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AR070033A1 - INJECTABLE COMPOSITIONS, THEIR PROCESSES AND USES - Google Patents

INJECTABLE COMPOSITIONS, THEIR PROCESSES AND USES

Info

Publication number
AR070033A1
AR070033A1 ARP080104860A ARP080104860A AR070033A1 AR 070033 A1 AR070033 A1 AR 070033A1 AR P080104860 A ARP080104860 A AR P080104860A AR P080104860 A ARP080104860 A AR P080104860A AR 070033 A1 AR070033 A1 AR 070033A1
Authority
AR
Argentina
Prior art keywords
biocompatible
composition
optionally
polymer
pharmaceutically acceptable
Prior art date
Application number
ARP080104860A
Other languages
Spanish (es)
Inventor
Rajesh Jain
Sampath Kumar Devrajan
Sukhjeet Singh
Original Assignee
Panacea Biotec Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Panacea Biotec Ltd filed Critical Panacea Biotec Ltd
Publication of AR070033A1 publication Critical patent/AR070033A1/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/08Drugs for disorders of the urinary system of the prostate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/28Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Neurosurgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Pain & Pain Management (AREA)
  • Hospice & Palliative Care (AREA)
  • Urology & Nephrology (AREA)
  • Dermatology (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Hydrogenated Pyridines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Se proveen composiciones inyectables que comprenden al menos un agente activo seleccionado de un grupo que incluye antipsicoticos, inhibidores de aromatasa, agentes bloqueantes adrenérgicos alfa-1, inhibidores de acetilcolinesterasa o sales farmacéuticamente aceptables, derivados, isomeros, polimorfos, solvatos, hidratos, análogos, enantiomeros, formas tautoméricas o mezclas de los mismos; al menos un polímero bioerosionable biocompatible; al menos un solvente no toxico biocompatible y opcionalmente uno o más excipientes farmacéuticamente aceptables. La presente también describe el proceso para la preparacion de tales composiciones y el método para su utilizacion. Reivindicacion 2: Una composicion tal como se reivindica en la reivindicacion 1, caracterizada porque la composicion comprende como agente activo al menos un antipsicotico, preferentemente ziprasidona u olanzapina o aripiprazol, o al menos un inhibidor de aromatasa preferentemente anastrozol o letrozol, o al menos un agente bloqueante adrenérgico preferentemente tamsulosina o al menos un inhibidor de acetilcolinesterasa preferentemente donepezil, o sales farmacéuticamente aceptables, derivados, isomeros, polimorfos, solvatos, hidratos, análogos, enantiomeros, formas tautoméricas o sus mezclas; al menos un polímero bioerosionable biocompatible; al menos un solvente no toxico biocompatible y opcionalmente uno o más excipientes farmacéuticamente aceptables, las cuales están en forma de una composicion gelificante in situ o una composicion de implante y que forman un deposito luego de la administracion in vivo y del contacto con los fluidos corporales con lo cual se provee una liberacion prolongada del agente activo durante períodos prolongados de tiempo. Reivindicacion 7: Una composicion tal como se reivindica en la reivindicacion 6, caracterizado porque el polímero basado en ácido glicolico o láctico es un polímero poliláctido (PLA) o un polímero poliglicolido o un copolímero poli(láctido-co-glicolido) (PLGA). Reivindicacion 8: La composicion tal como se reivindica en cualquiera de las reivindicaciones precedentes 1 a 7, caracterizada porque la composicion provee una composicion gelificante in situ que comprende el agente activo y preferentemente un polímero PLGA, disuelto o disperso o suspendido en un solvente adecuado opcionalmente disuelto o dispersado o suspendido adicionalmente en un diluyente líquido tal como un vehículo acuoso o un solvente orgánico o un vehículo oleoso. Reivindicacion 22: La composicion tal como se reivindica en cualquiera de las reivindicaciones 1 a 21, caracterizada porque el solvente no toxico biocompatible se selecciona de un grupo que comprende triacetina, etanol, bencil alcohol, 1-butano!, 2-butanol, cloroformo, ácido acético, alcohol isopropílico, acetonitrilo, N-metil-2-pirrolidona (NMP), 2-pirrolidona, migliol, glicerol, acetato de metilo, metil isobutil cetona, benzoato de bencilo, propilenglicol, dimetil isosorbida, propilen carbonato, etil acetato, etil lactato, dimetil sulfona, N,N-dietil-m-toluamida, metil etil cetona, dimetilformamida, diclorometano, benzonitrilo, dimetil isosorbida, dimetil sulfoxida, ácido oleico y 1-dodecilazaciclo-heptan-2-ona y similares o sus mezclas. Reivindicacion 36: Un kit farmacéutico adecuado para la formacion in situ de un implante o gel de deposito biodegradable a partir de las composiciones tal como se reivindican en la reivindicacion 1, en el cuerpo de un sujeto que lo necesita, caracterizado porque comprende un dispositivo que contiene ziprasidona u olanzapina o aripiprazol o anastrozol o letrozol o tamsulosina o donepezil corno agente activo, opcionalmente al menos un polímero bioerosionable biocompatible y opcionalmente uno o más excipientes farmacéuticamente aceptables; y un dispositivo que contiene al menos un solvente no toxico biocompatible, opcionalmente al menos un polímero bioerosionable biocompatible y opcionalmente uno o más excipientes farmacéuticamente aceptables; en donde