Microneedle System for Interferon Delivery via PVP Formulation
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Solution Overview
Problem
Current methods for delivering interferon beta-1a for multiple sclerosis treatment, such as intramuscular or subcutaneous injections, result in frequent side effects and compliance issues due to the skin's natural impermeability and the need for cold storage, which can be mitigated by an intradermal delivery system that effectively penetrates the skin barrier.
Innovation Solution
A microneedle system using a polyvinylpyrrolidone-based formulation that allows for the complete solubility and stability of interferon, enabling its direct intradermal delivery without stabilizers, with microneedles penetrating the stratum corneum to facilitate transdermal administration and storage at room temperature for extended periods.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If intramuscular or subcutaneous injection is used for interferon delivery, then the drug can be delivered systemically, but patient compliance deteriorates due to frequent pinprick injuries and infection risks
Solution Approach 1:
The injection device is segmented into a disposable microneedle array patch that penetrates the skin and a reusable pen-like applicator. The microneedle array is replaced after each use, eliminating the need for patients to repeatedly sterilize or maintain the same device, thereby reducing infection risks and improving compliance.
Solution Approach 2:
The microneedle array is designed as a disposable component that is discarded after a single use. This eliminates the accumulation of biohazardous materials on reusable devices and removes the burden of sterilization from patients, directly addressing compliance issues related to infection risks and pinprick injuries.
2Reliability
If traditional injection methods are used, then interferon can be delivered effectively, but storage requirements worsen due to the need for cold storage
Solution Approach 1:
The formulation parameters of interferon are optimized to enable stable storage at room temperature. By modifying the excipient composition and concentration, the drug maintains its biological activity and stability without requiring refrigeration, thereby eliminating the cold storage requirement while preserving delivery effectiveness.
3Quantity of substance
If the skin barrier is penetrated using conventional needles, then interferon delivery is achieved, but patient compliance deteriorates due to pain and tissue damage
Solution Approach 1:
The microneedle array features needles with diameters of 20-500 micrometers, creating extremely small puncture wounds that are nearly imperceptible. This localized minimization of tissue disruption reduces pain and visual stigma, thereby improving patient compliance while maintaining effective drug delivery through the skin barrier.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The microneedle system achieves stable and effective interferon delivery with reduced side effects, maintaining antiviral potency comparable to traditional injections, even after prolonged storage at room temperature, and demonstrates improved patient compliance by minimizing pinprick injuries and infection risks.
Implementation Method 1
Microneedle systems (MNS), which are composed of a microneedle array (MNA) and possibly further components, can use a pressure force to press the microneedles (also referred to as skin penetration elements) of the array (MNA) against the delivery site on the skin so as to penetrate the stratum corneum
Implementation Method 2
polyvinylpyrrolidone (for short: PVP) is particularly well-suited for producing a completely soluble formulation for an MNA for the intradermal delivery of interferon
Data Source
AI summary
The present invention relates to a microneedle system (MNS) for the intradermal delivery of interferon, wherein polyvinylpyrrolidone is the major constituent of a completely soluble formulation.