Taste Masked Nasal Spray of a Combination Drug Therapy: Development and Characterization

Abstract

Background: The product under the present study is a combination drug nasal spray comprising of two drugs, an antihistamine and a corticosteroid used for the treatment of allergic rhinitis. With the increased demand and with the intension of reducing the dose frequency, it was decided to increase the strength of the anti-histamine drug which is highly bitter and thereby converting the product from twice daily administration to once daily. However the new strength product was developed as desired but it posed a problem of bitter taste. Need for the Study: The bitter taste is a very nagging problem in the intra-nasal delivery. The clinical studies have shown that the bitter taste of the antihistaminic API is an undesired element as a portion of the medication usually drips down into the pharynx after the intranasal administration leading to an unpleasant and undesired taste experience by the patient. Hence there remains a need for a formulation containing proper pharmaceutically acceptable carriers or excipients playing the role of a taste masking agent that masks the bitter taste associated with the drug. Aim and Objective: Aim: Development of the Combination Nasal Spray Comprising Corticosteroid and an increased dose of Anti-histaminic and bitter taste masking of the resultant product. Objective: The main objective of this work was to develop and characterize a higher strength nasal spray using the prototype formula of the existing local product and to resolve the problem of taste to make it patient compliant. Methodology:The product was developed using the prototype formula of the existing drug with a slight variation in a few excipients. For taste masking, considering the industrial feasibility, the trials were mostly focused on the use of flavors, cooling agents and sweeteners as taste masking agents. A lot of trials were conducted, which were analyzed using chemical analysis (artificial sensory evaluation) and through setting up a human panel. The final product was charged on 3 months stability. Simultaneously chemical analysis and device.