Formulation and optimization of gentamicin hydrogel infused with tetracarpidium conophorum extract via Central composite design for topical delivery

Abstract

ÖZAmaç: İstatistiksel olarak tasarlanmış deney ile birlikte Yüzey cevap grafiği metodolojisinin çok değişkenli prosesleri optimize etmede çok yararlı olduğu bulunmuştur. Bu çalışmanın amacı, iki bağımsız değişken olan permeabilite arttırıcılar/antioksidanlar (Transcutol ve Tetracarpidium conophorum EETC'nin etanolik ekstraktı) ve karıştırma oranının gentamisin hidrojelin akı ve permeasyonu üzerine olan etkisini değerlendirmektir. Gereç ve Yöntemler: Gentamisin hidrojelin formüle edilmesi için bir serbest radikal başlangıç polimerizasyon modifikasyonu kullanıldı. Permeabilite arttırıcı Transcutol: EETC (X1), Karıştırma hızı (X2) bağımsız değişkenlerinin etkisini araştırmak için bağımlı değişkenler Akı (Y1) ve 12 saatten sonra etken maddenin ex-vivo permeasyon miktarı açısından değerlendirilen 14 formülasyon serisi ile 32 faktöryel santral kompozit tasarım (CCD) kullanıldı. Introduction:Response surface methodology coupled with statistically designed experiment has been found to be very useful in optimising multivariable processes. The aim of this study is to evaluate the influence of two independent variables, a ratio of permeation enhancers/antioxidants (Transcutol and ethanolic extract of Tetracarpidium conophorum EETC) and stirring rate, on the flux and permeation of gentamicin hydrogel. Methods: A modification of free radical initial polymerization was utilized to formulate the gentamicin hydrogel. A 3² factorial central composite design was then utilized to investigate the effect of independent variables of permeation enhancer Transcutol: EETC (X1), Stirring speed (X2) via 14 formulation batches which were evaluated for dependent variables Flux (Y1) and amount of drug permeated after 12 hours (Y2) ex vivo. Results:The results of analysis of variance carried out to determine the fit of the models revealed that the models were statistically significant (p < 0.05) and did not show lack of fit (R2 > 0.80). The regression equation generated for flux was Y1 = 19.35 -25.82X1 -0.044X2 + 0.0097X1X2 + 11.86X21 and for cumulative permeation of gentamicin in 12 hours Y2= 315.50 -189.67X1 + 0.28X2 -1.29X1X2 + 123.55X21. The validity of the statistical models used for predicting flux and drug permeation was confirmed by carrying out three confirmation experimental runs at the identified optimum conditions. The results showed that there was no significant difference between the experimental results and those predicted by the statistical models. Discussion And Conclusion: The excellent correlation between the predicted and measured values shows the validity of statistical models (R2= 0.95). Utilization of antioxidant and permeation enhancer has been used for the first time to investigate the influence on dependent variables. Optimization of gentamicin hydrogel using central composite statistical design is valid for prediction of drug permeation and flux utilizing variables in formulation.

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