PL EN


Preferencje help
Widoczny [Schowaj] Abstrakt
Liczba wyników
Tytuł artykułu

Electron beam sterilization of implantable rods with risperidone and with 17-β-estradiol: a structural, thermal and morphology study

Treść / Zawartość
Identyfikatory
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
Poly(L-lactide-co-glycolide-co-trimethylene carbonate) rods with risperidone and 17-β-estradiol were sterilized by electron beam irradiation. The aim of the study was to assess electron beam irradiation impact on terpolymer composition, chain microstructure, glass transition temperature, molecular weight and the morphological features of rods. Methods: Hot melt extrusion in the formulation of rods was applied. Sterilization of the rods was performed by electron beam in an electron beam accelerator (10 MeV, 360 mA, 25 kGy). The following methods in the development of rods were applied: nuclear magnetic resonance, differential scanning calorimetry, gel permeation chromatography and scanning electron microscopy. Results: Sterilization influenced only glass transition temperature in blind rods and rods with risperidone. As for the other parameters, no significant changes were observed as far as a sterilization effect is concerned. However, some changes were noted after introducing drug substances and after extrusion. Conclusions: Electron beam irradiation of rods with risperidone and rods with 17-β-estradiol is an adequate method for sterilizing implantable drug delivery systems.
Rocznik
Strony
39--47
Opis fizyczny
Bibliogr. 30 poz., rys., tab., wykr.
Twórcy
  • School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia, Katowice, Chair and Department of Biopharmacy, Sosnowiec, Poland
autor
  • School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia, Katowice, Chair and Department of Biopharmacy, Sosnowiec, Poland
  • Centre of Polymer and Carbon Materials, Polish Academy of Sciences, Zabrze, Poland
autor
  • School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia, Katowice, Chair and Department of Biopharmacy, Sosnowiec, Poland
  • School of Pharmacy with the Division of Laboratory Medicine in Sosnowiec, Medical University of Silesia, Katowice, Chair and Department of Biopharmacy, Sosnowiec, Poland
  • Centre of Polymer and Carbon Materials, Polish Academy of Sciences, Zabrze, Poland
Bibliografia
  • [1] AMANN L.C., GANDAL M.J., LIN R., LIANG Y., SIEGEL S.J., In vitro–in vivo correlations of scalable PLGA-risperidone implants for the treatment of schizophrenia, Pharm. Res, 2010, 27(8), 1730–1737, DOI: 10.1007/s11095-010-0152-4.
  • [2] CAIRNS M.L., DICKSON G.R., ORR J.F., FARRAR D., HARDACRE C., SA J., LEMOINE P., MUGHAL M.Z., BUCHANAN F.J., The potential of electron beam radiation for simultaneous surface modification and bioresorption control of PLLA, J. Biomed. Mater. Res. A, 2012, 100 (9), 2223–2229, DOI:10.1002/jbm.a.34156.
  • [3] DOBRZYNSKI P., KASPERCZYK J., SMOLA A., PASTUSIAK M., SOBOTA M., Patent No. EP 2647656 A2, Munich, Germany, European Patent Office.
  • [4] DORATI R., COLONNA C., SERRA M., GENTA I., MODENA T., PAVANETTO F., PERUGINI P., CONTI B., γ-Irradiation of PEGd, lPLA and PEG-PLGA multiblock copolymers: I. effect of irradiation dose, AAPS PharmSciTech, 2008, 9 (2), 718–725, DOI: 10.1208/s12249-008-9103-3.
  • [5] DORATI R., PATRINI M., PERUGINI P., PAVANETTO F., STELLA A., MODENA T., GENTA I., CONTI B., Surface characterization by atomic force microscopy of sterilized PLGA microspheres, J Microencapsul, 2006, 23 (2), 123–133, DOI:10.1080/02652040500435220.
  • [6] ELLÄ V., NIKKOLA L., KELLOMÄKI M., Process-induced monomer on a medical-grade polymer and its effect on short-term hydrolytic degradation, J. Appl. Polym. Sci., 2011, 119 (5), 2996–3003, DOI: 10.1002/app.33027.
  • [7] FRIESS W., SCHLAPP M., Sterilization of gentamicin containing collagen/PLGA microparticle composites, Eur. J. Pharm. Biopharm., 2006, 63 (2), 176–187, DOI: 10.1016/j.ejpb.2005.11.007.
