Fixed Dose Combination Drugs: Why And How?

By Beny Fricano

Fixed dose combination drugs are becoming increasingly popular, as part of the life-cycle management strategies to extend intellectual property and minimize generic exposure of mature pharmaceutical products.  A combination drug or fixed-dose combination (FDC) is a formulation of two or more active ingredients combined in a single dosage form, available in certain fixed doses.  To combine various actives for a synergic therapeutic effect, or different formulations of the same active in order to achieve a specific release profile, might be a viable way to achieve a product with improved efficacy or less side-effects, for which supplementary patent protection can be granted.

Even if a powder mixture of two or more formulations can be compressed in a single tablet, often a multiple-layer tablet is preferred, in order to avoid interactions between the different drugs and to optimize each formulation in terms of pharmacokinetics and manufacturability. Additionally, layered tablets might be a means to strengthen brand identity, as they clearly differentiate from other products.