Chitosan Loaded Mucoadhesive Microspheres of Gliclazide - Journal

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again weighed and recorded. Followed by 2 trials were done. Then the average of initial weights and final weights were recorded. initial weight - Final weight % Friability = ---------------------------------------- * 100 Initial weight In-vitro Mucoadhesive Strength Measurement Porcine buccal mucosa was obtained from local slaughter house and stored in Kreb's buffer solution. The experiment was performed within the 3 hours of procurement of mucosa. The porcine mucosa was washed with the distilled water and carefully tied to the glass slide with the help of cyanoacrylate adhesive and placed in petridish. Kreb's solution was added into the petridish up to the upper surface of the buccal mucosa to maintain buccal mucosal viability during the experiment. During the experiment the solution was maintained at 37°C. The tablet was stuck on to the glass stopper by using cyanoacrylate adhesive. The preload of 20 gm was placed on the glass stopper for 7 minutes to establish the adhesion bonding between tablet and porcine buccal mucosa. The preload and preload time were kept constant for all formulations. The preload was removed from stopper and water was added in to beaker from separating funnel at a constant rate of 100 drops per minute (Fig 1). The addition of the water was stopped when the tablet was removed from porcine buccal mucosa. The weight of water collected in 5 beaker was weighed which is taken as mucoadhesive strength . In-vitro Dissolution Studies The dissolution studies of the buccoadhesive tablet was performed in 900 ml of phosphate buffer (pH=6.8) using the USP type II dissolution apparatus under sink condition at 37 0 ± 0.2 C and 50 rpm. At the appropriate time interval, the sample was withdrawn and volume made up with distilled water. The samples were filtered through a 0.45 µm Millipore filter and amount of MT which was released determined spectrophotometrically at 274 nm and the release data were 17 evaluated kinetically . Glass Stopper Buccal Tablet Buccal mucosa Prakash Rao B et al./ Formulation and Evaluation of Mucoadhesive Buccal Drug Delivery System of Metoprolol Tartrate by Using Central Composite Design Fig. 1: Schematic diagram of in-vitro bioadhesive strength measurement device Separating Funnel 148 Analytical Method Accurate weight of powder equivalent to 50 mg metoprolol tartrate was taken and transferred in to 100 ml volumetric flask and volume was made up with distilled water. The powder solution was transferred in 250 ml of beaker and heated for 30 minutes for the extraction of the drug. Then, the solution was cooled and filtered. The samples were diluted appropriately and the absorbance was measured at 274 nm using the Shimadzu (model 1601) UV- visible 16 spectrophotometer. Regression Analysis The response parameters were statistically analyzed by applying one way ANOVA at 0.05 levels using commercially available software Design-Expert software (Stat-Ease Inc, Minneapolis, USA). The individual parameters were evaluated using the F test and Linear, 2FI, Quadratic models were generated for each response parameter using the multiple linear regression analysis (MLRA) equation: 2 2 2 2 R = b 0 + b 1 A+ b2B + b3AB + b4A + b5B + b6AB + b7A B (1) Where, R is the level of measured response, b 0 is the intercept of the arithmetic mean response of the 13 runs, A and B are the coded level of the independent variables. The AB is the interaction term, show how response changes when two 2 2 factors are simultaneously used. A , B are quadratic terms of the independent variables to evaluate the nonlinearity. Kinetic release Studies For the determination of the drug release kinetics from the buccal tablet, the in vitro release data were analyzed by zero order, first order, Higuchi and Korsmeyer and Peppas 17 equations . Zero order release Kinetic To study the zero order release kinetics the release data was fitted into the Following equation: dQ/dt = K (2) 0 Where, 'Q' is the amount of drug release, 'K ' is the zero order 0 release rate constant and 't' is the release time. The graph is plotted percentage cumulative drug release (%CDR) verses time. First Order Release Kinetic To study the first order release kinetics the release rate data are fitted into the following equation: dQ/dt = K Q (3) 1 Where, 'Q' is the fraction of drug release, 'K ' is the first order 1 release rate constant and't' is the release time. The graph is plotted log %CDR remaining verse time. RJPS, Jul - Sep, 2011/ Vol 1/ Issue 2
Prakash Rao B et al./ Formulation and Evaluation of Mucoadhesive Buccal Drug Delivery System of Metoprolol Tartrate by Using Central Composite Design Higuchi Release Model To study the Higuchi release model the release rate data are fitted into the following equation: ½ Q = K H t (4) Where, 'Q' is the fraction of drug release, 'KH' is the release rate constant and't' is the release time. The graph is plotted % CDR verses square root of time. Korsmeyer and Peppas Kinetics To study the Korsmeyer and Peppas release kinetics the release rate data are fitted in to following equation: n Mt/M∞ = K KP t (5) Where, Mt/M∞ is the fraction of drug release, 'K ' is the KP release rate constant and 't' is the release time and 'n' is the diffusion exponent related to mechanism of drug release. The graph is plotted log %CDR verses log time. Fourier Transform Infrared Spectroscopy (FT-IR) IR spectroscopy was carried out for the following A) Pure drug, B) Drug + carbopol C) Drug + HPC using Shimadzu FTIR model 8700by taking KBr disc. The instrument was operated under dry air purge and the scans were collected at -1 scanning speed of 2mm\sec with resolution of 4cm over the -1 18 region of 4000-400 cm . Differential Thermal Analysis (DTA) The sample of MT, carbopol, HPC and their binary mixtures were weighed and sealed in 40 ml aluminum crucibles with a pierced aluminum lid. The analyses were performed under nitrogen (nitrogen flow rate 50 ml/min) in order to eliminate oxidative and pyrrolytic effects at a standard heating rate of 15ºC/minute over a temperature range of 30ºC - 300ºC using a Mettler-Toledo star system. Stability studies An accelerated stability study was carried out according to ICH guidelines. The optimized formulation was kept in 2 ml 0 of glass vial and closed. The vials were kept at 40 ± 2 C / 75 RH ± 5% RH for six months in a dessicator. After end of every month, tablets were evaluated for bioadhesive strength and drug content. RESULTS AND DISCUSSION Development of Formulations Evaluation of Tablets The average thickness of the all buccal tablets ranges from 2.12 to 3.25 mm. The value of percentage variation in weight and friability were found to be with in the limit of 149 conventional oral tablets stated in the Indian pharmacopeia. Hardness of all buccal tablets was higher because of the carbopol. In all the formulations, the assay for drug content was found to be in the range from 47.56 mg to 49.65 mg. In-vitro drug release study after 8 hour Total amount of metoprolol tartrate released from all formulations ranges from 60.45% to 87.90% in 8 hours (Table 3). Decreased rate of drug release was observed with increase of the concentration of polymers. (Fig. 2-4) illustrates the release profile of all formulations. When the tablets contact Fig. 2: In-vitro drug release profiles of formulation F-1 to F-5 Fig. 3: In-vitro drug release profiles of formulation F-6 to F-9 Fig. 4: In- vitro drug release profiles of formulation F-10 to F-13 RJPS, Jul - Sep, 2011/ Vol 1/ Issue 2
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R G U H S Journal of Pharmaceutical
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RGUHS Journal of Pharmaceutical Sci
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Chitosan Loaded Mucoadhesive Microspheres of Gliclazide - Journal

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