AR072828A1 - ANTIMICROBIAL COMPOSITIONS OF CONTROLLED LIBERATION OR DEVICES METHODS FOR THE TREATMENT OF OTHICAL DISORDERS USES - Google Patents

ANTIMICROBIAL COMPOSITIONS OF CONTROLLED LIBERATION OR DEVICES METHODS FOR THE TREATMENT OF OTHICAL DISORDERS USES

Info

Publication number
AR072828A1
AR072828A1 ARP090102772A AR072828A1 AR 072828 A1 AR072828 A1 AR 072828A1 AR P090102772 A ARP090102772 A AR P090102772A AR 072828 A1 AR072828 A1 AR 072828A1
Authority
AR
Argentina
Prior art keywords
pharmaceutical composition
antimicrobial agent
composition
disease
agent
Prior art date
Application number
Other languages
Spanish (es)
Original Assignee
Otonomy Inc
Univ California
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
Priority claimed from CL2009000956A external-priority patent/CL2009000956A1/en
Priority claimed from CL2009001178A external-priority patent/CL2009001178A1/en
Application filed by Otonomy Inc, Univ California filed Critical Otonomy Inc
Publication of AR072828A1 publication Critical patent/AR072828A1/en

Links

Abstract

Reivindicacion 1: Una composicion farmacéutica o dispositivo, caracterizado porque comprende un agente antimicrobiano que es típicamente efectivo para tratar una enfermedad o condicion otica asociada con una infeccion microbiana, la composicion o dispositivo comprende sustancialmente productos de degradacion sustancialmente baja del agente antimicrobiano, la composicion o dispositivo farmacéutico además comprende dos o más características seleccionadas a partir de: (i) entre aproximadamente 0.1% hasta aproximadamente 10% en peso del agente antimicrobiano, o profármaco o sal del mismo farmacéuticamente aceptable; (ii) entre aproximadamente 14% hasta aproximadamente 21% en peso de un copolímero de tribloque de polioxietileno-polioxipropileno de la formula general E106 P70 E106; (iii) agua estéril, c.s., amortiguada para proporcionar un pH entre aproximadamente 5.5 y aproximadamente 8.0; (iv) agente antimicrobiano multiparticulado; (v) una temperatura de gelificacion entre aproximadamente 19 sC hasta aproximadamente 42 °C; (vi) menos de aproximadamente 50 unidades que forman colonias (cfu) de agentes microbiologicos por gramo de formulacion; (vii) menos de aproximadamente 5 unidades de endotoxina (EU) por Kg. de peso corporal de un sujeto; (viii) un tiempo de disolucion medio de aproximadamente 30 horas para el agente antimicrobiano; y (ix) una viscosidad aparente de aproximadamente 100,000 cP hasta aproximadamente 500,000 cP. Reivindicacion 7: La composicion farmacéutica o dispositivo de conformidad con cualquiera de las reivindicaciones 1-6, caracterizada porque la composicion farmacéutica o dispositivo es un gel termorreversible aceptable al auris. Reivindicacion 9: La composicion farmacéutica o dispositivo de conformidad con cualquiera de las reivindicaciones 1-8, caracterizada porque además comprende un mejorador de la penetracion. Reivindicacion 10: La composicion farmacéutica o dispositivo de conformidad con cualquiera de las reivindicaciones 1-9, caracterizada porque además comprende un tinte. Reivindicacion 12: La composicion o dispositivo de conformidad con cualquiera de las reivindicaciones 1-11, caracterizada porque además comprende el agente antimicrobiano o sal del mismo farmacéuticamente aceptable, profármaco o combinacion del mismo como un agente de liberacion inmediata. Reivindicacion 14: La composicion farmacéutica o dispositivo de conformidad con cualquiera de las reivindicaciones 1-13, caracterizada porque el agente antimicrobiano está esencialmente en la forma de partículas micronizadas. Reivindicacion 17: La composicion farmacéutica o dispositivo de conformidad con cualquiera de las reivindicaciones 1-16, caracterizada porque además comprende un agente antiinflamatorio. Reivindicacion 18: La composicion farmacéutica o dispositivo de conformidad con la reivindicacion 1, caracterizada porque la enfermedad o condicion otica es otitis externa, otitis media, síndrome Ramsay Hunt, otosífilis, enfermedad autoinmune del oído interno (AIED), enfermedad de Meniere o neuronitis vestibular.Claim 1: A pharmaceutical composition or device, characterized in that it comprises an antimicrobial agent that is typically effective for treating a disease or otic condition associated with a microbial infection, the composition or device substantially comprises products of substantially low degradation of the antimicrobial agent, the composition or The pharmaceutical device further comprises two or more features selected from: (i) between about 0.1% to about 10% by weight of the antimicrobial agent, or pharmaceutically acceptable prodrug or salt thereof; (ii) between about 14% to about 21% by weight of a polyoxyethylene-polyoxypropylene triblock copolymer of the general formula E106 P70 E106; (iii) sterile water, c.s., buffered to provide a pH between about 5.5 and about 8.0; (iv) multiparticulate antimicrobial agent; (v) a gelation temperature between about 19 sC to about 42 ° C; (vi) less than about 50 units that form colonies (cfu) of microbiological agents per gram of formulation; (vii) less than about 5 endotoxin units (EU) per kg of body weight of a subject; (viii) an average dissolution time of approximately 30 hours for the antimicrobial agent; and (ix) an apparent viscosity of about 100,000 cP to about 500,000 cP. Claim 7: The pharmaceutical composition or device according to any of claims 1-6, characterized in that the pharmaceutical composition or device is a heat-reversible gel acceptable to the auris. Claim 9: The pharmaceutical composition or device according to any of claims 1-8, characterized in that it further comprises a penetration enhancer. Claim 10: The pharmaceutical composition or device according to any of claims 1-9, characterized in that it further comprises a dye. Claim 12: The composition or device according to any of claims 1-11, characterized in that it further comprises the pharmaceutically acceptable antimicrobial agent or salt thereof, prodrug or combination thereof as an immediate release agent. Claim 14: The pharmaceutical composition or device according to any of claims 1-13, characterized in that the antimicrobial agent is essentially in the form of micronized particles. Claim 17: The pharmaceutical composition or device according to any of claims 1-16, characterized in that it further comprises an anti-inflammatory agent. Claim 18: The pharmaceutical composition or device according to claim 1, characterized in that the disease or otic condition is otitis externa, otitis media, Ramsay Hunt syndrome, otosyphilis, autoimmune disease of the inner ear (AIED), Meniere's disease or vestibular neuronitis .

