ES2995466T3 - Methods for dose initiation of aripiprazole treatments - Google Patents
Methods for dose initiation of aripiprazole treatments Download PDFInfo
- Publication number
- ES2995466T3 ES2995466T3 ES21720012T ES21720012T ES2995466T3 ES 2995466 T3 ES2995466 T3 ES 2995466T3 ES 21720012 T ES21720012 T ES 21720012T ES 21720012 T ES21720012 T ES 21720012T ES 2995466 T3 ES2995466 T3 ES 2995466T3
- Authority
- ES
- Spain
- Prior art keywords
- aripiprazole
- depot formulation
- dose
- oral
- patient
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 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 description 344
- 229960004372 aripiprazole Drugs 0.000 title claims abstract description 299
- 238000011282 treatment Methods 0.000 title claims abstract description 37
- 238000000034 method Methods 0.000 title claims abstract description 22
- 230000000977 initiatory effect Effects 0.000 title abstract description 23
- 238000002347 injection Methods 0.000 claims abstract description 110
- 239000007924 injection Substances 0.000 claims abstract description 110
- 239000000203 mixture Substances 0.000 claims abstract description 85
- 238000009472 formulation Methods 0.000 claims abstract description 84
- 238000007918 intramuscular administration Methods 0.000 claims abstract description 40
- 108010001237 Cytochrome P-450 CYP2D6 Proteins 0.000 claims description 23
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- 201000000980 schizophrenia Diseases 0.000 claims description 21
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- 238000011105 stabilization Methods 0.000 claims description 6
- 150000003839 salts Chemical group 0.000 claims description 5
- 208000007220 Cytochrome P-450 CYP2D6 Inhibitors Diseases 0.000 claims description 4
- 208000009011 Cytochrome P-450 CYP3A Inhibitors Diseases 0.000 claims description 4
- 208000028683 bipolar I disease Diseases 0.000 claims description 4
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- CDONPRYEWWPREK-UHFFFAOYSA-N 7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-1h-quinolin-2-one Chemical compound ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)C=CC4=CC=3)CC2)=C1Cl CDONPRYEWWPREK-UHFFFAOYSA-N 0.000 description 5
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- 230000000007 visual effect Effects 0.000 description 4
- UXQBDXJXIVDBTF-UHFFFAOYSA-N 7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-1h-quinolin-2-one;hydrate Chemical compound O.ClC1=CC=CC(N2CCN(CCCCOC=3C=C4NC(=O)CCC4=CC=3)CC2)=C1Cl UXQBDXJXIVDBTF-UHFFFAOYSA-N 0.000 description 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 description 3
- DDINXHAORAAYAD-UHFFFAOYSA-N aripiprazole lauroxil Chemical compound C1=C2N(COC(=O)CCCCCCCCCCC)C(=O)CCC2=CC=C1OCCCCN(CC1)CCN1C1=CC=CC(Cl)=C1Cl DDINXHAORAAYAD-UHFFFAOYSA-N 0.000 description 3
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- 229940102213 injectable suspension Drugs 0.000 description 3
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- 238000002372 labelling Methods 0.000 description 2
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 2
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- 238000002560 therapeutic procedure Methods 0.000 description 2
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- 210000000689 upper leg Anatomy 0.000 description 2
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- 102000049773 5-HT2A Serotonin Receptor Human genes 0.000 description 1
- 206010067484 Adverse reaction Diseases 0.000 description 1
- WSVLPVUVIUVCRA-KPKNDVKVSA-N Alpha-lactose monohydrate Chemical compound O.O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O WSVLPVUVIUVCRA-KPKNDVKVSA-N 0.000 description 1
- PNEYBMLMFCGWSK-UHFFFAOYSA-N Alumina Chemical compound [O-2].[O-2].[O-2].[Al+3].[Al+3] PNEYBMLMFCGWSK-UHFFFAOYSA-N 0.000 description 1
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- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 description 1
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- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
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- 206010026749 Mania Diseases 0.000 description 1
- 229930195725 Mannitol Natural products 0.000 description 1
- 241000489861 Maximus Species 0.000 description 1
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- 102100021702 Putative cytochrome P450 2D7 Human genes 0.000 description 1