  • [8] GĘBAROWSKA K., KASPERCZYK J., DOBRZYŃSKI P., SCANDOLA M., ZINI E., LI S., NMR analysis of the chain microstructure of biodegradable terpolymers with shape memory properties, Eur. Polym. J., 2011, 47 (6), 1315–1327, DOI: 10.1016/j.eurpolymj.2011.02.022.
  • [9] HOLY C.E., CHENG C., DAVIES J.E., SHOICHET M.S., Optimizing the sterilization of PLGA scaffolds for use in tissue engineering, Biomaterials, 2000, 22 (1), 25–31, DOI: 10.1016/S0142-9612(00)00136-8.
  • [10] JOZWIAKOWSKA J., WACH R.A., ROKITA B., ULAŃSKI P., NALAWADE S.P, GRIJPMA D.W., FEIJEN J., ROSIAK J.M., Influence of electron beam irradiation of physicochemical properties of poly(timetylene carbonate), Polym. Degrad. Stab., 2011, 96 (8), 1430–1437, DOI: 10.1016/j.polymdegradstab.2011.05.010.
  • [11] KOBIELARZ M., GAZIŃSKA M., TOMANIK M., STĘPAK B., SZUSTAKIEWICZ K., FILIPIAK J., ANTOŃCZAK A., PEZOWICZ C., Physicochemical and mechanical properties of CO2 lasermodified biodegradable polymers for medical applications, Polym. Degrad. Stabil., 2019, 165, 182–195, DOI: 10.1016/j.polymdegradstab.2019.05.010.
  • [12] KONARZEWSKA B., WOŁCZYŃSKI S., SZULC A., GALIŃSKA B., POPŁAWSKA R., WASZKIEWICZ N., Effect of risperidone and olanzapine on reproductive hormones, psychopathology and sexual functioning in male patients with schizophrenia, Psychoneuroendocrino, 2009, 34 (1), 129–139, DOI: 10.1016/j.psyneuen.2008.08.015.
  • [13] KOTLARZ M., JORDAN R., WEGENER E., DOBRZYŃSKI P., NEUNZEHN J., LEDERER A., WOLF-BRANDSTETTER C., PAMUŁA E., SCHARNWEBER D., One step 3D printing of surface functionalized composite scaffolds for tissue engineering applications, Acta Bioeng. Biomech., 2018, 20 (2), 35–45, DOI:10.5277/ABB-01131-2018-02.
  • [14] LEONARD D.J., PICK L.T., FARRAR D.F., DICKSON G.R., ORR J.F., BUCHANAN F.J., The modification of PLA and PLGA using electron-beam radiation, J. Biomed. Mater. Res. A, 2009, 89 (3), 567–574, DOI: 10.1002/jbm.a.31998.
  • [15] LIU Y., SHIMIZU I., OMOYA T., ITO S., GU X.S., ZUO J., Protective effect of estradiol on hepatocytic oxidative damage, World J. Gastroenterol., 2002, 8(2), 363–366, DOI: 10.3748/wjg.v8.i2.363.
  • [16] LOO S.C.J., OOI C.P., BOEY Y.C.F., Influence of electronbeam radiation on the hydrolytic degradation behaviour of poly(lactide-co-glycolide) (PLGA), Biomaterials, 2005, 26 (18), 3809–3817, DOI: 10.1016/j.biomaterials.2004.10.014.
  • [17] MARTINEZ-SANCHO C., HERRERO-VANRELL R., NEGRO S., Study of gamma-irradiation effects on aciclovir poly(D,L--lactic-co-glycolic) acid microspheres for intravitreal administration, J. Control Release, 2004, 99(1), 41–52, DOI:10.1016/j.jconrel.2004.06.004.
  • [18] MOHR D., WOLFF M., KISSEL T., Gamma irradiation for terminal sterilization of 17β-estradiol loaded poly-(D,L--lactide-co-glycolide) microparticles, J. Control Release, 1999, 61 (1–2), 203–217, DOI: 10.1016/S0168-3659(99)00118-2.
  • [19] MONTANARI L., COSTANTINI M., SIGNORETTI E.C., VALVO L., SANTUCCI M., BARTOLOMEI M., FATTIBENE P., ONORI S., FAUCITANO A., CONTI B., GENTA I., Gamma irradiation effects on poly(DL-lactictide-co-glycolide) microspheres, J. Control Release, 1998, 56(1–3), 219–229, DOI: 10.1016/S0168-3659 (98)00082-0.
  • [20] PARK P.I.P., JONNALAGADDA S., Predictors of glass transition in the biodegradable poly‐lactide and poly‐lactide‐co-glycolide polymers, J. Appl. Polym. Sci., 2006, 100 (3), 1983–1987, DOI: 10.1002/app.22135.
