Functional Excipients
DFE Pharma Expands its Inhalation Portfolio With New Launch
DFE Pharma recently announced the expansion of its Dry Powder Inhalation (DPI) portfolio with the launch of Lactohale 400. The addition of Lactohale 400 further enhances the completeness of DFE Pharma’s portfolio of inhalation-grade lactose…..
US Government to Support Expansion of Croda Lipid Systems Capability
Croda International Plc recently announced it has entered into a cooperative agreement with the US government in which the government will provide up to $75 million to expand the….
Evonik Invests $220 Million to Build New Lipid Production Facility for mRNA-based Therapies in the US
Evonik is building a new, highly flexible, global-scale production facility for pharmaceutical lipids in the US. The new plant at Evonik’s Tippecanoe site in Lafayette,…
CordenPharma Increases xRNA-based Capabilities with a Strategic Investment in LNP Formulation Services at its Caponago Injectable Facility
CordenPharma has recently increased its xRNA capabilities at its sterile injectable facility in Caponago, Italy. The company reports that it is investing over €10M in new Lipid Nanoparticle (LNP) formulation,….
Gattefossé Strengthens its International Footprint & Breaks Ground on its Production Site in Texas
Gattefossé will break ground on its first North American manufacturing facility in Lufkin city, TX. Gattefossé as well as officials of Lufkin city will attend the ceremony. This asset will manufacture….
DFE Pharma Opens New Center of Excellence in India to Provide Fast-Track Formulation Services
DFE Pharma recently announced the launch of its new Center of Excellence Closer to the Formulator (C2F) in Hyderabad, India. The C2F center is based in Genome Valley….
Croda Announces the New Pharma Business
Croda recently announced that its Health Care division will now become Croda Pharma, bringing its core speciality excipient portfolio together with the recent acquisition, Avanti Polar Lipids and its….
Entera Bio Files Patent Applications for Inventions that Optimize its Platform Technology for Oral Delivery of Large Molecule Therapeutics
Entera Bio Ltd. recently announced it recently filed multiple US patent applications to further strengthen the company’s patent protection and support future developments. These patent…
WEBINAR - Understanding Patch Composition for Effective Transdermal Delivery
As the advantages of transdermal drug delivery grow, the global market for transdermal patches also is growing. Join DuPont™ Liveo™ Healthcare Solutions and Gattefossé Pharmaceuticals for a complimentary one-hour webinar to explore the current….
Lubrizol Life Science Health Launches Innovative Apisolex(TM) Technology to Improve Solubility & Simplify Manufacturing of Parenteral Drug Products
Lubrizol Life Science (LLS) Health, a global leader in accelerating success and innovation in pharmaceutical development, has launched Apisolex, a novel solubility-enhancing excipient for use in….
WHITE PAPER - Poloxamer: A Simple & Powerful Solution for Accelerating Dissolution
This white paper will introduce the concept of dissolution and discuss how poloxamers are a simple yet powerful formulation approach that can enhance dissolution rate, while minimizing resource requirements.
SPECIAL FEATURE - Excipients: Exciting Expansion & Innovation
Contributor Cindy H. Dubin speaks with several companies and presents a unique look at how excipients are being used to support current and future innovative active pharmaceutical ingredients.
FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
UK Government to Support Expansion of Croda’s Lipid Systems Manufacturing Facility
Croda International Plc that uses smart science to create high performance ingredients and solutions that improve lives, recently announced that it has been awarded a £15.9 million grant by the UK Government to expand….
DFE Pharma, Harro Höfliger & Sterling Announce Unique Partnership to Provide Formulation Services for Respiratory Products
Three leading companies in their respective fields – DFE Pharma (excipients solution provider), Harro Höfliger (equipment supplier), and Sterling (API manufacturer) recently announced a unique partnership….
Evonik Increases Global Supply of Pharma-Grade Plant-Derived Cholesterol for mRNA Vaccines & Gene Therapies
Evonik has boosted its supply of plant-derived cholesterol, one of the most critical components for the manufacture of mRNA vaccines and gene therapies. The large-scale production of….
Exclusive License for Croda to Commercialize SSI’s CAF® Vaccine Adjuvants
Croda International Plc, which uses smart science to improve lives, recently announces it has entered a strategic collaboration with Statens Serum Institut (SSI), the leading…
FORMULATION DEVELOPMENT - Impact of Excipients & Manufacturing Process on Solubility-Enhanced Ritonavir Tablet Size & Weight Reduction
Gayatri Khanvilkar, MPharm, Ajit Bhagat, and Tejas Gunjikar, PhD, investigate bulking agents and disintegrants to develop efficacious Rotonavir tablets with improved in vitro release.
EXECUTIVE INTERVIEW - Kytosan USA, Inc.: Blazing a Trail in Chitosan Manufacturing in the United States
Dr. Joseph F. Bristow, Chief Technology Officer for Kytosan USA, discusses chitosan and its impact on the pharmaceutical industry, as well as Kytosan USA’s production plans.
Gattefossé Strengthens its CSR Approach & Reaches Two Major Milestones
In line with its CSR commitment, Gattefossé has received ISO 14001:2015 certification for its main production site in France and has been ranked in the…
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.