HRP20211853T1 - Sastavi in situ injekcijskih biorazgradivih implantata - Google Patents
Sastavi in situ injekcijskih biorazgradivih implantata Download PDFInfo
- Publication number
- HRP20211853T1 HRP20211853T1 HRP20211853TT HRP20211853T HRP20211853T1 HR P20211853 T1 HRP20211853 T1 HR P20211853T1 HR P20211853T T HRP20211853T T HR P20211853TT HR P20211853 T HRP20211853 T HR P20211853T HR P20211853 T1 HRP20211853 T1 HR P20211853T1
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- polymer
- water
- drug
- Prior art date
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- 239000000203 mixture Substances 0.000 title claims 9
- 239000007943 implant Substances 0.000 title claims 2
- 238000011065 in-situ storage Methods 0.000 title claims 2
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims 8
- 229920000642 polymer Polymers 0.000 claims 6
- 239000003814 drug Substances 0.000 claims 5
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Chemical compound OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims 4
- 229940079593 drug Drugs 0.000 claims 4
- 238000002347 injection Methods 0.000 claims 4
- 239000007924 injection Substances 0.000 claims 4
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 4
- 229920000249 biocompatible polymer Polymers 0.000 claims 3
- 239000000243 solution Substances 0.000 claims 3
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims 2
- 239000003795 chemical substances by application Substances 0.000 claims 2
- 230000001684 chronic effect Effects 0.000 claims 2
- 201000010099 disease Diseases 0.000 claims 2
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims 2
- 239000004310 lactic acid Substances 0.000 claims 2
- 235000014655 lactic acid Nutrition 0.000 claims 2
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 claims 2
- 239000000347 magnesium hydroxide Substances 0.000 claims 2
- 229910001862 magnesium hydroxide Inorganic materials 0.000 claims 2
- 235000012254 magnesium hydroxide Nutrition 0.000 claims 2
- 230000005855 radiation Effects 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- 208000020925 Bipolar disease Diseases 0.000 claims 1
- 208000017667 Chronic Disease Diseases 0.000 claims 1
- 125000005907 alkyl ester group Chemical group 0.000 claims 1
- 125000000217 alkyl group Chemical group 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- PJMPHNIQZUBGLI-UHFFFAOYSA-N fentanyl Chemical compound C=1C=CC=CC=1N(C(=O)CC)C(CC1)CCN1CCC1=CC=CC=C1 PJMPHNIQZUBGLI-UHFFFAOYSA-N 0.000 claims 1
- 229960002428 fentanyl Drugs 0.000 claims 1
- 238000007918 intramuscular administration Methods 0.000 claims 1
- HPJKCIUCZWXJDR-UHFFFAOYSA-N letrozole Chemical compound C1=CC(C#N)=CC=C1C(N1N=CN=C1)C1=CC=C(C#N)C=C1 HPJKCIUCZWXJDR-UHFFFAOYSA-N 0.000 claims 1
- 229960003881 letrozole Drugs 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 239000000178 monomer Substances 0.000 claims 1
- 229960005017 olanzapine Drugs 0.000 claims 1
- KVWDHTXUZHCGIO-UHFFFAOYSA-N olanzapine Chemical compound C1CN(C)CCN1C1=NC2=CC=CC=C2NC2=C1C=C(C)S2 KVWDHTXUZHCGIO-UHFFFAOYSA-N 0.000 claims 1
- 229960001534 risperidone Drugs 0.000 claims 1
- RAPZEAPATHNIPO-UHFFFAOYSA-N risperidone Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC=3C(=O)N4CCCCC4=NC=3C)=NOC2=C1 RAPZEAPATHNIPO-UHFFFAOYSA-N 0.000 claims 1
- 201000000980 schizophrenia Diseases 0.000 claims 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
-
- 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
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4196—1,2,4-Triazoles
