Development and Optimization of Controlled Drug Release Formulation of Diclofenac Sodium Based on Osmotic Technology
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Date
2012-07-03
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Int J Pharm Res Allied Sci
Abstract
The aim of this study is to develop and optimize an osmotically controlled drug delivery system of Diclofenac
sodium. Osmotically controlled oral drug delivery systems utilize osmotic pressure for controlled delivery of active
drugs. Drug delivery from these systems, to a large extent, is independent of the physiological factors of the
gastrointestinal tract .Differential scanning calorimeter (DSC) was used to evaluate the drug–excipient
compatibility , based on the results of DSC, excipients defined in the formula were found to be compatible with
Diclofenac sodium. Formulation variables like type of osmotic agent (Sodium chloride, Mannitol, Lactose) , level of
pore former and plasticizer , percent weight gain were found to affect the drug release from the developed
formulations. The release performance of Diclofenac sodium from the optimized formulations was studied over a
period of 12 h. Drug release was inversely proportional to the membrane weight but directly related to the initial
level of pore former in the membrane. On the basis of release results, a three-level three-factorial Box–Behnken
experimental design was used to characterize and optimize three formulation parameters, i.e. level of osmotic agent ,
pore former and plasticizer .The chosen dependent variables (responses) were a cumulative percentage of dissolved
diclofenac sodium over a period of 12 h..The release from the developed formulations was independent of pH and
agitational intensity, but dependent on the osmotic pressure of the release media. From dissolution models it was
observed that drug release from optimized formulation exhibited zero order release kinetics. The formulations were
found to be stable after 3 months of accelerated stability studies (40 o C and 75%RH). Prediction of steady-state
levels using the superposition method showed the plasma concentrations of Diclofenac sodium to be within the
desired range
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Citation
Mutyaba, M. R., Wang, B., & Xue, Y. (2012). Development and optimization of controlled drug release formulation of diclofenac sodium based on osmotic technology. Int J Pharm Res Allied Sci, 1(3), 43-59.