DOI: https://doi.org/10.15587/2519-4852.2019.165650

Selection of flavoring agents and primary packaging for the combined oral solution named «Maglycimet»

Daria Snehyrova, Lyudmila Almakaeva

Abstract


Aim. The main aim of research is selection of flavoring agents and primary packaging for a combined oral solution named «Maglycimet» based on theoretical and experimental. The solution consists of magnesium aspartate, magnesium glutamate, glycine and methylcobalamin.

Methods. During the studying organoleptic, physicochemical and pharmaco-technological methods were used according to the requirements of the State Pharmacopoeia of Ukraine and the European Pharmacopoeia.

Results. We investigated a series of the obtained solution with various corrective agents and their concentrations in order to give the medicine pleasant organoleptic characteristics. In the course of research next sweeteners were used: sodium cyclamate with concentrations 0.05-0.15 %; saccharin sodium with concentrations 0.05-0.15 %; saccharin sodium and sorbitol in such ratios: 0.1 and 5 %, 0.1 and 8.5 %, 0.15 and 10 %; sucrose with concentrations 20-30 %. Studies were performed using methods of A.I. Tentsova and I.A. Egorov in three separate stages. At the first stage 12 series of solution with different sweeteners were obtained. Four of them were selected to the second stage. At the third stage the best one was chosen according to the evaluation of volunteers group. It turned out to be saccharin sodium with concentration 0.1 %. The following flavoring agents were also investigated: «cherry», «raspberry», and «peach» with concentrations from 0.1 to 1.0 %. As a result of the research it was determined that the sample with the «cherry» flavoring agent with concentration 0.6 % had the best taste. 100 ml vials of orange glass and polyethylene terephthalate (two types) allowed for utilization in Ukraine were investigated as primary packaging. After 3, 6, 9, 12 and 18 months of solution storage in bottles monitoring of the main quality indicators was made. It was established that all types of packaging did not cause changes in the main indicators of the solution quality, beyond the design of quality control methods. This allows us to recommend all types of test vials.

Conclusions. Sweetener saccharin sodium with concentration 0.1 % and a flavoring agent «cherry» with concentration of 0.6 % were chosen for the combined oral solution named «Maglycimet» based on the theoretical and experimental studies. Next types of bottles are recommended as a primary packaging: from orange glass and polyethylene terephthalate (two types)


Keywords


oral solution; magnesium salts; correction of taste; primary packaging

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References


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GOST Style Citations


Spasov A. A. Magniy v meditsinskoy praktike: monograph. Volgograd, 2000. 268 p.

Defitsit magniya kak problema stressa i dezadaptatsii u detey / Gromova O. A., Torshin I. Y., Grishina T. R., Fedotova L. E. // Russkiy meditsinskiy zhurnal. 2012. Vol. 20, Issue 16. P. 813–821.

DiNicolantonio J. J., O’Keefe J. H., Wilson W. Subclinical magnesium deficiency: a principal driver of cardiovascular disease and a public health crisis // Open Heart. 2018. Vol. 5, Issue 1. P. e000668. doi: http://doi.org/10.1136/openhrt-2017-000668 

Al Alawi A. M., Majoni S. W., Falhammar H. Magnesium and Human Health: Perspectives and Research Directions // International Journal of Endocrinology. 2018. Vol. 2018. P. 1–17. doi: http://doi.org/10.1155/2018/9041694 

Kuznetsov A. A., Kabakova T. I., Kuznetsov A. V. Udobstvo primeneniya kak ekonomicheskiy faktor optimizatsii ratsionalnogo ispolzovaniya lekarstvennyih sredstv // Fundamentalnyie issledovaniya. 2012. Vol. 10. P. 397–399.

Schiffman S. S. Influence of medications on taste and smell // World Journal of Otorhinolaryngology – Head and Neck Surgery. 2018. Vol. 4, Issue 1. P. 84–91. doi: http://doi.org/10.1016/j.wjorl.2018.02.005 

Printsipyi korrektsii vkusa peroralnyih geley s sinteticheskimi lekarstvennyimi veschestvami / Anurova M. N., Bahrushina E. O., Pyatigorskaya N. V., Yambikova O. M. // Farmatsiya i farmakologiya. 2015. Vol. 4 (11). P. 15–20.

Campbell G. A., Vallejo E. Primary Packaging Considerations in Developing Medicines for Children: Oral Liquid and Powder for Constitution // Journal of Pharmaceutical Sciences. 2015. Vol. 104, Issue 1. P. 52–62. doi: http://doi.org/10.1002/jps.24223 

Raina Н., Jindal А. Packaging of Non-Injectable Liquid Pharmaceuticals: A Review // Journal of Applied Pharmaceutical Science. 2017. Issue 2. P. 248–257.

Singh K., Gupta R. Stability studies on a cough syrup in plastic containers // Indian Journal of Pharmaceutical Sciences. 2007. Vol. 69, Issue 3. P. 408–413. doi: http://doi.org/10.4103/0250-474x.34551 

Almakaeva L. G., Begunova N. V., Almacaev M. S. Issledovaniya po vyiboru pervichnoy upakovki dlya oralnogo rastvora arginina asparaginata: processing. Tovaroznavchi aspekti spozhivchih tovariv. Kharkiv: Vid-vo NFaU, 2013. P. 9–10.

Derzhavna Farmakopeya Ukrayini. Vol. 1–3. Kharkiv: Derzhavne pidpriemstvo «Ukrayinskiy naukoviy farmakopeyniy tsentr yakosti likarskih zasobiv», 2014–2015. 1128 p., 724 p., 732 p.

European Pharmacopoeia. 9th Edition. European Directorate for the Quality of Medicines (EDQM). Strasbourg: Council of Europe, 2016. 4016 p.

Japanese Pharmakopeia 16-th ed. The Ministry of Health, Labour and Welfare, 2011–2014.

Voda ochyshchena // Derzhavna Farmakopeia Ukrainy. Dopovnennia 2. Kharkiv: Derzhavne pidpryiemstvo «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 2014. P. 129.

Lyuk E., Yager M. Konservantyi v pischevoy promyishlennosti. Svoystva i primenenie. Saint Petersburg: GIORD, 2003. 256 p.

Buldakov A. S. Pischevyie dobavki: Handbook. Moscow: DeLi-print, 2003. 436 p.

Getalo O. V., Tsihotska O. O., Saliy O. O. Rozrobka siropu z magniyu hloridom i vitaminom B6 // Visnik farmatsiyi. 2005. Vol. 3. P. 59–61.

Sheryakova Yu. A., Hishova O. M. Podslastiteli v siropah i ih harakteristika. Vestnik farmatsii. 2014. Vol. 2. P. 106–111.

Tehnologiya likiv promislovogo virobnitstva / Chueshov V. I., Hohlova L. M., Lyapunova O. O., Sayko I. V., Gladuh E. V., Egorov I. A. et. al.; ed. by Chueshov V. I. Kharkiv: Zoloti storinki, 2003. 720 p.

Tentsova A. I. Aktualnyie voprosyi poiska i tehnologiya lekarstv. Kharkiv, 1981. 145 p.







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