-
- 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
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/445—Non condensed piperidines, e.g. piperocaine
- A61K31/4468—Non condensed piperidines, e.g. piperocaine having a nitrogen directly attached in position 4, e.g. clebopride, fentanyl
-
- 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
- A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
- A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
- A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Psychiatry (AREA)
- Neurology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Materials For Medical Uses (AREA)
Claims (13)
1. Injekcijski sterilan depo za intramuskularnu primjenu sadrži:
biokompatibilan polimer, koji je polimer ili kopolimer na osnovi mliječne kiseline i/ili mliječne kiseline plus glikolne kiseline s monomernim omjerom mliječne i glikolne kiseline u rasponu od 48 : 52 do 100 : 0 i inherentnom viskoznošću u rasponu od 0,25 – 0,48 dl/g izmjerenom pri 25 °C u kloroformu koncentracije 0,1 %, te se sastoji od krajnjih alkilnih ili alkilno-esterskih skupina;
otapalo koje se miješa s vodom, s dipolnim momentom od približno 3,7 – 4,5 D i dielektričnom konstantom između 30 i 50, koja je dimetilsulfoksid (DMSO), i
lijek s topljivošću u vodi manjom od 2 mg/ml, odabran iz skupine koja se sastoji od fentanila, risperidona, olanzapina i letrozola, samostalno ili u bilo kojoj međusobnoj kombinaciji;
naznačen time što
viskoznost polimerne otopine, koja se sastoji od polimera i DMSO-a je u rasponu 0,20 – 7,0 Pa s, pri čemu se navedena viskoznost polimerne otopine mjeri pri 25 °C.
2. Sastav injekcijskog depoa prema zahtjevu 1, sadrži i u vodi topljivo sredstvo za modificiranje pH.
3. Sastav injekcijskog depoa prema zahtjevu 2 u kojem se u vodi topljivo sredstvo za modificiranje pH sastoji od Mg(OH)2 u molarnom omjeru lijeka : Mg(OH)2 između 2 : 3 i 2 : 5.
4. Sastav injekcijskog depoa prema bilo kojem od prethodnih zahtjeva 1 – 3 sterilan je kao gotov proizvod a u njemu je lijek i/ili biokompatibilan polimer steriliziran zračenjem u rasponu od 5 – 25 kGy.
5. Sastav injekcijskog depoa prema bilo kojem od prethodnih zahtjeva 1 – 4, u kojem viskoznost polimerne otopine polimera i DMSO-a u rasponu između 0,7 i 7,0 Pa s.
6. Sastav injekcijskog depoa prema bilo kojem od prethodnih zahtjeva 1 – 5 za uporabu u liječenju kroničnih ljudskih bolesti.
7. Sastav prema zahtjevu 6 kad je kronična bolest shizofrenija ili bipolarni poremećaj.
8. Uporaba sastava prema bilo kojem od prethodnih zahtjeva 1 – 5 u proizvodnji lijeka za liječenje kroničnih ljudskih bolesti.
9. Farmaceutski komplet prikladan za stvaranje in situ biorazgradivog implantata u tijelu, a čiji je sastav prema bilo kojem od zahtjeva 1 – 5, pri čemu se lijek i biokompatibilan polimer nalaze u prvom spremniku, a otapalo koje se miješa s vodom nalazi se u drugom, odvojenom spremniku.
10. Farmaceutski komplet prema zahtjevu 9, u kojem je barem jedan od prvih i drugih spremnika štrcaljka, bočica, uređaj ili uložak, za jednokratnu uporabu ili ne.
11. Farmaceutski komplet prema zahtjevu 10, iz kojega su spremnici spojivi priključnim uređajem.
12. Farmaceutski komplet prema bilo kojem od zahtjeva 9 do 11, u kojem je sadržaj barem jednog prvog i drugog spremnika liofiliziran.
13. Farmaceutski komplet prema bilo kojem od zahtjeva 9 do 12, čiji je sadržaj barem jednog prvog i drugog spremnika sterilizira zračenjem u rasponu od 5 – 25 kGy.
