In the present investigation an attempt was made to prepare colon targeted enteric coated tablet containing different prednisolone solid dispersion formulations, to prevent ulcerative colitis, improve the patient compliance and reduce the side effects of drug in the gastro intestinal tract (GIT). Solid dispersion is one of the most widely used approaches to enhance the solubility as well as dissolution rate of poorly water soluble drugs. Solid dispersions (SDs) of Prednisolone with D-mannitol, PEG 4000 and Kollicoat IR were prepared and evaluated to deliver Prednisolone to the colon in a pre-solubilized form. The selected formula using drug compatible excipients was compressed into fast disintegrating tablets and then coated with Eudragit S100 (pH-responsive polymer), several variables related to both solid dispersion preparation (carrier type and drug to the carrier ratio) and tablet coating (coat level) were studied to show their effects on drug solubility and dissolution. Different analytical techniques like differential scanning caloremitry (DSC), powder x-ray diffraction (PXRD) and scanning electron microscopy (SEM) were studied to prove the change of drug particle from crystal to amorphous form in SDs. The 1:3 Prednisolone/Kollicoat IR SDs showed the greatest improvement in the dissolution rate. The coating level was critical for determining the duration of the lag phase. Best result was given by the 16% coat (Eudragit S100/ Dibutyl phthalate/ talc). This coating level showed an acceptable lag time for the proposed colonic targeting (5 h) as the selected tablet resisted pre-colonic pH values, followed by an immediate release stage in pH 7.4. The suggested covered (coated) tablets may provide a colonic delivery system for prednisolone with enhanced solubility and bioavailability.
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