The effect of moisture regulators on the stability of exemporaneous powders with eufilin
Keywords:powders, difficult extemporaneous prescriptions, extemporaneous formulation, euphilin, aerosol, stability
Aim. To study the effect of moisture regulators on the stability of extemporaneous powders with euphilin and substantiate scientifically and experimentally the rational technology of powders according to difficult extemporaneous prescriptions taking into account the physicochemical properties of the ingredients included and the general rules for the preparation of complex powders to increase their shelf-life.
Materials and methods. The extemporaneous formulation of Kharkiv production pharmacies was used; the statistical sample and the purposeful selection of extemporaneous prescriptions were made to identify the study objects. The model samples of powders without and with the addition of aerosol were prepared according to the traditional rules of preparation of complex powders. The organoleptic control in the process of preparation and storage was performed.
Results and discussion. The technology of powders with euphilin has been experimentally substantiated according to difficult extemporaneous prescriptions using two brands of aerosil as a moisture regulator. On the basis of the organoleptic quality control of model powder samples the effect of aerosil as a moisture regulator on the stability of powders during storage has been found.
Conclusions. Based on the technological studies the technology of powders with euphilin has been experimentally substantiated according to difficult extemporaneous prescriptions. The studies conducted allow us to recommend the introduction of the technology of powders developed in the work of production pharmacies as an intra-pharmaceutical preparation.
Tikhonov, A. I. (Ed.). (1999). Spravochnik ekstemporalnoi retseptury. Kiev: MORION, 496.
Tykhonov, O. I., Yarnykh, T. G. (2016). Aptechna tekhnolohiia likiv. 4th ed. Vinnytsia: NovaKnyha, 536.
Derzhavnyi reiestrlikars’kyh zasobiv Ukrainy. Available at: http://www.drlz.com.ua/.
DP “Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv”. (2015). Derzhavna Farmakopeia Ukrainy. 2nd ed. (Vols. 1-3. Vol. 1). Kharkiv: DP “Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv”, 1128.
European Directorate for the Quality of Medicines & HealthCare of the Council of Europe. (2018). The European Pharmacopoeia. 9th ed. (Vol. 6.). Strasbourg. URL: http://online6.edqm.eu/ep900/.
Panda, Sagar Suman, Kumar, Bera Venkata Varaha Ravi, Mohanta, Ganeswar. (2013). Stability-indicating RP-HPLC method for simultaneous estimation of levosalbutamol sulfate and theophylline in combined dosage form. Brazilian Journal of Pharmaceutical Sciences, 49, 475-490. doi: 10.1590/S1984-82502013000300009.
Sunil Paul, M. M., Aravind, U. K., Pramod, G., Saha, A., Aravindakumar, C. T. (2014). Hydroxyl radical induced oxidation of theophylline in water: a kinetic and mechanistic study. Org. Biomol. Chem., 12 (30), 5611–5620.
Pranab, Ghosh, Rakesh, Ranjan Chakraborty. (2017). Clean and Green Approach for One-pot Synthesis of Pyrazines from Ethylenediamine and 1, 2-Diketone or Its Analogues Under Neat Reaction Condition. Letters in Organic Chemistry, 14, 566.
Pertsev, I. M., Dmytriievskyi, D. I., Rybachuk, V. D. (2010). Dopomizhni rechovyny v tekhnolohii likiv. Kharkiv: Zoloti storinky, 28-72, 117-516.
Tran, D. T., Majerová, D., Veselý, M., Kulaviak, L., Ruzicka, M. C., Zámostný, P. (2019). On the mechanism of colloidal silica action to improve flow properties of pharmaceutical excipients. International journal of pharmaceutics, 556, 383-394.
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