DOI: https://doi.org/10.15587/2519-4852.2019.158618

Pharmacotechnological studies of model samples in the development of a composition of solid gastrosoluble capsules

Liliia Vyshnevska, Elizaveta Bysaga, Dmytro Soldatov

Abstract


Aim: the aim of our work was to experimentally substantiate the choice of auxiliary substances in the development of the composition of solid gastro-soluble capsules for the treatment of diseases of the gastrointestinal tract

Methods: pharmacotechnological research methods were used

Results. Conducted research on the development of the composition and technology of hard gelatin gastro-soluble capsules with a dry extract under the conventional name urocholum. The effect of a number of auxiliary substances and dry extract on the pharmacotechnological properties of the powder mass for filling capsules by the parameters of moisture absorption, fluidity and bulk density is studied. The optimal ratio of fillers and lubricants relative to the active pharmaceutical substance. The optimal composition of capsules that contain 50 mg of dry extract of urocholum and excipients in the amount of 0.210 g (lactose in the amount of 0.2074 g and magnesium stearate - 0.026 g) has been developed.

Analysis of the technological parameters of the capsules made on the basis of the developed composition showed that they meet the requirements of the State Pharmacopoeia of Ukraine.

Conclusions: it has been experimentally proved that it is expedient to use in the composition of capsules with a dry extract of the urocholum with complex of excipients - lactose in the amount of 0.2048 g and magnesium stearate - 0.026 g (per capsule)


Keywords


gelatin capsules; composition; dry extract; excipients; technology; gastrointestinal diseases

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References


Walters, P. A., Rowley, G., Pearson, J. T., Taylor, C. J. (1992). Formulation and physical properties of thixotropic gels for hard gelatin capsules. Drug Development and Industrial Pharmacy, 18 (15), 1613–1631. doi: https://doi.org/10.3109/03639049209040890

Chubka, M. B., Vronska, L. V., Zarivna, N. O., Hroshovyi, T. A., Hureieva, S. M. (2012). Suchasnyi stan stvorennia, vyrobnytstva i kontroliu yakosti kapsul. Farmatsevtychnyi chasopys, 2, 165–168.

Dudok, T., Savaryn, V., Meyer, C., Cherpak, V., Fechan, A., Lychkovskyy, E. et. al. (2016). Lasing cholesteric capsules. Ukrainian Journal of Physical Optics, 17 (4), 169. doi: https://doi.org/10.3116/16091833/17/4/169/2016

Pertsev, I. M., Rybachuk, V. D., Dmytrievskyi, D. I.; Pertsev, I. M. (Ed.) (2010). Dopomizhni rechovyny v tekhnolohii likiv: vplyv na tekhnolohichni, spozhyvchi, ekonomichni kharakterystyky i terapevtychnu efektyvnist. Kharkiv: Zoloti storinky, 600.

Felle, I., Whiteside, R., Vollmer, R. (2007). Alternatives for lactose. News technical, JRS Pharma, 10–12.

Kazarinov, M. O., Shteinhart, M. V., Pashneva, R. O. (2005). Tverdi likarski formy: pidsumky ta perspektyvy rozrobok tekhnolohichnykh laboratoriy DP DNTsLZ. Farmakom, 2-3, 18–24.

Heorhyevskoho, V. P., Koneva, F. A. (Eds.) (2000). Tekhnolohyia i standartyzatsyia lekarstv. Vol. 2. Kharkiv: RYREH, 784.

Ennis, B. (2005). Theory of Granulation. Drugs and the Pharmaceutical Sciences, 7–78. doi: ttps://doi.org/10.1201/9780849354953.ch2

Derzhavna Farmakopeia Ukrainy. Vol. 1 (2015). Kharkiv: DP «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 1128.

Swarbrick, J. (Ed.) (2007). Encyclopedia of pharmaceutical technology. New York: Informa Healthcare USA, Inc., 4372.

European Pharmacopоeia 9.0. Available at: http://online6.edqm.eu/ep900


GOST Style Citations


Formulation and physical properties of thixotropic gels for hard gelatin capsules / Walters P. A. et. al. // Drug Development and Industrial Pharmacy. 1992. Vol. 18, Issue 15. P. 1613–1631. doi: https://doi.org/10.3109/03639049209040890 

Suchasnyi stan stvorennia, vyrobnytstva i kontroliu yakosti kapsul / Chubka M. B. et. al. // Farmatsevtychnyi chasopys. 2012. Issue 2. P. 165–168.

Lasing cholesteric capsules / Dudok T. et. al. // Ukrainian Journal of Physical Optics. 2016. Vol. 17, Issue 4. P. 169. doi: https://doi.org/10.3116/16091833/17/4/169/2016 

Pertsev I. M., Rybachuk V. D., Dmytrievskyi D. I. Dopomizhni rechovyny v tekhnolohii likiv: vplyv na tekhnolohichni, spozhyvchi, ekonomichni kharakterystyky i terapevtychnu efektyvnist / ed. by Pertsev I. M. Kharkiv: Zoloti storinky, 2010. 600 p.

Felle I., Whiteside R., Vollmer R. Alternatives for lactose // News technical, JRS Pharma. 2007. Р. 10–12.

Kazarinov M. O., Shteinhart M. V., Pashneva R. O. Tverdi likarski formy: pidsumky ta perspektyvy rozrobok tekhnolohichnykh laboratoriy DP DNTsLZ // Farmakom. 2005. Issue 2-3. P. 18–24.

Tekhnolohyia i standartyzatsyia lekarstv. Vol. 2 / ed. by Heorhyevskoho V. P., Koneva F. A. Kharkiv: RYREH, 2000. 784 p.

Ennis B. Theory of Granulation // Drugs and the Pharmaceutical Sciences. 2005. P. 7–78. doi: ttps://doi.org/10.1201/9780849354953.ch2 

Derzhavna Farmakopeia Ukrainy. Vol. 1. Kharkiv: DP «Ukrainskyi naukovyi farmakopeinyi tsentr yakosti likarskykh zasobiv», 2015. 1128 p.

Encyclopedia of pharmaceutical technology / J. Swarbrick (Ed.). 3-rd ed. New York: Informa Healthcare USA, Inc., 2007. 4372 p.

European Pharmacopоeia 9.0. URL: http://online6.edqm.eu/ep900







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