los dispositivos permiten la expulsion de los contenidos de los dos dispositivos para permitir su mezcla antes de administrar el contenido en el cuerpo de un sujeto que lo necesite. Reivindicacion 51: El uso de la composicion de acuerdo con la reivindicacion 1, caracterizado porque comprende ziprasidona u olanzapina o aripiprazol como agente activo para la fabricacion de un medicamento para la profilaxis, mejora y/o el tratamiento de los signos y los síntomas de esquizofrenia.Injectable compositions are provided comprising at least one active agent selected from a group that includes antipsychotics, aromatase inhibitors, alpha-1 adrenergic blocking agents, acetylcholinesterase inhibitors or pharmaceutically acceptable salts, derivatives, isomers, polymorphs, solvates, hydrates, analogs, enantiomers, tautomeric forms or mixtures thereof; at least one biocompatible biocompatible polymer; at least one non-toxic biocompatible solvent and optionally one or more pharmaceutically acceptable excipients. The present also describes the process for the preparation of such compositions and the method for their use. Claim 2: A composition as claimed in claim 1, characterized in that the composition comprises as active agent at least one antipsychotic, preferably ziprasidone or olanzapine or aripiprazole, or at least one aromatase inhibitor preferably anastrozole or letrozole, or at least one adrenergic blocking agent preferably tamsulosin or at least one acetylcholinesterase inhibitor preferably donepezil, or pharmaceutically acceptable salts, derivatives, isomers, polymorphs, solvates, hydrates, analogs, enantiomers, tautomeric forms or mixtures thereof; at least one biocompatible biocompatible polymer; at least one biocompatible non-toxic solvent and optionally one or more pharmaceutically acceptable excipients, which are in the form of an in situ gelling composition or an implant composition and which form a reservoir after in vivo administration and contact with body fluids thereby providing a prolonged release of the active agent for extended periods of time. Claim 7: A composition as claimed in claim 6, characterized in that the glycolic or lactic acid based polymer is a polylactide polymer (PLA) or a polyglycolide polymer or a poly (lactide-co-glycolide) copolymer (PLGA). Claim 8: The composition as claimed in any one of the preceding claims 1 to 7, characterized in that the composition provides an in situ gelling composition comprising the active agent and preferably a PLGA polymer, dissolved or dispersed or suspended in a suitable solvent optionally dissolved or dispersed or suspended further in a liquid diluent such as an aqueous vehicle or an organic solvent or an oily vehicle. Claim 22: The composition as claimed in any one of claims 1 to 21, characterized in that the biocompatible non-toxic solvent is selected from a group comprising triacetin, ethanol, benzyl alcohol, 1-butane !, 2-butanol, chloroform, acetic acid, isopropyl alcohol, acetonitrile, N-methyl-2-pyrrolidone (NMP), 2-pyrrolidone, migliol, glycerol, methyl acetate, methyl isobutyl ketone, benzyl benzoate, propylene glycol, dimethyl isosorbide, propylene carbonate, ethyl acetate, ethyl lactate, dimethyl sulfone, N, N-diethyl-m-toluamide, methyl ethyl ketone, dimethylformamide, dichloromethane, benzonitrile, dimethyl isosorbide, dimethyl sulfoxide, oleic acid and 1-dodecylazacyclo-heptan-2-one and the like or mixtures thereof. Claim 36: A pharmaceutical kit suitable for the in situ formation of a biodegradable deposit implant or gel from the compositions as claimed in claim 1, in the body of a subject in need thereof, characterized in that it comprises a device that contains ziprasidone or olanzapine or aripiprazole or anastrozole or letrozole or tamsulosin or donepezil as an active agent, optionally at least one biocompatible bioerodible polymer and optionally one or more pharmaceutically acceptable excipients; and a device containing at least one biocompatible non-toxic solvent, optionally at least one biocompatible bioerodible polymer and optionally one or more pharmaceutically acceptable excipients; where the devices allow the expulsion of the contents of the two devices to allow their mixing before administering the content in the body of a subject that needs it. Claim 51: The use of the composition according to claim 1, characterized in that it comprises ziprasidone or olanzapine or aripiprazole as an active agent for the manufacture of a medicament for the prophylaxis, improvement and / or treatment of the signs and symptoms of schizophrenia .

ARP080104860A 2007-11-06 2008-11-06 INJECTABLE COMPOSITIONS, THEIR PROCESSES AND USES AR070033A1 (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
IN2321DE2007 2007-11-06

Publications (1)

Publication Number Publication Date
AR070033A1 true AR070033A1 (en) 2010-03-10

Family

ID=40626309

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP080104860A AR070033A1 (en) 2007-11-06 2008-11-06 INJECTABLE COMPOSITIONS, THEIR PROCESSES AND USES

Country Status (3)

Country Link
AR (1) AR070033A1 (en)
CL (1) CL2008003305A1 (en)
WO (1) WO2009060473A2 (en)

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Also Published As

Publication number Publication date
WO2009060473A2 (en) 2009-05-14
WO2009060473A3 (en) 2009-10-15
CL2008003305A1 (en) 2009-06-05

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