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Characterization of Target Topical Ocular Delivery form of Levofloxacin
Clinical Therapeutics and milk are taken at different times. Also, having knowledge about medicines and which foods affect its therapeutic action is of utmost importance.
Characterization of Target Topical Ocular Delivery form of Levofloxacin N. Gongadze1; M. Dvali1; G. Sukoyan2; E. Tsivtsivadze2; T. Kezeli3; Z. Chapichadze4; I. Margvelashvili5; N. Dolidze3; and S. Jibuti4 1 Tbilisi State Medical University, Tbilisi, Georgia; 2Research Laboratory, Biotechpharm CE, Tbilisi, Georgia; 3Iv. Javakhishvili Tbilisi State University, Tbilisi, Georgia; 4LEPL State Regulation Agency for Medical Activies; and 5Association of Pharmaceutical Companies Representatives in Georgia Introduction: In the present work we developed and optimized levofloxacin loaded PLGA nanodispersions for enhanced ocular delivery of levofloxacin. Materials and Methods: The optimized nanodispersions were prepared by double emulsification solvent evaporation method using high pressure homogenizer. Particle size of nanodispersion was found to be dependent on PLGA concentration, PLGA:drug ratio, PVA concentration and Water:Oil phase volume ratio whereas drug encapsulation was related to PLGA concentration and PLGA:drug ratio. Encapsulation efficiency of optimized nanodispersion was 78% with a mean particle size of around 178 ± 12 nm which makes them a suitable candidate for ocular administration. The plasma half-life of levofloxacin was estimated to be 13 hours. Drug release kinetic studies of a sustained release profile of levofloxacin from nanodispersions was studied. Results: Plasma concentrations of levofloxacin were measured in 21 male and female adult subjects receiving bilateral topical ocular doses of levofloxacin solution every 8 hours for a total of 13 doses. Biphasic extended-release profile was produced in vitro. The mean steadystate Cmax and AUC were 2.87 ± 0.23 ng/mL and 44.5 ng·hr/mL, respectively. These systemic exposure values were at least 1000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of levofloxacin. Prevent ocular drainage of levofloxacin in nanodispersion form enhanced ocular bioavailability by 3.7-fold. The antibacterial activities of the nanosuspension were performed against S. aureus and P. aeruginosa. The levofloxacin-loaded PLGA nanosuspensions showed uniform in vitro corneal permeability across isolated goat cornea, indicating the suitability of the nanosuspension formulation in the ophthalmic delivery of levofloxacin. Conclusion: The optimised nano-suspension was found to be more active against S. aureus and P. aeruginosa compared to the marketed eye drops.
Characterization of Target Topical Ocular Delivery form of Levofloxacin Nikoloz N. Gongadze1; Merab M. Dvali1; Galina G. Sukoyan2; Edisher E. Tsivtsivadze2; Tamara T. Kezeli3; Zaza Z. Chapichadze4; Irakli I. Margvelashvili5; Nino N. Dolidze3; and Shota S. Jibuti4 1 Tbilisi State Medical University, Tbilisi, Georgia; 2Research Laboratory, Biotechpharm CE, Tbilisi, Georgia; 3Iv. Javakhishvili Tbilisi State University, Tbilisi, Georgia; 4LEPL State Regulation Agency For Medical Activies; and 5Association of Pharmaceutical Companies Representatives in Georgia Introduction: In the present work we developed and optimized levofloxacin loaded PLGA nanodispersions for enhanced ocular delivery of levofloxacin.
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Materials and Methods: The optimized nanodispersions were prepared by double emulsification solvent evaporation method using high pressure homogenizer. Particle size of nanodispersion was found to be dependent on PLGA concentration, PLGA:drug ratio, PVA concentration and Water:Oil phase volume ratio whereas drug encapsulation was related to PLGA concentration and PLGA:drug ratio. Encapsulation efficiency of optimized nanodispersion was 78% with a mean particle size of around 178 ± 12 nm which makes them a suitable candidate for ocular administration. The plasma half-life of levofloxacin was estimated to be 13 hours. Drug release kinetic studies of a sustained release profile of levofloxacin from nanodispersions was studied. Results: Plasma concentrations of levofloxacin were measured in 21 male and female adult subjects receiving bilateral topical ocular doses of levofloxacin solution every 8 hours for a total of 13 doses. Biphasic extended-release profile was produced in vitro. The mean steady-state Cmax and AUC were 2.87 ± 0.23 ng/mL and 44.5 ng·hr/mL, respectively. These systemic exposure values were at least 1000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of levofloxacin. Prevent ocular drainage of levofloxacin in nanodisperssion form enhanced ocular bioavailability by 3.7-fold. The antibacterial activities of the nanosuspension were performed against S. aureus and P. aeroginosa. The levofloxacin-loaded PLGA nanosuspensions showed uniform in vitro corneal permeability across isolated goat cornea, indicating the suitability of the nanosuspension formulation in the ophthalmic delivery of levofloxacin. Conclusion: The optimised nano-suspension was found to be more active against S. aureus and P. aeruginosa compared to the marketed eye drops.
