HRP20121036T1 - Intranazalni spojevi - Google Patents
Intranazalni spojevi Download PDFInfo
- Publication number
- HRP20121036T1 HRP20121036T1 HRP20121036AT HRP20121036T HRP20121036T1 HR P20121036 T1 HRP20121036 T1 HR P20121036T1 HR P20121036A T HRP20121036A T HR P20121036AT HR P20121036 T HRP20121036 T HR P20121036T HR P20121036 T1 HRP20121036 T1 HR P20121036T1
- Authority
- HR
- Croatia
- Prior art keywords
- poloxamer
- formulation
- apomorphine
- formulation according
- treatment
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title claims 16
- 238000009472 formulation Methods 0.000 claims 14
- 229960004046 apomorphine Drugs 0.000 claims 8
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 claims 7
- VMWNQDUVQKEIOC-CYBMUJFWSA-N apomorphine Chemical compound C([C@H]1N(C)CC2)C3=CC=C(O)C(O)=C3C3=C1C2=CC=C3 VMWNQDUVQKEIOC-CYBMUJFWSA-N 0.000 claims 7
- 229920001983 poloxamer Polymers 0.000 claims 5
- 229960000502 poloxamer Drugs 0.000 claims 5
- 239000007921 spray Substances 0.000 claims 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 3
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims 2
- 208000010228 Erectile Dysfunction Diseases 0.000 claims 2
- 208000018737 Parkinson disease Diseases 0.000 claims 2
- 229940079593 drug Drugs 0.000 claims 2
- 239000003814 drug Substances 0.000 claims 2
- 238000012377 drug delivery Methods 0.000 claims 2
- 201000001881 impotence Diseases 0.000 claims 2
- 238000004519 manufacturing process Methods 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- 229920001993 poloxamer 188 Polymers 0.000 claims 2
- 229940044519 poloxamer 188 Drugs 0.000 claims 2
- 229920002507 Poloxamer 124 Polymers 0.000 claims 1
- 229920002511 Poloxamer 237 Polymers 0.000 claims 1
- 239000003963 antioxidant agent Substances 0.000 claims 1
- 230000003078 antioxidant effect Effects 0.000 claims 1
- CXWQXGNFZLHLHQ-DPFCLETOSA-N apomorphine hydrochloride Chemical compound [H+].[H+].O.[Cl-].[Cl-].C([C@H]1N(C)CC2)C3=CC=C(O)C(O)=C3C3=C1C2=CC=C3.C([C@H]1N(C)CC2)C3=CC=C(O)C(O)=C3C3=C1C2=CC=C3 CXWQXGNFZLHLHQ-DPFCLETOSA-N 0.000 claims 1
- 239000013011 aqueous formulation Substances 0.000 claims 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims 1
- 239000011521 glass Substances 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- 229940097496 nasal spray Drugs 0.000 claims 1
- 239000007922 nasal spray Substances 0.000 claims 1
- 229910052757 nitrogen Inorganic materials 0.000 claims 1
- 239000012299 nitrogen atmosphere Substances 0.000 claims 1
- 239000001301 oxygen Substances 0.000 claims 1
- 229910052760 oxygen Inorganic materials 0.000 claims 1
- 229940093448 poloxamer 124 Drugs 0.000 claims 1
- 229920002503 polyoxyethylene-polyoxypropylene Polymers 0.000 claims 1
- 238000007789 sealing Methods 0.000 claims 1
- 239000002904 solvent Substances 0.000 claims 1
Classifications
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/40—Cyclodextrins; Derivatives thereof
-
- 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
- A61K9/0043—Nose
-
- 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
- A61P15/10—Drugs for genital or sexual disorders; Contraceptives for impotence
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
- A61P25/16—Anti-Parkinson drugs
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Neurosurgery (AREA)
- Otolaryngology (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Reproductive Health (AREA)
- Gynecology & Obstetrics (AREA)
- Endocrinology (AREA)
- Psychology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Other In-Based Heterocyclic Compounds (AREA)
Claims (15)
1. Tekuća vodena formulacija za intranazalno davanje apomorfina, koja sadrži:
(a) barem 15 mg/ml apomorfina; i
(b) barem jedan kopolimer polioksietilen-polioksipropilena (poloksamer) kao solubilizirajući agens, pri čemu poloksamer ima prosječnu molekulsku masu od 9,7000 Da ili nižu i ima opću formulu:
HO(C2H4O)a(C3H6O)b(C2H4O)aH, pri čemu je a od 2 do 90 i b je od 15 do 40.
