By virtue of gastrointestinal physiology, the viability of an oral controlled release product is generally limited by the pH-dependent properties of the compound (solubility, stability and permeability), enzymatic stability, residence time and site specific absorption. Low solubility drugs, particularly weak bases, are notably troublesome in achieving the desired exposure and/or duration for controlled release products.
The formulation team at Kashiv has developed multiple technologies that can be successfully applied to achieve a true controlled release profile for a wide range of compounds. These technologies can be further customized to modulate the release profile to meet specific therapeutic needs, such as chronobiology or a target patient population (e.g., pediatric). In addition to addressing the absorption issues in the GI-tract, these controlled release technologies can also improve the performance of drugs with high first pass effect by controlling the site of absorption, and thereby reducing the dose.