Citizen Perception Regarding Drug Information And Safety C. Gurruchaga; G. Manso; F.J. Jimeno; L. Ordoñez; and E. Salgueiro University of Oviedo Introduction: To ascertain public opinion on drug information aimed at citizens enclosed in the package leaflet information and public perception of some safety aspects of medicines. Methods: Descriptive, cross-sectional study by means of a voluntary, anonymous survey aimed at citizens from May to December 2014 in Asturias, Northern Spain. An initial pilot study was performed to analyse the validity and feasibility of the survey. Surveys were filled out by the researcher according to the answers provided or self-completed. Considering the characteristics of the surveyed population, we analysed the reading comprehension difficulty of the package leaflet information as well as the public perception of drug safety. Results: A total of 223 (84.5%) of those surveyed claimed to read the medicine information leaflet: always read 166 (62.9%) (women 105 [39.8%], men 61 [23.1%]) and sometimes 57 (21.6%) (women 38 [14.4%], men 19 [7.2%]). Regarding educational level, 109 (41.3%) of those surveyed with higher or secondary education and 46 (17.4%) with primary studies, always read the information. Of those interviewed, 196 (74.2%) perceived prescribed medicines to be safer. Only 37 (14.0%) consider that both prescription and over-the-counter medicines are safe. In total 110 (41.7%) claimed to have had some adverse drug reaction (78.2% of them reported it to their doctor, 0.9% to the pharmacist, and 1.8% to both). Other medicine-related problems were experienced by 36 (13.6%) of those surveyed. Conclusions: Women claimed to read the package leaflet information more than men and also recognized a greater difficult in understanding. Although understanding the information leaflet is directly related
Volume 37 Number 8S
Characterization of Target Topical Ocular Delivery form of Levofloxacin N. Gongadze1; M. Dvali1; G. Sukoyan2; E. Tsivtsivadze2; T. Kezeli3; Z. Chapichadze4; I. Margvelashvili5; N. Dolidze3; and S. Jibuti4 1 Tbilisi State Medical University, Tbilisi, Georgia; 2Research Laboratory, Biotechpharm CE, Tbilisi, Georgia; 3Iv. Javakhishvili Tbilisi State University, Tbilisi, Georgia; 4LEPL State Regulation Agency for Medical Activies; and 5Association of Pharmaceutical Companies Representatives in Georgia Introduction: In the present work we developed and optimized levofloxacin loaded PLGA nanodispersions for enhanced ocular delivery of levofloxacin. Materials and Methods: The optimized nanodispersions were prepared by double emulsification solvent evaporation method using high pressure homogenizer. Particle size of nanodispersion was found to be dependent on PLGA concentration, PLGA:drug ratio, PVA concentration and Water:Oil phase volume ratio whereas drug encapsulation was related to PLGA concentration and PLGA:drug ratio. Encapsulation efficiency of optimized nanodispersion was 78% with a mean particle size of around 178 ± 12 nm which makes them a suitable candidate for ocular administration. The plasma half-life of levofloxacin was estimated to be 13 hours. Drug release kinetic studies of a sustained release profile of levofloxacin from nanodispersions was studied. Results: Plasma concentrations of levofloxacin were measured in 21 male and female adult subjects receiving bilateral topical ocular doses of levofloxacin solution every 8 hours for a total of 13 doses. Biphasic extended-release profile was produced in vitro. The mean steadystate Cmax and AUC were 2.87 ± 0.23 ng/mL and 44.5 ng·hr/mL, respectively. These systemic exposure values were at least 1000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of levofloxacin. Prevent ocular drainage of levofloxacin in nanodispersion form enhanced ocular bioavailability by 3.7-fold. The antibacterial activities of the nanosuspension were performed against S. aureus and P. aeruginosa. The levofloxacin-loaded PLGA nanosuspensions showed uniform in vitro corneal permeability across isolated goat cornea, indicating the suitability of the nanosuspension formulation in the ophthalmic delivery of levofloxacin. Conclusion: The optimised nano-suspension was found to be more active against S. aureus and P. aeruginosa compared to the marketed eye drops.