2. Formulacija prema patentnom zahtjevu 1, koja sadrži barem 20 mg/ml apomorfina.
3. Formulacija prema patentnom zahtjevu 2, koja sadrži od 25 do 60 mg/ml apomorfina.
4. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu je poloksamer Poloxamer 124, Poloxamer 188 ili Poloxamer 237.
5. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, pri čemu je poloksamer prisutan u količini od 50 do 250 mg/ml.
6. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, koja sadrži od 20 do 40 mg/ml HCl apomorfina i od 100 do 200 mg/ml poloksamera 188.
7. Formulacija prema bilo kojem od prethodnih patentnih zahtjeva, koja sadrži antioksidant.
8. Uređaj za nazalno davanje lijeka ili dozni uložak za upotrebu u uređaju za nazalno davanje lijeka napunjen sa formulacijom definiranom u bilo kojem od patentnih zahtjeva 1 do 7.
9. Formulacija definirana prema bilo kojem od patentnih zahtjeva 1 do 7 za upotrebu u intranazalnom davanju apomorfina pacijentu kojem je to potrebno.
10. Formulacija prema patentnom zahtjevu 9 za upotrebu u liječenju i/ili kontroli Parkinsonove bolesti ili upotrebu u liječenju i/ili kontroli erektilne disfunkcije.
11. Upotreba formulacije prema patentnom zahtjevu 1 u proizvodnji lijeka za liječenje i/ili kontrolu Parkinsonove bolesti ili u proizvodnji lijeka za liječenje i/ili kontrolu erektilne disfunkcije.
12. Uređaj prema patentnom zahtjevu 8, koji obuhvaća bocu koja sadrži formulaciju definiranu u bilo kojem od patentnih zahtjeva 1 do 7 na koju je montirana pumpa za raspršivanje (sprej pumpa).
13. Komplet koji se sastoji od (i) formulacije prema bilo kojem od patentnih zahtjeva 1 do 7 zapečaćene u staklenoj boci ili bočici i (ii) nazalne pumpe za raspršivanje (sprej pumpe).
14. Komplet prema patentom zahtjevu 13, pri čemu je formulacija prema bilo kojem od patentnih zahtjeva 1 do 7 zapečaćena u bocu ili bočicu sa dušičnim prepunjenjem.
15. Postupak za dobijanje kompozicije prema bilo kojem od patentnih zahtjeva 1 do 7, pri čemu postupak obuhvaća (a) minimiziranje sadržaja otopljenog kisika u vodi; (b) rastvaranje poloksamera u vodi dobivenoj u stupnju (a); (c) dodavanje apomorfina u proizvod iz stupnja (b) i rastvaranje apomorfina; (d) prilagođavanje pH proizvoda iz stupnja (c) kada je potrebno i dovođenje formulacije do krajnje težine ili zapremine sa vodom dobijenom u stupnju (a); i (e) premještanje proizvoda iz stupnja (d) u posudu i pečaćenje u atmosferi dušika.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP07254426A EP2057982A1 (en) | 2007-11-09 | 2007-11-09 | Intranasal compositions |
PCT/GB2008/003782 WO2009060226A1 (en) | 2007-11-09 | 2008-11-10 | Intranasal compositions |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20121036T1 true HRP20121036T1 (hr) | 2013-01-31 |
Family
ID=39052379
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20121036AT HRP20121036T1 (hr) | 2007-11-09 | 2012-12-17 | Intranazalni spojevi |
Country Status (21)
Country | Link |
---|---|
US (1) | US8309108B2 (hr) |
EP (2) | EP2057982A1 (hr) |
JP (1) | JP5530931B2 (hr) |
KR (1) | KR101522529B1 (hr) |
CN (1) | CN101883555B (hr) |
AU (1) | AU2008326220B2 (hr) |
BR (1) | BRPI0819115A2 (hr) |
CA (1) | CA2705153C (hr) |
CY (1) | CY1113824T1 (hr) |
DK (1) | DK2214640T3 (hr) |
ES (1) | ES2398267T3 (hr) |
HK (1) | HK1146711A1 (hr) |
