US Patent Issued to Profs. Glasser and Muzzio and Former PhD Student Dr. Grigorov

A US Patent (Patent Number: US 10,004,682) entitled “Formulation and Manufacture of Pharmaceuticals by Impregnation onto Porous Carriers” was issued to Professors Benjamin Glasser and Fernando Muzzio and their former PhD student, Dr. Plamen Grigorov. The patent is on a novel method for manufacturing pharmaceuticals by utilizing impregnation of Active Pharmaceutical Ingredient (API) solutions onto porous carriers (excipients). Impregnation of solutions onto porous carriers allows extremely uniform distribution of small amounts of the drug substance, which can be used for drug dosage regulation. Currently, the method has been implemented for drug content as low as 0.1% and as high as 20%, thus spanning a wide range of interest for poorly soluble, highly potent compounds in oral delivery applications. The drug release profile can also be controlled through the manufacturing process. Since the impregnated material can be filled directly into capsules, many inactive substances that were previously required for formula stability throughout encapsulation (i.e. compression aids, glidants, surfactants, disintegrants, or lubricants) can be eliminated as well. The impregnated material can also readily be made into tablets. Also, the method is uniquely suited for drug formulation development and clinical supply manufacturing, as it is safer than processes that require drugs to be handled in dry, powder form. Advantages include: Approach eliminates API operations after synthesis and purification (i.e., crystallization, drying, milling,) making issues related to flow, cohesion, electrostatics, and particle size distribution no longer relevant; Extremely good drug content uniformity in finished dosages; Enhances deliverability of poorly soluble drugs; Significant simplification of product manufacturing sequence; Safety and environmental improvements; Simplified scale-up procedure; Reduced number of critical raw material attributes and control parameters.