Studies On Ibuprofen Rapidly Dissolving Oral Tablet

In order to increase solubility and bioavailability of poorly soluble drugs and make taking easier for special patients, new preparations have been developed. As one kind of fast release preparations, rapid dissolving tablet in mouth has some advantages of both tablets and liquid preparation, which not only solves the problems of difficult oral taking, improves bioavailability, but also brings convenience to manufacturing, transportation and preservation. Ibuprofen is selected as a model drug.Following pharmaceutical pre-formulation and blank formulation investigation,preparation technology and combined excipients formulation are screened. The final formulation and preparation technology of ibuprofen rapidly dissolving oral tablet are developed. The optimal formulation: The tablet weighs 0.310g and contains 40mg ibuprofen, 6.45% Gelatin, 51.61% Mannitol, 8.06% PEG6000 and 6.45% Glycine. The optimal preparation technology: solutionⅠis prepared by dissolving excipients in water while solutionⅡis prepared by dissolving ibuprofen in anhydrous alcohol. Then, with magnetic force mixing, solutionⅡis poured into solutionⅠ. After stirring for 30min, the above liquid mixture is loaded into PVC bubbling cap and the load volume is 1mL per hole. After that they are frozen for 12h and then lyophilized for 5h. The final product is obtained.The release kinetics in vitro of the ibuprofen rapidly dissolving oral tablet is studied and accumulated dissolution of ibuprofen is about 94% in 45s. The release profile closely conforms to Higuchi model. The appearance, disintegration time, hardness and friability, content, content uniformity and tablets weight difference of the rapid dissolving tablet in mouth are proved to meet the specificationThe stability of the rapid dissolving tablet is studied. From the results of the classical stress tests, it can be concluded that the sample is stable under 4500Lx and below 60℃, after 10 days under RH75% and RH92.5%, its weight increases 3.62% and 4.83% respectively and after 1h under 80℃, every index changes largely. Long-term observation tests proved the samples are stable under 25℃for 3 month.