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Abstract

Grant Number:	5R44AG017413-03
PI Name:	NICHOLS, L D.
PI Email:	bio21tek@aol.com
PI Title:
Project Title:	A One Year Estrogen/Progestin Implant

Abstract: DESCRIPTION (provided by applicant): This program targets a one-year biodegradable estrogen/progestin implant for postmenopausal hormone replacement therapy. Estradiol plus levonorgestrel will be incorporated into an innovative implant design already being developed by BIOTEK for delivery of pure levonorgestrel as a maintenance contraceptive. The implant consists of a drug-free, biodegradable polymer core surrounded by a drug-containing shell, which provides efficient drug delivery. Such implants will biodegrade if left in place for more than a year, yet they can be surgically removed before the end of a year if necessary. With no need to keep track of daily pills or weekly patches, and with little reason to fear an unpleasant removal episode, such implants should provide a welcome new form of sustained hormone replacement therapy. Phase I demonstrated the feasibility of delivering estradiol and levonorgestrel at acceptable rates from the same implants. Phase II will now modify the core polymer to accelerate degradation, improve production methods, characterize promising designs in vitro, and confirm performance in rabbits. PROPOSED COMMERCIAL APPLICATION: The proposed work should lead to the development of a new kind of long lasting, highly effective, biodegradable drug delivery implant. Once fully impemented, implants of similar design should be useful for many other kinds of drug maintenance therapy.

Thesaurus Terms:
biodegradable product, biomaterial development /preparation, drug delivery system, estrogen, implant, levonorgestrel, progestin
drug administration rate /duration, drug screening /evaluation, estradiol, hormone therapy, microcapsule, pharmacokinetics, placebo
histology, laboratory rabbit

Institution:	BIOTEK, INC.
	21-C OLYMPIA AVE
	WOBURN, MA 01801
Fiscal Year:	2003
Department:
Project Start:	01-SEP-1999
Project End:	28-FEB-2004
ICD:	NATIONAL INSTITUTE ON AGING
IRG:	ZRG1

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