Fixed-Dose Combinations

Developing fixed-dose combinations (FDCs) is one of the many reformulation strategies used in product lifecycle management. It has the potential to offer quicker commercial returns compared to developing a new chemical entity. For pharmaceutical companies seeking to maximize the value of their drug products, FDCs can provide a means of obtaining supplementary patent protection and differentiating against cheaper generic-drug formulations. These formulations have shown success in the treatment of cardiovascular diseases, diabetes, HIV/AIDS, tuberculosis, and malaria.

Drivers for FDCs

“FDCs can be used either to combine different actives in one single dosage form or to achieve a precise release profile of a specific active—for example, by combining an immediate-release with an extended-release formulation,” explains Stefania Barzanti, marketing manager at IMA Active division. According to her, the success of FDCs is driven by two concurrent needs. “On one side, there is the need for welfare systems to contain healthcare costs; and on the other side, the need for pharmaceutical companies to optimize product lifecycle and exploit the potential of their existing product portfolio,” she says. FDCs are more cost-effective than individual drugs administered separately. They are known for their ability to reduce the pill burden. It is presumed that the simplification of therapy and its convenience lead to better overall patient compliance. The other main advantage of FDCs is the enhanced efficacy and lower incidence of side effects as a result of the synergistic combination of potentially lower doses of the different actives.

Developing an FDC, however, requires careful assessment of the potential advantages against the possible disadvantages, such as the difficulty or inflexibility of dose titration. “It is true that the flexibility in dosing options is reduced with FDCs, and it becomes more difficult to have fine tuning of the medication prescription to the needs of a specific patient,” Barzanti notes. “That’s why careful evaluation of the pros and cons of developing an FDC should drive the choice between the different solutions on the basis of a patient-centric approach that considers lifestyle needs and the medical condition.”

Drug developers are required to justify the pharmacological and medical rationale behind each FDC for the intended therapeutic indication. According to the European Medicines Agency, the rationale should consider the posology and dosing frequency of the different components included in the FDC (1).

05.01.2017

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Fixed-Dose Combinations