6

BDS

Our bioadhesive delivery system (BDS) is a unique drug delivery technology that facilitates binding to mucosal surfaces upon administration, and allows release of the active drug in a controlled and sustained manner until the BDS formulation is discharged upon normal cell turnover. This occurs every three to five days for the vaginal epithelium, and up to every 24 hours for the oral mucosa.

The key BDS ingredient is polycarbophil, which is a non-immunogenic, hypo-allergenic, bioadhesive polymer. Polycarbophil bonds to the cells of the body’s mucosal surfaces upon administration. This happens because polycarbophil mimics negatively charged mucin, the glycoprotein component of mucus that is responsible for its attachment to underlying epithelial surfaces.

Two types of BDS formulations have been developed: gels and tablets.

  • Bioadhesive vaginal gels such as Crinone® (progesterone gel), which delivers active drug, and Replens® and RepHresh®, which contain just the polycarbophil bioadhesive gel. These products are self-administered using a patient-friendly, pre-filled applicator.
  • Bioadhesive progressive hydration tablets have been developed for buccal and vaginal delivery. Each tablet contains a polycarbophil component and a water-soluble carbomer. Active drug can be composited into the tablet or buccal system, and as the tablet absorbs water, the active drug is gradually released and absorbed across the targeted surface. Secondarily, the active drug is protected from enzymatic degradation or metabolism as well as unaffected by pH fluctuations or environmental changes of the surrounding milieu.

We are evaluating additional clinical applications of this legacy technology, focusing on potential opportunities where the bioadhesive properties and shorter duration of the BDS align with desired product profile and unmet need.

Crinone® is a registered trademark of Merck KGaA, Darmstadt, Germany, outside the U.S. and of Allergan, Inc. in the U.S. 

Replens® and RepHresh® are registered trademarks of Church & Dwight Co.