Switch to
Predicate | Object |
---|---|
rdf:type | |
lifeskim:mentions | |
pubmed:issue |
3
|
pubmed:dateCreated |
1990-10-12
|
pubmed:abstractText |
The development and characterization of a lyophilized dosage form for recombinant Interleukin-1 beta is described. Included in the evaluation of the drug product are accelerated and long-term stability studies utilizing a number of biophysical techniques (reverse-phase HPLC, SDS-PAGE, isoelectric focusing and ELISA). Data collected with these methods were examined for correlations with biological activity assessments provided by an in-vitro cell culture system (mouse thymocyte proliferation). Results of these studies demonstrate that a lyophilized dosage form of Interleukin-1 beta can be prepared which retains its potency for at least 1 year when stored at ambient temperature. The analytical methodology used to assess the physicochemical integrity of the protein provided a sensitive and reproducible means of predicting changes in biological activity.
|
pubmed:language |
eng
|
pubmed:journal | |
pubmed:citationSubset |
IM
|
pubmed:chemical | |
pubmed:status |
MEDLINE
|
pubmed:issn |
0277-6766
|
pubmed:author | |
pubmed:issnType |
Print
|
pubmed:volume |
9
|
pubmed:owner |
NLM
|
pubmed:authorsComplete |
N
|
pubmed:pagination |
425-34
|
pubmed:dateRevised |
2006-11-15
|
pubmed:meshHeading |
pubmed-meshheading:2398744-Animals,
pubmed-meshheading:2398744-Biological Assay,
pubmed-meshheading:2398744-Dosage Forms,
pubmed-meshheading:2398744-Drug Stability,
pubmed-meshheading:2398744-Freeze Drying,
pubmed-meshheading:2398744-Injections, Intravenous,
pubmed-meshheading:2398744-Interleukin-1,
pubmed-meshheading:2398744-Lymphocyte Activation,
pubmed-meshheading:2398744-Mice,
pubmed-meshheading:2398744-T-Lymphocytes,
pubmed-meshheading:2398744-Temperature
|
pubmed:year |
1990
|
pubmed:articleTitle |
Development and characterization of a lyophilized dosage form of IL-1 beta.
|
pubmed:affiliation |
Institute of Pharmaceutical Sciences, Syntex Research, Palo Alto, Ca.
|
pubmed:publicationType |
Journal Article,
In Vitro
|