Injectable LNG in PLA/PLGA Microspheres
LNG Long-Acting Microsphere Injectable (LLMI)
- User: Female
- Hormonal: Hormonal
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Delivery type:
- Injectable
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Intended Duration:
- Short-Acting
- Development Stage: Pre-Clinical
- Developer(s)/researcher(s): FHI 360, Shanghai Institute for Biomedical and Pharmaceutical Technologies
Details
- API: Levonorgestrel
- Target: Progesterone Receptor
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Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Endometrial Changes
- Inactive Materials: PLGA
- Regimen: 1 Injection/6 Months
- MPT: Not Potential MPT
- Promising Attributes: A longer-acting injectable with a more-controlled release may improve method adoption and continuation and minimize side effects associated with an initial burst of LNG following injection.
Product Status
CMC and Pre-Clinical Research Ongoing. First-in-Human Trial Planned.
History
1989: US FDA approves first injectable drug to use PLGA microspheres loaded with an API.
1985-2009: Pre-clinical studies indicate promise for the controlled release of LNG both in vivo and in vitro. PLGA is a desirable encapsulation material due to its consistent biodegradability and biocompatability.
2011-Present: User acceptablity research and market research indicate strong and consistent user interest in a 6-month contraceptive injectable method
2011: FHI 360 launches the Longer-Acting Injectable Initiative, which supports a number of proposals for development of new/modified injectables.
2020-Present: Researchers from SIBPT and FHI 360 collaborate to develop appropriate encapsulation, suspension, and delivery processes and systems for PLGA-encased LNG.