Development of a New Dissolution Test Method for Soft Chewable Dosage Forms.
Soft chewable dosage forms are a new approach to improve the compliance of medication for special patient populations. Based on their texture, they are chewed several times before they get swallowed. A suitable dissolution method based on in vivo chewing data was developed. The method covers parts of dissolution within the oral cavity (simulation of chewing) as well as the dissolution of the swallowed bolus within the gastrointestinal tract. Chewing was simulated by the help of a steel tooth assembled to a texture analyzer and wedge gliding on an inclined plane, imitating the occlusal glide. Chewing cycles of non-brittle, elastically deformable foods were predicted by a multiple linear regression (Radj= 0.985) using hardness, stickiness, fat/water content, and softening behavior as independent variables. Cross-validation of three sets of chewing data led to a root mean square error of prediction of 0.408 or 0.658 chewing cycles, respectively. The new method is able to distinguish between different soft chewable formulations which had been approved as similar by the dissolution method of the European Pharmacopoeia. Furthermore, it provides information about the drug content released within the time of chewing (7-15%).
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstr. 1, 40225, Düsseldorf, Germany.
Carmen
C
Stomberg
Bayer Animal Health GmbH, Monheim, Germany.
Venkata-Rangarao
VR
Kanikanti
Bayer Animal Health GmbH, Monheim, Germany.
Hans-Jürgen
HJ
Hamann
Institute of Pharmaceutics and Biopharmaceutics, Heinrich Heine University, Universitätsstr. 1, 40225, Düsseldorf, Germany. Kleinebudde@hhu.de.
Peter
P
Kleinebudde
D000284:Administration, Oral; D000328:Adult; D005260:Female; D005502:Food; D006244:Hardness; D006801:Humans; D008297:Male; D008409:Mastication; D008875:Middle Aged; D012995:Solubility; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods; D055815:Young Adult
D013607:Tablets
dissolution test; soft chewable; texture analysis