The stability of protein/peptide based drug formulations is known to be greater in the solid state than in the liquid state. A solid formulation offers the advantages of higher stability at ambient storage temperature and thereby often removes the necessity for cold chain storage and transportation. Many protein/peptide based drugs are prepared as solid dosage forms by freeze-drying or spray drying.
Freeze drying or lyophylisation is a very well-established dehydration process for preparing biopharmaceuticals. It is typically performed with the product directly filled in the final container and gives a high quality dry cake with a high porosity that enables quick reconstitution of the liquid form when needed. Freeze-drying formulations are best suited when no further processing is required after drying and are therefore commonly delivered parenterally by subcutaneous or intramuscular route after being reconstituted.
Lately, research on powder based methods for protein delivery has increased. Even though very well-known in the industry, lyophilization is not a direct particle formation method and would require additional procedures to break the cake into smaller particles. Spray drying on the other hand is an elegant one-step process to produce a powder with unique particle characteristics from a biopharmaceutical formulation. Even though high temperatures are applied during the process, most of the energy is used to evaporate the liquid and the actives will not be subjected to excessive temperatures. When appropriate formulation strategies are used to minimize the effect of heat and drying on the biomolecules, spray drying is an effective, well-established research and production tool to obtain powders of proteins and peptides formulation opening the door to a wider scope of deliver methods.
Find out about the use of Buchi instruments in the formulation of Protein Drugs.
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Spray Drying of Biopharmaceuticals: Stability and Process Considerations
Do you have a specific question regarding protein based formulation? We have specialists who will quickly and efficiently provide you with competent application support or a feasibility study specifically tailored to your needs. Get in contact with our team via application@buchi.com or find out when our next training takes place.
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