SI2170279T1 - Postopki za izdelavo suspenzij aripiprazola in sublimacijsko sušenih formulacij - Google Patents
Postopki za izdelavo suspenzij aripiprazola in sublimacijsko sušenih formulacij Download PDFInfo
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- SI2170279T1 SI2170279T1 SI200831925T SI200831925T SI2170279T1 SI 2170279 T1 SI2170279 T1 SI 2170279T1 SI 200831925 T SI200831925 T SI 200831925T SI 200831925 T SI200831925 T SI 200831925T SI 2170279 T1 SI2170279 T1 SI 2170279T1
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- Prior art keywords
- suspension
- pulverization
- aripiprazole
- mpa
- pressure
- Prior art date
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- 239000000725 suspension Substances 0.000 title claims abstract 38
- CEUORZQYGODEFX-UHFFFAOYSA-N Aripirazole Chemical compound ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)CCC4=CC=3)CC2)=C1Cl CEUORZQYGODEFX-UHFFFAOYSA-N 0.000 title claims abstract 22
- 229960004372 aripiprazole Drugs 0.000 title claims abstract 22
- 238000000034 method Methods 0.000 title claims abstract 19
- 238000009472 formulation Methods 0.000 title claims abstract 4
- 239000000203 mixture Substances 0.000 title claims abstract 4
- 238000010298 pulverizing process Methods 0.000 claims abstract 24
- 239000002245 particle Substances 0.000 claims abstract 9
- 238000004519 manufacturing process Methods 0.000 claims abstract 6
- 239000006185 dispersion Substances 0.000 claims abstract 5
- 239000000463 material Substances 0.000 claims abstract 2
- 238000000265 homogenisation Methods 0.000 claims 8
- 229920002134 Carboxymethyl cellulose Polymers 0.000 claims 2
- 239000001768 carboxy methyl cellulose Substances 0.000 claims 2
- 235000010948 carboxy methyl cellulose Nutrition 0.000 claims 2
- 239000008112 carboxymethyl-cellulose Substances 0.000 claims 2
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 claims 1
- 239000001913 cellulose Substances 0.000 claims 1
- 229920002678 cellulose Polymers 0.000 claims 1
- 235000010980 cellulose Nutrition 0.000 claims 1
- 238000001816 cooling Methods 0.000 claims 1
- 239000013078 crystal Substances 0.000 claims 1
- 238000001035 drying Methods 0.000 claims 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 claims 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 claims 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims 1
- -1 hydroxypropylethyl Chemical group 0.000 claims 1
- 150000004682 monohydrates Chemical class 0.000 claims 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims 1
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims 1
- 150000003839 salts Chemical class 0.000 claims 1
- 229910052710 silicon Inorganic materials 0.000 claims 1
- 239000010703 silicon Substances 0.000 claims 1
- 238000000859 sublimation Methods 0.000 claims 1
- 230000008022 sublimation Effects 0.000 claims 1
- 239000000375 suspending agent Substances 0.000 claims 1
- 230000001804 emulsifying effect Effects 0.000 abstract 2
- 239000000084 colloidal system Substances 0.000 abstract 1
- 238000001132 ultrasonic dispersion Methods 0.000 abstract 1
Classifications
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- 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
- A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
-
- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- 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
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Dispersion Chemistry (AREA)
- Psychiatry (AREA)
- Neurosurgery (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
Claims (14)
- Postopki za izdelavo suspenzij aripiprazola in sublimacij sko sušenih formulacij1. Postopek za izdelavo suspenzije aripiprazola, obsega naslednje korake: (a) sestavljanje prostega aripiprazola in nosilca, da tvorimo primarno suspenzijo; (b) izpostavljanje primarne suspenzije prvi pulverizaciji, da tvorimo sekundarno suspenzijo; in (c) izpostavljanje sekundarne suspenzije drugi pulverizaciji, da tvorimo končno suspenzijo, kjer je v prvi pulverizaciji v koraku (b) sekundama suspenzija tvoijena s pulverizacijo primarne suspenzije z uporabo naprave za pulverizacijo z velikimi strižnimi silami ali disperzij ske naprave, ki na materialu, ki bo obdelan uporablja strižno silo, in je v drugi pulverizaciji v koraku (c) končna suspenzija tvorjena s pulverizacijo sekudname suspenzije, z uporabo naprave za visokotlačno homogenizacijo.
