DeliveredDoseUniformityInhalerQualityChecker

Delivered Dose Uniformity Inhaler Quality Checker — Delivered Dose Uniformity of Inhalers

ℹ️  Utility checks critical parameters of Delivered Dose Uniformity (DDU) per USP <601>:
   • Mean delivered dose: 80–120% of Label Claim (LC)
   • Relative Standard Deviation (RSD): ≤10.0%
   • Individual doses: 75–125% of LC

⚠️  CRITICAL: DDU non-compliance leads to under-dosing or over-dosing of the patient!
   Inhalers (MDI, DPI) require strict control of each actuation.

Usage:
 DeliveredDoseUniformityInhalerQualityChecker.exe                            → demo mode (console output)
 DeliveredDoseUniformityInhalerQualityChecker.exe input.csv output.json      → evaluate your data

Input format:
BatchNumber,LabelClaim,Dose1,Dose2,Dose3,Dose4,Dose5,Dose6,Dose7,Dose8,Dose9,Dose10

Example:
 INHALER-DDU-2026-001,100.0,98.5,101.2,99.0,100.5,97.8,102.1,99.5,100.0,98.9,101.5

— WHY IS THIS NEEDED?
For Metered-Dose Inhalers (MDI) and Dry Powder Inhalers (DPI), the amount of drug reaching the lungs is critical.
• USP <601> regulates testing methods for aerosols, nasal sprays, and inhalers.
• DDU test guarantees that each actuation delivers the correct amount of drug.
• Typically, 10 actuations are tested (or 4 for beginning/end of canister life tests).
• Analysis is performed using dose collection systems (e.g., Copley Scientific, Logan Instruments) followed by chromatographic analysis (HPLC/UV).

⚠️  CRITICAL:
• Mean value must be close to 100% LC (tolerance 80-120%).
• RSD ≤ 10% ensures dose reproducibility from actuation to actuation.
• No individual dose should fall outside 75-125% of LC.
• For some drugs (e.g., beclomethasone), stricter criteria may apply.

Key features:
• Automatic calculation of DDU statistics per USP <601>.
• Check of individual and mean limits.
• Report generation for regulatory dossier.

Critical parameters:
• Mean Dose: 80-120% of LC
• RSD: <= 10.0%
• Individual Doses: 75-125% of LC

💡 Usage tips:
1. Use calibrated dose collection systems (impactors/filters) for accurate drug capture.
2. Condition the inhaler before testing (primer shots) if required by instructions.
3. Account for airflow rate influence (for DPI) on delivered dose.
4. Store inhalers at controlled temperature and humidity before testing.
5. Confirm results by chromatographic method with appropriate sensitivity.

⚠️ Note: DDU differs from Content Uniformity (CU) for tablets as it measures the actually released dose, not the content in a packaging unit. For inhalers, this is the only way to guarantee effective drug delivery.