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 230000006838 adverse reaction Effects 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 238000013459 approach Methods 0.000 description 1
- 229940029131 aripiprazole 10 mg Drugs 0.000 description 1
- 229940006021 aripiprazole oral tablet Drugs 0.000 description 1
- 230000001174 ascending effect Effects 0.000 description 1
- 239000003693 atypical antipsychotic agent Substances 0.000 description 1
- 229940127236 atypical antipsychotics Drugs 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 230000036983 biotransformation Effects 0.000 description 1
- 125000004106 butoxy group Chemical group [*]OC([H])([H])C([H])([H])C(C([H])([H])[H])([H])[H] 0.000 description 1
- 210000001217 buttock Anatomy 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 239000003086 colorant Substances 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 239000008120 corn starch Substances 0.000 description 1
- 229940099112 cornstarch Drugs 0.000 description 1
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- 230000003467 diminishing effect Effects 0.000 description 1
- 239000002612 dispersion medium Substances 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 229960003638 dopamine Drugs 0.000 description 1
- 229940102215 extended release suspension Drugs 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000023611 glucuronidation Effects 0.000 description 1
- 230000010224 hepatic metabolism Effects 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 229940071676 hydroxypropylcellulose Drugs 0.000 description 1
- 238000000338 in vitro Methods 0.000 description 1
- KHLVKKOJDHCJMG-QDBORUFSSA-L indigo carmine Chemical compound [Na+].[Na+].N/1C2=CC=C(S([O-])(=O)=O)C=C2C(=O)C\1=C1/NC2=CC=C(S(=O)(=O)[O-])C=C2C1=O KHLVKKOJDHCJMG-QDBORUFSSA-L 0.000 description 1
- 235000012738 indigotine Nutrition 0.000 description 1
- 239000004179 indigotine Substances 0.000 description 1
- 238000011221 initial treatment Methods 0.000 description 1
- UQSXHKLRYXJYBZ-UHFFFAOYSA-N iron oxide Inorganic materials [Fe]=O UQSXHKLRYXJYBZ-UHFFFAOYSA-N 0.000 description 1
- 229960001021 lactose monohydrate Drugs 0.000 description 1
- 235000019359 magnesium stearate Nutrition 0.000 description 1
- 229940057948 magnesium stearate Drugs 0.000 description 1
- 239000000594 mannitol Substances 0.000 description 1
- 235000010355 mannitol Nutrition 0.000 description 1
- 235000012054 meals Nutrition 0.000 description 1
- 235000019813 microcrystalline cellulose Nutrition 0.000 description 1
- 239000008108 microcrystalline cellulose Substances 0.000 description 1
- 229940016286 microcrystalline cellulose Drugs 0.000 description 1
- NDLPOXTZKUMGOV-UHFFFAOYSA-N oxo(oxoferriooxy)iron hydrate Chemical compound O.O=[Fe]O[Fe]=O NDLPOXTZKUMGOV-UHFFFAOYSA-N 0.000 description 1
- 239000003002 pH adjusting agent Substances 0.000 description 1
- 239000004031 partial agonist Substances 0.000 description 1
- 230000037361 pathway Effects 0.000 description 1
- 239000008194 pharmaceutical composition Substances 0.000 description 1
- 238000009520 phase I clinical trial Methods 0.000 description 1
- 238000011240 pooled analysis Methods 0.000 description 1
- 229940002612 prodrug Drugs 0.000 description 1
- 239000000651 prodrug Substances 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 229940001470 psychoactive drug Drugs 0.000 description 1
- 239000004089 psychotropic agent Substances 0.000 description 1
- 238000011002 quantification Methods 0.000 description 1
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- 238000011160 research Methods 0.000 description 1
- 238000009097 single-agent therapy Methods 0.000 description 1
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 description 1
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 description 1
- BBMHARZCALWXSL-UHFFFAOYSA-M sodium dihydrogenphosphate monohydrate Chemical compound O.[Na+].OP(O)([O-])=O BBMHARZCALWXSL-UHFFFAOYSA-M 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 230000003319 supportive effect Effects 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
- 230000009897 systematic effect Effects 0.000 description 1
- 239000007916 tablet composition Substances 0.000 description 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
- A61K31/495—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
