Applicability of two automated disintegration apparatuses for rapidly disintegrating (mini)tablets.
OBJECTIVE
Orally disintegrating (mini)tablets (OD(M)Ts) are of interest in the field of pharmaceutics. Their orodispersible character is defined by the disintegration time, which is measured with a basket apparatus according to the European Pharmacopoeia. This method, however, lacks applicability for ODTs and especially ODMTs. New disintegration apparatuses have been described in literature, but a qualification to assess the applicability has not been described. A qualification procedure for two automated disintegration apparatuses, OD-mate and Hermes apparatus, is introduced.


METHODS
Aspects of the operational qualification as well as precision and accuracy regarding a performance qualification were evaluated for both apparatuses analog to the ICH guideline Q2. While the OQ study is performed separately for each apparatus, accuracy and precision were performed following the same protocol for both testers.


RESULTS
Small RSDs (16.9% OD-mate; 15.2% Hermes compared to 32.3% for the pharmacopeial method) were found despite very fast disintegration times (1.5 s for both apparatuses). By comparing these RSDs to practical examples, the authors propose threshold values for repeatability depending on the mean disintegration time. Obtained results from the qualification were used to assess the applicability of both apparatuses.
a Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Duesseldorf , Duesseldorf , Germany.
Daniel
D
Sieber
a Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Duesseldorf , Duesseldorf , Germany.|b Department of Chemical and Pharmaceutical Sciences , University of Trieste , Trieste , Italy.
Alessia
A
Lazzari
a Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Duesseldorf , Duesseldorf , Germany.
Julian
J
Quodbach
a Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University Duesseldorf , Duesseldorf , Germany.
Miriam
M
Pein
D000284:Administration, Oral; D004339:Drug Compounding / Q000295:instrumentation*; D004867:Equipment Design; D006801:Humans; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry; D012995:Solubility; D013607:Tablets / Q000737:chemistry*
D004364:Pharmaceutical Preparations; D013607:Tablets
Disintegration; OD-mate; ODMT; minitablets; qualification procedure