Freeze‐Drying of Parenteral Drug Products and Vaccines

Résumé fourni par la source

Parenteral drug products and vaccines are those given by an injection of a low-viscosity liquid formulation, for example, an aqueous solution containing the active ingredient and, usually, a number of carefully selected excipients (additives) that are usually intended to stabilize the product. However, many of these products have a short shelf life in an aqueous liquid state and require an additional step to manufacture them in a stable solid state, by the process of freeze-drying. This chapter provides an introduction to the traditional batch manufacturing approach to freeze-drying. In this process, large numbers of vials, each containing a small volume of an aqueous solution of the product formulation, are freeze-dried on temperature-controlled shelves inside a drying chamber at low pressure (usually, from 50 to 500 μbar) with the water vapor evolved trapped by a condenser, which is housed within another chamber connected to the drying chamber by a duct. The chapter includes descriptions of (i) the formulation requirements for drug product solutions intended for freeze-drying; (ii) the stages, design features, and critical parameters of the freeze-drying process; and (iii) an introduction to the commonly employed process analytical technologies (PAT).

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.