- 2. Postopek po zahtevku 1, kjer v koraku (c) naprava za visokotlačno homogenizacijo uporabljena pri tlaku od 30 MPa do 100 MPa.
- 3. Postopek po zahtevku 1, kjer v koraku (c) naprava za visokotlačno homogenizacijo uporabljena pri temperaturi od 1°C to 70°C.
- 4. Postopek za izdelavo suspenzije aripiprazola, obsega naslednje korake: (a) sestavljanje prostega aripiprazola in nosilca, da tvorimo primarno suspenzijo; (b) izpostavljanje primarne suspenzije prvi pulverizaciji, da tvorimo sekundarno suspenzijo; in (c) izpostavljanje sekundarne suspenzije drugi pulverizaciji, da tvorimo končno suspenzijo, kjer je v prvi pulverizaciji v koraku (b) sekundama suspenzija tvorjena s pulverizacijo primarne suspenzije z uporabo naprave za visokotlačno homogenizacijo pri tlaku od 5 MPa do 20 MPa, in je v drugi pulverizaciji v koraku (c) končna suspenzija tvoijena s pulverizacijo sekudname suspenzije, z uporabo naprave za visokotlačno homogenizacijo pri tlaku od 20 MPa do 100 MPa, kjer je razlika med tlakom pulverizacije v koraku (b) in tlakom pulverizacije v koraku (c) od 10 MPa do 90 MPa.
- 5. Postopek po zahtevku 4, kjer je v koraku (b) tlak pulverizacije naprave za visokotlačno homogenizacijo v območju od 5 MPa do 20 MPa, in v koraku (c) pulverizacija poteka večkrat in je tlak pulverizacije postopno povišan v območju od 20 MPa do 100 MPa.
- 6. Postopek po zahtevku 4, kjer je v korakih (b) in (c) naprava za visokotlačno homogenizacijo uporabljena pri temperaturi od 1°C do 50°C.
- 7. Postopek po zahtevku 1 ali po zahtevku 4, kjer nosilec vsebuje vsak eno sredstvo za suspendiranje izbrano iz skupine, ki vsebuje karboksimetil celulozo, soli karboksimetil celuloze, hidroksipropil celulozo, hidroksipropiletil celulozo, hidroksipropilmetil celulozo in polivinil pirolidon.
- 8. Postopek po zahtevku 1 ali po zahtevku 4, kjer prosti aripiprazol vsebuje delce aripiprazola, z velikostjo delcev 100 pm ali več, v količini 10% ali več, in ima srednjo volumsko velikost delcev od 20 pm do 1.000 pm, meijeno s sipanjem laserske svetlobe (LLS).
- 9. Postopek po zahtevku 1 ali po zahtevku 4, kjer ima prosti aripiprazol srednjo volumsko velikost delcev od 110 pm do 1.000 pm, merjeno z LLS.
- 10. Postopek po zahtevku 1 ali po zahtevku 4, kjer ima prosti aripiprazol v suspenziji aripiprazola srednjo volumsko velikost delcev od 1 pm do 10 pm, merjeno z LLS.
- 11. Postopek po zahtevku 1 ali po zahtevku 4, kjer ima prosti aripiprazol v suspenziji aripiprazola srednjo volumsko velikost delcev od 2 pm do 4 pm, merjeno z LLS.
