Soybean Polysaccharides Increase the Stability of Lansoprazole Enteric Coated Pellets.

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.