PE20240934A1 - EXTENDED-RELEASE ANTIPSYCHOTIC INJECTABLE COMPOSITION - Google Patents
EXTENDED-RELEASE ANTIPSYCHOTIC INJECTABLE COMPOSITIONInfo
- Publication number
- PE20240934A1 PE20240934A1 PE2024000524A PE2024000524A PE20240934A1 PE 20240934 A1 PE20240934 A1 PE 20240934A1 PE 2024000524 A PE2024000524 A PE 2024000524A PE 2024000524 A PE2024000524 A PE 2024000524A PE 20240934 A1 PE20240934 A1 PE 20240934A1
- Authority
- PE
- Peru
- Prior art keywords
- micrometers
- particle size
- drug
- powder
- composition
- Prior art date
Links
Classifications
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- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES, NOT OTHERWISE PROVIDED FOR; PREPARATION OR TREATMENT THEREOF
- A23L11/00—Pulses, i.e. fruits of leguminous plants, for production of food; Products from legumes; Preparation or treatment thereof
- A23L11/05—Mashed or comminuted pulses or legumes; Products made therefrom
-
- 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
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23B—PRESERVATION OF FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES; CHEMICAL RIPENING OF FRUIT OR VEGETABLES
- A23B2/00—Preservation of foods or foodstuffs, in general
- A23B2/90—Preservation of foods or foodstuffs, in general by drying or kilning; Subsequent reconstitution
- A23B2/92—Freeze drying
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/20—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Biomedical Technology (AREA)
- Polymers & Plastics (AREA)
- Food Science & Technology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Dermatology (AREA)
- Neurology (AREA)
- Psychiatry (AREA)
- Organic Chemistry (AREA)
- Dispersion Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Wood Science & Technology (AREA)
- Zoology (AREA)
- Agronomy & Crop Science (AREA)
- Botany (AREA)
- Nutrition Science (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
La presente invencion se refiere a una composicion de liberacion sostenida inyectable antipsicotica de accion prolongada que tiene al menos farmaco, disolvente y copolimero PLGA. En particular, se refiere a una composicion inyectable de liberacion prolongada que comprende una mezcla en polvo que comprende, a su vez, farmaco en polvo y copolimero PLGA en polvo, en donde: a) el farmaco es risperidona, paliperidona o una mezcla de las mismas; y b) el copolimero PLGA tiene una proporcion de monomeros entre lactido (L) y glicolido (G) de 50:50±10 % a 75:25 ±10 %, 50:50 ±10 % o 75:25 ±10 % y tiene una distribucion de tamano de particula seleccionada del grupo que consiste en: i) distribucion de masa de tamano de particula con no mas del 10 % superior a 300 micrometros, preferiblemente no superior a 250 micrometros; ii) distribucion de volumen de tamano de particula con un D90 no superior a 300 micrometros, preferiblemente no superior a 280 micrometros segun medida por analisis de difraccion laser; entre otros. La composicion muestra un rendimiento farmaceutico mejorado debido al empleo de polimero PLGA con una distribucion mejorada del tamano de particula.The present invention relates to a long-acting antipsychotic injectable sustained release composition having at least drug, solvent and PLGA copolymer. In particular, it refers to a prolonged release injectable composition comprising a powder mixture comprising, in turn, powder drug and powder PLGA copolymer, where: a) the drug is risperidone, paliperidone or a mixture of the themselves; and b) the PLGA copolymer has a monomer ratio between lactide (L) and glycolide (G) of 50:50 ± 10% to 75:25 ± 10%, 50:50 ± 10% or 75:25 ± 10% and has a particle size distribution selected from the group consisting of: i) particle size mass distribution with no more than 10% larger than 300 micrometers, preferably no larger than 250 micrometers; ii) particle size volume distribution with a D90 not exceeding 300 micrometers, preferably not exceeding 280 micrometers as measured by laser diffraction analysis; among others. The composition shows improved pharmaceutical performance due to the use of PLGA polymer with improved particle size distribution.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163246446P | 2021-09-21 | 2021-09-21 | |
