Chapter 10: Development Programs for Oral Fixed Dose Combination Products

Drug–drug combinations can be very effective at managing a wide range of clinical conditions. Successes have included the treatment of bacterial infections by broadening antimicrobial spectra. Combinations have also been very effective in treating HIV infection. In a wider context a chronic condition that requires more than one medication for its management can pose patient compliance challenges when dose frequencies for the (separate) medications differ. Furthermore, elderly patients who suffer from more than one clinical condition are likely to need different medications to manage each ailment. If times for dosing or dose frequencies differ for each condition there is potential for confusion, medication mix-up with efficacy and compromised safety. Asymptomatic conditions that require frequent daily dosage also pose compliance challenges, the patient does not get a “biological reminder” on “need-to-dose”. This chapter discusses rationales, possibilities and strategies for dosage form design and evaluation of drug–drug combinations to help resolve some of these issues. Regulatory definitions and requirements for different product programs are also considered and examples provided for the various categories of combination products. Finally, comments are provided on future opportunities and possibilities for drug–drug combination products.