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Control of drug release kinetics from hot-melt extruded drug-loaded polycaprolactone matrices
Yun-Chu Chen1, Sota Shishikura1, Dana E Moseson1
1Department of Industrial and Physical Pharmacy, Purdue University, 575 Stadium Mall Drive, West Lafayette, IN 47907, USA.
Abstract:
Sustained local delivery of meloxicam by polymeric structures is desirable for preventing subacute inflammation and biofilm formation following tissue incision or injury. Our previous study demonstrated that meloxicam release from hot-melt extruded (HME) poly(ε-caprolactone) (PCL) matrices could be controlled by adjusting the drug content. Increasing drug content accelerated the drug release as the initial drug release generated a pore network to facilitate subsequent drug dissolution and diffusion. In this study, high-resolution micro-computed tomography (HR μCT) and artificial intelligence (AI) image analysis were used to visualize the microstructure of matrices and simulate the drug release process. The image analysis indicated that meloxicam release from the PCL matrix was primarily driven by diffusion but limited by the amount of infiltrating fluid when drug content was low (i.e., the connectivity of the drug/pore network was poor). Since the drug content is not easy to change when a product has a fixed dose and dimension/geometry, we sought an alternative approach to control the meloxicam release from the PCL matrices. Here, magnesium hydroxide (Mg(OH)2) was employed as a solid porogen in the drug-PCL matrix so that Mg(OH)2 dissolved with time in the aqueous environment creating additional pore networks to facilitate local dissolution and diffusion of meloxicam. PCL matrices were produced with a fixed 30 wt% meloxicam loading and variable Mg(OH)2 loadings from 20 wt% to 50 wt%. The meloxicam release increased in proportion to the Mg(OH)2 content, resulting in almost complete drug release in 14 d from the matrix with 50 wt% Mg(OH)2. The porogen addition is a simple strategy to tune drug release kinetics, applicable to other drug-eluting matrices with similar constraints.
Insights
Controlling meloxicam release from poly(ε-caprolactone) (PCL) matrices is key for local anti-inflammatory delivery. Adding magnesium hydroxide (Mg(OH)2) as a porogen effectively tuned drug release kinetics in PCL matrices.
Area of Science:
- Biomaterials Science
- Drug Delivery Systems
- Materials Engineering
Background:
- Sustained local delivery of meloxicam from polymeric structures is crucial for preventing post-injury inflammation and biofilm formation.
- Previous work showed drug content influences meloxicam release from poly(ε-caprolactone) (PCL) matrices, with higher content accelerating release via pore network formation.
- Drug release from PCL matrices is diffusion-driven but can be limited by fluid infiltration and poor pore connectivity at low drug concentrations.
Purpose of the Study:
- To investigate an alternative method for controlling meloxicam release from PCL matrices, independent of drug loading.
- To evaluate the efficacy of magnesium hydroxide (Mg(OH)2) as a solid porogen to enhance meloxicam release kinetics.
- To optimize Mg(OH)2 content for predictable and sustained meloxicam delivery.
Main Methods:
- Fabrication of PCL matrices containing fixed 30 wt% meloxicam and variable Mg(OH)2 loadings (20-50 wt%) using hot-melt extrusion.
- Utilized high-resolution micro-computed tomography (HR μCT) for visualizing matrix microstructure.
- Employed artificial intelligence (AI) image analysis to simulate and understand meloxicam release mechanisms.
Main Results:
- Meloxicam release rate was directly proportional to the Mg(OH)2 content in the PCL matrices.
- Matrices with 50 wt% Mg(OH)2 achieved nearly complete meloxicam release within 14 days.
- Mg(OH)2 addition created additional pore networks, facilitating drug dissolution and diffusion.
Conclusions:
- Magnesium hydroxide serves as an effective porogen to control and enhance meloxicam release from PCL matrices.
- This porogen addition strategy offers a simple and versatile method for tuning drug release kinetics in drug-eluting devices.
- The approach is applicable to other drug-eluting matrices facing similar drug release control challenges.
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