Разработка метода получения полимерных микросфер, содержащих иммобилизованный диклофенак

The dependence of characteristics of microspheres and the kinetics of drug release from the particles on the type and intensity of mechanical action on the emulsion upon the preparation of polymeric microspheres containing encapsulated diclofenac based on a copolymer of lactic and glycolic acids was investigated. According to the results of the research conditions were selected for the production of microspheres with the gradual release of drug from the particles during two weeks. The polymer microspheres are promising for further study and creation of prolonged dosage forms of diclofenac on their basis.На основании проведенных исследований предложен метод получения полимерных микросфер с иммобилизованным диклофенаком. Разработанная методология иммобилизации диклофенака позволила получить полимерные микросферы с характеристиками, обеспечивающими пролонгированное высвобождение лекарственного вещества из полимерной матрицы

Разработка и валидация метода количественного определения диклофенака в полимерных микросферах

This article describes a new method of determining concentration of active ingredient in diclofenac-loaded polymer microspheres by using HPLC analysis. Proposed method showed better repeatability than more commonly used UV-Vis spectrometry. Isocratic liquid chromatograph with Luna C18 (2) Phenomenex column and UV detector (254 nm) was employed. Various parameters, such as specificity, repeatability, limit of quantification and stability, were measured to validate the method. Chromatogram showed only diclofenac-related peaks, which means specificity was adequate. Recovery was determined using 5 standard diclofenac solutions with known concentration. Repeatability and reproducibility were calculated based on data from two series of microspheres. LOQ was found using standard curve. Stability was observed during 30 days since sample preparation. Based on these results, suggested method successfully passed the validation process and can be used for quality control of diclofenac-loaded microspheres.В статье предложена новая методология количественного определения диклофенака в виде свободной кислоты, инкапсулированного в полимерный носитель, позволившая повысить точность определения содержания лекарственного вещества

Development of a method for preparing polymer microspheres containing immobilized diclofenac

The dependence of characteristics of microspheres and the kinetics of drug release from the particles on the type and intensity of mechanical action on the emulsion upon the preparation of polymeric microspheres containing encapsulated diclofenac based on a copolymer of lactic and glycolic acids was investigated. According to the results of the research conditions were selected for the production of microspheres with the gradual release of drug from the particles during two weeks. The polymer microspheres are promising for further study and creation of prolonged dosage forms of diclofenac on their basis

Elaboration and validation of method of quantitative determination of diclofenac in polymeric microspheres

This article describes a new method of determining concentration of active ingredient in diclofenac-loaded polymer microspheres by using HPLC analysis. Proposed method showed better repeatability than more commonly used UV-Vis spectrometry. Isocratic liquid chromatograph with Luna C18 (2) Phenomenex column and UV detector (254 nm) was employed. Various parameters, such as specificity, repeatability, limit of quantification and stability, were measured to validate the method. Chromatogram showed only diclofenac-related peaks, which means specificity was adequate. Recovery was determined using 5 standard diclofenac solutions with known concentration. Repeatability and reproducibility were calculated based on data from two series of microspheres. LOQ was found using standard curve. Stability was observed during 30 days since sample preparation. Based on these results, suggested method successfully passed the validation process and can be used for quality control of diclofenac-loaded microspheres