Magee-Womens Research Institute & Foundation

The pharmaceutics laboratory at Magee is dedicated to identifying essential criteria for the design of drug delivery systems specific for women’s health issues. We are using this information to develop new products for women. Pharmaceutics involves the development of essential information that can be used to design drug delivery systems or dosage forms. Our focus is to get drugs to their target for action in a patient acceptable and safe manner while enhancing drug efficacy. Drug delivery research in the pharmaceutics laboratory covers a broad range of therapeutic areas. Specific areas include infectious disease, gynecologic health and oncology, vaccines, irritable bowel syndrome, and oral health. A major focus of research in the lab has been toward the development of products intended to prevent sexually transmitted infections including HIV. Specifically they are developing products that can prevent or reduce transmission of sexually- transmitted infections when applied to the vagina or rectum. Microbicide products would offer a female controlled method for prevention. HIV infection is a significant health problem worldwide with infection rates reaching pandemic levels. A number of products designed in the Pharmaceutics lab have been progressed from the bench to first in human clinical evaluation. The Pharmaceutics lab is involved in all aspects of pharmaceutical product development from preformulation and formulation development to formulation assessment, manufacturing, and scale-up.

In order to successfully design such drug delivery systems it is essential to have a full understanding of the female genital mucosa (vagina and ectocervix). Due to the anatomy and physiology of the female reproductive tract, women are twice as likely to become infected with the HIV/AIDS virus.

The Pharmaceutics Laboratory is conducting research in this area to better understand aspects which are needed for development of safe and effective vaginal products. The Pharmaceutics Laboratory is currently working on a number of funded research projects in the area of microbicide product development. Several of these projects are listed below.

1U19AI120249 (PROGRAM CO-PI WITH HILLIER, S.; PROJECT 1 PI; PROJECT 4 PI) NIH/NIAID “FILM ANTIROTROVIRAL MICROBICIDE EVALUATION (FAME)”

Microbicides are products which are being developed for the prevention of HIV. This multiproject program will develop a new formulation of the antiretroviral drug MK-2048 that women will use just once weekly to prevent HIV infection transmitted through unprotected vaginal intercourse. The program includes laboratory, animal model and clinical trials to achieve these goals over 5 years. 

U01FD005447 (PI; CO:IS: LITTLE, S AND SFEIR C) FDA “A BIORELEVANT DISSOLUTION METHOD FOR PARTICULATE DOSAGE FORMS IN THE PERIODONTAL POCKET”

Currently there is no available standard dissolution system which can be applied to “prove” bioequivalence for long acting periodontal drug products. Dissolution testing is a key component in any pharmaceutical product development program. It provides data which describes how reproducibly drug is released from a product and can be used to predict drug release in the body. The goal of this proposal is to design a dissolution testing method which mimics the environment in periodontal pocket of the human body. This method can become a standard method used to test bioequivalence for generic products intended to treat periodontal disease.

OPP1110953 (PI ) BILL & MELINDA GATES FOUNDATION “CONTINUED ASSESSMENT OF FILMS FOR MULTI-PURPOSE PREVENTION TECHNOLOGY (MPT) DEVELOPMENT”

These studies serve to generate critical gap activities toward the application of vaginal polymeric thin film dosage forms to address female sexual and reproductive health issues. Specifically, the utility of this platform for on demand multi-purpose technologies (MPT) will be established.

UM1 A1106707 (CENTRAL LABORATORY: CO-DIRECTOR, COMPARATIVE ASSESSMENT CORE; PROGRAM PI: DEZZUTTI, C) NIH “LABORATORY CENTER (LC): MICROBICIDE TRIALS NETWORK

Within the Central Lab Core of the MTN, the Pharmaceutics Lab is responsible for all product related issues with respect to clinical protocol implementation.

U19 A1113182 (CORE PI; PROGRAM PI: PALMER,K) NIH/NIAID “GRIFFITHSIN-BASED RECTAL MICROBICIDES FOR PREVENTION OF VIRAL ENTRY (PREVENT)

The goal of the PREVENT Program is to develop a Griffithsin rectal gel that could be used prior to receptive anal intercourse (RAI) to reduce the risk of HIV infection.

R01 A1116292 (CO-INVESTIGATOR; PI: HLADIK, F) NIH/NIAID “SYSTEMS AND CARCINOGENIC IMPACT ASSESSMENT OF TOPICAL MICROBICIDES ON HUMAN MUCOSA” 

• Rohan LC, et al. Development of a vaginal microbicide formulation for the prevention of sexually transmitted infections. J Control Release. 2019; 295: 1-10.
• Rohan LC, et al. Design and evaluation of a polymeric film for the delivery of HIV microbicides. Pharm Res. 2018; 35(3): 1-12.
• Rohan LC, et al. Development of a nasal spray for the prevention of COVID-19. J Pharm Sci. 2021; 110(3): 1-10.

For additional publications, click here.

Sep 30, 2023
MAGEE-WOMENS RESEARCH ROUNDUP: SEPTEMBER 2023

Dec 14, 2020
MWRI-Developed Nasal Spray Receives Funding From Department of Defense

May 5, 2020
NEXTPittsburgh highlights Dr. Lisa Rohan's research into a nasal spray that could prevent COVID-19

May 4, 2020
Lisa Rohan featured in story about a nasal spray that could possibly prevent COVID-19

Feb 3, 2020
Dr. Lisa Rohan: What Women Want