Soybean Polysaccharides Increase the Stability of Lansoprazole Enteric Coated Pellets

TL;DR

This study shows that adding soybean polysaccharides to lansoprazole capsules improves their stability and acid resistance, which could lead to better drug formulations.

Contribution

The novel use of soybean polysaccharides as a disintegrant in lansoprazole formulations is explored for the first time in pharmaceutical applications.

Findings

SSPS-containing pellets showed higher release rates and better acid resistance compared to commercial pellets.

X-ray analysis confirmed similar crystal forms between new and commercial lansoprazole pellets.

The new formulation demonstrated improved stability under both long-term and accelerated storage conditions.

Abstract

Background/Objectives: Lansoprazole (LNS) is widely used to treat and prevent stomach and intestinal ulcers and as a proton pump inhibitor with low solubility and high permeability. Soluble soybean polysaccharides (SSPS) are well-known disintegrants in food processing but are rarely used in the pharmaceutical field. In this study, we included SSPS as a disintegrant in LNS formulation for pharmaceutical use to investigate the effect of SSPS on the characteristics, dissolution curve, and stability of LNS enteric coated pellets. Methods: The screening of multiple excipients in formulation optimized the release and stability profile of enteric LNS pellets. The final enteric coated LNS pellet containing SSPS were evaluated by LNS crystal form, release profile, and stability. Results: X-ray powder diffraction revealed that this new LNS pellet and commercial reference LNS pellet had similar crystal form by X-ray powder diffraction. Under both long-term and accelerated conditions, these new SSPS-containing LNS pellets had higher release rate and better acid resistance than reference marketed LNS pellets. Conclusions: Inclusion of SSPS in LNS formulation could increase the physicochemical stability of the enteric coated capsules after storage, providing the basis of SSPS for further development and utilization in pharmaceutical formulation as a promising excipient.

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