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Film Coatings Based on Aqueous Shellac Ammonium Salt "Swanlac® ASL 10" and Inulin for Colon Targeting.
AAPS Pharmscitech
|October 3, 2023
Summary
This study developed novel ethylcellulose and shellac films for colon-targeted drug delivery. Formulations with inulin demonstrated promising prolonged drug release in the colon, protecting theophylline in the upper gastrointestinal tract.
Area of Science:
- Pharmaceutical Sciences
- Biomaterials Science
- Drug Delivery Systems
Background:
- Colon targeting offers advantages for treating intestinal diseases and delivering sensitive biologics like proteins and vaccines due to reduced enzymatic activity.
- Current strategies for colonic drug delivery involve various biomaterials and formulation approaches.
- Ethylcellulose and shellac are explored as key components for developing advanced drug delivery systems.
Purpose of the Study:
- To evaluate ethylcellulose and shellac blends as film coatings for colon-specific drug delivery.
- To investigate the impact of varying blend ratios and the addition of inulin on drug release profiles.
- To assess the potential of these formulations for protecting drugs in the upper gastrointestinal tract and enabling sustained release in the colon.
Main Methods:
- Formulation of thin films and coated mini-tablets using ethylcellulose and shellac ammonium salt at different ratios (80:20, 75:25, 60:40).
- Inclusion of the natural polysaccharide inulin to enhance colonic targeting.
- In vitro drug release studies simulating gastric (0.1 M HCl) and intestinal (PBS pH 6.8) conditions.
- Exposure of coated mini-tablets to human fecal samples to mimic colonic environment.
Main Results:
- Several formulations successfully protected theophylline (model drug) for up to 8 hours in simulated upper gastrointestinal conditions.
- Prolonged drug release kinetics were observed specifically within the colonic environment.
- The addition of inulin significantly influenced and improved the colonic release profiles.
Conclusions:
- Ethylcellulose and shellac blends are effective biomaterials for creating colon-targeted drug delivery systems.
- The incorporation of inulin is a key factor in achieving desired prolonged release in the colon.
- These advanced formulations hold significant potential for oral delivery of therapeutics requiring colonic targeting.
