Functional Excipients
Ligand Partner SQ Innovation Receives FDA Approval for Lasix ONYU, an At-Home Treatment for Edema in Heart Failure Patients
Ligand Pharmaceuticals Incorporated recently announced that its partner SQ Innovation Inc. has received approval from the US FDA for Lasix ONYU (furosemide injection), a novel…
Roquette Boosts Extensive Cyclodextrins Portfolio With Launch of KLEPTOSE® Crysmeb methyl-beta-cyclodextrin for Oral & Parenteral Formulations
Roquette, a global leader in plant-based ingredients and pharmaceutical excipients for the health and nutrition sectors, recently launched of its latest novel pharmaceutical excipient: KLEPTOSE®…
SPECIAL FEATURE - Excipients: Innovation in a Shifting Pharma Landscape
Cindy H. Dubin speaks with several companies and highlights this innovation and reveals how excipient suppliers are doing their part to ensure a reliable, resilient, and compliance-driven supply chain.
LIPID FORMULATION DEVELOPMENT - Why Softgels Are the Technology of Choice
Dipanwita De, PhD, and Kaspar van den Dries say solubility and bioavailability in OSD formulations remain major challenges within the early stages of drug development. While technological innovations have allowed the pharmaceutical industry to make progress in solving this hurdle, choosing formulations that help achieve desirable solubility and bioavailability can help speed up development of the most promising molecules.
EXCIPIENT TECHNOLOGY - Driving Oral Drug Delivery Innovation With Safe, Reliable Lipid Excipients
Nick DiFranco, MEM, says amidst the uncertainty of novel ingredients and formulation techniques, lipid excipients provide a safe, proven platform for enhancing in vivo formulation performance, enabling innovation without sacrificing scalability or regulatory confidence.
LIPID SOURCING & SELECTION - Navigating the Lipid Landscape: Overcoming the Challenges of Lipid Sourcing & Selection for LNPs
Donald Kelemen, PhD, says one of the most significant challenges lies in selecting and sourcing the molecules at the heart of LNPs: lipids. The right choices can optimize stability, efficacy, and scalability, while the wrong ones can introduce roadblocks that are difficult (and costly) to overcome.
Roquette Unveils POLYOX ES Packaging to Advance Excipient Stability & Sustainability
Roquette has recently launched POLYOX Extended Stability (ES) packaging, a customer-driven innovation that delivers measurable improvements in excipient stability, handling, and environmental impact. POLYOX Water…
BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America
New Good Manufacturing Practice (GMP) Solution Center in Wyandotte, Michigan expands BASF’s existing network of poloxamers sites Production capabilities are unique to industry and enable…
Veranova Devens Site Breaks Ground on ADC Facility Expansion
Devens, MA, USA — Government officials, industry leaders, and local business representatives gathered yesterday to mark the groundbreaking of Veranova’s latest expansion at its Devens,…
SPECIAL FEATURE- Outsourcing Formulation Development & Manufacturing: CDMOs Are Making Their Supply Chains More Resilient & Secure
Contributor Cindy H. Dubin speaks with many CDMO professionals to get their insights and perspectives on the current state of the industry.
Colorcon & ASHA Cellulose Announce New Partnership to Support the Development & Manufacture of Barrier Membrane Formulations for the Pharmaceutical & Nutraceutical Industries
Colorcon recently announced an exclusive partnership with ASHA Cellulose, a leading provider of organo-soluble Ethyl cellulose polymers widely used in the pharmaceutical and dietary supplement…
Roquette Announces New Organization Following Acquisition of IFF Pharma Solutions
Roquette recently announced a new organization following the successful acquisition of IFF Pharma Solutions announced on May 1. The new organization is designed to enhance…
Roquette Completes the Acquisition of IFF Pharma Solutions
Roquette recently announced the successful completion of its acquisition of IFF Pharma Solutions. This strategic milestone marks a significant step forward in its ambition to…
SPECIAL FEATURE - Bioavailability & Solubility: The Promise of Novel Ingredients
Contributor Cindy H. Dubin, speaks with several innovating companies to discuss the use of novel excipients as well as other methods and technologies for tackling bioavailability and solubility once and for all.
