HRP20161100T1 - Sastav injektibilnog antipsihotika u depo obliku - Google Patents
Sastav injektibilnog antipsihotika u depo obliku Download PDFInfo
- Publication number
- HRP20161100T1 HRP20161100T1 HRP20161100TT HRP20161100T HRP20161100T1 HR P20161100 T1 HRP20161100 T1 HR P20161100T1 HR P20161100T T HRP20161100T T HR P20161100TT HR P20161100 T HRP20161100 T HR P20161100T HR P20161100 T1 HRP20161100 T1 HR P20161100T1
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- Prior art keywords
- drug
- polymer
- composition according
- solvent
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Links
- 239000000203 mixture Substances 0.000 title claims 15
- 230000000561 anti-psychotic effect Effects 0.000 title claims 2
- 229940079593 drug Drugs 0.000 claims 16
- 239000003814 drug Substances 0.000 claims 16
- 229920000642 polymer Polymers 0.000 claims 10
- 239000002904 solvent Substances 0.000 claims 10
- 229920000249 biocompatible polymer Polymers 0.000 claims 4
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical group CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims 3
- AEMRFAOFKBGASW-UHFFFAOYSA-N Glycolic acid Chemical class OCC(O)=O AEMRFAOFKBGASW-UHFFFAOYSA-N 0.000 claims 3
- 239000002245 particle Substances 0.000 claims 3
- HEDRZPFGACZZDS-UHFFFAOYSA-N Chloroform Chemical compound ClC(Cl)Cl HEDRZPFGACZZDS-UHFFFAOYSA-N 0.000 claims 2
- 229910019440 Mg(OH) Inorganic materials 0.000 claims 2
- JVTAAEKCZFNVCJ-UHFFFAOYSA-N lactic acid Chemical compound CC(O)C(O)=O JVTAAEKCZFNVCJ-UHFFFAOYSA-N 0.000 claims 2
- PMXMIIMHBWHSKN-UHFFFAOYSA-N 3-{2-[4-(6-fluoro-1,2-benzoxazol-3-yl)piperidin-1-yl]ethyl}-9-hydroxy-2-methyl-6,7,8,9-tetrahydropyrido[1,2-a]pyrimidin-4-one Chemical compound FC1=CC=C2C(C3CCN(CC3)CCC=3C(=O)N4CCCC(O)C4=NC=3C)=NOC2=C1 PMXMIIMHBWHSKN-UHFFFAOYSA-N 0.000 claims 1
- 208000020925 Bipolar disease Diseases 0.000 claims 1
- 229920001577 copolymer Polymers 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 239000007943 implant Substances 0.000 claims 1
- 238000010952 in-situ formation Methods 0.000 claims 1
- 235000014655 lactic acid Nutrition 0.000 claims 1
- 239000004310 lactic acid Substances 0.000 claims 1
- 239000000178 monomer Substances 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
- 229960001534 risperidone Drugs 0.000 claims 1
- 201000000980 schizophrenia Diseases 0.000 claims 1
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
- A61K9/0012—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
- A61K31/42—Oxazoles
-
- 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
- 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
- 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
-
- 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
-
- 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
-
- 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
- A61P25/24—Antidepressants
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurology (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Claims (17)
1. Injektabilna sterilna depo formulacija koja se sastoji:
barem od antipsihotika koji je risperidon i/ili 9-OH-risperidon u bilo kojoj kombinaciji;
barem od biokompatibilnog polimera koji je kopolimer koji se temelji na zatvorenim završecima karboksilne, mliječne i glikolne kiseline s omjerom monomera mliječne kiseline naspram glikolne kiseline u rasponu d 50:50 do 75:25 i
omjera mase lijeka/polimera između 15 i 40% izražen kao postotak težine lijeka s obzirom na lijek plus polimer;
barem otapalo mješljivo s vodom s dipolnim momentom u rasponu od 3,9-43 D, naznačeno time što je spomenuto otapalo DMSO
biokompatibilni polimer ima intrinzičnu inherentnu viskoznost u rasponu od 0,16-0,60 dl/g mjerenu u kloroformu pri 25°C i pri koncentraciji od 0,1%; a koncentracija biokompatibilnog polimera sadržana je u rasponu od 25%-50%, a postotak težine polimera na temelju ukupne otopine polimera;
viskozitet otopine koja se sastoji od polimera i otapala je između 0,5 i 7,0 Pa.s; i
distribucija veličine čestica lijeka je sljedeća:
- manje od 10% čestica manje je od 10 mikrona;
2. manje od 10% čestica većih od 225 mikrona i
3. vrijednost d0,5 u rasponu od 60 do 130 mikrona.