- 12. Postopek po zahtevku 1, ki obsega naslednje korake: (I) sestavljanje sterilnega prostega aripiprazola s srednjo volumsko velikostjo delcev od 200 pm do 400 pm merjeno z LLS in sterilnega nosilca, da tvorimo primarno sterilno suspenzijo; (II) izpostavljanje sterilne primarne suspenzije prvi pulverizaciji, z uporabo naprave za pulverizacijo z velikimi strižnimi silami ali disperzij ske naprave, ki na materialu, ki bo obdelan uporablja strižno silo, da tvorimo sekundarno suspenzijo; in (III) izpostavljanje sterilne sekundarne suspenzije drugi pulverizaciji, z uporabo naprave za visokotlačno homogenizacijo, da tvorimo končno suspenzijo; kjer ima aripiprazol v sterilni končni suspenziji srednjo volumsko velikost delcev od 1 pm do 10 pm, merjeno z LLS.
- 13. Postopek po zahtevku 1 ali po zahtevku 4, kjer je prosti aripiprazol v obliki, izbrani iz skupine, ki vsebuje monohidrat in anhidridne kristale B.
- 14. Postopek za izdelavo sublimacijsko sušene formulacije hidrata aripiprazola A, kjer postopek obsega naslednje korake: ohlajanje suspenzije izdelane po postopku po zahtevku 1 ali po zahtevku 4 in vsebuje hidrat aripiprazola A na od -20°C do - 55°C, da suspenzijo zamrznemo; in naknadno izvedbo sušenja pri temperaturi pod približno 0°C.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2007200088 | 2007-07-31 | ||
| PCT/JP2008/064076 WO2009017250A1 (en) | 2007-07-31 | 2008-07-30 | Methods for producing aripiprazole suspension and freeze-dried formulation |
| EP08792242.3A EP2170279B1 (en) | 2007-07-31 | 2008-07-30 | Methods for producing aripiprazole suspension and freeze-dried formulation |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI2170279T1 true SI2170279T1 (sl) | 2018-04-30 |
Family
ID=39816777
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200831925T SI2170279T1 (sl) | 2007-07-31 | 2008-07-30 | Postopki za izdelavo suspenzij aripiprazola in sublimacijsko sušenih formulacij |
Country Status (28)
| Country | Link |
|---|---|
| US (6) | US9457026B2 (sl) |
| EP (1) | EP2170279B1 (sl) |
| JP (1) | JP4879349B2 (sl) |
| KR (1) | KR101546106B1 (sl) |
| CN (1) | CN101801342B (sl) |
| AR (2) | AR067747A1 (sl) |
| BR (1) | BRPI0815382A2 (sl) |
| CA (1) | CA2695178C (sl) |
| CO (1) | CO6290634A2 (sl) |
| CY (1) | CY1120165T1 (sl) |
| DK (1) | DK2170279T3 (sl) |
| ES (1) | ES2661037T3 (sl) |
| HR (1) | HRP20180295T1 (sl) |
| HU (1) | HUE036214T2 (sl) |
| IL (2) | IL244186A0 (sl) |
| LT (1) | LT2170279T (sl) |
| MX (1) | MX2010001311A (sl) |
| MY (1) | MY152789A (sl) |
| NO (1) | NO2170279T3 (sl) |
| NZ (1) | NZ582415A (sl) |
| PL (1) | PL2170279T3 (sl) |
| PT (1) | PT2170279T (sl) |
| RU (1) | RU2483711C2 (sl) |
| SI (1) | SI2170279T1 (sl) |
| TW (1) | TWI410255B (sl) |
| UA (1) | UA97286C2 (sl) |
| WO (1) | WO2009017250A1 (sl) |
| ZA (1) | ZA201000307B (sl) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2009017250A1 (en) * | 2007-07-31 | 2009-02-05 | Otsuka Pharmaceutical Co., Ltd. | Methods for producing aripiprazole suspension and freeze-dried formulation |
