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Floating dosage forms: an in vivo study demonstrating prolonged gastric retention
L Whitehead1, J T Fell, J H Collett
1Department of Pharmacy and Pharmaceutical Sciences, University of Manchester, Manchester M13 9PL, UK.
Summary
This study shows that freeze-dried calcium alginate floating dosage forms (FDFs) significantly prolong gastric residence time (GRT) in fed humans. These FDFs offer potential for sustained drug delivery, unlike non-floating forms.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Biomedical Engineering
Background:
- Gastroretentive dosage forms enhance drug delivery by increasing gastric residence time (GRT).
- Floating dosage forms (FDFs) are a strategy to prolong GRT, enabling sustained drug release for local or systemic effects.
- Multiple-unit FDFs overcome the limitations of single-unit systems, offering more predictable gastric emptying.
Purpose of the Study:
- To evaluate the in vivo performance of a novel freeze-dried calcium alginate multiple-unit FDF.
- To compare the gastric transit of the FDF with a non-floating multiple-unit dosage form in healthy volunteers.
Main Methods:
- Development of a freeze-dried calcium alginate multiple-unit FDF.
- Radiolabelling of FDFs and non-floating formulations for tracking.
- In vivo gamma-scintigraphy in seven healthy volunteers following a standard breakfast.
Main Results:
- The developed FDF achieved prolonged GRTs exceeding 5.5 hours in all subjects.
- Floating formulations remained in the upper stomach throughout the study period.
- Non-floating dosage forms exhibited rapid gastric emptying, with a mean onset of 1 hour.
Conclusions:
- The freeze-dried calcium alginate FDF demonstrates significant potential for sustained drug delivery in the fed state.
- This system offers a viable approach for both local gastric and systemic drug administration.
- The FDF's prolonged GRT supports its application in controlled-release drug delivery systems.