Objective: The aim of the present work was to develop and validate a simple UV spectroscopic method for the determination of duloxetine, which is a thiophene derivative and a selective neurotransmitter reuptake inhibitor for serotonin, norepinephrine, and to lesser degree dopamine. Methods: The UV Spectrophotometric analysis was performed using Shimadzu UV-1800 and Shimadzu UV-1700 spectrophotometer by using solvent system acetonitrile and water in the ratio of 8:2. Detection was performed at a wavelength of 290 nm. Method validation was carried out according to ICH Q2R1 guidelines by taking the parameters linearity, accuracy, precision, ruggedness, and robustness, LOD and LOQ. Results: The UV Spectrophotometric method was found linear in the range of 10-50 μg/ml. The method was rugged and robust with % relative standard deviation less than 2. The extraction recoveries were found to be higher than 99% in all experimental conditions. Conclusion: Based upon the performance characteristics, the proposed method was found accurate, precise and rapid and suitable for the determination of Duloxetine for routine analysis.
Objective: The objective of this study is to develop extended release matrix tablet by taking mixture of chitosan and anionic polymers and then to study the drug release pattern for a low solubility drug Tramadol Hydrochloride (TH). TH has mean elimination half-life is ~6 hrs and requires dosing every 6 hrs in order to maintain optimal relief of chronic pain. So once-daily extended-release tablets are formulated by taking Chitosan (CS) and anionic polymers Eudragit-L100-55. Methods: The tablets were prepared by direct compression method. In vitro drug release was carried out under simulated gastric and intestinal condition to achieve drug release more than 20 hrs. Fourier transform infrared spectroscopy (FTIR) study was conducted to study any interaction between dug and ingredients. Results: CS and Eudragit-L combination form a Poly Electrolyte Complex which is responsible for extending drug release for low solubility drug. This complex formation is also confirmed by FTIR study. Conclusion: Stability studies (40ºC and 75 ± 5%RH) for 3 months indicated that Tramadol hydrochloride was stable in the matrix tablets.
In this experimental work an extended release matrix tablet of Benidipine Hydrochloride (BH) has been prepared to extend drug release for more than 18 hr which has advantage of continuous 24 hr control of blood pressure (BP) in hypertension patient, showing long-lasting pharmacological activity and increases the patient compliance. Benidipine is a calcium channel blocker that is used for the treatment of mild to moderate hypertension and angina pectoris and BH extended release tablets reduce the side effects associated with multiple dosing used during conventional tablets. Tablets are prepared tablets containing different polymers concentration through direct compression method. The in vitro percentage drug release and drug release mechanism were studied. From the drug release mechanism, the tablets showed the Higuchi square root model and R2 values for batch F2 (R2 =0.998) indicates that the drug released by diffusion mechanism and from Peppas equation n value 0.720 (range 0.89-1) indicates that diffusion–erosion mechanisms resulting from swelling and hydration behavior of Chitosan and along with HPMC K 100 M and Eudragit R S 100 extending drug release. Different pharmacokinetics parameters has been studied from results of in vivo study by using PK solver software which shows that marketed conventional BH tablet reached peak plasma concentration of 830.986 µg/ml after 2 hr of administration, where as selected optimized prepared tablets reached the maximum concentration of 708.83 µg/ml after 1 hr of administration, but it continues to release drug for more than 36 hr when in vivo was carried out in carried out on white New Zealand rabbits. These results proved that drug is released slowly for prolonged period of time and achieving better BP control. So based on this research outcome and results, we may conclude our objective is achieve by extending drug release pattern of BH.
Background: In this research study, an attempt has been made using Box–Behnken design (BBD) Response Surface Methodology to find optimized formulation variables at their 3 levels (Low, medium and high) to affect the dependent response which is % drug release pattern at different time intervals in extending drug release of Benidipine Hydrochloride(BH) matrix tablets. BH extended release tablets reduce the side effects associated with multiple dosing used during conventional tablets. Methods: As in the preliminary work, we have found the most profound formulation factors for extending drug release of BH matrix tablets are Eudragit RS 100 amount (X1), HPMC K 100 M (X2), chitosan amount (X3), which we selected as independent factors at their low and high levels for this study considering % drug release at three different time intervals i.e. R1 (% of drug release in 2hr), R2 (% of drug release in 15hr) and R3 (% of drug release in 18hr) as dependent variables using dissolution media of phosphate buffer pH 6.8 with 75rpm. Results: From the experimental runs of prepared tablets as predicted by Design Expert software, the model shows a quadratic equation due to less p value, and a very less difference was observed between adjusted R2 and predicted values R2in all selected responses which we considered as % drug release. Conclusion: Thereforeby using the graphical response surface plot of BBD software,the optimized formulation of BH extended release tablet of Eudragit RS 100, HPMC K 100 M, Chitosan containing an amount of 45mg , 105 mg, and 45.71 mg respectively which shows an extended drug release of more than 18 hr. For constructing a satisfying fit of the model for the optimized formulation, result analysis was carried out for the internally studentized residuals versus the experimental runs indicating all data points are placed within the limits and the values of the predicted and actual response of each run were normally distributed near a straight line.
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