Excipients Articles - Latest

Polyols (aka polyhydroxy co-solvents aka osmolytes) such as sucrose have long been known to impart thermodynamic stability to proteins in solution. Recent advances in biotechnology and in the development of proteins for therapeutic applications has led to an increased interest in these neutral co-solvents (more than 60 % of mAb formulations currently in market have polyhydroxy alcohols as excipients). read more

When drug crystals are heated they undergo changes that can be observed under a microscope. Characteristics that can be analyzed under a microscope include melting point, melting range, crystal nucleation, crystal growth, crystal transformations and more. read more

An excipient’s functional category is a qualitative classification or term that describes the purpose or role of an excipient in a drug product. However, the current regulatory environment and the paradigm of QbD go beyond simply identifying excipient function and emphasizes performance through the identification, evaluation, and control of critical material attributes (CMA) that assure consistent performance throughout a product’s life-cycle [1]. read more

Pharmaceutical excipients are defined in United States Pharmacopoeia (USP) 33 as “substances other than the active pharmaceutical ingredient (API) that have been appropriately evaluated for safety and are intentionally included in a drug delivery system”. Excipients are essential components to enable the delivery, manufacturability and stabilization of the API in a formulation. read more