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CapsMorph® technology for oral delivery--theory, preparation and characterization.
Qionghua Wei1, Cornelia M Keck2, Rainer H Müller1
1Institute of Pharmacy, Department of Pharmaceutics, Biopharmaceutics & NutriCosmetics, Freie Universität Berlin, Kelchstr. 31, 12169 Berlin, Germany.
International Journal of Pharmaceutics
|December 3, 2014
Summary
Capsules prepared using CapsMorph® technology enhance oral drug delivery by encapsulating amorphous drugs into porous materials, significantly improving solubility and dissolution rates for poorly soluble compounds like hesperidin.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Materials Science
Background:
- Poorly soluble drugs often exhibit low oral bioavailability.
- Developing effective oral formulations for such drugs remains a significant challenge in pharmaceutical research.
- Amorphous solid dispersions are a common strategy to enhance solubility and dissolution.
Purpose of the Study:
- To evaluate the CapsMorph® technology for preparing amorphous hesperidin formulations.
- To compare the oral bioavailability properties of CapsMorph® formulations with raw hesperidin powder and nanocrystals.
- To assess the impact of formulation variables on drug solubility and release.
Main Methods:
- Hesperidin was loaded onto AEROPERL® 300 Pharma using wetness impregnation with dimethyl sulfoxide (DMSO), with and without Tween 80.
- Amorphous state was confirmed using X-ray diffraction and differential scanning calorimetry.
- Saturation solubility and in vitro dissolution rates were measured and compared to controls.
Main Results:
- CapsMorph® formulations achieved approximately 30% hesperidin loading in an amorphous state.
- Saturation solubility of CapsMorph® (654 μg/ml) was 36-fold higher than raw hesperidin powder (18 μg/ml) and 20-fold higher than nanocrystals (30 μg/ml).
- In vitro release from CapsMorph® was rapid (100% in 10 min at pH 6.8), significantly exceeding that of nanocrystals (15%).
Conclusions:
- CapsMorph® technology effectively prepares amorphous drug formulations with enhanced solubility and dissolution rates.
- Porous materials loaded with amorphous drugs show superior performance for oral delivery compared to nanocrystals for poorly soluble drugs.
- Tween 80 addition modulated solubility and release, extending supersaturation duration.
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