[Formulation and stability study of sucred solutions for a clinical trial in neonates].
A randomized, double blind clinical trial have been initiated in the neonatology unit of CHRU in Lille to compare the analgesic effect of two oral solutions (25% dextrose and 30% glucose) after heel prick sampling. As part of this trial, the pharmacy was asked to perform the preparation and the randomization. In agreement with good clinical practices and good manufacturing practices, we have valided manufacturing processes, and performed microbiological tests, chromatography control and polarimetric dosage. The stability study of solutions (six months), allows preparation of only one batch in accordance with good manufacturing practice for 25% sucrose and 30% glucose. The participation of hospital pharmacist in the preparation of investigational products is becoming more and more frequent. This enhances his involvement in the quality control of clinical trials.
Senis-Loiseau
C
C
Pharmacie centrale, CHRU de Lille, 2, rue Philippe Marache, F 59037 Lille Cedex.
Vaillant
C
C
Markiewicz-Massy
A
A
Torck
M
M
Thielmans
B
B
D002626:Chemistry, Pharmaceutical; D004311:Double-Blind Method; D004339:Drug Compounding; D004340:Drug Contamination / Q000517:prevention & control; D004355:Drug Stability; D005947:Glucose / Q000008:administration & dosage* / Q000737:chemistry; D006801:Humans; D007231:Infant, Newborn; D019999:Pharmaceutical Solutions; D010607:Pharmacy Service, Hospital; D011786:Quality Control; D013395:Sucrose / Q000008:administration & dosage* / Q000737:chemistry
D019999:Pharmaceutical Solutions; D013395:Sucrose; D005947:Glucose