The Glatt CPS® Technology (Complex Perfect Spheres) is a fluid bed rotor technology for producing spherical matrix pellets with a smooth surface and high density. Typically, microcrystalline cellulose is used as a basic excipient for pelletization using the CPS® Technology [1]. In the past extensive studies using soluble APIs (active pharmaceutical ingredient) as Metoprolol succinate [2] and Propranolol hydrochloride [3] were performed. During this study matrix pellets containing an insoluble API shall be developed whereby a high drug load was envisaged (not less than 50 %). Furthermore, the particles shall be as spherical as possible, and the D90 value of the particle size distribution should not exceed 400 μm.

CONCLUSION

By using the Glatt CPS®-Technology it was possible to develop spherical pellets using a water-insoluble API with a high drug load and the targeted particle size distribution. The pellets showed a spherical shape and smooth surface and the reproducibility of the process was demonstrated.

Contrary to former studies [2, 3] the CPS® Technology was used as a stand-alone unit without pre-mixing of the powders in a high-shear granulator and drying using a fluidbed unit. Nonetheless, the pellets were built and dried within short process times. Data obtained are a profound basis for further studies using APIs with different physicochemical characteristics such as solubility and particle size distribution.

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