3D-Printed Gastroretentive Sustained Release Drug Delivery System by Applying Design of Experiment Approach.

Hyeon Myeong Jeong,Soyoung Shin,Beom Soo Shin,Kwon-Yeon Weon

doi:10.3390/molecules25102330

Hyeon Myeong Jeong, Soyoung Shin + Show 2 more

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https://doi.org/10.3390/molecules25102330

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Abstract

This study aimed to develop a novel oral drug delivery system for gastroretentive sustained drug release by using a capsular device. A capsular device that can control drug release rates from the inner immediate release (IR) tablet while floating in the gastric fluid was fabricated and printed by a fused deposition modeling 3D printer. A commercial IR tablet of baclofen was inserted into the capsular device. The structure of the capsular device was optimized by applying a design of experiment approach to achieve sustained release of a drug while maintaining sufficient buoyancy. The 2-level factorial design was used to identify the optimal sustained release with three control factors: size, number, and height of drug-releasing holes of the capsular device. The drug delivery system was buoyant for more than 24 h and the average time to reach 80% dissolution (T80) was 1.7–6.7 h by varying the control factors. The effects of the different control factors on the response factor, T80, were predicted by using the equation of best fit. Finally, drug delivery systems with predetermined release rates were prepared with a mean prediction error ≤ 15.3%. This approach holds great promise to develop various controlled release drug delivery systems.

Highlights

Solid oral dosage forms such as tablets and capsules are the most preferred drug formulations in the current market
Drug delivery systems with predetermined release rates were prepared with a mean prediction error ≤ 15.3%
The popularity of oral dosage forms is associated with its advantages of an accurate unit dose, stability, ease of handling, and high patient compliance compared to other drug formulations

Summary

Introduction

Solid oral dosage forms such as tablets and capsules are the most preferred drug formulations in the current market. The popularity of oral dosage forms is associated with its advantages of an accurate unit dose, stability, ease of handling, and high patient compliance compared to other drug formulations. Traditional immediate release (IR) oral formulations present high peak-to-trough fluctuations and need frequent doses, i.e., administrations several times a day to maintain the therapeutic concentration. They often lead to extend the periods of toxicity or ineffectiveness, and discourage patient compliance. Sustained release (SR) oral drug delivery systems are intended to achieve stable plasma drug concentrations within the desired range for an extended period of time [1], thereby overcoming the limitations of conventional IR formulations. The ideal drug delivery system for SR formulations should be inert, biocompatible, mechanically robust, Molecules 2020, 25, 2330; doi:10.3390/molecules25102330 www.mdpi.com/journal/molecules

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