ACCURACY OF DOSAGE IN NEGENT MICELLAR DROPS, CE MEDICAL DEVICE: A COMPARISON BETWEEN PIPETTE DROPPERS AND GRAVITY DROPPERS

Dosage accuracy is a critical requirement for medical devices based on cannabidiol microemulsions. Some users of NegEnt Micellar Drops, CE Medical Device, reported a shorter-than-expected duration of the bottle equipped with a pipette dropper, suggesting possible variability in drop formation. This study compares the precision and homogeneity of drops delivered by a pipette dropper versus a pharmaceutical-grade gravity dropper. Twenty subjects participated in a controlled drop-weight test, followed by a 30-day longitudinal assessment. Results show significantly lower variability with the gravity dropper (SD ±2 mg) compared to the pipette dropper (SD ±5 mg), with statistical significance (p < 0.05). The second phase confirms the stability of the gravity system over time. We conclude that the gravity dropper ensures more accurate and reproducible dosing, improving the clinical reliability of the medical device.