Accelerate OINDP Development with Nanopharm: Full-Spectrum Support from Preclinical to Commercialization

In this insightful video, discover how Nanopharm provides cutting-edge support for the development and commercialization of orally inhaled and nasal drug products (OINDPs). Nanopharm is as a global leader in inhalation science, formulation expertise, and regulatory support.

Nanopharm offers comprehensive development services for OINDPs, designed to reduce risk, accelerate timelines, and ensure regulatory compliance. This video highlights Nanopharm’s state-of-the-art facilities in the UK, proprietary technologies, and unique expertise that enable seamless progression from preclinical R&D to CGMP-compliant clinical and commercial production.

Specialized OINDP Expertise for Complex Drug Delivery Challenges

OINDPs require a deep understanding of both formulation science and device performance. Nanopharm’s end-to-end capabilities include:

• Materials characterization
• Formulation development
• In vitro analytical tools
• In silico modeling of drug delivery

These services are tailored to optimize performance, bioavailability, and stability of OINDPs—factors critical to successful clinical outcomes.

Industry-Leading CGMP Capabilities

A highlight of the video is Nanopharm’s expansion into a 25,000 sq. ft. purpose-built facility offering CGMP (current Good Manufacturing Practices) services, which include:

• Chemistry, manufacturing and controls (CMC)
• In vitro bioequivalence studies
• Analytical method development and validation
• Batch release and ICH stability testing

These services are crucial to ensuring the quality and compliance of drug products with global regulatory standards, especially as OINDPs move from early-stage development into clinical trials and market readiness.

SmartTrack™ Platform – Revolutionizing Generic OINDP Development

A recent innovation is SmartTrack™, Nanopharm’s proprietary in vitro and in silico platform, developed in collaboration with the FDA. SmartTrack™ is designed to:

• Simulate clinical trials within targeted patient populations
• Serve as a bioequivalence waiver tool
• Enable faster, less risky development of generic OINDPs

This unique platform enhances confidence in product performance and can significantly reduce the need for costly clinical endpoint studies.

The video also shares successful case studies, such as:

• Repurposing glucagon from an injection to a nasal powder for diabetes
• Reformulating ketamine into a nasal spray for depression
• Delivering tobramycin via inhalation for home-based cystic fibrosis treatment

These examples illustrate Nanopharm’s ability to transform complex molecules into effective OINDPs using Aptar’s industry-leading delivery devices.

Tailored Support from Preclinical to Market Launch

Nanopharm supports the full product lifecycle, from feasibility assessments and PBPK modeling in preclinical stages, through analytical method evolution, to regulatory dossier submission. Their flexible approach ensures that drug development strategies align with clinical phase requirements and are optimized for each molecule, device, and patient need.

The team emphasizes the importance of early-stage strategic planning, especially for products with no existing regulatory precedents. By focusing on APSD (aerodynamic particle size distribution) and other critical performance metrics, Nanopharm strives to ensure your product’s success at every regulatory milestone.

Trusted Partner with Deep Regulatory Knowledge

With a robust track record, experienced scientific teams, and close collaboration with global regulatory bodies, Nanopharm offers unmatched guidance in navigating the complexities of OINDP development. Their rigorous quality systems, validated methods, and customized services make them the preferred partner for pharmaceutical and biotech companies worldwide.