Parenteral protein formulations: an overview of approved products within the European Union
V Gervasi, RD Agnol, S Cullen, T McCoy… - European Journal of …, 2018 - Elsevier
The study presented is a comprehensive overview of commercial parenteral protein
formulations, approved by the European Medicines Agency (EMA), 1995–2018. The …
formulations, approved by the European Medicines Agency (EMA), 1995–2018. The …
Excipients in freeze-dried biopharmaceuticals: Contributions toward formulation stability and lyophilisation cycle optimisation
M Bjelošević, AZ Pobirk, O Planinšek… - International journal of …, 2020 - Elsevier
Biopharmaceuticals are one of the fastest growing areas within the pharmaceutical industry.
As protein drugs require parenteral administration, they are commonly formulated as …
As protein drugs require parenteral administration, they are commonly formulated as …
Lyophilized liposome-based parenteral drug development: Reviewing complex product design strategies and current regulatory environments
Y Wang, DW Grainger - Advanced drug delivery reviews, 2019 - Elsevier
Given the successful entry of several liposomal drug products into market, and some with
decades of clinical efficacy, liposomal drug delivery systems have proven capabilities to …
decades of clinical efficacy, liposomal drug delivery systems have proven capabilities to …
Excipients in parenteral formulations: selection considerations and effective utilization with small molecules and biologics
BM Rayaprolu, JJ Strawser… - Drug development and …, 2018 - Taylor & Francis
Excipients form a major component of pharmaceutical formulations and are classified as any
ingredient other than the active ingredient which is included within the product formulation to …
ingredient other than the active ingredient which is included within the product formulation to …
Lyophilization of small-molecule injectables: an industry perspective on formulation development, process optimization, scale-up challenges, and drug product quality …
A Butreddy, N Dudhipala, KY Janga, RP Gaddam - Aaps Pharmscitech, 2020 - Springer
Lyophilization is a pivotal manufacturing process to obtain a stable drug product that is
unstable as a ready-to-use formulation. Some formulations may require the addition of drug …
unstable as a ready-to-use formulation. Some formulations may require the addition of drug …
Process development and quality attributes for the freeze-drying process in pharmaceuticals, biopharmaceuticals and nanomedicine delivery: a state-of-the-art review
SR Pardeshi, NS Deshmukh, DR Telange… - Future Journal of …, 2023 - Springer
Background Process intensification is a major hurdle in pharmaceutical process scale-up.
Solvent removal strategies have limited the effectiveness of the overall stability of …
Solvent removal strategies have limited the effectiveness of the overall stability of …
Recent advances in freeze-drying: variables, cycle optimization, and innovative techniques
MM Mehanna, KK Abla - Pharmaceutical development and …, 2022 - Taylor & Francis
Freeze-drying (FD) is the most substantial drying technique utilized in the pharmaceutical
and biopharmaceutical industries. It is a drying process where the solvent is crystallized at …
and biopharmaceutical industries. It is a drying process where the solvent is crystallized at …
[HTML][HTML] Structural modifications for the conversion of proteins and peptides into stable dried powder formulations: A review
The drying of biomolecules into powdered formulations has become the main form of long-
term product stabilisation, allowing for the delivery of safe and efficient medicines. Stability of …
term product stabilisation, allowing for the delivery of safe and efficient medicines. Stability of …
Scalable nanoprecipitation of niclosamide and in vivo demonstration of long-acting delivery after intramuscular injection
JJ Hobson, AC Savage, AB Dwyer, C Unsworth… - Nanoscale, 2021 - pubs.rsc.org
The control of COVID-19 across the world requires the formation of a range of interventions
including vaccines to elicit an immune response and immunomodulatory or antiviral …
including vaccines to elicit an immune response and immunomodulatory or antiviral …
Powder suspensions in non-aqueous vehicles for delivery of therapeutic proteins
C Marschall, M Witt, B Hauptmeier, W Friess - European Journal of …, 2021 - Elsevier
Formulating biopharmaceuticals is a challenging task due to their complex and sensitive
nature. Protein drugs are typically marketed either as an aqueous solution or as a …
nature. Protein drugs are typically marketed either as an aqueous solution or as a …