| US202263310884P | 2022-02-16 | 2022-02-16 | |
| PCT/EP2022/076186 WO2023046731A1 (en) | 2021-09-21 | 2022-09-21 | Antipsychotic injectable extended-release composition |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PE20240934A1 true PE20240934A1 (en) | 2024-04-30 |
Family
ID=83995229
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PE2024000524A PE20240934A1 (en) | 2021-09-21 | 2022-09-21 | EXTENDED-RELEASE ANTIPSYCHOTIC INJECTABLE COMPOSITION |
Country Status (16)
| Country | Link |
|---|---|
| EP (1) | EP4404913A1 (en) |
| JP (1) | JP2024534540A (en) |
| KR (1) | KR20240056731A (en) |
| CN (1) | CN117979957A (en) |
| AR (1) | AR127101A1 (en) |
| AU (1) | AU2022351480A1 (en) |
| CA (1) | CA3230338A1 (en) |
| CL (1) | CL2024000822A1 (en) |
| CO (1) | CO2024005012A2 (en) |
| GE (2) | GEAP202416492A (en) |
| IL (1) | IL311632A (en) |
| MX (1) | MX2024003381A (en) |
| PE (1) | PE20240934A1 (en) |
| TW (1) | TW202313047A (en) |
| WO (1) | WO2023046731A1 (en) |
| ZA (1) | ZA202402860B (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20230372331A1 (en) * | 2022-05-18 | 2023-11-23 | Anxo Pharmaceutical Co., Ltd. | Pharmaceutical composition |
Family Cites Families (33)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4389330A (en) | 1980-10-06 | 1983-06-21 | Stolle Research And Development Corporation | Microencapsulation process |
| 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 |
| US4938763B1 (en) | 1988-10-03 | 1995-07-04 | Atrix Lab Inc | Biodegradable in-situ forming implants and method of producing the same |
| US5656297A (en) | 1992-03-12 | 1997-08-12 | Alkermes Controlled Therapeutics, Incorporated | Modulated release from biocompatible polymers |
| SG47445A1 (en) | 1993-11-19 | 1998-04-17 | Janssen Pharmaceutica Nv | Microencapsulated 3-piperidinyl-substituted1 1 2-benzisoxazoles and 1 2-benzisothiazoles |
| WO1998027962A2 (en) | 1996-12-20 | 1998-07-02 | Alza Corporation | Injectable depot gel composition and method of preparing the composition |
| US6143314A (en) | 1998-10-28 | 2000-11-07 | Atrix Laboratories, Inc. | Controlled release liquid delivery compositions with low initial drug burst |
| US6194006B1 (en) | 1998-12-30 | 2001-02-27 | Alkermes Controlled Therapeutics Inc. Ii | Preparation of microparticles having a selected release profile |
| US6461631B1 (en) | 1999-11-16 | 2002-10-08 | Atrix Laboratories, Inc. | Biodegradable polymer composition |
| DK1248596T3 (en) | 2000-01-11 | 2007-07-02 | Bertex Pharma Gmbh | Implants, particles |
| WO2002038185A2 (en) | 2000-11-13 | 2002-05-16 | Atrix Laboratories, Inc. | Injectable sustained release delivery system with loperamide |
| BR0313539A (en) | 2002-07-31 | 2005-06-21 | Alza Corp | Injectable multimodal polymer deposit compositions and their uses |
| JP2007525429A (en) | 2003-03-11 | 2007-09-06 | キューエルティー ユーエスエー，インコーポレイテッド． | Formulations for cell schedule dependent anticancer agents |
| EP1615923A1 (en) | 2003-04-22 | 2006-01-18 | Synthon B.V. | Risperidone monohydrochloride |
| CA2553254C (en) | 2004-01-12 | 2013-12-17 | The Trustees Of The University Of Pennsylvania | Long-term delivery formulations and methods of use thereof |
| US8221778B2 (en) | 2005-01-12 | 2012-07-17 | The Trustees Of The University Of Pennsylvania | Drug-containing implants and methods of use thereof |
