LNG Gastric Resident Dosage Form
Alternative Name: Levonorgestrel Gastric Resident Dosage Form, Levonorgestrel Gastric Retentive Dosage Form
Description: The dosage form contains LNG and a polymer structure that is encapsulated for oral administration. In the stomach, the capsule dissolves and reveals the dosage form, which has six polymer arms that recoil to ~5.5 cm in diameter, preventing the dosage form from leaving the stomach through the ~2 cm pylorus for periods of time. The arms are made of a rigid polymer casing with an LNG-polymer matrix inside for drug release over time, and the dosage form technology is also being developed for the delivery of HIV and malaria drugs. The target product profile is described as allowing for 3 weeks of drug delivery, followed by a hormone-free week, for a contraceptive duration of 1 month.
Product Details
Duration: 1 month
Regimen:
Active Pharmaceutical Ingredient (API):
Inactive material: Poly(sebacic anhydride)- and/or polydimethylsiloxane (PDMS)-based polymer matrices; thermoplastic polymer arm casing of Sorona 3015G NC010; elastomer core of Elastollan 1185A10; 1 mm radiopaque steel balls; and gelatin capsule
Status Details
Developer: ,
Status Details: - Pre-clinical testing of ~33mg LNG-loaded dosage forms has achieved extended release of LNG in pigs.
- Pre-clinical testing of ~33mg LNG-loaded dosage forms has achieved extended release of LNG in pigs.
Additional Information
References: Kirtane AR, Hua T, et al. (2019). A once-a-month oral contraceptive. Science Translational Medicine. 11(521):eaay2602. dio:10.1126/scitranslmed.aay2602.
Kirtane AR, Hua T, et al. (2019). A once-a-month oral contraceptive. Science Translational Medicine. 11(521):eaay2602. dio:10.1126/scitranslmed.aay2602.