15790568T patent/ES2877973T3/es active Active
- 2015-11-05 CA CA2966473A patent/CA2966473A1/en active Pending
- 2015-11-05 LT LTEP15790568.8T patent/LT3215118T/lt unknown
- 2015-11-05 MA MA056414A patent/MA56414A/fr unknown
- 2015-11-05 EP EP15790568.8A patent/EP3215118B1/en active Active
- 2015-11-06 AR ARP150103620A patent/AR102571A1/es unknown
- 2015-11-06 TW TW104136694A patent/TWI685339B/zh active
-
2017
- 2017-05-03 IL IL252088A patent/IL252088B/en unknown
- 2017-05-05 PH PH12017550005A patent/PH12017550005A1/en unknown
- 2017-05-05 CL CL2017001119A patent/CL2017001119A1/es unknown
- 2017-05-06 SA SA517381471A patent/SA517381471B1/ar unknown
- 2017-06-05 CO CONC2017/0005578A patent/CO2017005578A2/es unknown
-
2020
- 2020-11-17 AU AU2020270480A patent/AU2020270480A1/en not_active Abandoned
-
2021
- 2021-05-10 US US17/316,208 patent/US20220040094A1/en not_active Abandoned
- 2021-06-16 HR HRP20210961TT patent/HRP20210961T1/hr unknown
- 2021-06-30 JP JP2021108386A patent/JP2021155444A/ja active Pending
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