AR127101A1 - Composición antipsicótica inyectable de liberación prolongada - Google Patents
Composición antipsicótica inyectable de liberación prolongadaInfo
- Publication number
- AR127101A1 AR127101A1 ARP220102531A ARP220102531A AR127101A1 AR 127101 A1 AR127101 A1 AR 127101A1 AR P220102531 A ARP220102531 A AR P220102531A AR P220102531 A ARP220102531 A AR P220102531A AR 127101 A1 AR127101 A1 AR 127101A1
- Authority
- AR
- Argentina
- Prior art keywords
- micrometers
- particle size
- measured
- exceeding
- distribution
- Prior art date
Links
- 239000000203 mixture Substances 0.000 title abstract 5
- 230000000561 anti-psychotic effect Effects 0.000 title 1
- 238000013265 extended release Methods 0.000 title 1
- 239000002245 particle Substances 0.000 abstract 16
- 238000002050 diffraction method Methods 0.000 abstract 4
- 229920001606 poly(lactic acid-co-glycolic acid) Polymers 0.000 abstract 4
- 229940079593 drug Drugs 0.000 abstract 3
- 239000003814 drug Substances 0.000 abstract 3
- 239000000843 powder Substances 0.000 abstract 3
- 238000007873 sieving Methods 0.000 abstract 3
- RKDVKSZUMVYZHH-UHFFFAOYSA-N 1,4-dioxane-2,5-dione Chemical compound O=C1COC(=O)CO1 RKDVKSZUMVYZHH-UHFFFAOYSA-N 0.000 abstract 1
- 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 abstract 1
- JJTUDXZGHPGLLC-UHFFFAOYSA-N lactide Chemical compound CC1OC(=O)C(C)OC1=O JJTUDXZGHPGLLC-UHFFFAOYSA-N 0.000 abstract 1
- 239000000178 monomer Substances 0.000 abstract 1
- 229960001057 paliperidone Drugs 0.000 abstract 1
- 229920000642 polymer Polymers 0.000 abstract 1
- 229960001534 risperidone Drugs 0.000 abstract 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 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
- 238000013268 sustained release Methods 0.000 abstract 1
- 239000012730 sustained-release form Substances 0.000 abstract 1
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 COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- 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
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L3/00—Preservation of foods or foodstuffs, in general, e.g. pasteurising, sterilising, specially adapted for foods or foodstuffs
- A23L3/40—Preservation of foods or foodstuffs, in general, e.g. pasteurising, sterilising, specially adapted for foods or foodstuffs by drying or kilning; Subsequent reconstitution
- A23L3/44—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
Abstract
Se proporciona una composición de liberación sostenida inyectable de acción prolongada que tiene al menos fármaco, disolvente y copolímero PLGA. La composición muestra un rendimiento farmacéutico mejorado debido al empleo de clases ventajosas de polímero PLGA con una distribución mejorada del tamaño de partícula. Reivindicación 1: Una mezcla en polvo que comprende fármaco en polvo y copolímero PLGA en polvo, caracterizado porque: a) el fármaco se selecciona del grupo que consiste en risperidona, paliperidona o una mezcla de las mismas; y b) el copolímero PLGA tiene una proporción de monómeros entre láctido (L) y glicólido (G) de 50:50 ± 10% a 75:25 ± 10%, 50:50 ± 10% o 75:25 ± 10% y tiene una distribución de tamaño de partícula seleccionada del grupo que consiste en: i) distribución de masa de tamaño de partícula con no más del 10% superior a 300 micrómetros, preferiblemente no superior a 250 micrómetros, según medida por tamizado analítico de acuerdo con USP<786>; ii) distribución de volumen de tamaño de partícula con un D₉₀ no superior a 300 micrómetros, preferiblemente no superior a 280 micrómetros según medida por análisis de difracción láser; iii) una distribución de masa de tamaño de partícula con no más del 10% superior a 300 micrómetros, preferiblemente no superior a 250 micrómetros, y en donde no más del 70% de las partículas tienen un tamaño de partícula inferior a 150 micrómetros, según medida por tamizado analítico de acuerdo con USP<786>; iv) una distribución de masa de tamaño de partícula en donde no más del 70% de las partículas tienen un tamaño de partícula inferior a 150 micrómetros, según medida por tamizado analítico de acuerdo con USP<786>; v) una distribución de volumen de tamaño de partícula con un D₉₀ no superior a 300 micrómetros, preferiblemente no superior a 280 micrómetros según medida por análisis de difracción láser y con un D₈₀ no inferior a 135 micrómetros según medida por análisis de difracción láser; vi) una distribución de volumen de tamaño de partícula con un D₈₀ no inferior a 135 micrómetros según medida por análisis de difracción láser; vii) una distribución de volumen de tamaño de partícula con un D₅₀ de aproximadamente 50 - 150 micrómetros; viii) una distribución de volumen de tamaño de partícula con un D₁₀ de aproximadamente 10 - 50 micrómetros; ix) una distribución de volumen de tamaño de partícula con un D₉₀ de aproximadamente 170 - 300 micrómetros; x) una distribución de volumen de tamaño de partícula con un D₅₀ de aproximadamente 50 - 150 micrómetros, un D₁₀ de aproximadamente 10 - 50 micrómetros y un D₉₀ de aproximadamente 170 - 300 micrómetros, y xi) una combinación de cualquiera de lo anterior.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202163246446P | 2021-09-21 | 2021-09-21 | |
