Dewi Melani Hariyadi and Tristiana Erawati and Vita Fitria Ramadhani (2019) Experimental Design Approach in Erythropoietin-alginate Microsphere Preparation with Different Concentrations of Drug and Polymer. Journal of Report in Pharmaceutical Sciences, 8 (1). pp. 78-84. ISSN 2322-1232

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Abstract

Background: Microspheres as drug delivery system has been selected to increase stability of Erythropoietin (EPO) to achieve efficacy. Aim: Aim of this research was to determine effect of polymer and EPO concentrations on the characteristics. Materials and Method: Microspheres involved sodium alginate as polymer and CaCl as  a  crosslinker. The  concentrations  of  sodium  alginate  used  were 2%  and 3%,  and EPO were 5000 IU and 10000 IU. Formula of microspheres which consist of 2% and 3% of alginate and 5000  IU  EPO  were  called  F1  and  F2  respectively,  whereas microspheres  using  2  and  3%  alginate  and 10000  IU  EPO  was  named  F3  and  F4  respectively. Characterization including morphology, particle size, swelling index, and yield of microspheres prepared by ionotropic gelation aerosolization technique. Design of Experiment  (DoE)  was  used  to  analyze  the  formula.  Results: Results showed that particle sizes of EPO‑alginate  microspheres  were  3.36  ±  0.126µm,  3.42  ±  0.098µm,  3.88  ±  0.131µm  and  3.95  ± 0.151µm for  F1,  F2,  F3  and  F4 respectively.  The  swelling  index  measurement  based  on  mass  and  particle  size  of microspheres  of  all  formulas showed  an  index  of  less  than  10.  Respectively,  yield  was  77.84  ±0.290%, 86.65  ±  0.191%,  91.89  ±  0.210%,  and  94.65  ±  0.252%  for  F1  to  F4.  Using  the ANOVA  factorial  design, it  was  found  that  increasing  sodium  alginate  concentration  significantly  increased  yield,  while increasing EPO  concentration  significantly  increased  particle  size  and  yield  of  microspheres.  Both  sodium  alginate and EPO concentrations did not affect swelling index of microspheres. Range concentrations of sodium alginate and EPO that produced optimal characteristics of microspheres can be observed in the feasible area of design space overlaid contour plot generated from DoE study. Conclusion: EPO-alginate microspheres demonstrated the prospective as carrier and DoE is potential for further optimized formulations.

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