the precise solution by sfm
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?
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) |
|---|---|
| Antibiotics | Infectiology |
| Antibodies, vaccines | Immunology, oncology |
| Enzymes | Substitution therapy, medication targets |
| Coagulation factors | Hematology |
| Hormones, vitamins | Endocrinology, substitution therapy |
Table 1: Examples of lyophilized active ingredients and their areas of application.
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
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).
How can a mixing and transfer device offer users more benefits and enhance usability through optimized user-friendliness? These were the questions we thoroughly considered when embarking on the development of the nextaro® product family.
The nextaro® product family continues to grow steadily. The new developments are oriented towards the wishes and needs of the market. The focus of the product family lies in the highest quality solutions for the user and patient.
We are pleased to announce that our innovative medical product nextaro® has been successfully approved in Canada. This further milestone represents an important step in our international expansion and confirms the quality and recognition of our product.
Medical device approval in Canada requires thorough review and compliance with strict regulatory requirements. Our team worked closely with Canadian health authorities to submit all required…
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nextaro® is manufactured and distributed by:
sfm medical devices GmbH, Brückenstraße 5, 63607 Wächtersbach (Germany)
