TY - JOUR T1 - MANUFACTURE OF SPHERICAL GRANULES OF ISOSORBIDE DINITRATE WITH MODIFIED RELEASE TT - MODİFİYE SALIMLI İSOSORBİT DİNİTRAT KÜRESEL GRANÜLLERİNİN ÜRETİMİ AU - Olıınykov, Dmytro AU - Kaplaushenko, Andrii AU - Trehub, Svetlana AU - Kovalyova, Katerina PY - 2020 DA - September Y2 - 2020 DO - 10.33483/jfpau.736331 JF - Journal of Faculty of Pharmacy of Ankara University JO - J. Fac. Pharm. Ankara PB - Ankara Üniversitesi WT - DergiPark SN - 1015-3918 SP - 481 EP - 493 VL - 44 IS - 3 LA - en AB - Objective: This study was aimed to obtain spherical matrix pellets of isosorbide dinitrate with different dissolution kinetics to create a multidosage medicinal form with controlled release of the active substance.Material and Method: Spherical matrix granules were obtained by extrusion-spherinization and coated with different amounts of polymer shell. Dissolution profiles of the obtained spheroids were compared with reference drug tablets.Result and Discussion: The results showed that the combination of spherical granules provides an isosorbide dinitrate release profile similar to the dissolution of Cardicet Retard tablets. The target dissolution profile is achieved using a combination of uncoated spherical granules and spheroids with a 10% film coating. The similarity coefficient (f2) is 73.6. KW - Isosorbide dinitrate KW - release profile KW - spherical matrix pellets N2 - Amaç: Bu çalışma, etkin maddenin kontrollü salımını yapan çok dozlu bir tıbbi form oluşturmak için farklı çözünme kinetiklerine sahip izosorbit dinitratın küresel matris pelletlerini elde etmeyi amaçlamıştır.Gereç ve Yöntem: Küresel matris granüller ekstrüder-sferonizer yöntemi ile elde edilmiş ve farklı miktarlarda polimer kabuk ile kaplanmıştır. Elde edilen kürelerin çözünme profilleri, referans ilaç tabletleri ile karşılaştırılmıştır.Sonuç ve Tartışma: Sonuçlar, küresel granüllerin kombinasyonunun, Cardicet Retard tabletlerinin çözünmesine benzer bir izosorbit dinitrat salım profili sağladığını göstermiştir. Hedef çözünme profili, kaplanmamış küresel granüller ve % 10'luk film kaplı kürelerin bir kombinasyonu kullanılarak elde edilmiştir. Benzerlik katsayısı (f2) 73.6'dır. CR - 1. Kovalenko, V.M., Lutaj, M.I., Bratus’, V.V. et. al.; Kovalenkao, V.M. (Ed.) (2008). Rukovodstvo po kardiologii’ [Guide for cardiology]. Kyiv: МОRІОN, 1424. http://snsk.az/snsk/file/2013-06-20_09-52-44.pdf CR - 2. Soman, B., Vijayaraghavan, G. (2017). The role of organic nitrates in the optimal medical management of angina. European Society of Cardiology 15 (2) CR - 3. Kumar, S., Jeet, K., Baldi, A. (2015). Recent technological advancements in multiparticulate formulations: The smart drug delivery systems. Asian Journal of Pharmaceutic 9 (4): 13-25. https://www.researchgate.net/publication/28891779 CR - 4. Roy, P., Shahiwala, A. (2009). Multiparticulate formulation approach to pulsatile drug delivery: current perspectives. J Control Release 134: 74–80. https://doi.org/10.1016/j.jconrel.2008.11.011 CR - 5. Shah, S., Shah, B.P., Patel,M., Patel, M.R. (2015) A review on extended release drug delivery system and multiparticulate system. World Journal of Pharmaceutical Research 4 (8):724-747. https://www.researchgate.net/publication/281098252 CR - 6. Jadhav, N., Irny, P., Mokashi, A., Souche, P., Paradkar, A. (2012). Pelletization by Extrusion Spheronization Technique: An Excipient Review. Drug Delivery Letters. 2. 132-145. https://www.researchgate.net/publication/284590372 CR - 7. Sagar, M., Tanaji, N., Sushilkumar, P. (2016). Extrusion–spheronization a promising pelletization technique: In-depth review. Asian Journal of Pharmaceutical Sciences II: 684–699. http://dx.doi.org/10.1016/j.ajps.2016.08.001 CR - 8. Oliinykov, D.S., Kaplaushenko, A.G. (2019a). Substantiation of manufacture technology development for the tablets of isosorbide dinitrate with modified release. Current issues in pharmacy and medicine: science and practice 12 (2): 160–165. https://doi.org/10.14739/2409-2932.2019.2.170982 CR - 9. European Directorate for the Quality of Medicines et al. & HealthCare: European Pharmacopoeia 9.0.[Internet]. 2019. CR - 10. Oliinykov, D.S., Kaplaushenko, A.G. (2019b). Development and validation of the HPLC-procedure for the quantitative determination of isosorbide dinitrate in matrix granules. Journal of Organic and Pharmaceutical Chemistry 17 (3): 51-58. https://doi.org/10.24959/ophcj.19.174771 CR - 11. CPMP/QWP/EWP/1401/98 Rev.1/Corr** «Guideline on the Investigation of Bioequivalence» CR - 12. Access mode: https://healthcare.evonik.com/sites/lists/NC/DocumentsHC/Evonik-Eudragit_brochure.pdf CR - 13. Bhaskaran, S., Lakshmi, P.K. (2010). Extrusion Spheronization –A Review. Int.J. PharmTech Res 2(4): 2429-2433. UR - https://doi.org/10.33483/jfpau.736331 L1 - http://dergipark.org.tr/tr/download/article-file/1100242 ER -