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1. PE2021-2261 - EXTRACTOS BACTERIANOS ESTABLES COMO FARMACOS

Office
Peru
Application Number 2021001517
Application Date 12.03.2020
Publication Number 2021-2261
Publication Date 29.11.2021
Publication Kind A1
IPC
A61K 9/00
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
A61K 35/74
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
35Medicinal preparations containing materials or reaction products thereof with undetermined constitution
66Microorganisms or materials therefrom
74Bacteria
A61K 39/02
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
39Medicinal preparations containing antigens or antibodies
02Bacterial antigens
A61M 15/08
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
15Inhalators
08Inhaling devices inserted into the nose
C12N 1/06
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
1Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
06Lysis of microorganisms
C12N 1/08
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
1Microorganisms, e.g. protozoa; Compositions thereof; Processes of propagating, maintaining or preserving microorganisms or compositions thereof; Processes of preparing or isolating a composition containing a microorganism; Culture media therefor
08Reducing the nucleic acid content
CPC
C12N 1/06
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
1Microorganisms, e.g. protozoa; Compositions thereof
06Lysis of microorganisms
C12N 1/08
CCHEMISTRY; METALLURGY
12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
1Microorganisms, e.g. protozoa; Compositions thereof
08Reducing the nucleic acid content
A61K 35/74
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
35Medicinal preparations containing materials or reaction products thereof with undetermined constitution
66Microorganisms or materials therefrom
74Bacteria
A61K 9/0043
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
0043Nose
A61K 9/0078
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
0012Galenical forms characterised by the site of application
007Pulmonary tract; Aromatherapy
0073Sprays or powders for inhalation; Aerolised or nebulised preparations generated by other means than thermal energy;
0078for inhalation via a nebulizer such as a jet nebulizer, ultrasonic nebulizer, e.g. in the form of aqueous drug solutions or dispersions
A61K 9/08
AHUMAN NECESSITIES
61MEDICAL OR VETERINARY SCIENCE; HYGIENE
KPREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES
9Medicinal preparations characterised by special physical form
08Solutions
Applicants OM PHARMA SA
Inventors Jacques BAUER
Christian PASQUALI
Title
(ES) EXTRACTOS BACTERIANOS ESTABLES COMO FARMACOS
Abstract
(ES) La presente invencion se refiere a un extracto bacteriano de especies bacterianas Gram positivo y Gram negativo, en donde dichas especies bacterianas se seleccionan entre Moraxella catarrhalis, Haemophilus influenzae, Klebsiella pneumoniae, entre otras. Dicho extracto bacteriano puede ser obtenido mediante un proceso que comprende: a) cultivar cada especie de cepa bacteriana en un medio de cultivo adecuado; b) matar por calor a la bacteria, remover el medio de cultivo y recolectar la biomasa concentrada; c) lisar cada cepa en un pH inicial mayor de 10; d) disminuir el pH del(los) extracto(s) obtenido(s) en el paso (c), al agregar acidos organicos seleccionados entre acido acetico, acido propionico, acido lactico, acido 3-hidroxipropanoico, entre otros, una combinacion de los mismos, y/o sus esteres y sales farmaceuticamente aceptables; e) pasar el producto del paso (d) a traves de un microfiltro y retener el producto en un ultrafiltro para obtener un extracto soluble purificado; y (f) ajustar a un pH fisiologico final entre 5 y 8, al agregar acido organico o combinacion de lo mismo, usado para dicha neutralizacion. El extracto soluble purificado comprende 100 microgramos/ml de acidos nucleicos y 0.1 mg/ml de sacaridos, siendo estable en forma liquida a temperatura ambiente, 4°C, -20°C y -80°C. Tambien se refiere a formulaciones farmaceuticas basadas en los extractos bacterianos estabilizados y dispositivos de liberacion para el tratamiento y/o prevencion de trastornos inmunologicos agudos y cronicos resultantes de infecciones, inflamacion, neoplasmas y/o disbiosis.
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