NIH GUIDE, Volume 21, Number 11, March 20, 1992


P.T. 34



  Dosage Forms+ 


National Institute of Child Health and Human Development

The Contraceptive Development Branch, Center for Population Research,

National Institute of Child Health and Human Development, has a

requirement for the development of a bi-compartment transdermal

contraceptive system capable of delivering a progestin from one

compartment and an estrogen from the other compartment in such a way

that the delivery of progestin(s) will be independent of the delivery

of the estrogen and vice versa.  The overall size of the bi-compartment

transdermal contraceptive system should be about 10cm2.

The objective of the project is to design and develop a transdermal

contraceptive system that will have the potential of (1) using one of

the several progestins currently used in various oral contraceptive

formulations and estradiol-17beta as the estrogen, (2) delivering the

progestin or the estrogen alone, and (3) changing the delivery of the

progestin(s) and/or the estrogen without affecting the delivery of the

other drug.  The blood concentration of the contraceptive drug(s) must

be comparable to that achieved through oral contraceptive regimen(s)

containing that progestin.

Organizations (and their collaborators, if any) must have adequate

facilities to perform all necessary in vitro and in vivo animal studies

preliminary to filing an Investigational New Drug (IND) application

with the Food and Drug Administration, conduct Phase I Clinical

Studies, and supply a sufficient number of the bi-compartment

transdermal delivery systems for Phase II studies.  The Phase II

studies will not be a part of this project.

This announcement is not a Request for Proposals (RFP).  The RFP will

be issued on or about March 20, 1992.  Proposals will be due

approximately 60 days thereafter.  NICHD expects to fund two contracts

from this solicitation.  Copies of RFP may be obtained by sending

written requests to:

Paul J. Duska, Contracting Officer

Contracts Management Branch, OGC

National Institute of Child Health and Human Development

Executive Plaza North, Room 610

9000 Rockville Pike

Bethesda, MD  20892-9903

FAX:  (301) 402-0915


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