(776e) Formation and Dissolution Characteristics of Paracetamol Granules

The ability of active pharmaceutical ingredients (APIs) to affectively influence the targeted region is of great importance. Therefore, there is a need to offer lasting solutions and improve upon the current methods of formulation. This research analyzes physical and dissolution characteristics to determine the bonding tendencies of paracetamol granules formed using the drop method. Paracetamol is a common API and is considered a Category III drug. Initially, a series of experiments were conducted to form similarly sized granules. The process involved creating a paracetamol powder bed and dropping liquid binder onto the bed. Granules were separated from the powder bed using sieve trays. The cohesiveness of the granules was tested by dropping the granules onto a flat surface from various heights. The weights of each granule was measured before and after dropping to determine a percent attrition. The final investigation involved the ability of the granule to dissolve over time. This testing method involved the use of a USP Apparatus 3 to prevent coning seen in Apparatus 2. Further testing was conducted using UV Vis. Various binders were considered for this research including natural and synthetic polymers. Results show that using 8 drops of binder to form granules will deliver close to the normal dosage (325 – 500 mg) of the API. Synthetic binders produced more cohesive granules during the drop testing. Granules formed using polyvinylpyrrolidone (PVP) binder had the smallest percent attrition (0.1%) when dropped from a height of 24 inches. The rate of dissolution differed for each material examined; however, polyethylene glycol had a very consistent dissolution rate and reached a percent dissolution of 85% in one hour.