- A61K47/08—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
- A61K47/32—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
- A61K9/0012—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
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Neurosurgery (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Dermatology (AREA)
- Inorganic Chemistry (AREA)
- Physiology (AREA)
- Nutrition Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Hospice & Palliative Care (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202063003544P | 2020-04-01 | 2020-04-01 | |
| PCT/JP2021/014194 WO2021201239A1 (en) | 2020-04-01 | 2021-04-01 | Methods for dose initiation of aripiprazole treatments |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2995466T3 true ES2995466T3 (en) | 2025-02-10 |
Family
ID=75581573
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES21720012T Active ES2995466T3 (en) | 2020-04-01 | 2021-04-01 | Methods for dose initiation of aripiprazole treatments |
Country Status (16)
| Country | Link |
|---|---|
| US (6) | US20230129919A1 (https=) |
| EP (3) | EP4467194A3 (https=) |
| JP (4) | JP7733000B2 (https=) |
| KR (3) | KR20220161402A (https=) |
| CN (3) | CN115379842A (https=) |
| AU (2) | AU2021248212A1 (https=) |
| BR (2) | BR112022018721A2 (https=) |
| CA (3) | CA3163321C (https=) |
| ES (1) | ES2995466T3 (https=) |
| HR (1) | HRP20241574T1 (https=) |
| HU (1) | HUE069157T2 (https=) |
| MX (2) | MX2022012354A (https=) |
| PL (1) | PL4125903T3 (https=) |
| TW (3) | TW202523329A (https=) |
| WO (2) | WO2021201238A1 (https=) |
| ZA (1) | ZA202210633B (https=) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20050032811A1 (en) * | 2003-08-06 | 2005-02-10 | Josiah Brown | Methods for administering aripiprazole |
| HUE069157T2 (hu) | 2020-04-01 | 2025-02-28 | Otsuka Pharma Co Ltd | Eljárások aripiprazol kezelések adagoláskezdésére |
| CA3197997A1 (en) | 2023-03-17 | 2025-01-23 | Otsuka Pharmaceutical Co., Ltd. | METHODS FOR DISPERSING INJECTABLE PREPARATIONS OF ARIPIPRAZOLE |
| CN120957722A (zh) | 2023-04-26 | 2025-11-14 | 大塚制药株式会社 | 用阿立哌唑治疗精神分裂症或i型双相障碍的剂量启动 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7053092B2 (en) | 2001-01-29 | 2006-05-30 | Otsuka Pharmaceutical Co., Ltd. | 5-HT1a receptor subtype agonist |
| AR033485A1 (es) | 2001-09-25 | 2003-12-26 | Otsuka Pharma Co Ltd | Sustancia medicinal de aripiprazol de baja higroscopicidad y proceso para la preparacion de la misma |
| US20050032811A1 (en) | 2003-08-06 | 2005-02-10 | Josiah Brown | Methods for administering aripiprazole |
| UA82561C2 (uk) | 2003-10-23 | 2008-04-25 | Оцука Фармасьютикалз Ко., Лтд. | Стерильна ін'єкційна композиція арипіпразолу з контрольованим вивільненням, спосіб її виготовлення та спосіб лікування шизофренії |
| UA96342C2 (en) | 2007-06-25 | 2011-10-25 | Оцука Фармасьютикал Ко., Лтд. | Microspheres having core/shell structure |
| JOP20200109A1 (ar) | 2012-04-23 | 2017-06-16 | Otsuka Pharma Co Ltd | مستحضر قابل للحقن |
| US10525057B2 (en) * | 2013-09-24 | 2020-01-07 | Otsuka Pharmaceutical Co., Ltd. | Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function |
| EP4082546A1 (en) | 2017-05-16 | 2022-11-02 | Bow River LLC | Methods of treatment with cyp3a4 substrate drugs |
| EP3761983A1 (en) * | 2018-03-05 | 2021-01-13 | Alkermes Pharma Ireland Limited | Aripiprazole dosing strategy |
| CN108498456B (zh) | 2018-05-16 | 2021-01-01 | 丽珠医药集团股份有限公司 | 一种阿立哌唑缓释微球及其制备方法 |
| CN110327296B (zh) | 2019-08-06 | 2021-10-22 | 深圳市泛谷药业股份有限公司 | 一种阿立哌唑长效注射制剂及其制备方法 |
| HUE069157T2 (hu) | 2020-04-01 | 2025-02-28 | Otsuka Pharma Co Ltd | Eljárások aripiprazol kezelések adagoláskezdésére |
-
2021
- 2021-04-01 HU HUE21720012A patent/HUE069157T2/hu unknown
- 2021-04-01 WO PCT/JP2021/014192 patent/WO2021201238A1/en not_active Ceased
- 2021-04-01 CN CN202180026022.3A patent/CN115379842A/zh active Pending
- 2021-04-01 KR KR1020227037400A patent/KR20220161402A/ko active Pending
- 2021-04-01 BR BR112022018721A patent/BR112022018721A2/pt unknown
- 2021-04-01 BR BR112022018647A patent/BR112022018647A2/pt unknown
- 2021-04-01 KR KR1020227037401A patent/KR102732030B1/ko active Active
- 2021-04-01 US US17/907,583 patent/US20230129919A1/en not_active Abandoned
- 2021-04-01 MX MX2022012354A patent/MX2022012354A/es unknown
- 2021-04-01 US US17/594,292 patent/US20220160621A1/en not_active Abandoned
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