The pharmaceutical industry continues to move toward more patient-centric drug delivery solutions, prioritizing non-invasive administration routes, improved therapeutic performance, and greater convenience. Among these innovations, dry powder inhaler (DPI) nasal powder technologies are gaining momentum as a promising alternative to traditional liquid nasal sprays and injectable therapies.
At Mikart, this shift aligns closely with our mission to support innovative drug developers through flexible, GMP-compliant manufacturing solutions. Recent clinical manufacturing successes—particularly in collaboration with Nano PharmaSolutions (NPS)—highlight how advanced particle engineering and expert CDMO capabilities can work together to accelerate next-generation nasal drug products.
Why the Industry is Shifting Toward DPI Nasal Powders
Intranasal delivery has long been recognized for its potential advantages, including non-invasive administration, rapid onset of action, and the ability to bypass the blood-brain barrier. Traditional nasal sprays often use liquid formulations that require preservatives, which can cause irritation and limit stability, reducing shelf life. In order to unlock such significant benefits, appreciation must be given to the complexities associated with delivering drugs to the nose, from the earliest stages of formulation all the way through to device design and manufacture. Moreover, these factors must be considered in the context of the specific molecule, which can range from smaller APIs through to complex, fragile biologics.
DPI nasal powders offer several distinct advantages that align with modern drug development goals:
- Enhanced Stability: Without water, powder formulations eliminate the need for preservatives and offer better stability for sensitive, high-value molecules and biologics.
- Superior Nose-to-Brain Delivery: Dry powders can achieve significantly higher deposition in the upper posterior region of the nasal cavity, the key area for targeting the olfactory region for direct delivery to the brain.
- Patient Compliance: These systems offer rapid onset of action, are easy to self-administer, and are portable, making them ideal for acute, “on-demand” therapies.
Mikart & Nano PharmaSolutions: A Partnership Delivering Results
Our collaboration with Nano PharmaSolutions has proven that combining advanced particle engineering with expert CDMO manufacturing produces superior results. Following the successful installation of NPS’s NanoTransformer® technology at our Atlanta facility, we have been working together to develop NT-301, a proprietary nasal powder spray designed for the rapid treatment of Parkinson’s disease OFF episodes.
Key Takeaways from Recent Phase 1 Interim Data (Sept 2025):
- Positive Data: The Phase 1 clinical trial of NT-301 showed positive safety and pharmacokinetics results.
- Rapid Absorption: The 1-3 mg doses tested reached a Tmax (time to maximum concentration) of approximately 20 minutes, highlighting the speed of the NanoTransformer® nanoparticle technology.
- Solvent-Free Precision: The NanoTransformer® uses physical vapor deposition (PVD) to coat APIs onto carriers without solvents or polymers, enhancing solubility while maintaining product purity.
Conclusion: The Future of Nasal Delivery
The market for nasal drug delivery is expanding, with a projected 8% CAGR in the US through 2030, driven by the growing need for complex formulations. By using advanced, solvent-free nanotechnology in our GMP manufacturing environment, Mikart enables developers to transition from invasive injections to patient-friendly, high-performance DPI nasal products. As you advance toward commercialization, partnering with the right CDMO ensures your product is in expert hands—prepared for regulatory approval, optimized for scale, and aligned with your business goals. Mikart is proud to support biotech innovators with flexible, full-service CDMO solutions, including dry powder inhalation and nasal drug product development and manufacturing.
Are you looking to accelerate your nasal drug development? Contact Mikart today to discuss how our integrated capabilities can bring your formulation from concept to clinic.
Reach out to our Business Development team at BizDev@mikart.com or contact us here to start the conversation.