Comparative Evaluation of Co-processed Lactose and Microcrystalline Cellulose with Their Physical Mixtures in the Formulation of Folic Acid Tablets

Abstract

In this study, a new co-processed filler–binder ingredient for direct compression, MicroceLac 100, was compared with three different lactoses mixed with microcrystalline cellulose. The aim was to improve a folic acid tablet formulation. Therefore, the influence of drug addition to these mixtures was studied with regard to flow and binding properties. Another part of the study was focused on the interaction and segregation behavior of the drug.

MicroceLac 100 showed superior flow and binding properties. Good adhesion of folic acid to the MicroceLac 100 particles could decrease demixing and segregation. The improved characteristics of co-processed material are attributed to spray drying. Sodium stearyl fumarate was chosen as a lubricant, based on ejection force measurements. The content uniformity of the newly formulated direct compression tablets met the official requirements.

Keywords:

• Co-processing
• Direct compression
• Lactose
• MicroceLac
• Segregation
• Spray-drying