The obstacle to developing an optimum placebo formulation for pharmaceutical freeze drying
Posted: 18 January 2019 | Henning Gieseler, Julia Kosan | No comments yet
Scale-up of pharmaceutical freeze-drying processes is cost and time consuming due to Quality by Design (QbD) requirements and novel compound costs or availability. The application of placebo formulations offers a promising way to improve drug development activities and save resources. Furthermore, placebos are used as a reference in clinical trials. However, there are obstacles to the development of placebo formulations regarding both intended uses.
Use of placebos in pharmaceutical freeze drying
The objective of the development phase of freeze dried pharmaceutical products is to achieve efficient processes and final products with high quality and stability.1 To achieve this aim, one needs to perform several experimental runs to develop an optimum formulation and robust cycle.2-4
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Related topics
Analytical techniques, Clinical Trials, Freeze Drying, Quality by Design (QbD)
