Development of Ultrafine Particles for Intranasal Delivery of Antipsychotics

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$296,413.00
Award Year:
2012
Program:
STTR
Phase:
Phase I
Contract:
1R41MH098521-01
Agency Tracking Number:
R41MH098521
Solicitation Year:
2012
Solicitation Topic Code:
NIMH
Solicitation Number:
PA11-133
Small Business Information
LNKCHEMSOLUTIONS
4701 INNOVATION DRIVE, LINCOLN, NE, -
Hubzone Owned:
N
Socially and Economically Disadvantaged:
Y
Woman Owned:
N
Duns:
131068186
Principal Investigator:
SANDRA NORIEGA
(402) 416-1811
sandraneb@yahoo.com
Business Contact:
GUSTAVO LARSEN
(402) 416-1811
LNKChemsolutions@netscape.net
Research Institution:
UNIVERSITY OF CHICAGO

UNIVERSITY OF CHICAGO
5801 S ELLIS AVE
CHICAGO, IL, 60637-
() -
Nonprofit college or university
Abstract
DESCRIPTION: The goal of the proposed project is to develop a biocompatible ultrafine particle-based vector system for the intranasal delivery of clozapine for the pharmacological therapy of treatment- resistant schizophrenic disorders and their associatedsuicidal behavior. The rationale behind the use of intranasal clozapine is grounded on the observation of clozapine's extensive first- pass metabolism associated with buccal intake, clozapine's extensive binding to plasma proteins, its short elimination half-life, the absence of significantly active metabolites, and the potentially serious side effects brought about by the high oral doses required for therapeutic benefit. The LNK Chemsolutions LLC/University of Chicago team will use a series of particle design tools, in vivo, ex vivo and in vitro methods to develop the seminal Phase-I level research. Electrohydrodynamic methods will be used to design particles with well-defined sizes and drug payloads, using three different polymers. In vitro drug releaseexaminations will be complemented by muco-adhesive tests, and ex vivo (swine nasal membrane) drug permeation studies. These will guide in vivo (mouse model) studies aimed at elucidating particle and drug transport. PUBLIC HEALTH RELEVANCE: In this SBIR Phase I grant application, LNK Chemsolutions LLC and the University of Chicago researchers are partnering to develop an intranasal drug delivery platform for one anti-psychotic drug. In vitro and in vivo studies will be performed to investigate the potential of the proposed approach.

* information listed above is at the time of submission.

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