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.

Surface Modifiers on Composite Particles for Direct Compaction

“…Lactose, a fragile material, was modified by a binary modifier, i.e., MCC and cornstarch [ 160 ]. The proportion of lactose to MCC and cornstarch was 7:2:1, respectively, and they were co-processed by spray drying.…”

A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing

“…cellulose, MCC (microcrystalline cellulose), methyl cellulose, PVP (polyvinyl pyrollidone), PEG) are being used for tablet manufacturing [18]. Various coprocessed materials e.g., silicified MCC, α-lactose monohydrate-MCC, hydroxypropyl methylcellulose (HPMC)-α-lactose monohydrate, vinyl pyrollidone-vinyl acetate and corn starch-MCC-α-lactose monohydrate have been employed as binders in tablet formulations containing tramadol HCl, hydrochlorothiazide, acetyl salicylic acid [19][20][21][22].…”

Spray Drying for Direct Compression of Pharmaceuticals

“…CombiLac ® is composed of 70% α-lactose monohydrate, 20% microcrystalline cellulose, and 10% white native corn starch [94]. Mužíková et al [95] studied the properties of this spray-dried ternary mixture. They compared the flowability, compactability, and tablet properties of CombiLac ® with the corresponding physical mixture.…”