In Vitro Equivalence Assessment Method for Atomization Characteristics of Budesonide Nasal Spray Products
Abstract
In vitro testing is increasingly replacing systemic pharmacokinetic studies in assessing the equivalence of generic and reference locally acting nasal sprays. Establishing reliable in vitro methods and investigating factors that may affect equivalence tests is crucial. In this study, we evaluated the in vitro atomization characteristics of a self-prepared budesonide nasal spray (Formulation A) and a reference drug (Formulation B). A simple and efficient Python program was used to assess population bioequivalence, achieving a high level of automation with audit trail capabilities. The single actuation content, droplet size distribution, and plume geometry met the criteria for population bioequivalence (Hη
Fields of Study & Subjects
Inhalation and Respiratory Drug Delivery
Advanced Drug Delivery Systems
Pharmaceutical studies and practices
Publication details
- Journal / source
- Acta Poloniae Pharmaceutica - Drug Research
- Volume
- 82
- Issue
- 5
- Pages
- 717–730
- Publication date
- 3 March 2026
- Language
- EN