Influence of basket mesh size on the hydrodynamics in the USP rotating basket dissolution testing Apparatus 1
Document Type
Article
Publication Date
9-25-2021
Abstract
The USP Apparatus 1 (rotating basket), typically used to assess drug product reproducibility and evaluate oral solid dosage forms performance, consists of a cylindrical glass vessel with a hemispherical bottom and a wire basket rotating at constant speed. Baskets with different wire openings can be used in alternative to the standard mesh opening (40-mesh) in order to discriminate between drug formulations during early stage of drug product development. Any changes introduced by different basket geometries can potentially and significantly impact the system hydrodynamics and cause variability of results, thus affecting product quality. In this work, Particle Image Velocimetry (PIV) was used to experimentally quantify the velocity distribution in the USP rotating basket Apparatus 1 using baskets of different mesh sizes (10-, 20-, and 40-mesh size) under the typical operating conditions described in dissolution testing procedures. Similar flow patterns were observed in all cases. However, the radial and axial velocities in the USP Apparatus 1 generally increased with increasingly larger openings of the basket mesh. Increasing the basket agitation speed also resulted in an overall increase in the velocities, especially below in the innermost core region below the basket, where drug fragments typically reside. More importantly, the flow entering and leaving the baskets was quantified from the velocity profiles in the immediate vicinity of the baskets. It was found that the flow increased significantly with increasingly larger mesh openings, which can, in turn, promote faster dissolution of the oral solid dosage forms, thus affecting drug dissolution profiles. Hence, the selection of the basket mesh size must be carefully considered during drug product development.
Identifier
85112365876 (Scopus)
Publication Title
International Journal of Pharmaceutics
External Full Text Location
https://doi.org/10.1016/j.ijpharm.2021.120976
e-ISSN
18733476
ISSN
03785173
PubMed ID
34363918
Volume
607
Fund Ref
Merck
Recommended Citation
Sirasitthichoke, Chadakarn; Patel, Sanjaykumar; Reuter, Kevin G.; Hermans, Andre; Bredael, Gerard; and Armenante, Piero M., "Influence of basket mesh size on the hydrodynamics in the USP rotating basket dissolution testing Apparatus 1" (2021). Faculty Publications. 3807.
https://digitalcommons.njit.edu/fac_pubs/3807
