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Published on: March 2, 2011
Study of compression effect on testosterone tablets.
Loise Silveira da Silva1,2, Izabelle de Mello Gindri3, Maria Johann Fensterseifer1,2
1Biomechanical Engineering Laboratory, LEBm, University Hospital & Department of Mechanical Engineering, Federal University of Santa Catarina (UFSC), Florianópolis, Santa Catarina, Brazil.
This study analyzed testosterone tablet properties under different compression loads. High loads caused tablet defects, but dissolution was minimally affected by load or additives, highlighting manufacturing process importance.
Area of Science:
- Pharmaceutical Technology
- Materials Science
Background:
- Testosterone implants erode over 4-5 months for drug absorption.
- Testosterone exists in anhydrous and hydrated polymorphic forms.
- Compression may alter API polymorphic forms, impacting dissolution.
Purpose of the Study:
- Analyze physicochemical properties and dissolution of testosterone tablets.
- Evaluate the impact of compression load (2 vs. 15 tons) and additives.
- Assess compression-induced polymorphic changes in testosterone.
Main Methods:
- Tablet manufacturing via compression molding.
- Analysis using Differential Scanning Calorimetry (DSC), X-ray Diffraction (XRD), Scanning Electron Microscopy (SEM), and Fourier-Transform Infrared Spectroscopy (FTIR).
- Drug dissolution testing.
Main Results:
- 15-ton compression load resulted in fragile tablets with defects (lamination, cracks).
- DSC and FTIR indicated structural water presence; XRD confirmed anhydrous form.
- Dissolution was only slightly influenced by compression load and additives.
Conclusions:
- Compression load significantly impacts tablet physical integrity.
- Polymorphic form remained largely anhydrous despite compression.
- Compression load and additives have minor effects on testosterone tablet dissolution profiles.
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