Functional Excipients
MULTIPARTICULATE SYSTEM - Advances in Lipid Multiparticulate Technologies for Controlled Release
Jaspreet Arora, PhD, Samantha Saville, and Brett Waybrant, PhD, focus on a controlled-release LMP formulation to identify optimum annealing conditions and to better understand the annealing mechanism.
SPECIAL FEATURE - Challenging Molecules Drive Developers to Get More Creative With Excipients
Contributor Cindy H. Dubin highlights the techniques various excipient manufacturers are using to develop more innovative and effective ingredients to improve the performance of drug molecules.
LIPID-BASED DELIVERY - Are Lipid-Based Drug Delivery Systems in Your Formulation Toolbox?
Jason M. LePree, RPh, PhD, reviews the causes of poor bioavailability for drugs and provides an introduction to lipid-based drug delivery systems, and how the formulation approach can be used to overcome impediments to good bioavailability of therapeutic actives.
NANOPARTICLES - A Revolution in the Development of Drug Delivery Vehicles
Tim Leaver explains how his company has developed a proprietary technology for the rapid development of nanoparticles and seamless scale-up for clinical studies and commercial production, and how it is transforming the development and manufacturing of a range of nanoparticle formulations from a hit-and-miss affair to a standardized process, accelerating novel nanomedicines from the bench to the clinic.
SPECIAL FEATURE - Wanted: New Excipients to Meet the Demands of a Challenging Industry
Contributor Cindy H. Dubin recently spoke with some of the leading excipient innovators to find out what types of excipients they are developing, the advantages they offer to formulations, and where they see the industry focusing throughout the next few years.
EXCIPIENT UPDATE - Solvent-Less Film Coatings: New Ethylcellulose Grade Enables Rapid Dry Powder Coating
Nick Grasman and Paula Garcia Todd, MS, present ETHOCEL HP as an innovative new product that helps customers increase productivity while still maintaining the advantages of Dow manufactured ETHOCEL, such as tight viscosity, narrow ethoxyl distribution, and reduced fiber content.
SOFTGEL FORMULATIONS - Lipid-Based Drug Delivery System to Bring Poorly Soluble Drugs to Market
Ronak Savla, PhD, PharmD, and Jeffrey E. Browne, PhD, indicate formulation screening, development, scale-up, and commercial manufacture of LBDDSs require considerable expertise, and choosing an outsourcing partner with experience and a proven track record is critical.
SPECIAL FEATURE - Excipients: Manufacturers Look to Co-Processing as a Way of Improving Functionality
Contributor Cindy H. Dubin reports how leading excipient manufacturers are overcoming their own R&D challenges to deliver innovative excipients that address problems associated with both large and small molecules.
ALBUMIN MARKET - Global Human Albumin Market: Extra Revenues to Come Through Non-Therapeutic Applications
Aish Vivekanandan, Frost & Sullivan Analyst, reports that human albumin is widely considered as a plasma replacement or expander for therapeutic purposes. However, for over a decade, the healthcare industry has been exploring the use of human albumin as a non-therapeutic substance/excipient for commercial settings.
ORODISPERSIBLE TABLETS - Advanced Drug Delivery for Repositioning Promethazine for Improved Application & Patient Outcomes
Srinivas Tipparaju, PhD, Anastasia Groshev, Danielle Dantuma, et al designed and characterized a formulation of ODTs at three different compression settings to determine the effective formulation for manufacturing rapid-release ODT promethazine tablets.
EXCLUSIVE ONLINE CONTENT
Evonik Partners With University of Mainz to Commercialize New Class of PEG Lipids for Nucleic Acid Delivery
Evonik and the University of Mainz have signed a license agreement to commercialize randomized polyethylene glycols (rPEGs), a new class of PEGs. Evonik intends to use….
Novo Holdings to Acquire Catalent
Catalent, Inc., a leader in enabling the development and supply of better treatments for patients worldwide, and Novo Holdings, a holding and investment company that is responsible for managing the assets and wealth of the Novo Nordisk Foundation, recently announced they….
Colorcon Unveils Corelease - A Unified Brand for Novel Controlled-Release Formulated Systems
Ready formulated systems approach simplifies the development and manufacturing for controlled release…..
Roquette Completes Acquisition of Qualicaps & Reinforces Global Position in the Pharmaceutical Industry
This strategic investment creates a stronger leader, with an expanded global footprint, as well as an enriched offering of oral dosage solutions…..
Acquisition of Solus BioTech Expands Croda's Specialized Pharma Business in Asia
Croda International Plc recently announced it has acquired Solus BioTech, a global leader in premium, biotechnology-derived materials, from Solus Advanced Materials…..
MARKET NEWS & TRENDS
WEBINARS
WEBINAR - Beyond the Lab: Unleashing the Potential of In Silico Modeling in Drug Product Formulation
In this webinar you will learn how digital chemistry tools facilitate rapid screening of formulation parameters, aiding in the identification of optimal drug delivery systems, excipient selection, and dosage forms….
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….
Where Do We Stand on Poorly Soluble Drugs and Peptides in Oral Delivery?
The Rule of 5 suggests that, for oral bioavailability, a better chance for oral absorption is obtained when the molecules are within the parameters of the Rule of 5’. However, the pharmaceutical industry is achieving oral efficacy with drugs that exceed….
Oral Delivery of Hydrophilic Macromolecules: Lipid-Based Nanocarriers as Key to Success
This LIVE event has already taken place CLICK HERE to access the recorded version of this event and receive a copy of the presentation. Join…
WHITE PAPERS
WHITEPAPER - Copolymer Microstructures: Connecting Monomer Sequence Distribution With Biomedical End-Application Performance
To gain insights into advanced copolymer characterization techniques and their impact on drug release in biomedical products, we invite you to explore the latest Corbion white paper…..
WHITEPAPER - Monitoring Low Dose API Blend Uniformity With Parteck® M Mannitol Using Near-Infrared (NIR) Spectroscopy
Direct compression is often used for tablet manufacturing because it is the shortest, most effective, and least complex method. The physical properties of active pharmaceutical…
WHITEPAPER - The Viscosity Reduction Platform: Viscosity-Reducing Excipients for Protein Formulation
This white paper evaluates the viscosity-reducing capacities of excipients and excipient combinations…..
WHITEPAPER - Improving API Solubility by Salt & Cocrystal Formation
Ensuring sufficient solubility is critical to the success of small molecule drugs. An active pharmaceutical ingredient (API) must be absorbed by the body and enter the systemic circulation to deliver the desired therapeutic effect. Many APIs,….
WHITEPAPER - Overcoming the Knowledge Gap: Long-Acting Injectables & Implantables
This whitepaper delves into the numerous benefits of long-acting drug delivery systems, including their ability to harness highly potent APIs, streamline development and intellectual property protection, and provide consistent drug release over extended periods.
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.