2. Sastav u skladu sa zahtjevom 1, pri čemu se otopina sadrži polimer, a otapalo mješljivo s vodom ima viskozitet u rasponu od 0,7 do 2,0 Pa.s.
3. Sastav u skladu s bilo kojim od prethodnih zahtjeva pri čemu je omjer mase lijeka/polimera između 25 i 35% izražen kao postotak težine lijeka s obzirom na lijek plus polimer.
4. Sastav u skladu sa zahtjevom 3 gdje je omjer mase lijeka/polimera otprilike 33%.
5. Sastav u skladu s jednim od prethodnih zahtjeva, pri čemu je topivost lijeka u otapalu manja od 90 mg/ml.
6. Sastav u skladu sa zahtjevom 5, gdje je topljivost lijeka u otapalu manja od 10 mg/ml.
7. Sastav u skladu s bilo kojim od prethodnih zahtjeva, pri čemu je koncentracija lijeka s obzirom na ukupnu težinu sastava između 4 i 16 težinskog faktora/težinskog faktora%.
8. Sastav u skladu s jednim od prethodnih zahtjeva pri čemu je omjer mase otopine koja sadrži polimer i otapalo s obzirom na lijek niža je od 15% težinskog faktora/težinskog faktora%.
9. Sastav u skladu s bilo kojim od prethodnih zahtjeva pri čemu je omjer mase otapala/lijeka niži od 11,4% težinskog faktora/težinskog faktora izražen kao postotak težine otapala s obzirom na lijek.
10. Sastav u skladu s bilo kojim od prethodnih zahtjeva nadalje sadržava Mg(OH)2 u molarnom omjeru između 2/3 i 2/5, izražen kao molarni omjer lijeka naspram Mg(OH)2.
11. Sastav u skladu s bilo kojim od prethodnih zahtjeva ozračen u rasponu od 5-25 KGy.
12. Sastav iz jednog od bilo kojeg od prethodnih zahtjeva za liječenje shizofrenije ili bipolarnog događaja u ljudskom tijelu.
13. Farmaceutski komplet za in situ formiranje biorazgradivog implantata u tijelu koji sadržava sastav iz bilo kojeg od prethodnih zahtjeva 1 do 12, pri čemu se lijek i biokompatibilni polimer nalaze u prvom spremniku, a otapalo mješljivo s vodom nalazi se u drugom, zasebnom spremniku.
14. Farmaceutski komplet u skladu sa zahtjevom 13 pri čemu je barem jedan od prvog i drugog spremnika štrcaljka, bočica, uređaj ili uložak, za jednokratnu primjenu ili ne.
15. Farmaceutski komplet u skladu sa zahtjevom 14 pri čemu se spremnici mogu spojiti kroz uređaj za spajanje.
16. Farmaceutski komplet u skladu sa zahtjevima 13 ili 15 pri čemu je sadržaj od barem jednog od prvog ili drugog spremnika liofiliziran.
