Regulatory Frameworks for Polymeric Nanofiber-Based Drug Delivery Systems: Current Status, Challenges, and Future Perspectives.

Nidhi Sharma

Regulatory Frameworks for Polymeric Nanofiber-Based Drug Delivery Systems: Current Status, Challenges, and Future Perspectives.

Author(s)	Ms. Nidhi Sharma
Country	India
Abstract	Nanofibers are increasingly recognized as adaptable nanostructured materials with significant promise across biomedical, pharmaceutical, environmental, filtration, energy, and industrial fields. Their nanoscale size, large surface-area-to-volume ratio, flexibility, porosity, and adjustable properties render them especially appealing for advanced drug delivery, wound healing, tissue engineering, cancer therapy, gene delivery, and biosensing. A range of fabrication methods—such as electrospinning, centrifugal spinning, solution blow spinning, phase separation, self-assembly, and nanofiber printing—have been established to create nanofibrous structures. Of these, electrospinning continues to be one of the most extensively studied techniques, owing to its adaptability and capacity to produce fibers with controlled morphology. The characteristics of the resulting nanofibers are heavily affected by material choice and processing parameters, including polymer concentration, viscosity, molecular weight, solvent properties, applied voltage, and environmental conditions. Natural and biodegradable polymers have attracted growing interest as substitutes for conventional synthetic polymers, thanks to their biocompatibility, biodegradability, and environmental benefits. Nevertheless, difficulties concerning mechanical strength, stability, solvent toxicity, reproducibility, production cost, and large-scale manufacturing still limit broader application. Nanofiber-based systems also demand thorough assessment of toxicity, stability, drug-release behavior, characterization, and long-term biological effects prior to clinical and commercial translation. From a regulatory standpoint, nanofiber-based pharmaceutical products pose added challenges involving standardized characterization, quality control, manufacturing consistency, safety assessment, environmental impact, and regulatory harmonization. Differences in fiber diameter, morphology, porosity, composition, and processing conditions can influence product performance and make quality and regulatory assessment more complex. Consequently, future progress in nanofiber technology should emphasize sustainable materials, safer solvents, solvent-recovery systems, scalable manufacturing, advanced process monitoring, artificial intelligence-assisted optimization, and harmonized regulatory approaches. Cooperation among researchers, industry, and regulatory authorities will be crucial for moving nanofiber technologies from laboratory research into safe, effective, reproducible, and commercially viable applications.
Keywords	Nanofiber, Electrospinning; Drug delivery, Biopolymers, Biomedical applications, Sustainability, Regulatory challenges
Field	Medical / Pharmacy
Published In	Volume 8, Issue 5, September-October 2026
Published On	2026-09-29

View / Download PDF File

About IJFMR Fees & Payment Current Issue Publication Archive	Submit Research Paper Track Submission Status Publication Guidelines Publication Ethics Peer Review & Plagiarism	Join as a Reviewer Editors & Reviewers Reviewer Referral Program Get Reviewer Membership Certi.	Website/Journal Policies Usage Policy Content Policies Privacy Policy

Contact Us		+91-9687-828-838	editor@ijfmr.com

International Journal For Multidisciplinary Research

A Widely Indexed Open Access Peer Reviewed Multidisciplinary Bi-monthly Scholarly International Journal

Regulatory Frameworks for Polymeric Nanofiber-Based Drug Delivery Systems: Current Status, Challenges, and Future Perspectives.

Share this