Better lab tests for comparing rectal and vaginal creams and suppositories
In Vitro Based Approaches to Evaluate the Bioequivalence of Locally-Acting Rectal and Vaginal Semi-Solid Drug Products
This project develops laboratory methods to compare how rectal and vaginal creams and suppositories release and move medicines, to help create reliable generic options for patients.
Quick facts
| Grant type | U01 cooperative agreement |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Northeastern University NIH-funded |
| Lab location | 1 site (Boston, United States) |
| Project ID | NIH-11179155 on NIH RePORTER |
What this research studies
Researchers will identify the most important qualities of different suppositories and creams used in the rectum and vagina. They will create and validate lab tests (such as in vitro release and in vitro permeation tests) that mimic how medicines leave the product and pass through rectal and vaginal tissues. The team will study how drugs like miconazole nitrate and mesalamine move across mucosal membranes to understand absorption. This is lab-based work intended to make it easier to show that generic products perform the same as brand-name versions.
Who could benefit from this research
Good fit: Patients who use or may need rectal or vaginal topical medicines—such as people with yeast infections, cervical conditions, or inflammatory bowel disease affecting the rectum—are the groups most likely to benefit or be asked to provide samples.
Not a fit: People who do not use rectal or vaginal topical treatments or who require only oral or injected therapies are unlikely to directly benefit from this work.
Why it matters
Potential benefit: If successful, this work could make it easier and faster to approve safe, affordable generic rectal and vaginal medicines, improving access and lowering costs for patients.
How similar studies have performed: Similar lab methods (in vitro release and permeation tests) have supported approvals for other topical products, but applying and validating these tests specifically for rectal and vaginal semi-solid forms is more novel and still being refined.
Where this research is happening
Boston, United States
- Northeastern University — Boston, United States (Active)
Researchers
- Principal investigator: Shen, Jie — Northeastern University
- Study coordinator: Shen, Jie
About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page below.