| US202263310884P | 2021-09-21 | 2021-09-21 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| AR127101A1 true AR127101A1 (es) | 2023-12-20 |
Family
ID=83995229
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ARP220102531A AR127101A1 (es) | 2021-09-21 | 2022-09-20 | Composición antipsicótica inyectable de liberación prolongada |
Country Status (5)
| Country | Link |
|---|---|
| AR (1) | AR127101A1 (es) |
| AU (1) | AU2022351480A1 (es) |
| CA (1) | CA3230338A1 (es) |
| TW (1) | TW202313047A (es) |
| WO (1) | WO2023046731A1 (es) |
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 |
| HU219487B (hu) | 1993-11-19 | 2001-04-28 | Janssen Pharmaceutica Nv. | Riszperidont tartalmazó mikrorészecskék, eljárás előállításukra, alkalmazásuk és ezeket tartalmazó gyógyászati készítmények és előállításuk |
| US6331311B1 (en) | 1996-12-20 | 2001-12-18 | 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 |
| WO2001051024A2 (de) | 2000-01-11 | 2001-07-19 | Roland Bodmeier | Kit zur implantation enthaltend eine trägerphase und ein lösemittel |
| WO2002038185A2 (en) | 2000-11-13 | 2002-05-16 | Atrix Laboratories, Inc. | Injectable sustained release delivery system with loperamide |
| CN101057824A (zh) | 2002-07-31 | 2007-10-24 | 阿尔萨公司 | 可注射的多模式聚合物储库组合物以及其用途 |
| WO2004081196A2 (en) | 2003-03-11 | 2004-09-23 | Qlt Usa Inc. | Formulations for cell- schedule dependent anticancer agents |
| WO2004094415A1 (en) | 2003-04-22 | 2004-11-04 | Synthon B.V. | Risperidone monohydrochloride |
| US8221778B2 (en) | 2005-01-12 | 2012-07-17 | The Trustees Of The University Of Pennsylvania | Drug-containing implants and methods of use thereof |
| CA2553254C (en) | 2004-01-12 | 2013-12-17 | The Trustees Of The University Of Pennsylvania | Long-term delivery formulations 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 |
| AU2007303793A1 (en) | 2006-10-05 | 2008-04-10 | Panacea Biotec Ltd. | Injectable depot composition and it's process of preparation |
| FR2908775B1 (fr) | 2006-11-17 | 2012-08-31 | Biomatlante | Hydrogel et ses applications biomedicales |
| HUE030789T2 (en) | 2007-05-18 | 2017-06-28 | Durect Corp | Improved depot formulation |
| NZ581862A (en) | 2007-05-25 | 2012-06-29 | Tolmar Therapeutics Inc | Injectable subcutaneous formulation comprising risperidone capable of forming a solid, microporous implant in a patient |
| US8629172B2 (en) | 2008-04-18 | 2014-01-14 | Warsaw Orthopedic, Inc. | Methods and compositions for treating post-operative pain comprising clonidine |
| ES2600797T3 (es) | 2008-08-12 | 2017-02-10 | Novartis Ag | Composiciones farmacéuticas |
| WO2011042453A1 (en) | 2009-10-06 | 2011-04-14 | 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 |
| ES2897976T3 (es) | 2010-05-31 | 2022-03-03 | Farm Rovi Lab Sa | Composiciones para implantes in situ biodegradables inyectables |
| US10463607B2 (en) | 2010-05-31 | 2019-11-05 | Laboratorios Farmaceutics Rofi S.A. | Antipsychotic Injectable Depot Composition |
| US10881605B2 (en) | 2010-05-31 | 2021-01-05 | Laboratorios Farmaceuticos Rovi, S.A. | Methods for the preparation of injectable depot compositions |
| PL2394664T3 (pl) | 2010-05-31 | 2016-12-30 | Preparat przeciwpsychotyczny do wstrzykiwań o przedłużonym uwalnianiu | |
| PL2529756T3 (pl) | 2011-05-31 | 2021-11-15 | Laboratorios Farmaceuticos Rovi, S.A. | Formulacja implantu zawierającego rysperydon i/lub paliperydon |
| DK2529757T3 (en) | 2011-05-31 | 2014-02-24 | Rovi Lab Farmaceut Sa | Paliperidonimplantatformulering |
-
2022
- 2022-02-08 TW TW111104608A patent/TW202313047A/zh unknown
- 2022-09-20 AR ARP220102531A patent/AR127101A1/es unknown
- 2022-09-21 WO PCT/EP2022/076186 patent/WO2023046731A1/en active Application Filing
- 2022-09-21 AU AU2022351480A patent/AU2022351480A1/en active Pending
- 2022-09-21 CA CA3230338A patent/CA3230338A1/en active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| AU2022351480A1 (en) | 2024-03-28 |
| CA3230338A1 (en) | 2023-03-30 |
| TW202313047A (zh) | 2023-04-01 |
| WO2023046731A1 (en) | 2023-03-30 |
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