Freeze-drying of Pharmaceuticals and Biopharmaceuticals

Abstract

Freeze-drying, in the past popular in the food industry, has more recently been adopted by the pharmaceutical industry as a standard method for the production of stable solid preparations. Freeze-drying of Pharmaceuticals and Biopharmaceuticals is the first book to specifically describe this process, as related to the pharmaceutical industry. The emphasis of this book is on the properties of the materials processed, how effective formulations are arrived at, and how they are stored and marketed. Beginning with a historical overview of the process, Freeze-drying of Pharmaceuticals and Biopharmaceuticals briefly describes the processes and equipment involved, including: the physics, chemistry and biochemistry associated with freezing, aspects of formulation development, primary and secondary drying; the economics and engineering of scaling up; and, most importantly, attributes of the dried product. It also discusses in detail the science behind freeze-drying, such as the properties of crystalline and amorphous solids. The book concludes with selected case studies and discusses the future of freeze-drying, advances in alternative drying methods, and concludes with an extensive bibliography. This book, written by a leading expert in the field, is aimed primarily at product and process developers in the biopharmaceutical industry and academia.

Drying Technology Evolution and Global Concerns Related to Food Security and Sustainability

“…These substances are freeze-dried; thus, the quality of the dried product is retained [63,79]. Freeze drying is a process in which the water or another solvent is sublimated by the direct transition of water from solid (ice) to vapor, thus omitting the liquid state, and then desorbing water from the "dry" layer [80][81][82][83][84]. As a rule, freeze drying produces the highest-quality food product obtainable by any drying method.…”

Study of the composition of cryoprotector and technological regime in liophilization of liposomes with oxaliplatinum

“…The sublimation process can be divided into two physical stagessublimation of ice from the production and its capture by condenser shelves. The degree of water transfer, as well as the speed of the process is regulated by the temperature program of the shelves in product chamber and the total process time [7]. In Fig.…”

On the Use of Temperature Measurements as a Process Analytical Technology (PAT) for the Monitoring of a Pharmaceutical Freeze-Drying Process

“…The shelf temperature can be relatively high, as the heat transfer coefficient between the shelf and the bottom of the container is low as an effect of the very low pressure, but the product temperature remains low until there is ice that sublimates if the mass transfer resistance of the dried cake is sufficiently small to allow the flux of the vapor formed. If the driving force is not sufficient to allow this flux, heat accumulates in the product, increasing its temperature; in fact, the higher temperature at the frozen–dry layer interface increases the vapor tension of ice and thus, the driving force and flux [ 1 , 2 , 3 , 4 ].…”