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP10382153.4A EP2394663B1 (en) | 2010-05-31 | 2010-05-31 | Compositions for injectable in-situ biodegradable implants |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20211853T1 true HRP20211853T1 (hr) | 2022-03-04 |
Family
ID=43301929
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20211853TT HRP20211853T1 (hr) | 2010-05-31 | 2010-05-31 | Sastavi in situ injekcijskih biorazgradivih implantata |
HRP20230890TT HRP20230890T1 (hr) | 2010-05-31 | 2011-05-31 | Metode za pripremu injektabilnih depo sastava |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20230890TT HRP20230890T1 (hr) | 2010-05-31 | 2011-05-31 | Metode za pripremu injektabilnih depo sastava |
Country Status (21)
Country | Link |
---|---|
US (2) | US10058504B2 (hr) |
EP (2) | EP2394663B1 (hr) |
JP (1) | JP5923493B2 (hr) |
CN (1) | CN102933234A (hr) |
BR (1) | BR112012030707A2 (hr) |
CA (1) | CA2800641C (hr) |
CY (1) | CY1124783T1 (hr) |
DK (1) | DK2582395T3 (hr) |
EA (1) | EA024211B1 (hr) |
ES (2) | ES2897976T3 (hr) |
FI (1) | FI2582395T3 (hr) |
HR (2) | HRP20211853T1 (hr) |
HU (3) | HUE057236T2 (hr) |
LT (2) | LT2394663T (hr) |
MX (1) | MX346167B (hr) |
PL (2) | PL2394663T3 (hr) |
PT (2) | PT2394663T (hr) |
RS (2) | RS64451B1 (hr) |
SI (2) | SI2394663T1 (hr) |
WO (1) | WO2011151356A2 (hr) |
ZA (1) | ZA201209394B (hr) |
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CA2687979C (en) | 2007-05-25 | 2017-07-04 | Tolmar Therapeutics, Inc. | Sustained delivery formulations of risperidone compounds |
US10350159B2 (en) | 2010-05-31 | 2019-07-16 | Laboratories Farmacéuticos Rovi, S.A. | Paliperidone implant formulation |
US10285936B2 (en) | 2010-05-31 | 2019-05-14 | Laboratorios Farmacéuticos Rovi, S.A. | Injectable composition with aromatase inhibitor |
ES2390439B1 (es) * | 2012-08-03 | 2013-09-27 | Laboratorios Farmacéuticos Rovi, S.A. | Composición inyectable |
US10335366B2 (en) | 2010-05-31 | 2019-07-02 | Laboratorios Farmacéuticos Rovi, S.A. | Risperidone or paliperidone implant formulation |
ES2589106T3 (es) | 2010-05-31 | 2016-11-10 | Laboratorios Farmaceuticos Rovi, S.A. | Composición inyectable antipsicótica de liberación controlada |
US10881605B2 (en) | 2010-05-31 | 2021-01-05 | Laboratorios Farmaceuticos Rovi, S.A. | Methods for the preparation of injectable depot compositions |
US10463607B2 (en) | 2010-05-31 | 2019-11-05 | Laboratorios Farmaceutics Rofi S.A. | Antipsychotic Injectable Depot Composition |
LT2394663T (lt) | 2010-05-31 | 2022-02-10 | Laboratorios Farmaceuticos Rovi, S.A. | Kompozicijos, skirtos įšvirkščiamiems in situ biologiškai skaidiems implantams |
US9272044B2 (en) | 2010-06-08 | 2016-03-01 | Indivior Uk Limited | Injectable flowable composition buprenorphine |
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ES2456917T3 (es) * | 2011-05-31 | 2014-04-24 | Laboratorios Farmacéuticos Rovi, S.A. | Formulación de implante de paliperidona |
SI2529756T1 (sl) * | 2011-05-31 | 2021-09-30 | Laboratorios Farmaceuticos Rovi, S.A. | Formulacija vsadka z risperidonom in/ali paliperidonom |
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