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A New Approach to Bioequivalence Studies for Nasal Sprays: A Nasal Challenge Considering Histamine Intermediate-Late Phase Reaction

Natalia Fabbri, Eduardo Abib Junior, Bruna Scharlack Vian, Antonio Ricardo Amarante and Ricardo de Lima Zollner

Topical intranasal corticosteroids are widely recognized as the first-line anti-inflammatory treatment. Many of the most-prescribed nasal sprays containing local action drugs are expected to go off patent, with a consequent increase of the generic copies of these medications, creating greater product competition and consequently, price reduction. Bioequivalence studies for nasal sprays are still under discussion. The study designs for this purpose generally use long-term therapeutic intervention models with a high cost and long-term treatment of patients. This study was designed to demonstrate the feasibility of rhinomanometry in bioequivalence studies for nasal sprays. An open, randomized, crossover study, using two periods and two sequences to evaluate pharmacodynamic equivalence between two formulations of beclomethasone dipropionate spray. After nasal challenge with histamine, 25 healthy volunteers were submitted to an anterior rhinomanometry at the time 0; 15; 30 and 60 minutes building a baseline of flow, pressure and resistance of nasal chamber. The volunteers were then submitted to nasal drug spray Test ( T ) or Reference ( R ) of beclomethasone dipropionate, according to a randomized schedule. The Area Under Curve (AUC 0-t ) was analyzed. The ratio between the geometrics averages of AUC 0-t from T and R was 1.08 for 90% CI (0.2451; 0.2259), suggesting the bioequivalence between formulations.