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Improved dissolution behaviour of steam-granulated piroxicam
Cristina Cavallari1, Beatrice Albertini, Marisa L González-Rodríguez
1Dipartimento di Scienze Farmaceutiche, Università di Bologna, Bologna, Italy. cavallar@biocfarm.unibo.it
Summary
Steam-aided granulation enhances Piroxicam release using beta-cyclodextrins. This method significantly reduces water and processing time compared to traditional wet granulation.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Piroxicam, a non-steroidal anti-inflammatory drug (NSAID), exhibits poor water solubility, limiting its therapeutic efficacy.
- Beta-cyclodextrins are widely used to enhance the solubility and dissolution rate of poorly soluble drugs.
- Optimizing granulation techniques is crucial for improving drug release profiles and manufacturing efficiency.
Purpose of the Study:
- To prepare and characterize improved release granulates of Piroxicam complexed with beta-cyclodextrins.
- To evaluate the efficacy of steam-aided granulation compared to conventional methods for Piroxicam-beta-cyclodextrin formulations.
- To assess the impact of steam-aided granulation on the physical properties and in vitro dissolution of Piroxicam.
Main Methods:
- Preparation of Piroxicam-beta-cyclodextrin (1:2.5 molar ratio) granulates using steam-aided granulation in a one-step rotogranulator (Rotolab).
- Comparative analysis with granulates prepared by traditional wet granulation, physical mixture, kneading, and dry granulation.
- Characterization using scanning electron microscopy (SEM), fractal analysis, porosity testing, differential scanning calorimetry (DSC), infrared (IR) spectroscopy, X-ray diffraction (XRD), and in vitro dissolution testing.
Main Results:
- Steam-aided granulation required 50% less water and significantly reduced working time compared to traditional wet granulation.
- SEM and fractal analysis indicated diffuse porosity in steam-granulated samples, correlating with porosity test results.
- DSC, IR, and XRD analyses confirmed the absence of drug polymorphs, ensuring solid-state stability.
- In vitro dissolution tests demonstrated an improved dissolution rate for Piroxicam from steam-aided granulated formulations.
Conclusions:
- Steam-aided granulation is an efficient method for preparing Piroxicam-beta-cyclodextrin granulates with enhanced properties.
- This technique offers significant advantages in terms of reduced water consumption and processing time.
- The improved in vitro dissolution rate suggests potential for enhanced therapeutic performance of Piroxicam formulations.