RU2005102105A - Способы и лекарственные формы для контролируемой доставки палиперидона - Google Patents
Способы и лекарственные формы для контролируемой доставки палиперидона Download PDFInfo
- Publication number
- RU2005102105A RU2005102105A RU2005102105/15A RU2005102105A RU2005102105A RU 2005102105 A RU2005102105 A RU 2005102105A RU 2005102105/15 A RU2005102105/15 A RU 2005102105/15A RU 2005102105 A RU2005102105 A RU 2005102105A RU 2005102105 A RU2005102105 A RU 2005102105A
- Authority
- RU
- Russia
- Prior art keywords
- dosage form
- paliperidone
- acceptable salt
- pharmaceutically acceptable
- layer
- Prior art date
Links
- 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 title claims 14
- 229960001057 paliperidone Drugs 0.000 title claims 14
- 239000003814 drug Substances 0.000 title claims 4
- 229940079593 drug Drugs 0.000 title claims 2
- 239000002552 dosage form Substances 0.000 claims 21
- 150000003839 salts Chemical class 0.000 claims 13
- 229960001534 risperidone Drugs 0.000 claims 6
- 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 6
- 239000002357 osmotic agent Substances 0.000 claims 3
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical group [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims 2
- 230000000694 effects Effects 0.000 claims 2
- 229920000642 polymer Polymers 0.000 claims 2
- 208000019901 Anxiety disease Diseases 0.000 claims 1
- 206010010774 Constipation Diseases 0.000 claims 1
- 208000027776 Extrapyramidal disease Diseases 0.000 claims 1
- 206010041349 Somnolence Diseases 0.000 claims 1
- 239000000164 antipsychotic agent Substances 0.000 claims 1
- 230000036506 anxiety Effects 0.000 claims 1
- 208000002173 dizziness Diseases 0.000 claims 1
- 229920013821 hydroxy alkyl cellulose Polymers 0.000 claims 1
- 230000003285 pharmacodynamic effect Effects 0.000 claims 1
- 210000002381 plasma Anatomy 0.000 claims 1
- 239000011780 sodium chloride Substances 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
- A61K9/209—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat containing drug in at least two layers or in the core and in at least one outer layer
-
- 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
- A61K31/506—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim not condensed and containing further 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
- A61K31/495—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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- 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
- A61P25/22—Anxiolytics
-
- 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)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurosurgery (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Neurology (AREA)
- Biomedical Technology (AREA)
- Psychiatry (AREA)
- Pain & Pain Management (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
Claims (21)
1. Лекарственная форма для лечения субъекта, содержащая фармацевтически эффективное количество палиперидона, рисперидона или их фармацевтически приемлемой соли, при этом указанная лекарственная форма сохраняет возрастающую скорость высвобождения указанных палиперидона, рисперидона или их фармацевтически приемлемой соли на протяжении длительного периода времени.
2. Лекарственная форма по п.1, которая сохраняет возрастающую скорость высвобождения в течение от приблизительно 10 до приблизительно 24 ч после введения.
3. Лекарственная форма по п.1, которая сохраняет возрастающую скорость высвобождения в течение от приблизительно 16 до приблизительно 22 ч после введения.
4. Лекарственная форма по п.1, которая сохраняет возрастающую скорость высвобождения в течение от приблизительно 18 до приблизительно 21 ч после введения.
5. Лекарственная форма по п.1, где Cmax достигается приблизительно через 14 ч после введения.
6. Лекарственная форма по п.1, где Cmax достигается в интервале от приблизительно 16 до приблизительно 22 ч после введения.
7. Лекарственная форма по п.1, где Cmax достигается в интервале от приблизительно 18 до приблизительно 21 ч после введения.
8. Лекарственная форма по п.1, где T90 достигается в интервале от приблизительно 18 до приблизительно 22 ч после введения.
9. Лекарственная форма по п.1, которая подходит для введения один раз в день.
10. Лекарственная форма по п.1, где снижение побочных эффектов ассоциировано с высокой концентрацией антипсихотических агентов в плазме крови.
11. Лекарственная форма по п.10, где указанные побочные эффекты выбраны из группы, состоящей из тревоги, сонливости, головокружения, запора и экстрапирамидных симптомов.
12. Лекарственная форма, содержащая два или более слоев, в число которых входят первый и второй слои, указанный первый слой содержит палиперидон, рисперидон или их фармацевтически приемлемую соль, указанный второй слой содержит полимер; наружную оболочку, окружающую указанные два или более слоя; и отверстие в указанной наружной оболочке.
