# BIOEQUIVALENCE CONSIDERATIONS OF TOPICAL RECTAL AND VAGINAL SUPPOSITORIES

> **NIH FDA U01** · UNIVERSITY OF RHODE ISLAND · 2020 · $250,000

## Abstract

ABSTRACT
 Topical rectal and vaginal suppositories have been widely used for the localized treatment of
rectum or vagina diseases and disorders over the past few decades. Despite their prevalence, the
development and approval of generic topical rectal and vaginal drug products have remained
challenging due to the complexity of these products and a lack of regulatory guidance on comparative
product characterization-based bioequivalence (BE) assessment approaches. The main objective of
the project is to develop a rational framework to mitigate the risk of potential failure modes of BE
studies, for topical rectal and vaginal suppositories. The proposed research, builds upon our previous
research in the development of appropriate in vitro performance testing methods as well as in vitro-in
vivo correlation (IVIVC)/relationship (IVIVR) for complex dosage forms, including parenteral polymeric
microspheres and ophthalmic ointments. Based on the quality-by-besign (QbD) principles, quality
target product profile (QTPP) and critical quality attributes (CQA) of the topical suppositories will be
defined. A risk assessment will then be conducted to identify putative formulation and manufacturing
attributes that may have high likelihood to affect CQA of the target product. CANASA® (mesalamine)
and Terconazole (terconazole) suppositories have been selected as model rectal and vaginal
suppositories, respectively. Mesalamine and terconazole suppositories with manufacturing and
material differences will be prepared and thoroughly characterized, and in vitro and ex vivo
performance testing will be conducted. The commercially available mesalamine and terconazole
suppository products will be studied as controls. Based upon the outcomes of these studies, the key
manufacturing and material parameters that can impact product CQA will be identified. It is expected
that a comprehensive understanding of CQA and their relationship to manufacturing and material
differences will be provided for topical rectal and vaginal suppositories. In addition, robust,
appropriate in vitro and ex vivo performance testing methods will be identified and/or developed.
These will lead to the development of comparative product characterization-based BE approaches
that are suitable for topical rectal and vaginal suppository drug products. The proposed research will
facilitate the establishment of in vitro BE testing methods, thus helping advance the regulatory review
and approval processes for topical rectal and vaginal suppository products. This will in turn help
reduce the need for human studies and provide the public with high quality, affordable generic topical
medications in a timely fashion.

## Key facts

- **NIH application ID:** 10006319
- **Project number:** 5U01FD006721-02
- **Recipient organization:** UNIVERSITY OF RHODE ISLAND
- **Principal Investigator:** Jie Shen
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $250,000
- **Award type:** 5
- **Project period:** 2019-09-01 → 2022-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10006319

## Citation

> US National Institutes of Health, RePORTER application 10006319, BIOEQUIVALENCE CONSIDERATIONS OF TOPICAL RECTAL AND VAGINAL SUPPOSITORIES (5U01FD006721-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10006319. Licensed CC0.

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