Drug-beta-cyclodextrin containing pellets prepared with a high-shear mixer

Area of Science:

• Pharmaceutical Technology
• Materials Science

Background:

• Beta-cyclodextrin (BCD) and microcrystalline cellulose (MCC) are widely used excipients in drug formulation.
• Developing efficient methods for preparing drug-loaded pellets is crucial for controlled drug delivery.

Purpose of the Study:

• To investigate the preparation of BCD-MCC pellets using a high-shear mixer.
• To evaluate two drug-loading techniques: solution layering and powder layering, with ibuprofen as a model drug.
• To characterize the physical and biopharmaceutical properties of the prepared pellets.

Main Methods:

• High-shear mixing for pellet preparation.
• Drug loading via solution or powder layering.
• Characterization using size distribution, shape factor, friability, and dissolution rate analysis.
• Analysis of drug-excipient interaction using Differential Scanning Calorimetry (DSC) and component distribution using Micro Fourier Transform Infrared spectroscopy (MicroFTIR).

Main Results:

• Pellets with narrow size distribution and up to 90% BCD content were successfully prepared using water as a binder.
• Process yields were approximately 84% for drug-free pellets and 63% for drug-loaded pellets.
• Solution layering resulted in pellets with high drug content, reduced friability, and enhanced dissolution rates compared to powder layering.

Conclusions:

• Drug-loaded BCD-MCC pellets with desirable technological and biopharmaceutical properties can be produced using high-shear mixing.
• Solution layering is a more effective technique for achieving high drug loading, improved physical characteristics, and faster drug release.