Formulation and stability of directly compressed ibuprofen tablets

ABSTRACT

Different formulations of ibuprofen tablets were prepared by direct compression at 8 to 24 kN, employing lactose and dicalcium phosphate [Di-Cafos] as direct compressible vehicles [DCV]. For enhancing drug dissolution, hydrophilic materials, partially hydrolyzed gelatin [PHG], polyvinyl pyrrolidine [PVP] and urea were utilized in the formulations as simple and as ball-mill ground mixtures with the drug [1 1]. The tablets were tested after manufacture and during storage, at room temperature [RT] and at 40C or dissolution, disintegration time [DT], friability, hardness and drug content. Stability of ibuprofen in the different formulations were determined using a newly developed stability-indicating method HPLC. The fresh tablets fulfilled the USP XXIII specifications of dissolution for urea as a simple mixture. The dissolution of tablets stored at RT conformed with the pharmacopoeial limits, except gelatin/Di-Cafos tablets. At 40C, only PVP/lactose tablets failed the dissolution test. The hardness of the freshly prepared tablets exhibited the highest hardness values in addition to maximum sensitivity towards increase of compression force [8-24 kN], yet with longer DT