Controlled-release CNS modulating compositions and methods for the treatment of otic disorders

a technology of compositions and otic disorders, applied in the direction of drug compositions, biocide, heterocyclic compound active ingredients, etc., can solve the problems of active agent delivery, loss of balance and/or osification of auditory structures, hearing loss, etc., to and reduce the frequency of administration.

Inactive Publication Date: 2009-12-31
RGT UNIV OF CALIFORNIA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0009]The current standard of care for auris compositions requires multiple administrations of drops or injections (e.g. intratympanic injections) over several days (e.g., up to two weeks), including schedules of receiving multiple injections per day. In some embodiments, auris compositions described herein are controlled-release compositions and are administered at reduced dosing frequency compared to the current standard of care. In certain instances, when an auris composition is administered via intratympanic injection, a reduced frequency of administration alleviates discomfort caused by multiple intratympanic injections in individuals undergoing treatment for a middle and/or inner ear disease, disorder or condition. In certain instances, a reduced frequency of administration of intratympanic injections reduces the risk of permanent damage (e.g., perforation) to the tympanic membrane. The compositions described herein provide a constant, sustained, extended, delayed or pulsatile rate of release of an active

Problems solved by technology

The presence of the BLB limits delivery of active agents (e.g., CNS modulating agents, aural pressure modulators, antimicrobials) to the isolated microenvironment of the

Method used

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  • Controlled-release CNS modulating compositions and methods for the treatment of otic disorders
  • Controlled-release CNS modulating compositions and methods for the treatment of otic disorders
  • Controlled-release CNS modulating compositions and methods for the treatment of otic disorders

Examples

Experimental program
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Effect test

example 1

Preparation of a Thermoreversible Gel Diazepam Composition

[0397]

QuantityIngredient(mg / g of composition)Diazepam25.0methylparaben2.5Hypromellose25.0Poloxamer 407450.TRIS HCl buffer (0.1 M)1997.5

[0398]Diazepam is supplied in 5 mg / ml pre-filled glass syringes.

[0399]A 10-g batch of gel composition containing 1.0% of diazepam is prepared by first suspending Poloxamer 407 (BASF Corp.) in TRIS HCl buffer (0.1 M). The Poloxamer 407 and TRIS are mixed under agitation overnight at 4° C. to ensure complete dissolution of the Poloxamer 407 in the TRIS. The hypromellose, methylparaben and additional TRIS HCl buffer (0.1 M) is added. The composition is stirred until dissolution is observed. Diazepam is added and the composition is mixed until a homogenous gel is produced. The mixture is maintained below room temperature until use.

example 2

Preparation of a Mucoadhesive, Thermoreversible Gel Diazepam Composition

[0400]

QuantityIngredient(mg / g of composition)Diazepam25.0methylparaben2.5Hypromellose25.0Carbopol 934P5.0Poloxamer 407450.0TRIS HCl buffer (0.1 M)1992.5

[0401]A 10-g batch of mucoadhesive gel composition containing 1.0% of diazepam is prepared by first suspending Poloxamer 407 (BASF Corp.) and Carbopol 934P in TRIS HCl buffer (0.1 M). The Poloxamer 407, Carbopol 934P and TRIS are mixed under agitation overnight at 4° C. to ensure complete dissolution of the Poloxamer 407 and Carbopol 934P in the TRIS. The hypromellose, methylparaben and additional TRIS HCl buffer (0.1 M) is added. The composition is stirred until dissolution is observed. Diazepam is added and the composition is mixed until a homogenous gel is produced. The mixture is maintained below room temperature until use.

example 3

Preparation of a Hydrogel-Based Lidocaine Composition

[0402]

QuantityIngredient(mg / g of composition)Lidocaine HCl30.0paraffin oil600trihydroxystearate30.0cetyl dimethicon copolyol90.0waterqs ad 1000phosphate buffer pH 7.4qs pH 7.4

[0403]The cream-type composition is first prepared by gently mixing Lidocaine HCl with water. Then, the oil base is prepared by mixing paraffin oil, trihydroxystearate and cetyl dimethicon copolyol at temperatures up to 60° C. The oil base is cooled to room temperature and the Lidocaine HCl solution is added. The two phases are mixed until a homogenous, monophasic hydrogel is formed.

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Abstract

Disclosed herein are compositions and methods for the treatment of otic disorders with CNS modulating agent compositions and compositions administered locally to an individual afflicted with an otic disorder, through direct application of these compositions and compositions onto or via perfusion into the targeted auris structure(s).

Description

CROSS-REFERENCE[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 076,567, filed 27 Jun. 2008; U.S. Provisional Application No. 61 / 074,583, filed 27 Jun. 2008; U.S. Provisional Application No. 61 / 082,450, filed 21 Jul. 2008; U.S. Provisional Application No. 61 / 094,384, filed 4 Sep. 2008; U.S. Provisional Application No. 61 / 101,112, filed 29 Sep. 2008; U.S. Provisional Application No. 61 / 140,033, filed 22 Dec. 2008; U.S. Provisional Application No. 61 / 164,812, filed 30 Mar. 2009; and UK Patent Application No. 0907070.7, filed Apr. 24, 2009; all of that are incorporated herein in their entirety.BACKGROUND OF THE INVENTION[0002]Vertebrates have a pair of ears, placed symmetrically on opposite sides of the head. The ear serves as both the sense organ that detects sound and the organ that maintains balance and body position. The ear is generally divided into three portions: the outer ear, auris media (or middle ear) and the auris interna (or inner ear).SUMMA...

Claims

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Application Information

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IPC IPC(8): A61K31/5517A61K31/5513A61K31/164
CPCA61K9/0046A61K31/197A61K31/00A61K31/167A61K31/195A61K31/5513A61K45/06A61K47/10A61K47/14A61K47/38A61K47/44A61K9/06A61K2300/00A61P27/16
Inventor LICHTER, JAYVOLLRATH, BENEDIKTDURON, SERGIO G.LEBEL, CARLPIU, FABRICEYE, QIANGDELLAMARY, LUIS A.TRAMMEL, ANDREW M.SCAIFE, MICHAEL CHRISTOPHERHARRIS, JEFFREY P.
Owner RGT UNIV OF CALIFORNIA
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