Which active ingredients are lyophilized?

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 ingredientsAreas of application (examples)
Antibodies, vaccinesImmunology, oncology
EnzymesSubstitution therapy, medication targets
Coagulation factorsHematology
Hormones, vitaminsEndocrinology, 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).


  1. Kumar P. Lyophilization: an important formulation technique. International Journal of Research-GRANTHAALAYAH 2019; 7: 11-15.
  2. Feuerstein SJ, Skovmand K, Moller AM et al. Freeze-dried plasma in major haemorrhage: a systematic review. Vox Sang 2020; 115: 263-274. https://www.ncbi.nlm.nih.gov/pubmed/32090336
  3. Izutsu KI. Applications of Freezing and Freeze-Drying in Pharmaceutical Formulations. Adv Exp Med Biol 2018; 1081: 371-383. https://www.ncbi.nlm.nih.gov/pubmed/30288720
  4. 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
  5. Schiffter-Weinle HA. Immer schön trocken bleiben - Gefriertrocknung zur Stabilisierung von empfindlichen Proteinen. Deutsche Apotheker Zeitung 2016; 44: https://www.deutsche-apotheker-zeitung.de/daz-az/2016/daz-44-2016/immer-schoen-trocken-bleiben
  6. Hansen LJJ, Daoussi R, Vervaet C et al. Freeze-drying of live virus vaccines: A review. Vaccine 2015; 33: 5507-5519. https://www.ncbi.nlm.nih.gov/pubmed/26364685
  7. Jacob J, Haponiuk JT, Thomas S et al. Biopolymer based nanomaterials in drug delivery systems: A review. Materials Today Chemistry 2018; 9: 43-55. https://www.sciencedirect.com/science/article/pii/S2468519418300880
  8. Rezvankhah A, Emam-Djomeh Z, Askari G. Encapsulation and delivery of bioactive compounds using spray and freeze-drying techniques: A review. Drying Technology 2019; 38: 235-258. https://doi.org/10.1080/07373937.2019.1653906
  9. Sopyan I, Gozali D. A Review: A Novel of Efforts to Enhance Liposome Stability as Drug Delivery Approach. Systematic Reviews in Pharmacy 2020; 11.
  10. Wang W. Lyophilization and development of solid protein pharmaceuticals. Int J Pharm 2000; 203: 1-60. https://www.ncbi.nlm.nih.gov/pubmed/10967427

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