DEVELOPMENT OF A ONCE-DAILY CONTRACEPTIVE SKIN PATCH

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$500,000.00
Award Year:
1986
Program:
SBIR
Phase:
Phase II
Contract:
n/a
Award Id:
1457
Agency Tracking Number:
1457
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
21c Olympia Ave, Woburn, MA, 01801
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
E.s. Nuwayser
President
() -
Business Contact:
() -
Research Institution:
n/a
Abstract
THE OVERALL OBJECTIVE OF THE RESEARCH APPLICATION IS TO DEMONSTRATE THE POTENTIAL OF THE DERMAPATCH DRUG DELIVERY SYSTEM DEVELOPED BY BIOTEK FOR THE TRANSDERMAL DELIVERY OF THERAPEUTIC AGENTS. THE SPECIFIC OBJECTIVE IS TO ILLUSTRATE THIS POTENTIAL BY TESTING IN LIVING ANIMALS A DERMAPATCH FOR THE DELIVERY OF LEVONORGESTREL AND ESTRADIOL WHICH COMPRISE TWO MAJOR BIRTH CONTROL STEROIDS. THE DERMAPATCH TRANSDERMAL DELIVERY SYSTEM RELEASES THE DRUG FROM RATE CONTROLLING MICROPARTICLES (MICROCAPSULES AND/OR MICROSPHERES) WHICH ARE SUSPENDED IN A DERMATOLOGICALLY ACCEPTABLE VISCOUS LIQUID BASE. THE MICROCAPSULES RELEASE THE DRUG IN ZERO ORDER AND MAINTAIN A THERMODYNAMICALLY STABLE LIQUID BASE. RELEASE IS CONTROLLED BY MICROCAPSULE SIZE AND THICKNESS OF THE CAPSULE WALL. THE MICROCAPSULES ALSO PREVENT DOSE DUMPING CAUSED BY ACCIDENTAL RUPTURE OF THE MEMBRANE. ANOTHER IMPORTANT FEATURE OF THE SYSTEM IS A MACROPOROUS MEMBRANE WHICH DELIVERS A THIN LIQUID FILM OF THE VEHICLE TO THE SURFACE OF THE SKIN TO OCCLUDE THE SKIN. THE FILM FORCES HYDRATION OF THE STRATUM CORNEUM WITH WATER FROM THE LOWER LAYERS OF THE EPIDERMIS AND ACCELERATES THE DELIVERY OF THE STEROIDS. BECAUSE OF THE INTIMATE CONTACT BETWEEN THE SKIN SURFACE AND THE THERMODYNAMICALLY STABLE VISCOUS LIQUID BASE UNIFORM DELIVERY OF THE DRUG IS INSURED THROUGHOUT THE TREATMENT PERIOD. IN PRELIMINARY IN VITRO STUDIES WITH THE DERMAPATCH WE DEMONSTRATED THAT THE PERMEATION OF LEVONORGESTREL AND ESTRADIOL FROM THE SYSTEM IS CONSTANT AND SUSTAINED (FIGURE 1). WE FURTHER DEMONSTRATED THAT THE PERMEATION RATES OF THE DERMAPATCH IN FRESHLY EXCISED MOUSE SKIN SIGNIFICANTLY EXCEED THE MINIMUM 30 UG/DAY CONTRACEPTIVE DOSE FOR LEVONORGESTREL. DETAILS ARE PRESENTED IN SECTION C. OUR INITIAL OBJECTIVE IS TO OBTAIN ADDITIONAL DATA IN VITRO AND IN VIVO ON LEVONORGESTREL AND ESTRADIOL PERMEATION. THIS INFORMATION COULD LEAD TO THE DEVELOPMENT OF A DERMAPATCH WHICH COMBINES BOTH HORMONES AS A BIRTH CONTROL METHOD FOR ONCE-DAILY APPLICATION. A DERMAPATCH OF LEVONORGESTREL AND NATURAL ESTRADIOL WILL MAKE AN EXCELLENT ALTERNATIVE TO ORAL CONTRACEPTIVES COMPOSED OF A PROGESTAGEN AND THE POTENTIALLY HAZARDOUS SYNTHETIC, ETHINYL ESTRADIOL. THE TRANSDERMAL DELIVERY OF CONTRACEPTIVE STEROIDS OFFERS SIGNIFICANT ADVANTAGES FOR THE USER IN TERMS OF FLEXIBILITY, POTENTIAL REDUCED DOSAGE, AND REDUCED SIDE EFFECTS.

* information listed above is at the time of submission.

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