Kollicoat® IR: Minimizing the Risks for Oxidative Degradation of Drugs

Binders are important ingredients of solid oral dosage formulations (SODFs). The structure and function of binders play an important role in dosages’ shape and size, delivery, and stability of drug products. The stability of active ingredients depends on external factors, e.g. exposure to heat, oxygen and humidity but also on internal factors, e.g. the impurities such as peroxides, aldehydes, heavy metals and moisture contents often associated with the excipients [1,2]. These impurities may lead to undesired reactions and alter the efficacy of dosages with possibly adverse effects [3].Thus, controlling these impurities is important in alleviating the degradants to enhance the shelf life of drug products. Peroxides, amongst many of the impurities, remain the most challenging in drug development. For instance, wet granulation though remains widely practiced in the industry for its simplicity and easy scale up, can exert an enormous mechanical stress on the excipients caused by multiple formulation steps involving blending, mixing, granulation, drying, and sieving [4]. Such processing steps can lead to elevated impurity levels. Thus, minimizing the risks for elevated impurities in the excipients, especially the peroxides, is highly essential, which could otherwise be detrimental to long term stability of pharmaceutical dosages [5 6].