17. Farmaceutski komplet u skladu s bilo kojim od zahtjeva 13 do 16 ozračen u rasponu od 5-25 KGy.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP10382154.2A EP2394664B1 (en) | 2010-05-31 | 2010-05-31 | Antipsychotic injectable depot composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| HRP20161100T1 true HRP20161100T1 (hr) | 2016-11-04 |
Family
ID=43301889
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161049TT HRP20161049T1 (hr) | 2010-05-31 | 2016-08-19 | Sastav injektibilnog antipsihotika u depo obliku |
| HRP20161100TT HRP20161100T1 (hr) | 2010-05-31 | 2016-08-29 | Sastav injektibilnog antipsihotika u depo obliku |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20161049TT HRP20161049T1 (hr) | 2010-05-31 | 2016-08-19 | Sastav injektibilnog antipsihotika u depo obliku |
Country Status (32)
| Country | Link |
|---|---|
| US (2) | US10085936B2 (hr) |
| EP (2) | EP2394664B1 (hr) |
| JP (1) | JP5882993B2 (hr) |
| KR (1) | KR101784330B1 (hr) |
| CN (1) | CN103002917B (hr) |
| AP (1) | AP3524A (hr) |
| AU (1) | AU2011260318B2 (hr) |
| BR (1) | BR112012030686B1 (hr) |
| CA (1) | CA2800111C (hr) |
| CL (1) | CL2012003350A1 (hr) |
| CY (2) | CY1117964T1 (hr) |
| DK (2) | DK2394664T3 (hr) |
| EA (1) | EA024155B1 (hr) |
| ES (2) | ES2589106T3 (hr) |
| HR (2) | HRP20161049T1 (hr) |
| HU (2) | HUE029895T2 (hr) |
| IL (1) | IL223129A (hr) |
| LT (2) | LT2394664T (hr) |
| MA (1) | MA34296B1 (hr) |
| ME (1) | ME02501B (hr) |
| MX (1) | MX338373B (hr) |
| MY (1) | MY161930A (hr) |
| NZ (1) | NZ604342A (hr) |
| PL (2) | PL2394664T3 (hr) |
| PT (2) | PT2394664T (hr) |
| RS (1) | RS55190B1 (hr) |
| SG (1) | SG185775A1 (hr) |
| SI (2) | SI2394664T1 (hr) |
| SM (2) | SMT201600320B (hr) |
| UA (1) | UA108885C2 (hr) |
| WO (1) | WO2011151355A1 (hr) |
| ZA (1) | ZA201209346B (hr) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| ES2562878T3 (es) | 2007-05-25 | 2016-03-08 | Indivior Uk Limited | Formulaciones de liberación sostenida de compuestos de risperidona |
| US10335366B2 (en) * | 2010-05-31 | 2019-07-02 | Laboratorios Farmacéuticos Rovi, S.A. | Risperidone or paliperidone implant formulation |
| US10285936B2 (en) | 2010-05-31 | 2019-05-14 | Laboratorios Farmacéuticos Rovi, S.A. | Injectable composition with aromatase inhibitor |
| US10350159B2 (en) | 2010-05-31 | 2019-07-16 | Laboratories Farmacéuticos Rovi, S.A. | Paliperidone implant formulation |
| US10881605B2 (en) | 2010-05-31 | 2021-01-05 | Laboratorios Farmaceuticos Rovi, S.A. | Methods for the preparation of injectable depot compositions |
| PT2394663T (pt) | 2010-05-31 | 2021-11-26 | Farm Rovi Lab Sa | Composições para implantes biodegradáveis injectáveis |
| US10463607B2 (en) | 2010-05-31 | 2019-11-05 | Laboratorios Farmaceutics Rofi S.A. | Antipsychotic Injectable Depot Composition |
| ES2589106T3 (es) | 2010-05-31 | 2016-11-10 | Laboratorios Farmaceuticos Rovi, S.A. | Composición inyectable antipsicótica de liberación controlada |
| ES2456917T3 (es) * | 2011-05-31 | 2014-04-24 | Laboratorios Farmacéuticos Rovi, S.A. | Formulación de implante de paliperidona |
| LT2529756T (lt) * | 2011-05-31 | 2021-07-26 | Laboratorios Farmaceuticos Rovi, S.A. | Risperidono ir (arba) paliperidono implantų kompozicija |
| CA2903769A1 (en) | 2013-03-11 | 2014-10-09 | Durect Corporation | Injectable controlled release composition comprising high viscosity liquid carrier |
| US20140308352A1 (en) | 2013-03-11 | 2014-10-16 | Zogenix Inc. | Compositions and methods involving polymer, solvent, and high viscosity liquid carrier material |
| WO2016199170A2 (en) * | 2015-06-10 | 2016-12-15 | Cipla Limited | Paliperidone palmitate particles and compositions thereof |
