Nifedipine preparations on the Belgian market: a comparative study.
Nifedipine preparations formulated as immediate-release capsules and prolonged-release tablets were evaluated with different tests, including in vitro dissolution, assay and content uniformity, and determination of related compounds. The analytical methods were previously validated according to international guidelines. All examined products complied with the postulated requirements but the dissolution test for prolonged-release tablets showed that these products cannot be interchanged.
De Braekeleer
K
K
Service de Contrôle des Médicaments APB, Bruxelles.
Fierens
C
C
Corthout
J
J
D001530:Belgium; D001682:Biological Availability; D002121:Calcium Channel Blockers / Q000008:administration & dosage* / Q000032:analysis; D002214:Capsules; D002851:Chromatography, High Pressure Liquid; D003692:Delayed-Action Preparations; D004363:Drug Utilization; D018565:Food-Drug Interactions; D009543:Nifedipine / Q000008:administration & dosage* / Q000032:analysis; D015203:Reproducibility of Results; D012995:Solubility; D013056:Spectrophotometry, Ultraviolet; D013607:Tablets
D002121:Calcium Channel Blockers; D002214:Capsules; D003692:Delayed-Action Preparations; D013607:Tablets; D009543:Nifedipine