  • [21] PLIKK P., ODELIUS K., HAKKARAINEN M., ALBERTSSON A.C., Finalizing the properties of porous scaffolds of aliphatic polyesters through radiation sterilization, Biomaterials, 2006, 27 (31), 5335–5347, DOI: 10.1016/j.biomaterials.2006.06.024.
  • [22] ROSARIO-MELÉNDEZ R., LAVELLE L., BODNAR S., HALPERIN F., HARPER I., GRIFFIN J., UHRICH K.E., Stability of a salicylatebased poly(anhydride-ester) to electron beam and gamma radiation, Polym. Degrad. Stabil., 2011, 96 (9), 1625–1630, DOI: 10.1016/j.polymdegradstab.2011.06.005.
  • [23] RYCHTER P., ŚMIGIEL-GAC N., PAMUŁA E., SMOLA--DMOCHOWSKA A., JANECZEK H., PROCHWICZ W., DOBRZYŃSKI P., Influence of radiation sterilization on properties of biodegradable lactide/glycolide/trimethylene carbonate and lactide/glycolide/ε-caprolactone porous scaffolds with shape memory behavior, Materials (Basel), 2016, 9 (1), E64, DOI: 10.3390/ma9010064.
  • [24] SILINDIR M., OZER Y., The effect of radiation on a variety of pharmaceuticals and materials containing polymers, PDA J. Pharm. Sci. Technol., 2012, 66 (2), 184–199, DOI: 10.5731/pdajpst.2012.00774.
  • [25] SINTZEL M.B., MERKLI A., TABATABAY C., GURNY R., Influence of irradiation sterilization on polymers used as drug carriers-a review, Drug. Dev. Ind. Pharm., 1997, 23 (9), 857–878, DOI: 10.3109/03639049709148693.
  • [26] SZEWCZENKO J., KAJZER W., GRYGIEL-PRADELOK M., JAWORSKA J., JELONEK K., NOWIŃSKA K., GAWLICZEK M., LIBERA M., MARCINKOWSKI A., KASPERCZYK J., Corrosion resistance of PLGA-coated biomaterials, Acta Bioeng. Biomech., 2017, 19 (1), 173–179, DOI: 10.5277/ABB-00556-2016-04.
  • [27] TUREK A., BORECKA A., JANECZEK H., SOBOTA M., KASPERCZYK J., Formulation of delivery systems with risperidone based on biodegradable terpolymers, Int. J. Pharm., 2018, 548 (1), 159–172, DOI: 10.1016/j.ijpharm.2018.06.051.
  • [28] TUREK A., KASPERCZYK J., JELONEK K., BORECKA A., JANECZEK H., LIBERA M., GRUCHLIK A., DOBRZYŃSKI P., Thermal properties and morphology changes in degradation process of poly(L-lactide-co-glycolide) matrices with risperidone, Acta Bioeng. Biomech., 2015, 17 (1), 11–20, DOI: 10.5277/ABB-00210-2014-02.
  • [29] TUREK A., OLAKOWSKA E., BORECKA A., JANECZEK H., SOBOTA M., JAWORSKA J., KACZMARCZYK B., JARZĄBEK B., GRUCHLIK A., LIBERA M., LIŚKIEWICZ A., JĘDRZEJOWSKA-SZYPUŁKA H., KASPERCZYK J., Shape-memory terpolymer rods with 17-β-estradiol for the treatment of neurodegenerative diseases: an in vitro and in vivo study, Pharm. Res., 2016, 33(12), 2967–2978, DOI: 10.1007/s11095-016-2019-9.
  • [30] VETTEN M.A., YAH C.S., SINGH T., GULUMIAN M., Challenges facing sterilization and depyrogenation of nanoparticles: effect on structural stability and biomedical application, Nanomedicine, 2014, 10(7), 1391–1399. DOI: 10.1016/j.nano.2014.03.017.
Uwagi
Opracowanie rekordu ze środków MNiSW, umowa Nr 461252 w ramach programu "Społeczna odpowiedzialność nauki" - moduł: Popularyzacja nauki i promocja sportu (2020).
Typ dokumentu
Bibliografia
Identyfikator YADDA
bwmeta1.element.baztech-09681744-5d57-4a21-9eef-584ad8ca3699
JavaScript jest wyłączony w Twojej przeglądarce internetowej. Włącz go, a następnie odśwież stronę, aby móc w pełni z niej korzystać.