Abstract
Objective: The objective of the present study was to develop and characterize an optimal stable nanosponges of Gliclazide (GLZ) by using the emulsion solvent diffusion method and aimed to increase its bioavailability and release the drug in sustained and controlled manner.
 Methods: The GLZ nanosponge was prepared by emulsion solvent diffusion method using different drug-polymer ratios (1:1 to 1:5) Eudragit S100 is used as a polymer. Differential scanning calorimetry (DSC) and Fourier transform infrared spectroscopy (FTIR) estimated the compatibility of GLZ with polymer. All formulations evaluated for production yield, entrapment efficiency, in vitro drug release, scanning electron microscopy (SEM) and stability studies.
 Results: The DSC and FTIR Studies revealed that no interaction between drug and polymer. The Production yield of all batches in the range of 73.8±0.30 to 85.6±0.32. Batch F3 showed the highest production yield, the entrapment efficiency of batch F3 70.6±0.77. The average particle size ranges from 303±2.36 to 680±2.50 nm. By the end of 10th hour F3 formulation shown highest drug release was found to be 94.40±1.12%. The release kinetics of the optimized formulation shows zero-order drug release. The stability study indicates no significant change in the in vitro dissolution profile of optimized formulation.
 Conclusion: The results of various evaluation parameters, revealed that GLZ nanosponges would be possible alternative delivery systems to conventional formulation to improve its bioavailability, the emulsion solvent diffusion method is best method for preparation of nanosponges and release the drug in sustained and controlled manner.
Highlights
Nanosponge is a modern category of material and it is made up of tiny particles with a narrow cavity of few nanometers
The main objective of the study was to increase the amount of dissolved drug molecules at the absorption site by increasing the dissolution rate, since for class II drugs like GLZ, in vivo dissolution rate is ratelimiting step in drug absorption. nanosponges were selected as the method of choice since it would be easier in subsequent formulating
The percentage yield of different batches was determined by weighing the nanosponges after drying
Summary
Nanosponge is a modern category of material and it is made up of tiny particles with a narrow cavity of few nanometers. Nanosponge obtained by using suitable cross-linking agent by different organic and inorganic materials [5] The stability of these formulations over a wide range of pH in GI fluids and stable over 130 °C compatible with most vehicles and ingredients. Reducing dosing frequency and increase patient compliance and comfort This drug delivery system having entrap wide variety of ingredients and reducing side effects, improve stability, increased elegance and formulation flexibility [6]. Nanosponges has shown promising results in improving solubility, wettability, dissolution rate of drug and subsequently its bioavailability [7]. GLZ is one of the second-generation sulphonylurea, antidiabetic drug which stimulates insulin release. In acidic and neutral aqueous media, GLZ exhibits very poor solubility This poor solubility may cause poor dissolution and unpredicted bioavailability. The nanosponges were prepared at various drug-to carrier weight ratios by emulsion solvent diffusion method
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