Lacagpregs - a group of novel multifunctional excipients: development and solid state characterization

Abstract

Background: The need for multifunctional excipients useable in wet granulation and direct compression informed the quest for this study.

Objective: This study was aimed at developing multifunctional excipient series from which product(s) with suitable characteristics for application in tablet production may be harnessed.

Method: A mixture of lactose and cashew gum solutions at 50oC was co-precipitated with chilled ethanol. A dispersion of partially pregelatinized starch in ethanol was added to the co-precipitate and agitated using a planetary mixer operated at three arbitrary speed levels (L1, L2, L3) and time intervals (10, 30, 60 min) at 10±1oC to generate the products. Granule size was homogenized by ouble screening through 600 µm sieve. The granules were characterized and the best product was used to formulate tablets by direct compression and wet granulation.

Results: Agitating at the arbitrary speed, L2, for 30 min was the optimum condition for generating the highest excipient yield. FTIR revealed that interactions between primary constituents during the production process were physical. X-ray powder diffraction and DSC showed that higher agitator's speed and/or longer agitation time generated less crystalline products. The products differed in moisture sorption characteristics but the differences were not statistically significant. The less crystalline products displayed better deformation upon compaction with little or no voids. Tablets formulated with lacagpregs met official requirements on quality and compared without significant difference to those of similar tablets formulated with standard excipients.

Conclusion: Lacagpregs, the products of this simple technique, may function as multifunctional excipients in tablet formulation via wet granulation or direct compression.