Skip to main content
Industrial Research And Consultancy Centre
Patent
Low-Cost Clean-Room Free Fabrication of Polymeric Microneedles Patch
Abstract

This innovation is a simple, cost-effective, clean-room free fabrication method for polymeric microneedle patches using CNC-machined stainless steel molds and PDMS-based soft lithography. This process offers a robust and reproducible alternative to expensive MEMS-based microfabrication and enables mass production using biodegradable polymers for drug and vaccine delivery applications.

Figure (1) Graphical representation of the fabrication process of PVA-PVP MNs: (1a) PDMS was poured on the stainless-steel mold, (1b) The polymer solution was poured on the PDMS negative mold, (1c) Desiccation with the help of a vacuum pump to drive the polymeric solution's entry into the microneedle cavities, (1d) Polymeric microneedle patch; (2) Applying for ethical approval for benzoyl peroxide patches for acne treatment at ATREC hospital

Problem Statement

Conventional microneedle fabrication methods often require expensive clean-room environments and complex MEMS technologies, making them inaccessible for widespread applications in drug and vaccine delivery.

Uniqueness of the Solution
  • Clean-Room Free Fabrication: This technology eliminates the requirement for clean-room facilities by utilizing a CNC-machined stainless-steel mold along with PDMS-based soft lithography for microneedle fabrication. 
  • Low-Cost and Reproducible Process: The process involves a one-time fabrication of a master mold, which can be reused multiple times for casting, thereby significantly reducing overall production costs and ensuring high reproducibility. 
  • Material Versatility: The method is compatible with a wide range of soft biodegradable polymers such as PVA, PVP, PCL, and PLGA, allowing flexibility in material selection and enabling precise control over drug release profiles. 
  • High Mechanical Strength: The fabricated microneedles demonstrate a failure force greater than 0.24 N per needle, which is sufficient to ensure effective penetration into the skin without any risk of fracture.
Prototype Details

A prototype patch with 225 microneedles (15×15 array) using PVA/PVP (4:1) was fabricated via vacuum-assisted mold filling and drying at 37°C. It was tested for insertion in agarose gel, drug release through dialysis membranes, and penetration in goat skin.

Current Status of Technology

The technology is currently between the lab-scale and prototype stages of development.

Technology readiness level

3

Societal Impact

This clean-room free, affordable microneedle platform democratizes access to minimally invasive transdermal delivery systems, especially valuable in rural, low-income, or resource-constrained healthcare setups. It supports mass vaccination, painless therapeutic delivery, and potential home use.

Applications or Domain
  • Healthcare and Medical Devices: Used for painless, minimally invasive delivery of therapeutics, improving patient compliance and accessibility in clinical and home-care settings 
  • Transdermal Drug Delivery: Enables efficient delivery of drugs through the skin by bypassing the gastrointestinal tract and reducing side effects associated with oral or injectable routes 
  • Vaccine and Gene Delivery: Provides a needle-free platform for delivering vaccines and genetic materials directly into the dermis or epidermis, which are rich in immune-responsive cells 
  • Biosensing and Bioimaging: Microneedles can serve as tools for extracting interstitial fluids or detecting biological markers, making them suitable for wearable diagnostics and real-time health monitoring 
  • Pharmaceutical Manufacturing: Supports scalable production of drug-loaded patches, suitable for commercial manufacturing of advanced drug delivery systems

Geography of IP

Type of IP

Application Number

202221034506

Filing Date
Grant Number

544751

Grant Date
Assignee(s)
Indian Institute of Technology Bombay
**This IP is owned by IIT Bombay**