Characterization of Target Topical Ocular Delivery form of Levofloxacin Nikoloz N. Gongadze1; Merab M. Dvali1; Galina G. Sukoyan2; Edisher E. Tsivtsivadze2; Tamara T. Kezeli3; Zaza Z. Chapichadze4; Irakli I. Margvelashvili5; Nino N. Dolidze3; and Shota S. Jibuti4 1 Tbilisi State Medical University, Tbilisi, Georgia; 2Research Laboratory, Biotechpharm CE, Tbilisi, Georgia; 3Iv. Javakhishvili Tbilisi State University, Tbilisi, Georgia; 4LEPL State Regulation Agency For Medical Activies; and 5Association of Pharmaceutical Companies Representatives in Georgia Introduction: In the present work we developed and optimized levofloxacin loaded PLGA nanodispersions for enhanced ocular delivery of levofloxacin.
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Materials and Methods: The optimized nanodispersions were prepared by double emulsification solvent evaporation method using high pressure homogenizer. Particle size of nanodispersion was found to be dependent on PLGA concentration, PLGA:drug ratio, PVA concentration and Water:Oil phase volume ratio whereas drug encapsulation was related to PLGA concentration and PLGA:drug ratio. Encapsulation efficiency of optimized nanodispersion was 78% with a mean particle size of around 178 ± 12 nm which makes them a suitable candidate for ocular administration. The plasma half-life of levofloxacin was estimated to be 13 hours. Drug release kinetic studies of a sustained release profile of levofloxacin from nanodispersions was studied. Results: Plasma concentrations of levofloxacin were measured in 21 male and female adult subjects receiving bilateral topical ocular doses of levofloxacin solution every 8 hours for a total of 13 doses. Biphasic extended-release profile was produced in vitro. The mean steady-state Cmax and AUC were 2.87 ± 0.23 ng/mL and 44.5 ng·hr/mL, respectively. These systemic exposure values were at least 1000 times lower than the mean Cmax and AUC reported after therapeutic 400 mg oral doses of levofloxacin. Prevent ocular drainage of levofloxacin in nanodisperssion form enhanced ocular bioavailability by 3.7-fold. The antibacterial activities of the nanosuspension were performed against S. aureus and P. aeroginosa. The levofloxacin-loaded PLGA nanosuspensions showed uniform in vitro corneal permeability across isolated goat cornea, indicating the suitability of the nanosuspension formulation in the ophthalmic delivery of levofloxacin. Conclusion: The optimised nano-suspension was found to be more active against S. aureus and P. aeruginosa compared to the marketed eye drops.
Citizen Perception Regarding Drug Information And Safety C. Gurruchaga; G. Manso; F.J. Jimeno; L. Ordoñez; and E. Salgueiro University of Oviedo Introduction: To ascertain public opinion on drug information aimed at citizens enclosed in the package leaflet information and public perception of some safety aspects of medicines. Methods: Descriptive, cross-sectional study by means of a voluntary, anonymous survey aimed at citizens from May to December 2014 in Asturias, Northern Spain. An initial pilot study was performed to analyse the validity and feasibility of the survey. Surveys were filled out by the researcher according to the answers provided or self-completed. Considering the characteristics of the surveyed population, we analysed the reading comprehension difficulty of the package leaflet information as well as the public perception of drug safety. Results: A total of 223 (84.5%) of those surveyed claimed to read the medicine information leaflet: always read 166 (62.9%) (women 105 [39.8%], men 61 [23.1%]) and sometimes 57 (21.6%) (women 38 [14.4%], men 19 [7.2%]). Regarding educational level, 109 (41.3%) of those surveyed with higher or secondary education and 46 (17.4%) with primary studies, always read the information. Of those interviewed, 196 (74.2%) perceived prescribed medicines to be safer. Only 37 (14.0%) consider that both prescription and over-the-counter medicines are safe. In total 110 (41.7%) claimed to have had some adverse drug reaction (78.2% of them reported it to their doctor, 0.9% to the pharmacist, and 1.8% to both). Other medicine-related problems were experienced by 36 (13.6%) of those surveyed. Conclusions: Women claimed to read the package leaflet information more than men and also recognized a greater difficult in understanding. Although understanding the information leaflet is directly related
Volume 37 Number 8S