Abstract
Extrusion-spheronization and the fluid bed method are valuable commonly applied methods in microparticle production. However, the characteristics of resultants prepared by these two methods have seldom been compared. The aim of this study was to investigate differences in pharmaceutical properties and release kinetics of sustained-release ketoprofen microparticles prepared by different manufacturing processes. Microparticles prepared by extrusion-spheronization displayed slower release rate resulting in increased diffusion path of the drug, a behavior distinct for microparticles with less Surelease®. The effects of manufacturing method on release rate was also significant for microparticles with less Surelease®compared to microparticles with more Surelease®. The release profiles of coated microparticles fitted well to the Higuchi’s release model, but in cases of microparticles with larger Surelease® coating, the trend was towards a zero-order release model. These findings are valuable for comprehending the differences among different preparation processes and for choosing the optimal manufacturing method of sustained-release microparticles. Key words: Ketoprofen, microparticles, sustained drug delivery, extrusion-spheronization, fluid-bed, dissolution release kinetics.
Highlights
To improve efficiency and patient compliance, numerous oral sustained-release dosage forms are used in many therapeutic applications
Comparing the pharmaceutical characteristics of resulting sustained-release microparticles, the results showed variances between microparticles prepared by different methods
Due to the narrow size distribution and preferable flow behavior of core microparticles prepared by the fluid bed method, these microparticles
Summary
To improve efficiency and patient compliance, numerous oral sustained-release dosage forms are used in many therapeutic applications. Multiple-unit sustained-release dosage forms like microparticles are receiving greater attention due to advantages, such as flexibility during formulation development, that reduce batch-to-batch variability Bodea and Leucuta, 1997; Hamdani et al.,1996).Drug absorption is enhanced via increased surface area than single-unit dosage forms, reduced risk of side effects by decreased possibility of dose-dumping associated with single-unit sustained release tablets, and reduced peak plasma fluctuations resulting in more stable drug absorption (Follonier and Doelker, 1992). Extrusionspheronization and fluid bed method are the most commonly used techniques in micro-particulate drug delivery systems in the pharmaceutical industry because of advantages, which include convenience, reproducibility, and good control of process parameters
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