ARP090102772 2008-07-25 2009-07-21 ANTIMICROBIAL COMPOSITIONS OF CONTROLLED LIBERATION OR DEVICES METHODS FOR THE TREATMENT OF OTHICAL DISORDERS USES AR072828A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US8387108P 2008-07-25 2008-07-25
CL2009000956A CL2009000956A1 (en) 2008-04-21 2009-04-21 Sustained release pharmaceutical composition comprising a particulate nmda receptor antagonist and a triblock copolymer, with an osmolarity between 100-500 mosm / l; and its use to treat an otic disorder, such as meniere's disease or hearing loss.
CL2009001178A CL2009001178A1 (en) 2008-05-14 2009-05-14 Intratympanic otic composition comprising a thermoreversible aqueous gel comprising a polyoxypropylene and polyoxytylene polymer and a multiparticulate anti-inflammatory corticosteroid such that its sustained release through the cochlear membrane is for a period of at least 5 days after a single administration.

Publications (1)

Publication Number Publication Date
AR072828A1 true AR072828A1 (en) 2010-09-22

Family

ID=42829172

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP090102772 AR072828A1 (en) 2008-07-25 2009-07-21 ANTIMICROBIAL COMPOSITIONS OF CONTROLLED LIBERATION OR DEVICES METHODS FOR THE TREATMENT OF OTHICAL DISORDERS USES

Country Status (1)

Country Link
AR (1) AR072828A1 (en)

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