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Rheological evaluation of high concentration albumin aqueous solutions
Kahraman, Melda
Nowadays, biopharmaceuticals represents one of the crucial areas in the field of pharmacy and are widely used to treat several diseases, such as chronic viral hepatitis, rheumatoid arthritis, ...psoriasis, Crohn's diseases and different types of cancer. They comprise a broad group of biological molecules differentiating greatly compared to synthetic drugs, thus their development is very challenging. A main limitation in developing a protein based drugs is their stability, since they are prone to physical as well as chemical instability processes. Stability of protein based drug is of paramount importance as it is directly related to the efficacy of the final drug. Since protein molecules are usually instable in aqueous media, the transformation into solid state is desirable, most commonly by utilizing technological process of lyophilisation. In the past, most biopharmaceutical drugs were intended for intravenous administration, however current trends are oriented into the development of protein drugs for subcutaneous administration. One of the most limiting step in development of such formulations is higher viscosity given that large dose of protein drug has to be delivered due to the small volume intended for subcutaneous administration. Increased viscosity in high concentrated protein formulations affects both production processes and ability to deliver such formulations by using a syringe since it limits the injectability. Therefore development strategies to reduce the viscosity are essential. Diploma thesis aimed to evaluate rheological plus thermal characteristics of bovine serum albumin (BSA; model protein drug) based aqueous solutions in dependence of its concentrations (i.e. 5-100 mg/mL). As lyophilisation method was used, the critical quality attributes such as reconstitution time, visual appearance and particle size were under investigation before and after each lyophilisation process. Obtained results suggest that concentration of BSA affects the viscosity as well as the visual appearance and reconstitution time of lyophilisates, specifically by increasing BSA concentration the viscosity increased while reconstitution time was prolonged and lyophilised cake was more rugged.
Type of material - master's thesis
; adult, serious
Publication and manufacture - Ljubljana : [M. Kahraman], 2019
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