WHO Expert Committee on Specifications for Pharmaceutical Preparations - WHO Technical Report Series, No. 834 - Thirty-third Report
(1993; 36 pages) View the PDF document
Table of Contents
View the documentWHO Expert Committee on Specifications for Pharmaceutical Preparations
View the document1. Introduction
Close this folder2. The international pharmacopoeia and related activities
View the document2.1. Quality specifications for drug substances and dosage forms
View the document2.2. Dissolution test for solid oral dosage forms: paddle method
View the document2.3. Therapeutic equivalence of multisource products
View the document2.4. International nonproprietary names for pharmaceutical substances
Open this folder and view contents3. International Chemical Reference Substances and International Infrared Reference Spectra
View the document4. Quality control methods for medicinal plant materials
View the document5. The WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce
Open this folder and view contents6. Good manufacturing practices for pharmaceutical products
View the document7. Development of globally acceptable standards for excipients
Open this folder and view contents8. Stability of dosage forms
View the document9. Simple test methodology
View the document10. Quality assurance in pharmaceutical supply systems
Open this folder and view contents11. Pharmaceutical production in developing countries
View the document12. Training
View the documentAcknowledgements
View the documentReferences
View the documentAnnex 1 - List of available International Chemical Reference Substances1
View the documentAnnex 2 - List of available International Infrared Reference Spectra
Open this folder and view contentsAnnex 3 - Good manufacturing practices for biological products1
View the documentBack Cover
 

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.

 

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