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Ashland Previews Fall Conference Exhibits, Including Expanded High-Purity Sugar Portfolio

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Key Takeaways

  • Ashland is enhancing its portfolio with high-purity excipients for injectables and low-nitrite options for oral solid doses, addressing critical drug development needs.
  • The introduction of Vialose sucrose aims to stabilize proteins in parenteral formulations, meeting strict global standards for injectable formulations.
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At CPHI and AAPS, Ashland plans to detail the impacts of its advanced excipients: ultra-low nitrite materials curb nitrosamine risk, while high-purity sucrose stabilizes complex biologics.

Ball and stick model of sucrose molecule | © Wirestock - stock.adobe.com

Ball and stick model of sucrose molecule | © Wirestock - stock.adobe.com

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Ashland is enhancing its pharmaceutical ingredients portfolio, focusing on high-purity excipients for injectables and low-nitrite offerings for oral solid doses, according to an announcement detailing products to be featured at CPHI Frankfurt, from Oct. 28–30, 2025, and AAPS PharmSci 360, to be held in San Antonio, Texas from Nov. 9 to 12, 2025 (1).

The company is directly addressing critical needs in drug development and manufacturing by introducing substances designed to increase product stability and mitigate emerging regulatory risks, particularly those concerning complex biologic medicines and nitrosamine formation.

Specifically targeting the burgeoning biologics market, Ashland has expanded its high-purity sugar excipient line used in life-saving medicines (1). Simultaneously, the company is raising the standard for quality control and transparency in oral solid dose manufacturing by detailing ultra-low nitrite specifications for common excipients. These developments offer material benefits for researchers navigating complex formulation challenges and quality assurance personnel seeking enhanced compliance and safety measures.

For pharmaceutical scientists and development teams, these portfolio additions signify changes in how specific formulation risks, particularly protein degradation and nitrosamine formation, can be proactively managed. Key considerations for the industry include:

What new stabilizing options are available for biologics?

Ashland launched Vialose sucrose, a high-purity sugar designed for parenteral formulations to stabilize proteins and act as a lyoprotectant in biological molecules, including monoclonal antibodies, vaccines, and peptides (1). It meets strict global standards, including endotoxin levels below 0.2 EU/g, making it suitable for injectable formulations.

How are nitrosamine risks reduced in oral solid doses?

New low-nitrite grades of commonly used excipients, such as Plasdone low nitrite povidone and Polyplasdone LN crospovidone, are available, featuring transparent specifications (<100ppb) reported on the Certificate of Analysis (1). This level of quality control allows manufacturers to proactively mitigate the risk of nitrosamine formation in final drug products and supports enhanced patient safety.

Is the injectable excipient portfolio expanding further?

Ashland’s high-purity Vialose family of sugar excipients, which currently includes trehalose dihydrate and the new sucrose, is scheduled to broaden further with the anticipated launch of Vialose mannitol in late 2026, meeting diverse formulation needs (1).

Click here for our CPHI Frankfurt coverage—including the speaker lineup for a new Leadership Summit (2)—here for AAPS coverage, and here to unlock a video rundown of this article from PharmTech Group’s Patrick Lavery.

References

1. Ashland. Ashland Adds High Purity Sucrose and Parenteral Applications to Injectables Portfolio, and Highlights Expanded Low Nitrite Pharmaceutical Excipients. Press Release. Oct. 20, 2025.
2. Mirasol, F. CPHI Frankfurt 2025 to Showcase Advances in Biopharma Manufacturing, Digital Transformation, and Global Industry Collaboration. PharmTech.com, Oct. 21, 2025.

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