Bioavailability and disposition of azelastine and fluticasone propionate when delivered by MP29-02, a novel aqueous nasal spray.

British Journal of Clinical Pharmacology
H DerendorfJean Bousquet

Abstract

• The topical second generation anti-histamine azelastine hydrochloride (AZE) and the potent corticosteroid fluticasone propionate (FP) are well established first-line treatments in allergic rhinitis (AR). • MP29-02, a novel intranasal AZE and FP formulation, has been shown to control AR symptoms faster and better than standard intranasal AZE or FP. • The systemic bioavailabilities of marketed AZE and FP nasal spray products have been established at about 40% and 1% only, respectively. • For new combination medicinal products such as MP29-02, the determination of possible pharmacokinetic (PK) drug-drug interactions between both active components and formulation-based bioavailability alterations is essential. • This paper provides for the first time information on potential drug-drug interactions, AZE and FP bioavailability and disposition characteristics of each component administered by the novel nasal spray formulation MP29-02. • The studies employed highly sensitive FP and AZE LC-MS/MS assays and could therefore be conducted with recommended therapeutic doses, thereby circumventing previously recognized draw-backs that required nasal bioavailability studies to be conducted using supra-therapeutic doses. • No significant PK d...Continue Reading

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Citations

Aug 28, 2013·Expert Opinion on Pharmacotherapy·Jonathan A Bernstein
Jan 23, 2016·Expert Opinion on Pharmacotherapy·Ludger KlimekWytske Fokkens
Nov 4, 2015·Clinical and Molecular Allergy : CMA·G Walter CanonicaGianEnrico Senna
Feb 4, 2016·Expert Review of Clinical Pharmacology·Ludger KlimekDavid Price
Nov 14, 2013·Expert Opinion on Pharmacotherapy·Erminia RidoloGiorgio Walter Canonica
Aug 6, 2015·Clinical and Molecular Allergy : CMA·Oliviero RossiGiorgio Walter Canonica
Nov 8, 2015·European Archives of Oto-rhino-laryngology : Official Journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : Affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery·Shaoyan FengWanwei Cao
Apr 25, 2019·Allergy, Asthma, and Clinical Immunology : Official Journal of the Canadian Society of Allergy and Clinical Immunology·Leif BjermerMagnus C Wickman
Dec 15, 2020·Biochemical and Biophysical Research Communications·Leah R ReznikovDavid A Ostrov
Mar 19, 2021·Journal of Otolaryngology - Head & Neck Surgery = Le Journal D'oto-rhino-laryngologie Et De Chirurgie Cervico-faciale·James FowlerLeigh J Sowerby

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