Carbamazepine Formulation for Iv Epilepsy Therapy

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$618,905.00
Award Year:
1995
Program:
SBIR
Phase:
Phase II
Contract:
n/a
Award Id:
22376
Agency Tracking Number:
22376
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
336 Summit Point Drive, Suite, Henrietta, NY, 14467
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Michael R. Violante
(716) 321-1130
Business Contact:
() -
Research Institute:
n/a
Abstract
Epilepsy is a debilitating disorder affecting 1 adult in 200 in the United States. Although several drugs are valuable for epilepsy therapy, their poor aqueous solubility does not permit effective formulation for intravenous administration. No IV formulation exists for carbamazepine (CBZ), a drug of choice for epilepsy therapy. Since therapeutic levels of CBZ in the brain are not reached for several hours following oral administration, other, less desirable drugs must be used when acute intervention during epileptic seizures is required. We will develop a formulation for carbamazepine suitable for intravenous administration. This will be accomplished using patented technology to convert this nearly water-insoluble drug into spherical, amorphous, uniformly-sized submicron particles suspended in a biocompatible aqueous medium. This technology has been applied successfully to other compounds to produce formulations for improved diagnostic imaging as well as for anti-cancer and antimicrobial therapy. Nanoparticle formulations have also demonstrated improved bioavailability following oral administration. Other administration routes may benefit as well. The intravenous formulation of carbamazepine will be subjected to preliminary pharmacokinetic and biodistribution evaluations to demonstrate feasibility. Phase Il objectives will focus on preclinical efficacy and toxicity studies. A Phase III partner will be sought to conduct clinical trials for NDA submissions and marketing.

* information listed above is at the time of submission.

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