ISP has announced that a new generation of ultra pure crospovidones is now available to the pharmaceutical industry on a commercial scale. The high-purity crospovidone, sold under the trade names Polyplasdone® Ultra and Polyplasdone Ultra-10, will be manufactured to standards well above commercial products currently in the market. ISP invested heavily in a new state-of-the-art production facility at Texas City, Texas (US) to produce high-purity, high-quality grades of Polyplasdone Ultra crospovidone specifically for the pharmaceutical industry.
According to Philip Strenger, senior vice president global pharmaceuticals, with the launch of ultra high-purity crospovidone, the pharmaceutical industry can now use this excipient technology for a broader spectrum of drug formulations. “Formulators of pharmaceuticals have long appreciated the combined disintegrant and solubilization functionality Polyplasdone crospovidone brings to oral solid dosage formulations, and they have asked ISP to raise the benchmark in purity so it can be formulated in conjunction with virtually every drug active,” he said. “Beginning in November, ISP will offer samples of Polyplasdone Ultra and Ultra-10 crospovidones manufactured on commercial-scale, fulfilling the pharmaceutical industry’s request for the next generation of crospovidone with a purity profile that will allow for use in some of the world’s most sensitive APIs. This is a further step in strengthening the ISP tool kit for increasing the bioavailability of poorly soluble actives.”
State-of-the-art production system
Having re-engineered the production technology for crospovidone in 2008, ISP is fully equipped to produce the world’s highest purity grades in Texas City, Texas. The validated system is configured for precise control of all manufacturing steps, from the initial reaction through purification and drying. Polyplasdone Ultra grades of high-purity crospovidone will also be packed under nitrogen to maintain product quality during shipping and storage.
Superdisintegrant of choice
Crospovidone is the superdisintegrant of choice for oral solid dosage forms of pharmaceuticals. ISP, the supplier of Polyplasdone XL crospovidone (with average particle sizes of 110µm to 140µm) and Polyplasdone XL-10 crospovidone (with average particle sizes of 25µm to 40µm), now offers these grades in ultra pure form.
Polyplasdone Ultra and Polyplasdone Ultra-10 grades have significantly lower peroxide levels than standard forms of crospovidone. These high-purity grades have peroxide levels of more than ten times lower than standard forms of crospovidone and have more stringent specifications than current requirements of the European Pharmacopeia monograph for crospovidone. “The higher purity and quality of crospovidone coming off ISP’s production system is proof that a new benchmark is set for this extraordinary excipient technology,” Strenger said.
Plant qualifications
All of ISP’s Polyplasdone crospovidone products have received the United States Pharmacopeia (USP) Verified Pharmaceutical Ingredient Mark, which is awarded to companies and pharmaceutical ingredients that pass all USP verification requirements, including a comprehensive GMP audit by the USP, thorough documentation review, and testing for purity and potency. To request samples of Polyplasdone Ultra and Polyplasdone Ultra-10 crospovidones, visit ISP’s website.