Modular Titratable Polypills for Personalized Medicine and Simplification of Complex Medication Regimens

Simplification of complex medication regimens in polypharmacy positively contributes to treatment adherence and cost-effective improved health outcomes. Even though fixed dose combination (FDC) drug products are the only currently available single dose poly-pill regimens, the lack of flexibility in dose adjustment of a single drug in the combination limits their efficacy. To fill the existing gap in drug dose personalization and simplification of complex medication regimens commonly encountered in the treatment of cardiovascular disease, tuberculosis, and tapering of corticosteroid therapy, a modular titratable polypill approach that simultaneously addresses both aspects is proposed. The polypill consists of modular units that contain different drugs at incremental or decremental doses to be assembled in a single titratable polypill at the required dose for each drug through a stacking or interlocking process. The variable dose (VD) modular tablets are subjected to quality control tests and found to comply to pharmacopeia's acceptance criteria and requirements specified in the respective drug monographs. A cost-effectiveness analysis is conducted supporting the VD strategy as cost-effective compared to the FDC strategy and more effective and less expensive than standard of care. The VD approach stands to enable pill burden reduction, ease of administration, enhancement of treatment adherence, and potential cost-saving benefits.

Automated summary

Simplification of complex medication regimens through a modular titratable polypill approach that allows for personalized drug dosing and combination significantly improves treatment adherence and reduces costs. This approach involves assembling modular units containing different drugs at adjustable doses into a single polypill, enabling flexibility in dose adjustment for each drug. Cost-effectiveness analysis shows that this variable dose strategy is more cost-effective than fixed-dose combination (FDC) drug products and offers greater efficacy and cost savings compared to standard of care. The use of variable dose polypills can reduce pill burden, improve treatment adherence, and provide potential cost-saving benefits.