A recent study titled 'Raman spectroscopy reveals characteristics of sugar excipients in freeze-drying of nanofibrillated cellulos' by Aleksi Kröger, Julia Monola, Riina Harjumäki, Tatu Rojalin, Artturi Koivuniemi, Akseli Niemelä, Kirsi Svedström, Heikki Suhonen, Simo Huotari, Ossi Korthonen, Elle Koivunotok, and Marjo Yliperttula explores the freeze-drying (FD) process of nanofibrillated cellulose hydrogel (NFCh), a wood-derived product used in pharmaceutical applications, particularly focusing on its reconstitution and stability. The research investigates how different sugar excipients, such as disaccharides (saccharose, lactose, trehalose) and the amino acid glycine, influence the molecular and morphological changes of NFCh during FD.
By employing Timegated® Raman system alongside other techniques such as near-infrared (NIR) spectroscopy and Wide-Angle X-ray Scattering (WAXS), the authors reveal that disaccharides help achieve amorphous nanocellulose and form a two-phase system with NFCh, while glycine contributes to formulation stabilisation. These findings offer potential solutions for the storage and transportation of complex biologicals, addressing critical challenges within the pharmaceutical industry.
You can read more from the open-access article here.
Abstract
Freeze-Drying (FD) has become an ever more significant part of the pharmaceutical industry as the number of biopharmaceuticals has increased in recent decades. The growing number of advanced therapy medical products (ATMPs) creates new challenges for the FD industry as cells, virus vectors, and other complex biologicals need to be preserved in dry conditions at room temperature. Nanofibrillated cellulose hydrogel (NFCh) is a wood-derived sugar polymer-based product that is used in various pharmaceutical applications, such as wound dressings, as a three-dimensional (3D) cell culturing platform, and in tissue engineering. NFCh can also be utilized as an excipient in FD. However, NFCh requires the use of other excipients to provide a desirable reconstitution ability and sufficient residual moisture contents after the FD process. In this work, the effect of formulation on the FD-reconstitution process of NFCh with saccharose, lactose, trehalose, and glycine was studied. Raman- and near-infrared (NIR) spectroscopy were utilized as non-invasive technologies to determine molecular changes in the formulations during the FD-reconstitution process. Wide-Angle X-ray Scattering (WAXS) analyses were performed to reveal the morphological changes of the FD formulations. Disaccharides likely formed a two-phase system with NFCh and were found to have a clear decreasing effect on the crystallinity of the freeze-dried NFCh. Glycine as an amino acid was found to stabilize the formulation, possibly due to preferential exclusion, which was observed in NIR-spectra. In the future these NFCh formulations can be utilized in FD of complex biologicals to overcome issues regarding their storage and transportation.
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