Solvent/detergent treatment does not alter the tolerance or uptake of human normal immunoglobulin for intramuscular injection.
OBJECTIVE
The tolerability and pharmacokinetics of a solvent/detergent-treated intramuscular immunoglobulin were compared with those of the standard product.


METHODS
Single, 750-mg intramuscular (i.m.) injections were administered to a total of 36 healthy individuals: 23 in a double-blind trial and 13 in an open trial. Changes in specific serum hepatitis A and hepatitis B antibodies were monitored for a period of up to 3 months postinjection.


RESULTS
No serious adverse reactions were reported, and the bioavailability of the solvent/detergent-treated preparation was equivalent to that of the standard i.m. immunoglobulin.


CONCLUSIONS
There is no evidence that solvent/detergent treatment alters the pharmacokinetics or tolerance of human normal immunoglobulin, but it offers additional assurance against potential virus transmission.
Mould
G P
GP
Guildford Clinical Pharmacology Unit, Royal Surrey County Hospital, Guildford, Surrey, UK.
Sutton
J A
JA
Matejtschuk
P
P
Gascoigne
E W
EW
Dash
C H
CH
D000293:Adolescent; D000328:Adult; D000368:Aged; D019540:Area Under Curve; D001682:Biological Availability; D003902:Detergents / Q000494:pharmacology*; D004311:Double-Blind Method; D005260:Female; D035922:Hepatitis A Antibodies; D006508:Hepatitis Antibodies / Q000097:blood; D006510:Hepatitis B Antibodies / Q000097:blood; D006801:Humans; D007116:Immunization, Passive; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects / Q000187:drug effects / Q000302:isolation & purification* / Q000493:pharmacokinetics; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D010755:Organophosphates / Q000008:administration & dosage / Q000494:pharmacology; D012449:Safety; D012997:Solvents / Q000494:pharmacology*
D003902:Detergents; D035922:Hepatitis A Antibodies; D006508:Hepatitis Antibodies; D006510:Hepatitis B Antibodies; D016756:Immunoglobulins, Intravenous; D010755:Organophosphates; D012997:Solvents; C009524:tributyl phosphate