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Case Study

Mirai™ DPI Performance Validation

Budesonide Formulation vs. Reference Listed Drug

Validated Bioequivalent Performance in 1-2 Development Iterations

Independent GLP laboratory testing demonstrates the Mirai™ platform achieves near-equivalent APSD to reference listed drugs, validating our integrated device + formulation approach for rapid combination product development.

<5µg
Stages 3-5 Diff
<12µg
Total Profile
1-2
Iterations
GLP
Validated

Executive Summary

Independent laboratory testing conducted by Intertek demonstrates that the Mirai™ dry powder inhaler platform achieves near-equivalent aerodynamic particle size distribution (APSD) to established reference listed drugs (RLD) within 1-2 development iterations.

1Study Design

Drug Tested

Budesonide

Inhaled Corticosteroid (ICS)

Reference Product

Budesonide Turbuhaler

Reference Listed Drug (RLD)

Testing Laboratory

Intertek

Independent GLP Laboratory

Test Method

APSD via NGI

Next Generation Impactor per USP <601>

2Key Results

<5µg
Stages 3-5 Difference
Respirable fraction (1-5 µm)
<12µg
Throat-Stage 8 Difference
Total deposition profile
Similar APSD Profile to RLD

3APSD Comparison

APSD Comparison: Mirai™ vs. Reference Listed Drug

NGI at 60 L/min per USP <601>

020406080100120Amount (µg)MouthpieceThroatPresepStage 1Stage 2Stage 3Stage 4Stage 5Stage 6Stage 7MOCMirai Average — Mouthpiece: 7.5 µgMirai Average — Throat: 30.5 µgMirai Average — Presep: 112 µgMirai Average — Stage 1: 10 µgMirai Average — Stage 2: 17 µgMirai Average — Stage 3: 26 µgMirai Average — Stage 4: 30.5 µgMirai Average — Stage 5: 15 µgMirai Average — Stage 6: 5.5 µgMirai Average — Stage 7: 1.5 µgMirai Average — MOC: 0.7 µgRLD 2 Average — Mouthpiece: 9 µgRLD 2 Average — Throat: 35 µgRLD 2 Average — Presep: 110 µgRLD 2 Average — Stage 1: 10.2 µgRLD 2 Average — Stage 2: 19 µgRLD 2 Average — Stage 3: 26.5 µgRLD 2 Average — Stage 4: 33 µgRLD 2 Average — Stage 5: 18 µgRLD 2 Average — Stage 6: 6.2 µgRLD 2 Average — Stage 7: 1.8 µgRLD 2 Average — MOC: 0.8 µg
Mirai AverageRLD 2 Average

Dose Delivery

Dose Delivery Uniformity

04080120160Budesonide (µg)Mouthpiece — DD1: 5.68 µgCapsule — DD1: 70.79 µgDusa + Filter — DD1: 100.29 µg1Mouthpiece — DD2: 10.79 µgCapsule — DD2: 42.47 µgDusa + Filter — DD2: 124.73 µg2Mouthpiece — DD3: 9.34 µgCapsule — DD3: 35.14 µgDusa + Filter — DD3: 140.04 µg3Mouthpiece — DD4: 7.14 µgCapsule — DD4: 75.26 µgDusa + Filter — DD4: 92.82 µg4Mouthpiece — DD5: 6.74 µgCapsule — DD5: 85.09 µgDusa + Filter — DD5: 71.46 µg5Mouthpiece — DD6: 8.21 µgCapsule — DD6: 56.79 µgDusa + Filter — DD6: 97.17 µg6Mouthpiece — DD7: 7.62 µgCapsule — DD7: 62.91 µgDusa + Filter — DD7: 98.95 µg7Mouthpiece — DD8: 7.51 µgCapsule — DD8: 26.95 µgDusa + Filter — DD8: 124.57 µg8Mouthpiece — DD9: 9.69 µgCapsule — DD9: 27.37 µgDusa + Filter — DD9: 130.63 µg9Mouthpiece — DD10: 8.06 µgCapsule — DD10: 48.85 µgDusa + Filter — DD10: 108.11 µg10
MouthpieceCapsuleDusa + Filter

Shot Weight (mg) — per replicate

01020Shot weight — DD1: 11.7 mg11.71Shot weight — DD2: 18.4 mg18.42Shot weight — DD3: 18.4 mg18.43Shot weight — DD4: 13.5 mg13.54Shot weight — DD5: 10.1 mg10.15Shot weight — DD6: 15.4 mg15.46Shot weight — DD7: 13.7 mg13.77Shot weight — DD8: 18.3 mg18.38Shot weight — DD9: 16.2 mg16.29Shot weight — DD10: 17.1 mg17.110

Delivered Dose Data

StageDD 1DD 2DD 3DD 4DD 5DD 6DD 7DD 8DD 9DD 10Average%RSD
Mouthpiece5.6810.799.347.146.748.217.627.519.698.068.0818.7
Capsule70.7942.4735.1475.2685.0956.7962.9126.9527.3748.8553.1638.3
Dusa + Filter100.29124.73140.0492.8271.4697.1798.95124.57130.63108.11108.8819.1
Sum176.76177.99184.52175.22163.30162.17169.48159.03167.70165.02170.124.8
Shot Weight (mg)11.718.418.413.510.115.413.718.316.217.115.2819.4

Conclusions

  • Rapid development - near-RLD in 1-2 iterations
  • Integrated approach - device + formulation validated
  • Multi-molecule - Budesonide + Fluticasone confirmed

Additional Validation: Fluticasone Propionate

Comparable APSD performance independently achieved with Fluticasone Propionate vs. RLD, confirming platform versatility across multiple ICS formulations.

Why Partner with Knightpoint?

Granted Patent Protection

Device patents granted - US + 38 EU countries

Integrated Expertise

Device + formulation in-house

140+ Years Experience

GSK, Mylan, AstraZeneca alumni

Mirai™ Platform Advantages

Pull-apart - no piercing
Stationary - consistent dose
100% plastic - washable
Low resistance - all patients
Multi-size - capsule flexible
Mfg ready - Phillips-Medisize

About Knightpoint Group

Knightpoint Group is a specialty pharmaceutical company with a proprietary inhalation platform, developing FDA combination products.

140+
Years Experience
US + 38 EU
Patents Granted
ICS/LAMA/LABA
Expertise

Interested in Learning More?

Contact our business development team.

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