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Diltiazem Case Study

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Experimental design and procedure RSM has been widely used in optimization study, in which popular choices the box-behnken design used to establish as a convenient method for optimizing various processes. In the development of dosage form, crucial issue is to design an optimized pharmaceutical formulation in short time period with marginal trials. The levels of the three factors were selected on the basis of the preliminary studies carried out before implementing the experimental design. The dependent variables studied were the percent cumulative drug release (% CDR) at 8th hr (Y1), time to release 80 % (t80) of drug (Y2), mucoadhesive strength (Y3) and mucoadhesion retention time (Y4). The composition of different the mucoadhesive diltiazem …show more content…

This might have prevented the tablet from quick over-hydration and formation of slippery and weak mucilage that are easily removable from the mucosal surface. On the other hand, XNG might have formed weaker, more easily fractured gels due to its comparatively low molecular weight in addition to very low rate of swelling, resulting in low mucoadhesive strength. Wash off test was performed for all the matrix tablet formulations of diltiazem hydrochloride and the detachment time of the formulations is shown in table 6.6.10 and shown in Fig.6.6.5. The detachment time was found to be in the range of 4.33±0.06 to 9.68±0.28 hr, suggesting that all the formulations have sufficient mucoadhesive strength to remain intact with gastric mucosa for long time to release the drug in a controlled manner.Formation of hydrogen bonds between the hydrophilic functional groups of mucoadhesive polymers and the mucus layer or the mucosal surface is a prerequisite for extensive and longer mucoadhesion. The capillary force arises when water from the space between the mucosa and the polymer was taken up by a dry system. Once the bond is formed, reduction in the rate of swelling due to water uptake from the tissue surface may only prolong the association of the tablet with the mucosa.130 HECM and XNG alone therefore does not seem to play a significant role in imparting bioadhesive and gastric retention potential to the formulation. An individual and combined effect of these polymers along with compression force was conducted by plotting 3-D response and 2-D contour

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