A Comparative Study Between Spray-Drying and Fluidized Bed Coating Processes for the Preparation of Pramipexole Controlled-Release Microparticles for Orally Disintegrating Tablets

Abstract

In the present study, controlled-release microparticles for orally disintegrating tablets (ODT) were prepared using two different processes, spray drying and fluidized bed coating processes. Pramipexole dihydrochloride monohydrate (PRM), an anti-Parkinson's disease agent, was selected as a model drug. The in vitro release rate and morphology of microparticles were evaluated and compared. The size of microparticles prepared by spray drying (SD microparticles) and fluidized bed coating (FC microparticles) was around 10 and 200 µm, respectively. The latter size was defined by the size of an inert core bead. The release behavior of SD microparticles was characterized by a large initial burst release prior to slow release. In the case of FC microparticles, the initial burst release was smaller than that of SD microparticles and the compression process damaged the release-controlling layer, which led to a change in release rate. The results indicated the importance of carefully considering the manufacturing process for microparticles during the design of controlled-release ODT.

Keywords:

• Coatings
• Fluidized bed drying
• Microparticles
• Pharmaceuticals
• Spray drying

Notes

^a The amount was determined as weight of granules (containing 3.0 mg of PRM) to be 150 mg.

^a The amount was marked as solids content.

^b The weight of ODT was determined to be 270 mg.

^a Not determined.

Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/ldrt.