Development of a process flow diagram for the manufacturing and testing of a nasal spray for allergic rhinitis treatment
https://doi.org/10.31549/2542-1174-2023-7-1-110-117
Abstract
Introduction. Nasal administration is the optimal way to administer the drug to achieve maximum bioavailability in the topical treatment of nasal and paranasal sinus diseases. Due to the ease of administration and the possibility of dosing, nasal sprays have become the preferred way of active pharmaceutical substances delivery. In this regard, the composition and technology of a new nasal spray for the allergic rhinitis treatment based on fexofenadine hydrochloride and glycyrrhizic acid derivative was developed.
Aim. To conduct the pharmaceutical and technological tests for the previously proposed nasal spray composition for the treatment of allergic rhinitis and to develop a process flow diagram for its manufacturing.
Materials and methods. The substances used were fexofenadine hydrochloride and ammonium glycyrrhizinate. The weight uniformity of the nasal spray dose and the number of doses in the package were determined according to the corresponding article of the State Pharmacopoeia; the contact angle, the spray plume, and the spray angle were determined according to the methods from the literature data.
Results. During the experimental determination of the characteristics of the contact angle and the spray plume, an actuator manufactured by Coster Tecnologie Speciali S.p.A. (Italy) was selected which provided the best distribution of drops of the preparation and created the maximum area of the spray plume – 392.13 ± 28.075 mm2. As a result of tests to determine the average dose weight and the uniformity of dosing, compliance with the requirements of the current pharmacopoeia monograph was established. Comprehensive research enabled the development of a process flow diagram for the manufacturing of anti-allergic nasal spray.
Conclusion. The conducted research made it possible to determine a number of pharmaceutical and technological indicators characterizing nasal spray, and to propose the optimal process flow diagram for its manufacturing.
About the Author
A. E. Pozdnyakova
Pyatigorsk Medical and Pharmaceutical Institute, Branch of the Volgograd State Medical University
Russian Federation
Russian Federation
Anastasiуa E. Pozdnyakova – Lecturer, Department of Pharmaceutical Technology with a Course of Medical Biotechnology
11, Kalinina prosp., Pyatigorsk, Stavropol region, 357532
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For citations:
Pozdnyakova A.E. Development of a process flow diagram for the manufacturing and testing of a nasal spray for allergic rhinitis treatment. Journal of Siberian Medical Sciences. 2023;(1):110-117. https://doi.org/10.31549/2542-1174-2023-7-1-110-117
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