13. Лекарственная форма по п.12, где указанный первый слой содержит осмотический агент.
14. Лекарственная форма по п.13, где указанный осмотический агент представляет собой хлорид натрия.
15. Лекарственная форма по п.13, где указанный осмотический агент присутствует в количестве, по меньшей мере, 20 мас.% указанного первого слоя.
16. Лекарственная форма по пункту 12, где указанный второй слой дополнительно содержит палиперидон или его фармацевтически приемлемую соль, причем соотношение количества палиперидона или его фармацевтически приемлемой соли в указанном первом слое к количеству палиперидона или его фармацевтически приемлемой соли в указанном втором слое составляет менее 1,0.
17. Лекарственная форма по п.16, где соотношение количества палиперидона или его фармацевтически приемлемой соли в указанном первом слое к количеству палиперидона или его фармацевтически приемлемой соли в указанном втором слое составляет менее 0,44.
18. Лекарственная форма по п.17, где соотношение количества палиперидона или его фармацевтически приемлемой соли в указанном первом слое к количеству палиперидона или его фармацевтически приемлемой соли в указанном втором лекарственном слое составляет менее 0,33.
19. Лекарственная форма по п.12, дополнительно содержащая подслой, который находится в пределах указанной наружной оболочки и окружает указанный первый слой и указанный второй слой.
20. Лекарственная форма по п.12, где указанный подслой содержит гидроксиалкилцеллюлозный полимер, имеющий молекулярную массу от приблизительно 8500 до приблизительно 4000000.
21. Лекарственное средство для лечения субъекта, содержащее: лекарственное средство, изготовленное с содержанием фармацевтически эффективной дозы палиперидона, рисперидона или их фармацевтически приемлемой соли для введения указанному субъекту; которое сохраняет минимальную фармакодинамическую концентрацию указанных палиперидона, рисперидона или их фармацевтически приемлемой соли, одновременно сохраняя количество, которое не превышает предельно допустимую концентрацию указанных палиперидона, рисперидона или их фармацевтически приемлемой соли.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US39959002P | 2002-07-29 | 2002-07-29 | |
| US60/399,590 | 2002-07-29 | ||
| US40600502P | 2002-08-26 | 2002-08-26 | |
| US60/406,005 | 2002-08-26 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2005102105A true RU2005102105A (ru) | 2005-08-10 |
| RU2321391C2 RU2321391C2 (ru) | 2008-04-10 |
Family
ID=31191280
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2005102105/15A RU2321391C2 (ru) | 2002-07-29 | 2003-07-28 | Способы и лекарственные формы для контролируемой доставки палиперидона |
Country Status (29)
| Country | Link |
|---|---|
| US (1) | US20040092534A1 (ru) |
| EP (1) | EP1539115B1 (ru) |
| JP (1) | JP4500679B2 (ru) |
| KR (1) | KR100699516B1 (ru) |
| CN (1) | CN1684670A (ru) |
| AR (1) | AR040721A1 (ru) |
| AT (1) | ATE373472T1 (ru) |
| AU (1) | AU2003256844A1 (ru) |
| BR (1) | BR0313139A (ru) |
| CA (1) | CA2494234C (ru) |
| CO (1) | CO5580742A2 (ru) |
| CY (1) | CY1107096T1 (ru) |
| DE (1) | DE60316454T2 (ru) |
| DK (1) | DK1539115T3 (ru) |
| ES (1) | ES2293039T3 (ru) |
| HK (1) | HK1072559A1 (ru) |
| HR (1) | HRP20050077B1 (ru) |
| IL (1) | IL166489A (ru) |
| MX (1) | MXPA05001191A (ru) |
| MY (1) | MY137049A (ru) |
| NO (1) | NO324821B1 (ru) |
| NZ (1) | NZ570198A (ru) |
| PE (1) | PE20040132A1 (ru) |
| PL (1) | PL210119B1 (ru) |
| PT (1) | PT1539115E (ru) |
| RU (1) | RU2321391C2 (ru) |
| TW (1) | TWI363637B (ru) |
| WO (1) | WO2004010981A1 (ru) |
| ZA (1) | ZA200501641B (ru) |
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| US20070232624A1 (en) | 2006-04-03 | 2007-10-04 | Palumbo Joseph M | Use of paliperidone for the treatment of sleep disturbances and/or excessive daytime sleepiness in psychiatric patients |
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- 2003-07-28 DE DE60316454T patent/DE60316454T2/de not_active Expired - Lifetime
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