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Dissolution Chamber for Small Drug Delivery System in the Periodontal Pocket

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Abstract

Existing dissolution chambers have relatively large volume compared to the size of the periodontal pocket. A small volume dissolution method that simulates the physiological release environment for periodontal drug delivery is needed. The objectives were to construct a small, more physiologically relevant, dissolution chamber and investigate the properties of the new dissolution chamber for the assessment of sustained drug release systems in periodontal delivery. Flow-through dissolution chambers were constructed using three-dimensional (3D) printing. Drug release experiments were performed using the dissolution chamber and a commercially available long-acting periodontal insert product, PerioChip®. Similar experiments were performed under more traditional larger volume bulk solution conditions for comparison. Computer simulations and experimental results showed that drug clearance from the dissolution chamber was fast compared to drug release from the periodontal product. Drug clearance from the flow-through dissolution chamber and drug release from the sustained release product in the chamber were related to the dissolution medium flow rate and chamber volume. Drug release in the flow-through chamber was slower than that observed in bulk solution, but approached it when the medium flow rate increased. The presence of trypsin in the dissolution medium enhanced drug release from the product. A flow-through dissolution system was constructed that could evaluate drug release from a sustained release product in a small dimension environment by modifying the flow rate and composition of the dissolution medium.

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Acknowledgements

Funding for this project was made possible, in part, by the U.S. Food and Drug Administration (FDA) through a cooperative agreement (Research Award U01 FD005446). The views expressed in this paper do not reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government. The authors thank Yuchan Yuan, Dr. Phillip Simmers, and Dr. Jason Heikenfeld for their assistance in 3D printing, Sarah R. Li for her help in the preliminary study of Comsol modeling, and Dr. Yuan Zou and Dr. Ross Walenga for helpful discussion.

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This article reflects the views of the authors and should not be construed to represent the U.S. Food and Drug Administration’s views or policies.

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Authors and Affiliations

  1. Division of Pharmaceutical Sciences, James L Winkle College of Pharmacy, University of Cincinnati, 231 Albert Sabin Way, MSB # 3005, Cincinnati, Ohio, 45267-0514, USA

    Wei Ren, Michael Murawsky, Terri La Count, Apipa Wanasathop, Xin Hao, Gary R. Kelm & S. Kevin Li

  2. Office of Research and Standards, Office of Generic Drugs, U.S. Food and Drug Administration, Silver Spring, Maryland, 20993, USA

    Darby Kozak & Bin Qin

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  1. Wei Ren
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  2. Michael Murawsky
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  3. Terri La Count
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  4. Apipa Wanasathop
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  5. Xin Hao
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  6. Gary R. Kelm
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  7. Darby Kozak
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  8. Bin Qin
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  9. S. Kevin Li
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Correspondence to S. Kevin Li.

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Ren, W., Murawsky, M., La Count, T. et al. Dissolution Chamber for Small Drug Delivery System in the Periodontal Pocket. AAPS J 21, 51 (2019). https://doi.org/10.1208/s12248-019-0317-y

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