Each of Columbia’s marketed products and product candidates utilizes our bioadhesive drug delivery system (BDS) technology that differentiates Columbia from its competitors and provides a platform for numerous future applications.
Key Ingredient: DescriptionFormulations: Bioadhesive Gels and Progressive Hydration TabletsChemistry of BioadhesionBenefits of BioadhesionLooking Towards Tomorrow
The key ingredient in the BDS is polycarbophil, a non-immunogenic, hypo-allergenic, bioadhesive polymer. Polycarbophil bonds to the cells of the body’s mucosal surfaces upon administration. In our vaginally-administered products, it bonds to the vaginal epithelial cells. In our buccal products, it adheres to the cells of the oral mucosa. Once in place, the BDS releases the active drug in a controlled and sustained manner until it 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.
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Gels —The Company’s bioadhesive vaginal gels are self-administered using a patient-friendly, pre-filled applicator.
Tablets —The progressive hydration tablets, including the buccal system and an investigational vaginal tablet, contain the active drug, polycarbophil and a water-soluble carbomer. As the tablet absorbs water, the active drug is gradually released and absorbed across the mucosal surface to which the product is bonded. Meanwhile, the active ingredient is protected from the surrounding environment, preventing it from being metabolized or degraded by moisture, enzymes or pH effects.
Polycarbophil is lightly cross-linked with divinyl glycol. It is a weak polyacrylic acid (pKa = 4.2) containing multiple carboxyl radicals (COO-), which are the source of its negative charges. These acid radicals permit hydrogen bonding with the cell surface. Hydrogen bonds are weak, but in the case of polycarbophil they are numerous and therefore tenacious.
Polycarbophil mimics negatively charged mucin, the glycoprotein component of mucus responsible for its attachment to underlying epithelial surfaces.
Bioadhesive vaginal delivery of progesterone, whether in our bioadhesive gel or progressive hydration tablet:
Pre-filled applicators make these FDA-approved products easy to use and patient-friendly, without the mess of pharmacy-compounded suppositories.
Columbia’s technology is currently being used to develop bioadhesive, vaginally-administered anesthetic, testosterone, and carbamide peroxide products to treat a variety of women’s healthcare indications.
Our unique buccal delivery system is currently utilized in STRIANT ® (testosterone buccal system) to deliver testosterone to men with hypogonadism. Buccal administration:
While Columbia’s targeted technology has particular utility for molecules with low oral bioavailability, when extended duration of effectiveness is desirable, or where systemic levels of the active ingredient must be curtailed, it can deliver many types of compounds to address a host of medical conditions. In addition to proprietary product development, this facility invites collaboration with other companies to develop products with their compounds for indications other than women’s healthcare.
Animated video of unique bioadhesive delivery system
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