| US8313763B2 (en) | 2004-10-04 | 2012-11-20 | Tolmar Therapeutics, Inc. | Sustained delivery formulations of rapamycin compounds |
| US8852638B2 (en) | 2005-09-30 | 2014-10-07 | Durect Corporation | Sustained release small molecule drug formulation |
| US20100098735A1 (en) | 2006-10-05 | 2010-04-22 | Rajesh Jain | Injectable depot compositions and its process of preparation |
| FR2908775B1 (en) | 2006-11-17 | 2012-08-31 | Biomatlante | HYDROGEL AND ITS BIOMEDICAL APPLICATIONS |
| HUE030789T2 (en) | 2007-05-18 | 2017-06-28 | Durect Corp | Improved depot formulations |
| WO2008153611A2 (en) | 2007-05-25 | 2008-12-18 | Qlt Usa, Inc. | Sustained delivery formulations of risperidone compounds |
| US8629172B2 (en) | 2008-04-18 | 2014-01-14 | Warsaw Orthopedic, Inc. | Methods and compositions for treating post-operative pain comprising clonidine |
| PL2323623T3 (en) | 2008-08-12 | 2017-04-28 | Novartis Ag | Pharmaceutical compositions |
| US8758780B2 (en) | 2009-10-06 | 2014-06-24 | Ascendis Pharma As | Subcutaneous paliperidone composition |
| 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 |
| HUE029895T2 (en) | 2010-05-31 | 2017-04-28 | Farm Rovi Lab Sa | Antipsychotic injectable depot preparation |
| US10881605B2 (en) | 2010-05-31 | 2021-01-05 | Laboratorios Farmaceuticos Rovi, S.A. | Methods for the preparation of injectable depot compositions |
| LT2394663T (en) | 2010-05-31 | 2022-02-10 | Laboratorios Farmaceuticos Rovi, S.A. | COMPOSITIONS FOR INJITABLE BIODEGRADABLE IMPLANTS |
| US10463607B2 (en) | 2010-05-31 | 2019-11-05 | Laboratorios Farmaceutics Rofi S.A. | Antipsychotic Injectable Depot Composition |
| DK2529756T3 (en) | 2011-05-31 | 2021-08-02 | Farm Rovi Lab Sa | Risperidone and / or paliperidone implant formulation |
| PL2529757T3 (en) | 2011-05-31 | 2014-04-30 | Farm Rovi Lab Sa | Paliperidone implant formulation |
-
2022
- 2022-02-08 TW TW111104608A patent/TW202313047A/en unknown
- 2022-09-20 AR ARP220102531A patent/AR127101A1/en unknown
- 2022-09-21 PE PE2024000524A patent/PE20240934A1/en unknown
- 2022-09-21 EP EP22793529.3A patent/EP4404913A1/en active Pending
- 2022-09-21 CN CN202280064073.XA patent/CN117979957A/en active Pending
- 2022-09-21 GE GEAP202416492A patent/GEAP202416492A/en unknown
- 2022-09-21 WO PCT/EP2022/076186 patent/WO2023046731A1/en not_active Ceased
- 2022-09-21 CA CA3230338A patent/CA3230338A1/en active Pending
- 2022-09-21 KR KR1020247010409A patent/KR20240056731A/en active Pending
- 2022-09-21 GE GEAP202216492A patent/GEP20257827B/en unknown
- 2022-09-21 MX MX2024003381A patent/MX2024003381A/en unknown
- 2022-09-21 AU AU2022351480A patent/AU2022351480A1/en active Pending
- 2022-09-21 IL IL311632A patent/IL311632A/en unknown
- 2022-09-21 JP JP2024518093A patent/JP2024534540A/en active Pending
-
2024
- 2024-03-20 CL CL2024000822A patent/CL2024000822A1/en unknown
- 2024-04-12 ZA ZA2024/02860A patent/ZA202402860B/en unknown
- 2024-04-19 CO CONC2024/0005012A patent/CO2024005012A2/en unknown
Also Published As
| Publication number | Publication date |
|---|---|
| CL2024000822A1 (en) | 2024-07-26 |
| JP2024534540A (en) | 2024-09-20 |
| ZA202402860B (en) | 2024-11-27 |
| WO2023046731A1 (en) | 2023-03-30 |
| KR20240056731A (en) | 2024-04-30 |
| TW202313047A (en) | 2023-04-01 |
| CO2024005012A2 (en) | 2024-08-08 |
| GEP20257827B (en) | 2025-11-10 |
| CN117979957A (en) | 2024-05-03 |
| EP4404913A1 (en) | 2024-07-31 |
| MX2024003381A (en) | 2024-04-19 |
| CA3230338A1 (en) | 2023-03-30 |
| IL311632A (en) | 2024-05-01 |
| AU2022351480A1 (en) | 2024-03-28 |
| GEAP202416492A (en) | 2024-04-25 |
| AR127101A1 (en) | 2023-12-20 |
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