| PT105058B (pt) | 2010-04-21 | 2013-04-17 | Hovione Farmaciencia S A | Processo para processamento de partículas de ingredientes activos farmacêuticos |
| BR112012028368B8 (pt) * | 2010-08-24 | 2022-07-19 | Otsuka Pharma Co Ltd | Processo para prevenção de aglomeração de partículas de ingrediente ativo em uma suspensão, suspensão e composição de torta contendo derivado carbo estirila e óleo de silicone e/ou derivado de óleo de silicone |
| LT2667856T (lt) * | 2011-01-24 | 2021-11-25 | Otsuka Pharmaceutical Co., Ltd. | Medicininė priemonė, kurioje yra sausos masės kompozicija, apimanti aripiprazolą kaip veikliąją sudedamąją dalį, ir sausos masės kompozicija, apimanti aripiprazolą kaip veikliąją sudedamąją dalį |
| JO3410B1 (ar) * | 2011-06-07 | 2019-10-20 | Otsuka Pharma Co Ltd | تركيبة أريبيبرازول مجفف بالتبريد |
| KR101103011B1 (ko) * | 2011-10-13 | 2012-01-05 | (주)일신오토클레이브 | 스크루 형 고압 발생 장치 |
| CN102524261B (zh) * | 2011-12-16 | 2014-12-03 | 辽宁师范大学 | 一种强力生根剂纳米制剂、其制备方法及应用 |
| CN102450269A (zh) * | 2011-12-27 | 2012-05-16 | 辽宁师范大学 | 三唑酮纳米胶体悬浮剂及其制备方法 |
| AR090775A1 (es) | 2012-04-23 | 2014-12-03 | Otsuka Pharma Co Ltd | Preparado inyectable |
| JOP20200109A1 (ar) * | 2012-04-23 | 2017-06-16 | Otsuka Pharma Co Ltd | مستحضر قابل للحقن |
| JP5341282B1 (ja) * | 2012-06-29 | 2013-11-13 | 丸石製薬株式会社 | アリピプラゾールの経口医薬製剤 |
| EP2868319A4 (en) * | 2012-06-29 | 2016-02-24 | Maruishi Pharma | ORAL PHARMACEUTICAL PREPARATION OF ARIPIPRAZOLE |
| JP6007169B2 (ja) * | 2012-11-30 | 2016-10-12 | 大原薬品工業株式会社 | アリピプラゾール無水物を含有する固形製剤の製造方法 |
| US9655951B2 (en) * | 2013-01-23 | 2017-05-23 | Cartilast II LLC | Preservation of the biological activity of undenatured type II collagen |
| US9051268B2 (en) | 2013-04-30 | 2015-06-09 | Otsuka Pharmaceutical Co., Ltd. | Oral solid preparation comprising aripiprazole and method for producing oral solid preparation comprising aripiprazole |
| WO2017025930A1 (en) | 2015-08-12 | 2017-02-16 | Ftf Pharma Private Limited | Oral solution of aripiprazole |
| CN106474058B (zh) * | 2015-08-31 | 2020-01-07 | 南京诺瑞特医药科技有限公司 | 具有延长的保质期的阿立哌唑可注射悬浮液制剂 |
| CA3030972A1 (en) | 2016-07-28 | 2018-02-01 | Mylan Laboratories Ltd | Process for preparing sterile aripiprazole formulation |
| US10821200B2 (en) | 2016-12-05 | 2020-11-03 | Hyalo Technologies, LLC | Method of sterilization of microparticles |
| CN108938578A (zh) * | 2017-05-25 | 2018-12-07 | 万全万特制药（厦门）有限公司 | 阿立哌唑分散片及其制备方法 |
| US20230310417A1 (en) * | 2020-03-30 | 2023-10-05 | Cipla Limited | Injectable aripiprazole formulation |
| EP4043008A1 (en) | 2021-02-15 | 2022-08-17 | Warszawskie Zaklady Farmaceutyczne Polfa S.A. | Method for the preparation of a pharmaceutical composition comprising aripiprazole |
| CN115554253B (zh) * | 2022-10-14 | 2024-03-29 | 浙江圣兆药物科技股份有限公司 | 一种平稳释药的注射用阿立哌唑冻干制剂及其制备方法 |
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