A study of a novel coprocessed dry binder composed of α-lactose monohydrate, microcrystalline cellulose and corn starch

Abstract

This paper deals with a study of the novel coprocessed dry binder Combilac®, which contains 70% of α-lactose monohydrate, 20% of microcrystalline cellulose and 10% of native corn starch. These tests include flow properties, compressibility, lubricant sensitivity, tensile strength and disintegration time of tablets. Compressibility is evaluated by means of the energy profile of compression process, test of stress relaxation and tablet strength. The above-mentioned parameters are also evaluated in the physical mixture of α-lactose monohydrate, microcrystalline cellulose and native corn starch and compared with Combilac. Combilac shows much better flowability than the physical mixture of the used dry binders. Its compressibility is better, tablets possess a higher tensile strength. Neither Combilac, nor the physical mixture can be compressed without lubricants due to high friction and sticking to the matrix. Combilac has a higher lubricant sensitivity than the physical mixture of the dry binders. Disintegration time of Combilac tablets is comparable with the disintegration time of tablets made from the physical mixture.

Keywords:

• Coprocessed dry binder
• Combilac
• disintegration time of tablets
• flow properties
• energy profile of compression
• stress relaxation
• lubricant sensitivity
• tensile strength of tablets

Acknowledgements

The study was supported by the firms Meggle Pharma, DFE Pharma, Roquette, SPI Pharma, which supplied the samples of the excipients tested.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the content and writing of this paper.