HR (1) | HRP20121036T1 (hr) |
MX (1) | MX2010005013A (hr) |
NZ (1) | NZ585107A (hr) |
PL (1) | PL2214640T3 (hr) |
PT (1) | PT2214640E (hr) |
SI (1) | SI2214640T1 (hr) |
TW (1) | TWI426928B (hr) |
WO (1) | WO2009060226A1 (hr) |
ZA (1) | ZA201003172B (hr) |
Families Citing this family (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP1579862A1 (en) | 2004-03-25 | 2005-09-28 | Boehringer Ingelheim Vetmedica Gmbh | Use of PDE III inhibitors for the reduction of heart size in mammals suffering from heart failure |
US8980894B2 (en) | 2004-03-25 | 2015-03-17 | Boehringer Ingelheim Vetmedica Gmbh | Use of PDE III inhibitors for the treatment of asymptomatic (occult) heart failure |
EP1920785A1 (en) | 2006-11-07 | 2008-05-14 | Boehringer Ingelheim Vetmedica Gmbh | Liquid preparation comprising a complex of pimobendan and cyclodextrin |
EP2545905A1 (en) | 2011-07-11 | 2013-01-16 | Britannia Pharmaceuticals Limited | A new therapeutical composition containing apomorphine as active ingredient |
ES2924478T3 (es) | 2012-03-15 | 2022-10-07 | Boehringer Ingelheim Vetmedica Gmbh | Formulación de comprimidos farmacéuticos para el sector médico veterinario, método de producción y uso de los mismos |
EP3456315A1 (en) | 2012-06-05 | 2019-03-20 | Neuroderm Ltd | Compositions comprising apomorphine and organic acids and uses thereof |
EP2863897B1 (en) | 2012-06-21 | 2019-06-19 | Phosphorex Inc. | Nanoparticles of indirubin, derivatives thereof and methods of making and using same |
GB201217419D0 (en) * | 2012-09-28 | 2012-11-14 | Innotesto Bvba | Improvements in or relating to oromucosal apomorphine compositions |
CN113181110A (zh) * | 2013-07-19 | 2021-07-30 | 勃林格殷格翰动物保健有限公司 | 含有防腐的醚化的环糊精衍生物的液体水性药物组合物 |
EP3106150B1 (en) | 2013-12-04 | 2021-07-28 | Boehringer Ingelheim Vetmedica GmbH | Improved pharmaceutical compositions of pimobendan |
US10537570B2 (en) | 2016-04-06 | 2020-01-21 | Boehringer Ingelheim Vetmedica Gmbh | Use of pimobendan for the reduction of heart size and/or the delay of onset of clinical symptoms in patients with asymptomatic heart failure due to mitral valve disease |
GB201912686D0 (en) * | 2019-09-04 | 2019-10-16 | Reown Pharma Inc | Pharmaceutical composition |
CN115804754A (zh) * | 2022-12-16 | 2023-03-17 | 广州新济药业科技有限公司 | 吗啡鼻喷剂及其制备方法 |
Family Cites Families (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4727064A (en) * | 1984-04-25 | 1988-02-23 | The United States Of America As Represented By The Department Of Health And Human Services | Pharmaceutical preparations containing cyclodextrin derivatives |
US5376645A (en) | 1990-01-23 | 1994-12-27 | University Of Kansas | Derivatives of cyclodextrins exhibiting enhanced aqueous solubility and the use thereof |
GB9103824D0 (en) * | 1991-02-23 | 1991-04-10 | Fisons Ag | Formulation |
ATE290864T1 (de) | 1993-03-26 | 2005-04-15 | Franciscus Wilhelmus He Merkus | Pharmazeutische zusammensetzungen zur intranasalen verabreichung von dihydroergotamin |
GB9416884D0 (en) | 1994-08-20 | 1994-10-12 | Danbiosyst Uk | Drug delivery compositions |
EP0834308A1 (en) * | 1996-09-30 | 1998-04-08 | LG Chemical Limited | Ophthalmic formulation for treating myopia comprising dopamine agonist and cyclodextrin |
GB9713980D0 (en) | 1997-07-03 | 1997-09-10 | Danbiosyst Uk | New conjugates |
