Butyl-p-aminobenzoate. Preparation, characterization and quality control of a suspension injection for epidural analgesia.
The conditions for the preparation of a 10% butyl-p-aminobenzoate suspension for epidural administration were investigated. Pharmaceutically acceptable suspensions are composed of butyl-p-aminobenzoate particles dispersed in a solvent consisting of the surfactant polysorbate 80 added to normal saline in a concentration of 0.25 mg/ml. pH Correction is not necessary. The suspensions are sterilized at 120 degrees C followed by special milling procedures to accomplish acceptable particle size. Butyl-p-aminobenzoate suspensions are stable at 4 degrees C during a period of at least four weeks.
Grouls
R J
RJ
Hospital Pharmacy, Catharina Hospital, Eindhoven, The Netherlands.
Ackerman
E W
EW
Machielsen
E J
EJ
Korsten
H H
HH
D000700:Analgesics; D001566:Benzocaine / Q000031:analogs & derivatives*; D004355:Drug Stability; D006863:Hydrogen-Ion Concentration; D007268:Injections, Epidural; D010316:Particle Size; D011092:Polyethylene Glycols; D011136:Polysorbates; D011786:Quality Control; D013535:Suspensions
D000700:Analgesics; D011136:Polysorbates; D013535:Suspensions; D011092:Polyethylene Glycols; C004605:butamben; D001566:Benzocaine