Brittle Fracture Index as a Tool for Tablet Binder Selection.

      Аннотация: The effect of binder type and concentration on six high dose drugs was evaluated. The drugs which are used in this experiment are already in market and are available at a very high dose of 500mg and above. Three binders were used in the work at two different user levels. The binders are chosen of different chemistries so in order to predict a optimized formulation for each of the drug. The brittle fracture index of the formulation is calculated by compressing tablets with hole, the hole is an inbuilt defect which will help in propagation of crack into the tablet and enable capping and lamination. The tensile strengths of tablet with hole and without hole are used in calculating BFI. The so calculated BFI is correlated to the dissolution profile of the formulations and the most stable formulation can be formed. Here all the formulations showed excellent results minimum BFI values except Metformin HCl and Paracetamol giving high BFI values indicating susceptibility to Capp or laminate where as Efavirenz and Ciprofloxacin with low BFI values and less susceptible to Capp or laminate. Whereas Metformin has no dissolution failure but Efavirenz has dissolution issues.

Ключевые слова: Brittle Fracture Index, Binder Selection, Tablet Formulation, High Dose Drugs