Excipients in freeze-dried biopharmaceuticals: Contributions toward formulation stability and lyophilisation cycle optimisation

One-step microfluidics production of enzyme-loaded liposomes for the treatment of inflammatory diseases

“…Biopharmaceutical drugs, such as nucleic acids, monoclonal antibodies and therapeutic enzymes, are one of the fastest growing areas on the pharmaceutical industry [1]. Comparing with the synthetic drugs, biopharmaceuticals exhibits higher activity, selectivity and lower side effects [2].…”

Armamentarium of Cryoprotectants in Peptide Vaccines: Mechanistic Insight, Challenges, Opportunities and Future Prospects

“…Excipients in peptide formulations need very careful evaluation and selection because of the inherent sensitivity exhibited by peptides themselves (Bjelošević et al 2020 ). Peptide formulations are finally stored in freeze dried state so the formulators must consider this while selecting their excipients because not all excipients are stable under such situations of stress.…”

“…Synthetic peptide vaccines are preferred (Slingluff Jr 2011 ; Yang and Kim 2015 ) over the classical, live attenuated and subunit vaccines because of their characteristics like specificity, diversity, absence of allergic reactions to the pathogen and lack of cross immunization (Larché 2007 ; Mocellin et al 2009 ; Slingluff Jr 2011 ; Yang and Kim 2015 ). The efficacy of peptide vaccines is influenced by several critical factors like physicochemical chattels of peptides (Lloyd-Williams et al 1997 ; Smolenski et al 1990 ; Tregear et al 1973 ), excipients (Bjelošević et al 2020 ) and process parameters (Connolly et al 2015 ) involved in their formulation and development. Peptide vaccines are more stable in their secondary structure (Smolenski et al 1990 ; Wiesmüller et al 1989 ) than primary structure.…”

“…Further, cryoprotectant shields the peptide molecular structure in a mechanistic pathway. Hence, selection of suitable cryoprotectant is crucial step in peptide vaccine product development (Bjelošević et al 2020 ). For instance, 2% trehalose is added directly to Engerix-B vaccine to impart stability.…”

Pharmaceutical Development of Nitrosourea Compound for the Treatment of Neuroendocrine Tumours

“…This method ensures physico-chemical and pharmacological properties of hydrolytically and thermo-unstable substances during a long time and allows preparing dose form comfortable for administration after dissolution. [19][20][21] It was necessary to define the solution freezing temperature and to select a freezing method to determine the conditions for freezing. A special study was conducted to evaluate the effect of the freezing duration on the quality of the finished product.…”