| JP2020511483A (ja) | 2017-03-20 | 2020-04-16 | テバ・ファーマシューティカルズ・インターナショナル・ゲーエムベーハーＴｅｖａ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ Ｉｎｔｅｒｎａｔｉｏｎａｌ ＧｍｂＨ | 徐放性オランザピン製剤 |
| CN109589304A (zh) * | 2017-10-01 | 2019-04-09 | 万特制药(海南)有限公司 | 利培酮口服溶液及其制备方法 |
| CN110420212A (zh) * | 2019-08-19 | 2019-11-08 | 韩自勤 | 一种用于治疗精神分裂症组合物及其制备方法 |
| TW202313047A (zh) | 2021-09-21 | 2023-04-01 | 西班牙商禾霏藥品實驗室有限公司 | 抗精神病可注射儲積型組合物 |
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| BE758156R (fr) | 1970-05-13 | 1971-04-28 | Ethicon Inc | Element de suture absorbable et sa |
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| US4530840A (en) | 1982-07-29 | 1985-07-23 | The Stolle Research And Development Corporation | Injectable, long-acting microparticle formulation for the delivery of anti-inflammatory agents |
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| US5620700A (en) | 1990-10-30 | 1997-04-15 | Alza Corporation | Injectable drug delivery system and method |
| US5656297A (en) * | 1992-03-12 | 1997-08-12 | Alkermes Controlled Therapeutics, Incorporated | Modulated release from biocompatible polymers |
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| US20050003007A1 (en) | 2003-07-02 | 2005-01-06 | Michele Boix | Method of sterilization of polymeric microparticles |
| CA2915574C (en) * | 2003-07-18 | 2017-02-07 | Oakwood Laboratories, L.L.C. | Prevention of molecular weight reduction of the polymer, impurity formation and gelling in polymer compositions |
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| US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| US8076448B2 (en) | 2006-10-11 | 2011-12-13 | Tolmar Therapeutics, Inc. | Preparation of biodegradable polyesters with low-burst properties by supercritical fluid extraction |
| FR2908775B1 (fr) * | 2006-11-17 | 2012-08-31 | Biomatlante | Hydrogel et ses applications biomedicales |
| PT2115029E (pt) | 2007-02-15 | 2015-10-26 | Tolmar Therapeutics Inc | Poli-(lactido/glicolido) de efeito de libertação imediata reduzido e métodos de produção de polímeros |
| JP5599705B2 (ja) * | 2007-05-18 | 2014-10-01 | デュレクト コーポレーション | 改良されたデポー製剤 |
| ES2562878T3 (es) | 2007-05-25 | 2016-03-08 | Indivior Uk Limited | Formulaciones de liberación sostenida de compuestos de risperidona |
| WO2009060473A2 (en) * | 2007-11-06 | 2009-05-14 | Panacea Biotec Limited | Injectable compositions, processes and uses thereof |
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| US10350159B2 (en) | 2010-05-31 | 2019-07-16 | Laboratories Farmacéuticos Rovi, S.A. | Paliperidone implant formulation |
| US10335366B2 (en) | 2010-05-31 | 2019-07-02 | Laboratorios Farmacéuticos Rovi, S.A. | Risperidone or paliperidone implant formulation |
| US10285936B2 (en) | 2010-05-31 | 2019-05-14 | Laboratorios Farmacéuticos Rovi, S.A. | Injectable composition with aromatase inhibitor |
| ES2589106T3 (es) | 2010-05-31 | 2016-11-10 | Laboratorios Farmaceuticos Rovi, S.A. | Composición inyectable antipsicótica de liberación controlada |
| PT2394663T (pt) | 2010-05-31 | 2021-11-26 | Farm Rovi Lab Sa | Composições para implantes biodegradáveis injectáveis |
| LT2529756T (lt) | 2011-05-31 | 2021-07-26 | Laboratorios Farmaceuticos Rovi, S.A. | Risperidono ir (arba) paliperidono implantų kompozicija |
| ES2456917T3 (es) | 2011-05-31 | 2014-04-24 | Laboratorios Farmacéuticos Rovi, S.A. | Formulación de implante de paliperidona |
-
2010
- 2010-05-31 ES ES10382154.2T patent/ES2589106T3/es active Active
- 2010-05-31 HU HUE10382154A patent/HUE029895T2/en unknown
- 2010-05-31 EP EP10382154.2A patent/EP2394664B1/en active Active
- 2010-05-31 PT PT103821542T patent/PT2394664T/pt unknown
- 2010-05-31 LT LTEP10382154.2T patent/LT2394664T/lt unknown
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