ArticleThe AAPS journal2025
Formulation Factors Affecting the Formation of Visible-Bubbles During the Reconstitution Process of Freeze-Dried Etanercept Formulations: Protein Concentration, Stabilizers, and Surfactants.
Article in The AAPS journal, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Freeze drying is one of the common methods to extend the long-term stability of biologicals. Biological products in solid form have the advantages of convenient transportation and stable long-term storage. However, long reconstitution time and extensive visible bubbles are frequently generated during the reconstitution process for many freeze-dried protein formulations, which can potentially affect the management efficiency of staff, patient compliance, and product quality. The reconstitution time has been extensively studied, but the influence of the formulations on the formation of visible bubbles is often overlooked. This paper investigated the effect of freeze-drying formulation factors (i.e., protein concentrations, surfactant concentrations, and sucrose/mannitol compositions) on product stability and visible bubbles generated during reconstitution of freeze-dried etanercept formulations. The generating and breakup mechanisms of visible bubbles were detected via internal microstructure of cake, surface tension, and viscosity measurement. Under the same protein concentration, the formulation of mannitol mixed with sucrose in a weight ratio of 4:1 produces fewer visible bubbles during the reconstitution process compared to the formulation of sucrose with the same total mass. This has been proven to be due to the large number of smaller radius pores distributed in the pores of the freeze-dried cake of the former, while the average internal structure pores of the latter are much larger than those of the former. As an amorphous stabilizer, sucrose can ensure the long-term stability of protein and greatly reduce the generation and maintenance of foams in the reconstitution process, making it a more robust excipient for freeze-dried protein formulations.
Indexed as
Identifiers
39825117What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.