Bespoke hydroxypropyl methylcellulose-based solid foams loaded with poorly soluble drugs by tunable modular design

Abstract

A tunable modular design (TMD) as a new approach was proposed to tailor the dose and drug release profile of poorly water-soluble drugs from hydroxypropyl methylcellulose (HPMC)-based solid foams by combining two manufacturing principles: (1) freeze-drying aqueous HPMC-based gels to yield porous sturdy modules with specific doses of an active pharmaceutical ingredient (API) with the step size of 3 mg, and (2) fine-tuning the desired dose of the API with the step size of 0.1 mg by inkjet printing of the API-loaded ink onto the modules. Carvedilol (CAR) was used as a model poorly water-soluble API that requires frequent dose adjustment. The limitation of poor CAR solubility was overcome by designing pharmaceutically approved co-solvent systems. This approach ensured printable inks of a high drug content, and sturdy and flexible modules with uniform distribution of CAR to achieve effective and accurate doses of CAR. The tailored release rate of CAR from TMD products was succeeded by varying the composition, particularly, the content and grade of HPMC, and physical dimensions of modules. The TMD approach holds potential for designing bespoke high-quality products, containing hydrophilic cellulose ethers such as HPMC and poorly water-soluble APIs.