TO EVALUATE PHYSICOCHEMICAL CHARACTERISTICS OF GRANULATION FOR LACTOSE AND ACETAMINOPHEN BY UTILIZING RHEOLOGICAL AND THERMAL TOOLS

The purpose of the study is to evaluate the effect of the granulation properties of Lactose depending upon the use of its crystalline forms and the impact of active (Acetaminophen) concentration using rheological and thermal tools. Lactose was chosen as an excipient available in different hydrate forms (anhydrous and monohydrate) and Acetaminophen (APAP) was selected as a model drug for the subject research. Preliminary research was performed to determine wet-granulation end-point utilizing a real time off-line PAT tool, thermal effusivity. Further research was continued for low-shear wet granulation for the powder blends of drug and excipients. The properties of wet and dried granulation were determined using Powder Rheometer, Thermal effusivity and DSC. The dried granules crushing strength were evaluated using Texture Analyzer. Acetaminophen is a strong cohesive active, which upon wet granulation was found to bind strongly with Lactose particles to form more flowable and compressible granular mass. The granulation prepared using anhydrous form of Lactose with APAP showed higher bulk density and permeability as compared to hydrate form of Lactose. The evaluation of dried granules indicated that % compressibility was lower and peak crushing force was higher for Lactose anhydrous as compared to Lactose monohydrate. A clear distinction in granulation properties using the approach presented in the current research using Lactose and Acetaminophen will provide a time and cost effective approach for formulation scientists for an early on formulation design and selection of excipients using advanced techniques of rheological and thermal tools.