Quality of spraying of combination medicines produced by different manufacturers used for the treatment of upper respiratory tract infections
Viktoriya G. Yankova /
Svetlana V. Gribanova /
Viktoriya Yu. Grigorieva /
Irina L. Udyanskaya /
Tatiana K. Slonskaya /
Anna A. Zhukova /
Olga N. Plakhotnaya /
Ivan I. Krasnyuk (Jr.) /
Ksenia S. Chernikova /
Elnara S. Dosaeva /
Local pharmacotherapy plays an important role in the treatment of inflammatory diseases of the throat in children. Metereddose aerosols and sprays are very popular among both doctors and patients. One of such medicines is sold under the ‘Kameton’ brand. ‘Kameton’ is a combination local drug with anti-inflammatory, antiseptic, and moderate ‘distracting’ effects ensured by its components, namely hlorobutanol, camphor, levomentholum, and eucalyptus oil. This medicine is characterized by low systemic absorption, while the combination of synthetic and natural components makes it an effective and mild-acting agent with a minimum of side effects. ‘Kameton’ is one of the few ENT medications used not only for the treatment of inflammatory diseases of the throat, but also allows intranasal application; it is recommended for children aged 5 years and older.
Objective. To compare the spraying quality of ‘Kameton’ aerosols and sprays produced by different manufacturers to find an additional criterion to choose an optimal medicine of this brand.
Materials and methods. We analyzed 5 medicines (metered-dose sprays or aerosols) under the ‘Kameton’ brand produced by different manufacturers. We compared the following parameters: homogeneity of the dose mass (pharmacopoeial test), reproducibility of the dose mass (relative error of the mean dose mass), and spray width. The assessment of homogeneity and reproducibility of the dose mass was performed using the Electronic Balance B2104 electronic scale. To evaluate the spray width, we used planar simulation models (paper filters impregnated with Dragendorf reagent). The spray width was estimated as the print area obtained by spraying of one dose on a planar simulation model.
Results. All medicines studied met the requirements of the pharmacopoeial test for aerosols and sprays in terms of their homogeneity of the dose mass. Using the Student's t-test, we found that the relative error of the mean dose mass was approximately the same in all drugs analyzed (≈ 1%). The maximum print area and the most homogenous distribution of the medicine on the model was demonstrated by the spray produced by ‘VIPS-MED’ LLC.
Conclusion. Our findings on the quality of spraying allow us to recommend ‘Kameton’ produced by ‘VIPS-MED’ LLC as the most effective drug in terms of its active component delivery to the upper respiratory tract mucosa.
Key words: Kameton, spray nozzle, homogeneity of dosing, reproducibility of the dose mass, print area
For citation: Yankova V.G., Gribanova S.V., Grigoryeva V.Yu., Udyanskaya I.L., Slonskaya T.K., Zhukova A.A., Plakhotnaya O.N., Krasnyuk I.I. (Jr.), Chernikova K.S., Dosaeva E.S. Quality of spraying of combination medicines produced by different manufacturers used for the treatment of upper respiratory tract infections. Vopr. prakt. pediatr. (Clinical Practice in Pediatrics). 2021; 16(1): 112–117. (In Russian). DOI: 10.20953/1817-7646-2021-1-112-117
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