Abstract
Purpose
Jellies for oral administration can be ingested whole or chewed, which can affect drug dissolution and absorption. In this study, we aimed to evaluate the effect of ingestion methods on drug absorption using a stick-type jelly containing a fixed-dose combination (FDC) of four drugs.
Methods
A stick-type jelly containing a FDC of four drugs was prepared and administered as a whole or in pre-disintegrated form to beagle dogs. The jellies were fabricated using xanthan gum, carrageenan, locust bean gum containing acetaminophen (AAP), chlorpheniramine maleate (CPM), dextromethorphan hydrobromide (DMH), and dl-methylephedrine hydrochloride (MEH).
Results
The early-phase dissolution rates at pH 1.2 were significantly higher in the pre-disintegrated form than in the whole jelly form, whereas no differences were observed after 45 min with dissolution rate of more than 90%. For AAP and CPM, areas under the time-concentration curve (AUCs) did not significantly change by the ingestion method. On the contrary, for DMH and MEH, AUCs in the whole jelly form increased by 1.24- and 1.46-fold, respectively, compared to those in the pre-disintegrated form, suggesting that the initial slower dissolution rate was favorable for absorption.
Conclusion
The effect of the degree of pre-disintegration of jellies on drug absorption was dependent on the type of drug used. Collectively, the FDC jelly can be an alternative dosage form to improve the drug acceptability in pediatric and geriatric patients.
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Acknowledgements
This research was funded by the Chong Kun Dang Pharm. Co. and in part by the National Research Foundation of Korea (NRF) funded by the Ministry of Science and ICT (2019R1A2C1006524 to Mi-Kyung Lee).
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Mi-Kyung Lee received research grants from the CKD Pharm. Kyung Hee Han and Joong-Won Jeon are researchers at CKD Pharm. The funders had no role in the study design; in the collection, analyses, or interpretation of data; in the writing of the manuscript; or in the decision to publish the results.
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The study was conducted in accordance with the guidelines of the Declaration of Helsinki and approved by the Institutional Review Board of CKD Pharm (study number 03010-19001).
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Han, K.H., Jeon, JW., Chae, YJ. et al. Effect of ingestion methods of jellies for oral administration on drug absorption in beagle dogs. J. Pharm. Investig. 51, 587–595 (2021). https://doi.org/10.1007/s40005-021-00535-x
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DOI: https://doi.org/10.1007/s40005-021-00535-x