Source:http://linkedlifedata.com/resource/pubmed/id/10518237
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Predicate | Object |
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
9
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pubmed:dateCreated |
1999-11-30
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pubmed:abstractText |
We developed a "pH-jump method" to obtain transparent solutions of E5531, a synthetic lipid A analog, at neutral pH for pharmaceutical injection. E5531 has two pKa: pKa1 = 6.0 and pKa2 = 9.3. At pH 11.0, E5531 was dispersed as a dissociated form, and the phase transition temperature Tc of E5531 was determined to be 30 degrees C using differential scanning calorimetry (DSC). Based on these results, the pH-jump method procedure involves dispersing E5531 at pH 11.0 (above pKa2) at 50 degrees C (above Tc) and mixing with a phosphate buffer to neutralize the pH. No degradated products of E5531 were observed at 50 degrees C for 3 hr during dispersing in the alkaline solution. The turbidity of samples prepared with the pH-jump method was similar to that of water and superior to the samples dispersed directly in neutral pH. This method does not need mechanical power and is suitable for large-scale production.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical | |
pubmed:status |
MEDLINE
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pubmed:month |
Sep
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pubmed:issn |
0363-9045
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pubmed:author | |
pubmed:issnType |
Print
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pubmed:volume |
25
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
975-82
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pubmed:dateRevised |
2004-11-17
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pubmed:meshHeading |
pubmed-meshheading:10518237-Calorimetry, Differential Scanning,
pubmed-meshheading:10518237-Chemistry, Pharmaceutical,
pubmed-meshheading:10518237-Drug Stability,
pubmed-meshheading:10518237-Humans,
pubmed-meshheading:10518237-Hydrogen-Ion Concentration,
pubmed-meshheading:10518237-Injections,
pubmed-meshheading:10518237-Lipid A,
pubmed-meshheading:10518237-Nephelometry and Turbidimetry,
pubmed-meshheading:10518237-Temperature
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pubmed:year |
1999
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pubmed:articleTitle |
Preparation of transparent injectable formulation for lipid A analog E5531.
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pubmed:affiliation |
Formulation Research Laboratory, Kawashima, Eisai Company, Limited, Gifu, Japan.
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pubmed:publicationType |
Journal Article
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