EP1035833B1 (en) | 1997-12-02 | 2005-08-31 | Archimedes Development Limited | Compositions for nasal administration |
US6436950B1 (en) | 1998-08-14 | 2002-08-20 | Nastech Pharmaceutical Company, Inc. | Nasal delivery of apomorphine |
US7666876B2 (en) * | 2002-03-19 | 2010-02-23 | Vernalis (R&D) Limited | Buprenorphine formulations for intranasal delivery |
GB0300531D0 (en) * | 2003-01-10 | 2003-02-12 | West Pharm Serv Drug Res Ltd | Pharmaceutical compositions |
GB0403938D0 (en) * | 2004-02-21 | 2004-03-24 | West Pharm Serv Drug Res Ltd | Chitosan containing solution |
-
2007
- 2007-11-09 EP EP07254426A patent/EP2057982A1/en not_active Withdrawn
-
2008
- 2008-11-07 TW TW097143029A patent/TWI426928B/zh not_active IP Right Cessation
- 2008-11-10 AU AU2008326220A patent/AU2008326220B2/en not_active Ceased
- 2008-11-10 US US12/741,932 patent/US8309108B2/en not_active Expired - Fee Related
- 2008-11-10 KR KR1020107011658A patent/KR101522529B1/ko not_active IP Right Cessation
- 2008-11-10 WO PCT/GB2008/003782 patent/WO2009060226A1/en active Application Filing
- 2008-11-10 NZ NZ585107A patent/NZ585107A/en not_active IP Right Cessation
- 2008-11-10 ES ES08847366T patent/ES2398267T3/es active Active
- 2008-11-10 EP EP08847366A patent/EP2214640B1/en not_active Not-in-force
- 2008-11-10 JP JP2010532658A patent/JP5530931B2/ja not_active Expired - Fee Related
- 2008-11-10 DK DK08847366.5T patent/DK2214640T3/da active
- 2008-11-10 CN CN200880115432XA patent/CN101883555B/zh not_active Expired - Fee Related
- 2008-11-10 CA CA2705153A patent/CA2705153C/en not_active Expired - Fee Related
- 2008-11-10 PL PL08847366T patent/PL2214640T3/pl unknown
- 2008-11-10 MX MX2010005013A patent/MX2010005013A/es active IP Right Grant
- 2008-11-10 PT PT88473665T patent/PT2214640E/pt unknown
- 2008-11-10 SI SI200830875T patent/SI2214640T1/sl unknown
- 2008-11-10 BR BRPI0819115-8A patent/BRPI0819115A2/pt not_active IP Right Cessation
-
2010
- 2010-05-05 ZA ZA2010/03172A patent/ZA201003172B/en unknown
-
2011
- 2011-01-27 HK HK11100874.8A patent/HK1146711A1/xx not_active IP Right Cessation
-
2012
- 2012-12-17 HR HRP20121036AT patent/HRP20121036T1/hr unknown
-
2013
- 2013-01-23 CY CY20131100059T patent/CY1113824T1/el unknown
Also Published As
Publication number | Publication date |
---|---|
EP2057982A1 (en) | 2009-05-13 |
CN101883555A (zh) | 2010-11-10 |
PL2214640T3 (pl) | 2013-03-29 |
CA2705153C (en) | 2016-05-24 |
WO2009060226A1 (en) | 2009-05-14 |
JP2011503044A (ja) | 2011-01-27 |
US8309108B2 (en) | 2012-11-13 |
BRPI0819115A2 (pt) | 2015-07-07 |
TW200936179A (en) | 2009-09-01 |
EP2214640B1 (en) | 2012-10-24 |
PT2214640E (pt) | 2013-01-16 |
CY1113824T1 (el) | 2016-07-27 |
MX2010005013A (es) | 2010-05-27 |
CN101883555B (zh) | 2012-07-11 |
AU2008326220B2 (en) | 2013-05-23 |
AU2008326220A1 (en) | 2009-05-14 |
US20100249170A1 (en) | 2010-09-30 |
CA2705153A1 (en) | 2009-05-14 |
DK2214640T3 (da) | 2013-02-04 |
JP5530931B2 (ja) | 2014-06-25 |
SI2214640T1 (sl) | 2013-02-28 |
TWI426928B (zh) | 2014-02-21 |
AU2008326220A2 (en) | 2010-11-04 |
HK1146711A1 (en) | 2011-07-08 |
KR101522529B1 (ko) | 2015-05-26 |
NZ585107A (en) | 2012-05-25 |
ZA201003172B (en) | 2012-10-31 |
EP2214640A1 (en) | 2010-08-11 |
KR20100094980A (ko) | 2010-08-27 |
ES2398267T3 (es) | 2013-03-15 |
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