Imiquimod  well established first-line treatments in allergic rhinitis . M , a novel intranasal AZE and FP formulati 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 with about 0 and about on respectively. For newbination medicinal products such as M , the determination of possible pharmacokinetic drug-drug interactions between both activeponents and formulation-based bioavailability alterations is essential. This paper provides for the first time information on potential drug/drug interactio AZE and FP bioavailabili and disposition characteristics of eachponent administered by the novel nasal spray formulation M .

The Authors British Journal of Clinical Pharmacology The British Pharmacological Society  ITMN-191 Accepted Article .The studies employed highly sensitive FP and AZE LC/MS/MS assa and could therefore be conducted with rmended therapeutic dos thereby circumventing previously recognized draw-backs that required nasal bioavailability studies to be conducted using supra-therapeutic doses. No significant PK drug-drug interaction between the activeponents AZE and FP was noted for M . AZE bioavailabilty was equivalent when M data werepared with M-AZE-mono and Astelin . Increased FP exposure was observed with M based productspared to FP-BI. FP serum levels were generally very low with all investigational products and unlikely to suggest clinically meaningful pharmacodynamic differences in terms of systemic safety. INTRODUCTION Allergic rhinitis is a global health problem increasing in prevalen currently affecting more than  Dorzolamide 130693-82-2 million people worldwide.

Symptoms of AR affect social li sle learning and worki thereby translating into a substantial burden . Guidelines rmend H-antihistamines as first-line therapy for AR while intranasal corticosteroids are gold standard treatment in patients with more severe sympto buy Lacosamide particularly nasal congestion . Howev surveys of practice patterns show that over 0 of AR patients were dissatisfied with their current treatment due to insufficient effica indicating a still existent and significant unmet medical need . MP a novel azelastine hydrochloride and fluticasone propionate containing product using an optimized intra-nasal formulation was found to control AR The Authors British Journal of Clinical Pharmacology The British Pharmacological Society Accepted Article symptoms more effectively and faster in patients with moderate and severe AR than intranasal AZE or FP alone . In the clinical development of newbination medicinal produc possible drug-drug interactions between activeponents or formulation-based bioavailability alterations need to be addressed .

This paper presents the results of two separate pharmacokinetic studi which together addressed two major mechanistic objectiv ) Exclusion or characterisation of a potential pharmacokinetic interaction between the two activeponents in the novel product M , and .) Exclusion or characterisation of potential formulation-based product differences in the   cell theory nasal bioavailability of FP and AZE aspared to the marketed single-entity products. Besides these mechanistic objectives.