Self-Affirmed GRAS Status Granted for Plasdone Binders and Polyplasdone Disintegrants
ISP announced Plasdone K-29/32 and Plasdone K-90 binders as well as Polyplasdone XL and XL-10 disintegrants have earned self-affirmed GRAS (Generally Recognized as Safe) status. According to the FDA, self-affirmed GRAS status is awarded to any substance that is generally recognized among qualified experts as having been adequately shown to be safe under the conditions of its intended use. ISP excipients obtained GRAS status for use in nutritional and supplement products after a comprehensive evaluation of research and toxicology studies by a qualified, independent scientific panel.
Plasdone K-29/32 and Plasdone K-90 binders are linear homopolymers of N-vinyl-2-pyrrolidone. Among other uses, the polymers serve as highly efficient wet granulation binders. Plasdone K-29/32 and Plasdone K-90 polymer conform to USP/NF, Ph. Eur and Japanese monograph specifications for Povidone.
Polyplasdone XL and XL-10 disintegrants are insoluble, crosslinked, homopolymers of N-vinyl-2-pyrrolidone and provide rapid disintegration to wet and dry granulations and direct compression tablet formulations. Polyplasdone disintegrants conform to USP/NF, Ph. Eur and Japanese monograph specifications for Crospovidone.