(1993; 36 pages)
2.2. Dissolution test for solid oral dosage forms: paddle method
It was agreed that, since the paddle method had been recommended for inclusion in The international pharmacopoeia (2), it would be helpful to supplement the description of the method (which has been harmonized with that already published in other pharmacopoeias) with additional information, especially on validation. Consultation on a draft text incorporating such information was recommended before finalization for publication in The international pharmacopoeia. Inclusion of other methods might be considered in the future if needed for a particular application.
Meanwhile, publication of the paddle method would permit establishment of dissolution requirements for those preparations included in the WHO Model List of Essential Drugs (1) that had been singled out previously (2) as being of particularly high priority since they were widely considered to present bioavailability problems.1 It was agreed that the test conditions and the criteria for the acceptance of these preparations would be specified in the relevant monographs. The conditions and criteria would initially be based on existing pharmacopoeial specifications.
1 Ampicillin, chloroquine, digoxin, erythromycin, furosemide, griseofulvin, isoniazid, levodopa, mebendazole, metronidazole, phenoxymethylpenicillin, phenytoin, tetracycline, tolbutamide.