Mannitol is a crystallizing bulking agent in freeze-drying: with 4% mannitol and 1% sucrose, a cake of crystalline mannitol and amorphous sucrose allowed primary drying at -10 C where sucrose alone would have needed below -35 C.
established — replicated in humans, or settled by a regulator
every claim resolves to its source
All 2 citations resolve to their original source. · 0 posts naming it, 0 members counted once each.
Summary
Mannitol is a crystallizing bulking agent in freeze-drying: with 4% mannitol and 1% sucrose, a cake of crystalline mannitol and amorphous sucrose allowed primary drying at -10 C where sucrose alone would have needed below -35 C. · pmid:11948529
Mechanism
Formation of an unstable mannitol hydrate was avoided by secondary drying at 40 C or higher. · pmid:11948529
High protein concentration, a low relative mannitol content and annealing at -20 C were the factors that most promoted mannitol hemihydrate formation. · pmid:24239581
Proportion of the 2 claims about D-Mannitol standing at each tier. Community volume is shown on the Consensus tab beside this and is never averaged into it.
Living evidence history
2 resolved citations, oldest to newest, coloured by tier. Retractions and contradictions land here as they are recorded.
Structure
No structure representation on record. PepJunkie draws only what an authoritative record supplies; for a peptide that is the residue sequence, and none has been curated for D-Mannitol yet.
Dose evidence, rung by rung
A studied human dose exists on file. Open the rung: the dose is the paper's, in its context, never PepJunkie's.
Approved-label dose· a resolved regulatory document names a labelled dose
nothing resolved on this rung
Studied human doses· resolved human studies at the established tier
Mannitol-sucrose mixtures--versatile formulations for protein lyophilization. · pmid 11948529 · 2002
Observational evidence· resolved human data at the emerging tier: thin, or contested
nothing resolved on this rung
Community-reported protocols· protocol propositions from distinct members, counted once per human
nothing resolved on this rung
Preclinical evidence· resolved animal, cell or mechanistic work
Formation of mannitol hemihydrate in freeze-dried protein formulations--a design of experiment approach. · pmid 24239581 · 2014
2 resolved citations, 0 unresolved (an unresolved citation lends nothing). Community volume is its own rung and is never averaged into the evidence rungs.
Negative findings
failure is information
Nobody has filed a failure yet. Failures are information; this list is waiting for an honest one.