"BUCCAL DRUG DELIVERY SYSTEM FOR CANCER PAIN MANAGEMENT

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$50,000.00
Award Year:
1991
Program:
SBIR
Phase:
Phase I
Contract:
n/a
Agency Tracking Number:
16439
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
Anesta Corpon
825 North 300 West, Suite 200, Salt Lake City, UT, 84103
Hubzone Owned:
N
Socially and Economically Disadvantaged:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
Maland, Lynn
Principal Investigator
(801) 595-1405
Business Contact:
1 R43 CA55451-01
() -
Research Institution:
n/a
Abstract
WORLDWIDE, IT IS ESTIMATED THAT 4.3 MILLION PEOPLE DIE OF CANCER EACH YEAR AND THAT ROUGHLY 70 PERCENT OF THE TERMINALLY ILL CANCER PATIENTS EXPERIENCE PAIN AS A MAJOR SYMPTOM DURING THE COURSE OF THEIR DISEASE. EVEN THOUGH THE MAJORITY OF THESE PATIENTS RECEIVE OPIOIDS FOR PAIN MANAGEMENT, UP TO 30 PERCENT STILL EXPERIENCE BREAKTHROUGH PAIN THAT IS CONSIDERED MODERATE TO SEVERE. THE GOAL IS TO DEVELOP A NONINVASIVE, COST EFFECTIVE ALTERNATIVE TO TREAT INCIDENT PAIN IN CANCER PATIENTS. THIS PROPOSAL DESCRIBES AN ORAL TRANSMUCOSAL (OT) DRUG DELIVERY FORMULATION FOR THE NONINVASIVE ADMINISTRATION OF HIGH POTENCY OPIOIDS (FENTANYL, SUFENTANIL, AND ALFENTANIL) USING A UNIQUE, TITRATABLE, DOSE-TO-EFFECT FORMULATION. THE OT DELIVERY APPROACH IS DESIGNED FOR PATIENT CONTROLLED PAIN MANAGEMENT AND IS EASILY USED IN A HOSPITAL SETTING OR FOR OUTPATIENT PAIN MANAGEMENT THERAPY. PHASE I WORK WILL OPTIMIZE THE OT DELIVERY FORMULATION FOR FENTANYL. FORMULATION VARIABLES INCLUDE THREE MATRICES AND THREE BUFFER CONDITIONS. DISSOLUTION KINETICS WILL BE DETERMINED FOR EACH FORMULATION. A DOG MODEL HAS BEEN DEVELOPED TO SCREEN POTENTIAL FORMULATIONS USING A BUCCAL CELL DESIGNED TO EVALUATE DRUG DEPLETION KINETICS. THE DOG DRUG DEPLETION MODEL WILL BE VALIDATED BY DETERMINING PLASMA DRUG LEVELS OVER TIME USING A RADIOIMMUNOASSAY TECHNIQUE. PRELIMINARY ANIMAL EXPERIMENTS INDICATE THAT THE BUCCAL TRANSMUCOSAL PERMEABILITY COEFFICIENT OF FENTANYL CAN VARY DEPENDING ON THE BASE MATERIAL AND CAN SIGNIFICANTLY IMPROVE THE BIOAVAILABILITY OF THE DRUG.

* information listed above is at the time of submission.

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