Lactose-derived pharma excipients with real-time process monitoring
Use lactose derivatives as functional pharmaceutical excipients to improve blend uniformity, compressibility, and drug release. Integrate process analytical technology (PAT) with real-time spectroscopic monitoring such as NIR or Raman to support in-process quality control and consistent performance. Designed to support scalable continuous manufacturing and align with real-time release testing concepts.
Overview
This approach develops lactose-derived materials into high-functionality pharmaceutical excipients by integrating them with advanced manufacturing systems. By applying process analytical technology (PAT) and real-time spectroscopic monitoring, such as NIR or Raman, it aims to support consistent performance, process quality assurance, and alignment with regulatory trends. The method is intended to be scalable for continuous pharmaceutical manufacturing, expanding lactose applications into high-value, regulated markets.
Technical specifications
- Functional excipients: Enhance blend uniformity, compressibility, and drug release kinetics.
- Process integration: Incorporates real-time spectroscopic monitoring (NIR or Raman) for quality control.
- Manufacturing compatibility: Supports scalable continuous manufacturing processes.
- Regulatory alignment: Designed to meet real-time release testing requirements.
Technology readiness level
This technology is at Technology Readiness Level 5, with ongoing validation trials at Rutgers University's continuous manufacturing line. Initial evaluations of physical and chemical properties are underway, with subsequent trials planned to develop predictive models and assess scalability.
About Rutgers University
Rutgers University is a comprehensive public research university and New Jersey’s flagship, spanning campuses in New Brunswick–Piscataway, Newark, and Camden. For industry, it offers an integrated clinical and biomedical enterprise through its health system, a statewide extension network for field deployment, and campus-based incubators and pilot-scale facilities that enable prototyping and scale-up. Companies engage through sponsored research, shared core facilities, professional education, and flexible partnership models supported by corporate engagement teams. Research is supported by competitive federal funding from agencies such as NIH, NSF, DOE, and USDA. A dedicated technology transfer office manages IP, licensing, material transfer, and startup formation, providing clear pathways from lab discovery to market.
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