Ashland to Exhibit Excipients at CPHI Milan and AAPS PharmSci 360

Ashland, an additives and specialty ingredients company, will be showcasing its oral solid dose (OSD) ingredients at two tradeshow events in October 2024: CPHI Milan and AAPS PharmSci 360. Specifically, the company will be highlighting its new low-substituted hydroxypropyl cellulose (hpc) and its improved polyplasdoneLN superdisintegrant.

The company’s new low-substituted hpc, klucel ls, an OSD excipient, is a multifunctional binder and disintegrant for the formulation of smaller tablets. According to the company, klucel ls “offers quick disintegration and rapid dissolution, anti-capping effect, ease of adoption (as a monographed ingredient), and enhanced stability (non-ionic and low nitrite levels). It is also biodegradable (as a non-microplastic disintegrant)” (1).

Klucel ls adheres to low-substituted hpc monograph requirements and “has fewer hydroxypropoxy groups on the cellulose backbone. This lower substitution results in physical chemical properties that differ from traditional klucel grades, including insolubility in water (as klucel ls low-substituted hpc absorbs water and substantially swells in volume enabling rapid tablet disintegration—unlike klucel, which is soluble in water and used primarily as a binder in oral solid dosage forms),” the company stated in the press release. The excipient is one in a series of future low-substituted products the company has planned.

“As a company rooted in science and innovation, the drive to find ingenious solutions applied to chemistry is in our DNA,” said Deneen Law, global strategic marketing director—Klucel, Ashland, in the press release. “We thrive on developing solutions to complex problems through a collaborative approach that offers the features and benefits our customers require, with the dependability and quality they demand. The removal of single-source global supply for low-substituted hpc and the production of consistent, high-quality products are just a few reasons why Ashland’s customer-centric approach is driving success across diverse industries.”

“Klucel hpc formed the basis of a new generation of oral pharmaceutical dosage forms, and the scientists at Ashland continue to innovate and develop new hpc products to meet the needs of the pharmaceutical industry. While klucel ls low-substituted hpc is part of the klucel brand family, it is not the same as klucel hpc,” Law concluded.

The klucel hpc for pharmaceuticals portfolio includes:

• binders: klucel ef hpc; klucel elf hpc; klucel exf hpc; klucel exf ultra hpc
• melt binders: klucel fusion hpc
• multifunctional binder and disintegrant: klucel ls low-substituted hpc
• CR polymers: klucel gxf hpc; klucel hf hpc; klucel hxf hpc; klucel lf hpc; kucel lxf hpc; klucel mxf hpc; klucel xtend hpc.

At the tradeshows, Ashland will also be reintroducing its high-purity crospovidone, polyplasdone LN superdisintegrant, which has nitrite levels at no more than 100 parts per billion to minimize the risk of N-nitrosamine forming in OSD formulations that contain crospovidone.

“We are thrilled to lead the industry with this significant advancement, our commitment to quality and safety is at the forefront of everything we do,” said Alejandra Alvarez, global strategic marketing director—Vinyl Pyrrolidone and Derivatives, Ashland, in the press release. “By providing detailed nitrite specifications, we are empowering our customers to make informed decisions and enhance their own quality control measures.”

Ashland may be found at CPHI Milan, in Milan, Italy, from Oct. 8–10 at booth 6D20 and at AAPS PharmSci 360 at booth 1903 in Salt Lake City, Utah, from Oct. 20–23.

Reference

1. Ashland. Ashland to Showcase New Pharmaceutical Oral Solid Dose Excipients at CPHI and AAPS. Press Release. Oct. 2, 2024.