BOX-BEHNKEN OPTIMIZATION OF MELOXICAM MICROCAPSULE SCAFFOLDS FOR PRECISION DRUG DELIVERY IN ARTHRITIS: ENHANCED STABILITY, EFFECTIVE STERILIZATION, AND IN VIVO THERAPEUTIC POTENTIAL

SAMPATH KUMAR; MOTHILAL MOHAN

doi:10.22159/ijap.2025v17i1.52160

Authors

SAMPATH KUMAR Department of Pharmaceutics, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Tamil Nadu, India https://orcid.org/0000-0001-5960-3912
MOTHILAL MOHAN Department of Pharmaceutics, SRM College of Pharmacy, SRM Institute of Science and Technology, Kattankulathur-603203, Tamil Nadu, India https://orcid.org/0000-0003-0451-2890

DOI:

https://doi.org/10.22159/ijap.2025v17i1.52160

Keywords:

Entrapment, Implants, Microspheres, Meloxicam, Expulsion, Scaffolds

Abstract

Objective: This study aims to develop and evaluate an innovative implantable drug delivery system using gelatin microspheres loaded with Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) namely meloxicam (MXM), integrated into a gelatin scaffold. This system is designed to enhance drug delivery efficiency and sustain drug release.

Methods: MXM-loaded microspheres with a 1:1 ratio of Poly Lactic Acid (PLA) and Poly Lacto Glycolic Acid (PLGA) were optimized for size, yield, efficiency, and release. Gelatin scaffolds were designed as rod-shaped implants, tested for stability and degradation in pH 7.4 and pH 4.0 buffers at 37°C for 100 days, and sterilized with γ-radiation. Implants were evaluated in rabbits, with blood samples analyzed via High-Performance Liquid Chromatography (HPLC) for pharmacokinetic parameters statistically analyzed (P<0.05).

Results: The microspheres with a 1:1 ratio of PLA and PLGA demonstrated favorable characteristics such as smaller particle sizes, high yield, and efficient drug entrapment and release. Optimization using Design Expert resulted in highly desirable scaffolds, evidenced by a desirability factor close to one across all assessed variables. The scaffolds exhibited robust physicochemical properties, including sustained drug release over an extended period, highlighting their potential for diverse biomedical applications. Implants showed greater stability in pH 7.4 buffer solutions in contrast to pH 4.0 over 100 days, with higher mass loss in acidic environments (14.4% vs. 9.66%). γ-Radiation sterilization effectively prevented microbial contamination. In vivo studies confirmed MXM detection in plasma, with Scaffold-MXM microspheres (iS-MMS-17) (optimized implantable scaffold) showing higher mean C_max values and significant Area Under Curve (AUC) parameters, suggesting its potential for effective therapy.

Conclusion: The study found that the scaffolds exhibited strong physicochemical properties and sustained drug release, making them suitable for biomedical use. Implants were more stable at pH 7.4 than at pH 4.0, and γ-radiation effectively prevented microbial contamination. In vivo studies confirmed MXM detection, with iS-MMS-17 showing promising pharmacokinetic parameters for pain and arthritis therapy.

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