ORAL DOSAGE FORMS - The Future of Oral Dosage: Innovations, Challenges & the Path Forward in 2025
Sébastien Croquet explores the latest industry challenges, cutting-edge manufacturing techniques, and patient needs defining today’s oral delivery methods, and breaks down some of the ways drug producers can ride, or even define, the next wave of oral drug delivery.
Gattefossé Achieves Key Milestone With New US Plant Certifications
Gattefossé, a leading provider of specialty ingredients and formulation solutions for personal care and pharmaceutical industries, proudly announces the successful certification of its new manufacturing…
WHITEPAPER - Formulating Custom Viscosity Blends With POLYOX™ Polyethylene Oxide
Excipient variability plays a critical role in pharmaceutical product design. A risk-based, scientific approach to Quality by Design (QbD) is essential to ensure consistent drug…
2025 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
Gattefossé Announces Inauguration of its New Premises & Technical Center of Excellence in Mumbai
India is a strategic country for the business development of the Gattefossé Group. To support this growing market, Gattefossé continues to invest in the opening…
CONTROLLED RELEASE - How Advanced Excipient Knowledge is Shaping the Future of Controlled-Release Formulations
Matthias Knarr, PhD, and True Rogers, PhD, review the latest insights behind CR formulations using HPMC excipients and how HPMC substitution specifically can assist formulators in developing cutting-edge CR delivery systems with differentiated performance.
What are functional excipients?
The global pharmaceutical excipients market was valued at $7.7 billion in 2020 and is expected to reach $11.2 billion by 2026. Functional excipients are witnessing a strong demand as companies supply a wide range of functional excipients that help manufacturers produce cost-effective, high-quality, finished pharmaceutical product. Many industry experts point to a widening demand and use of organic pharmaceutical excipients. These organic excipients include oleochemicals, petrochemicals, proteins, carbohydrates, and others. Additionally, binders and functional excipients are witnessing a strong demand. Regarding delivery route, it is the topical segment that is witnessing fast growth in the global pharmaceutical excipients market, as topical drug delivery is witnessing a significantly stronger progression because of its ability to surpass the metabolism pathways of the stomach and liver.
However, the high cost associated with the drug development process will impede the growth rate of the pharmaceutical excipients market. Additionally, strict government regulations have hindered the pharmaceutical excipients market growth. Safety, quality concerns, and lack of awareness will further challenge the market in the forecast period mentioned above.
This is particularly true for novel excipients, which do have technical, therapeutic, and commercial benefits in oral drug delivery. Despite their formulation-enhancing benefits, novel excipients are sacrificed early in development because of a lack of precedence of use.
Without an independent pathway to allow new excipients or new uses for existing excipients into drug products, except when associated with a drug filing, there are limited tools available for pharmaceutical companies to formulate better performing, and in many cases, life-saving drugs. Meanwhile, drug manufacturers are reluctant to use new excipients and take on the additional layer of scrutiny from regulatory agencies to demonstrate full excipient characterization, safety, quality, function, and appropriateness of use.
Functional Excipients and the FDA
The Food & Drug Administration (FDA) has acknowledged that the lack of novel excipients is indeed a problem. In September 2021, the Agency announced the Novel Excipient Review Pilot Program, which will select and review four novel excipients in the next two years using a new pathway. This will allow manufacturers to obtain an FDA review prior to the use of the novel excipient in a drug formulation.
The FDA’s recent stance and acceptance that the novel excipients are critical in development of new drug candidates, the perceptions around the novel excipients are being changed as the Agency continues to embrace the facts that the pharma industry is in dire need of new excipients for bringing the innovative drugs to the market faster. This is the first time in history that the agency is opening doors for novel excipients to be freely evaluated and used in the innovative formulations for NCEs.
Note, though, that this is not an excipient approval process; the novel excipient would still be evaluated as part of the overall drug product approval. In the next 3 to 5 years, we can expect to see an acceleration in the examination of the composition and purity of excipients.