Milk‑Based Oral Formulations of Ibuprofen: An Investigation on the Role of Milk in Improving Dissolution Rate of Drug

Introduction: More than 40% of the newly developed drugs pose a problem of aqueous insolubility which  is  a  major  challenge  for  pharmaceutical  scientists  since  in  this  form;  drug  doesn’t  show  required  bioavailability  and  hence  sufficient  therapeutics  effect.  Objective: The improvement of dissolution  rate  of  ibuprofen  (IBF)  (poorly  water‑soluble  drug)  by  formulating  its  solid  dispersions  using milk as generally recommended as safe carrier was the goal and purpose of this study. Method:  For  this,  milk  containing  1.5%  fat  (named  yellow  milk  due  to  yellow‑colored  pack)  and milk containing 4.5% fat (named green milk due to green‑colored pack) were used. Initially, both  types  of  milk  were  rota  evaporated  to  obtain  free  flowing  powdered  form.  Then,  the  physical  mixtures were prepared in different ratios by simple mixing and solid dispersions were formulated in different ratios by solvent evaporation method using hot air oven. Various techniques were used to evaluate and characterize the physical mixtures and solid dispersions, which included melting point determination, solubility studies, differential scanning calorimetry (DSC), Fourier transform infrared spectroscopy, X‑ray diffraction (XRD), in vitro dissolution studies, and scanning electron microscopy (SEM).  Results: DSC and XRD studies showed reduction in peak intensity of drug indicating the conversion of crystalline drug into amorphous form. SEM studies indicated that the agglomerates formed were smaller and denser with a smooth surface. In vitro dissolution studies showed that the quantity of drug solubilized and the rate of dissolution increase after formulation into the solid dispersions. Conclusion: The milk powder was found to enhance the solubility of IBF due to the presence of casein which entrapped the hydrophobic drug by forming micelles.