Making A Case For A Fixed Dose Combination Drug Strategy

The emphasis on patient-centricity in healthcare has driven pharma companies to invest in new systems for delivering active pharmaceutical ingredients (APIs) in finished drug products to better promote patient compliance. Fixed dose combination (FDC) drug products are an oral solid dose (OSD) platform steadily gaining favor as they offer better pharmacokinetics and therapeutic synergies, simplified therapeutic administration and dispensing, reduced therapeutic polypharmacy, and improved patient compliance. From a Cost-of-Goods (CoGs) perspective, commercial FDC drugs are also more efficient to manufacture, distribute, and dispense than two or more finished dose forms.

Although similar development to traditional monotherapies is involved, developing and manufacturing FDC drug products necessitates a more complex formulation process. The presence of two or more APIs requires additional analysis including drug-drug interactions and dose-ranging studies to determine optimal API loads and ratios, which add to the complexity of FDC development. Successful support for commercial products requires a timely, cost-efficient development path to regulatory approval and a robust manufacturing strategy to deliver quality products to patients and markets.

Engaging fully capable external partners to execute your drug program expertly and cost-efficiently for advancing these drug products to market successfully. An FDC program developed with expert commercial partners is likely to be better able to generate the anticipated return whilst driving continuous innovation in OSD. Examine the potential of FDC drug products to provide convenient dosing options and how the right CDMO partner is essential for taking your product to market.