Freeze-drying (lyophilization) is one of the most important pharmaceutical processes. It ensures the shelf life and storability of sensitive drugs. In which areas are freeze-dried active ingredients preferred and which medication groups are suitable for this process?
Areas of application for lyophilized active ingredients
About 50% of all biopharmaceuticals are currently lyophilized.1 For example, they are administered in tablet form, as granules for oral intake or (after reconstitution) as an injection solution. Classic lyophilized pharmaceuticals include antibiotics, antibodies, vaccines, enzymes, coagulation factors, hormones, and vitamins (Table 1).2-6 In recent years, freeze-drying has been increasingly used to stabilize drug carriers such as liposomes.7-9
Lyophilized active ingredients
Areas of application (examples)
Substitution therapy, medication targets
Endocrinology, substitution therapy
Table 1: Examples of lyophilized active ingredients and their areas of application.
Which drug groups are suitable?
In principle, all active ingredients that are unstable in liquid form can be used for lyophilization. However, especially for protein-based medications, preservation of the three-dimensional protein structure during manufacture, transport, storage, and use is necessary to ensure their biological activity. Proteins may be denatured in an aqueous environment under unfavorable conditions (e.g., temperature, light). This leads to partial or complete loss of effectiveness.5 Lyophilization prevents instability reactions and ensures that the sensitive biopharmaceutical active ingredients are stable and can be stored.10
Reconstitution of lyophilized active agents
If freeze-dried medications are not administered directly as tablets, granules, or capsules, they must be dissolved in liquid (reconstituted) before use, e.g., for injection. Due to their porous structure, they usually dissolve quickly. However, the requirements for reconstitution differ according to the particular lyophilized active agent. The nextaro® premium transfer system from sfm medical devices GmbH has a modular structure and can be adapted to specific components. This optimizes the reconstitution process in the vial and provides ideal protection for the valuable active agent. This flexibility means that nextaro® might be used in many areas of application in the future (Figure 1).
Kumar P. Lyophilization: an important formulation technique. International Journal of Research-GRANTHAALAYAH 2019; 7: 11-15.
Schoenfeld H, Pruss A, Keller M et al. Lyophilised plasma: evaluation of clotting factor activity over 6 days after reconstitution for transfusion. J Clin Pathol 2010; 63: 726-730. https://www.ncbi.nlm.nih.gov/pubmed/20702474
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