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Published on:January 2018
Indian Journal of Pharmaceutical Education and Research, 2018; 52(2):218-229
Original Article | doi:10.5530/ijper.52.2.25

Factorial Design Methodology for Development of Pediatric Nasal Spray: Study on Xylometazoline Nasal Solution Used For Treatment of Nasal Congestion


Authors and affiliation (s):

Falgun Bhuva*, L D Patel, Krutagn Patel

Faculty of Pharmacy, Dharmsinh Desai University, Nadiad, Gujarat -387001, India.

Abstract:

Objective:The objective of the present work is to develop the meter dose pediatric formulation of xylometazoline hydrochloride for enhanced effectiveness for nasal decongestion. Experimental Work: The 32 factorial experimental design was employed for optimization of sodium cholate (X1) and Polyethyleneglycol 400 concentration (X2) in the formulation. The optimized formulation contains 1.18 % w/v sodium cholate and 13 % v/v Polyethyleneglycol 400. The formulation was further evaluated for its drug content, pH, viscosity, spray content uniformity, In vitro-diffusion studies, pump delivery, spray pattern, sterility and stability study. Results: The percentage diffusion and viscosity was observed 91.33 ± 1.15 % and 19.33 ± 0.57 centipoise respectively. The meter dose nasal formulation shows the superior performance during in-vitro drug release compared with current marketed formulations, which provides alternative option for treatment of nasal decongestion.

Key words: Nasal congestion, Factorial design, Meter dose formulation, Xylometazoline hydrochloride, Sodium cholate.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs