Dissolution testing of orally disintegrating tablets.
For industrially manufactured pharmaceutical dosage forms, product quality tests and performance tests are required to ascertain the quality of the final product. Current compendial requirements specify a disintegration and/or a dissolution test to check the quality of oral solid dosage forms. These requirements led to a number of compendial monographs for individual products and, at times, the results obtained may not be reflective of the dosage form performance. Although a general product performance test is desirable for orally disintegrating tablets (ODTs), the complexity of the release controlling mechanisms and short time-frame of release make such tests difficult to establish. For conventional oral solid dosage forms (COSDFs), disintegration is often considered to be the prerequisite for subsequent dissolution. Hence, disintegration testing is usually insufficient to judge product performance of COSDFs. Given the very fast disintegration of ODTs, the relationship between disintegration and dissolution is worthy of closer scrutiny. This article reviews the current status of dissolution testing of ODTs to establish the product quality standards. Based on experimental results, it appears that it may be feasible to rely on the dissolution test without a need for disintegration studies for selected ODTs on the market.
PHAST GmbH, Homburg, Germany. jkraemer@phast.de
Johannes
J
Kraemer
Jayachandar
J
Gajendran
Alexis
A
Guillot
Julian
J
Schichtel
Akif
A
Tuereli
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage*; D011786:Quality Control; D012995:Solubility; D013607:Tablets / Q000737:chemistry* / Q000592:standards
D004364:Pharmaceutical Preparations; D013607:Tablets