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A New Approach To Bioequivalence Studies For Nasal Sprays: Nasal Challenge Considering Histamine Intermediatelate Phase Reaction | 8258
ISSN: 0975-0851

Journal of Bioequivalence & Bioavailability
Open Access

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A new approach to bioequivalence studies for nasal sprays: Nasal challenge considering histamine intermediatelate phase reaction

2nd World Congress on Bioavailability & Bioequivalence: Pharmaceutical R & D Summit-2011 and International Conference on Pharmaceutics & Novel Drug Delivery Systems

Natalia Fabbri, Eduardo Abib- Jr, Bruna Sharlac Vian, Antonio Amarante and Ricardo L Zollner

ScientificTracks Abstracts: JBB

DOI: 10.4172/2153-2435.10000S4

T opical intranasal corticosteroids are widely recognized as the fi rst-line anti- infl ammatory 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. Th e study designs for this purpose generally use long-term therapeutic intervention models with a high cost and long-term treatment of patients. Th is study was designed to demonstrate the feasibility of nasal challenge, histamine intermediate- late phase reaction and 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. Aft er nasal challenge with 0.5mg/ml histamine (previously defi ned), 25 healthy volunteers were submitted to an anterior rhinomanometry at the time 0; 15; 30 and 60 minutes building a baseline of fl ow, pressure and resistance of nasal chamber. Th e volunteers were then submitted to nasal drug spray Test ( T ) or Reference( R ) of beclomethasone dipropionate, according to a randomized schedule. Th e Area Under Curve (AUC 0-t ) was analyzed. Th e ratio between the geometrics averages of AUC 0-t from T and R was 1.08 for 90% CI (0.245; 0.226), suggesting the bioequivalence between formulations.

Ricardo L Zollner, Graduated in Medicine (1981); Medical Residence (1984); MsC (1987) and PhD (1990) by Faculty of Medicine, Ribeir?o Preto, University of S?o Paulo, Ribeir?o Preto, SP, Brazil. (1975-97) Post-doctoral training in the Molecular Immunopathology Unit - MIP, MRC- Cambridge, UK. Areas of Research: Allergy and Autoimmunity. Associate Professor of Immunology and Head of Postgraduate Training Program in Clinical Medicine, Faculty of Medical Sciences, University of Campinas, Campinas, SP, Brazil