Functional Excipients
CordenPharma Colorado Expands Lipid Excipients Purfication
In response to the COVID-19 pandemic, mRNA (messenger RNA) vaccines have catapulted to center stage of the pharmaceutical and biotechnology industry. As of early 2021,…
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….
SPECIAL FEATURE - Excipients: Far From Inactive
Contributor Cindy Dubin speaks with several innovative excipient companies that assert novel excipients – agglomerated, co-processed, and multifunctional – actively and safely affect formulation stability, solubility, and bioavailability as well as foster faster drug disintegration.
AMRI Joins Network of Approved Manufacturers of Lipid Excipients for Pfizer-BioNTech COVID-19 Vaccine
Albany Molecular Research, Inc. recently announced that the company has been chosen to support the development and manufacture of lipid excipients for the Pfizer-BioNTech COVID-19 vaccine.…
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…
ProPerma™ Oral Formulation Technology
ProPerma™ uniquely improves both permeability and bioavailability of BCS III and BCS IV compounds by deploying an innovative and bespoke combination of GRAS and novel enhancing excipients…
PromoCell Receives EXCiPACT Certification as Manufacturer of Pharmaceutical Excipients to GMP Standards
PromoCell, one of the leading European manufacturers of human cell culture and cell biology products, has recently announced to have successfully completed a comprehensive EXCiPACT…
FORMULATION DEVELOPMENT - The Role of Excipient Selection in the Development of Orally Disintegrating Tablets
Torkel Gren, PhD, reviews the benefits that orally disintegrating products can bring to patients and developers and assesses the impact that excipient selection can have on the development of successful products.
Gattefossé Continues International Development & Builds Production Site in Texas
Gattefossé is investing 30 million euros in its industrial operations and announced the construction of a brand new manufacturing plant in Lufkin, TX. This asset will produce lipid-based….
2021 COMPANY PROFILES & CAPABILITIES
For each participating company, this section presents a detailed summary highlighting their core technologies, capabilities, technologies, and services.
FORMULATION FORUM - Age-Appropriate Pediatric Formulation Development
Jim Huang, PhD, reviews how a pediatric formulation should consider the following factors: difference in physiological and pharmacokinetic of patient populations, dosage form selection, route of administration, dose accuracy, dose flexibility, drug and excipient tolerability (safety and toxicity), patient compliance (palatability/swallowability), stability, and drug accessibility.
Croda Enters Contract With Pfizer for Innovative Delivery System for COVID-19 Vaccine
Croda International Plc recently announced it has entered into an agreement with Pfizer Inc. to supply novel excipients used in the manufacture of a COVID-19….
Evonik Launches Ready-to-Use Powder Premix to Improve Processing, Appearance & Swallowability of Oral Drug Products With an Immediate-Release Profile
Evonik recently launched a new ready-to-use powder premix blend of its EUDRAGIT functional polymers used for oral products with an immediate-release profile. EUDRAGIT IR ReadyMix…
Evonik Launches New Oral Drug Delivery Technology for Enteric Protection & Rapid Release in the Upper Small Intestine
Evonik has recently launched an advanced oral drug delivery technology that provides enteric protection followed by rapid, homogeneous release for effective….
PEGYLATION - PEGylation - Three Decades of Product Approvals & Technology Development
Esay Okutgen, PhD, Alper Orhan, MSc, and Josef Bossart, PhD, believe with the 30-year anniversary of the first product approval using PEG (polyethylene oxide polymer) conjugation, it seems an appropriate occasion to review the evolution of the technology (PEGylation) and subsequent product approvals.
Evonik Qualifies Advanced Aseptic Filling Line for Complex Parenteral Drug Products
Evonik recently announced the qualification of an advanced aseptic filling line for complex parenteral drug products at its FDA-inspected Birmingham….
Croda Strengthens Position in Life Sciences With Acquisition of Avanti Polar Lipids
Croda International Plc recently announced it has agreed to acquire Avanti Polar Lipids, Inc., a knowledge-intensive leader in lipid-based drug delivery technologies for next-generation pharmaceuticals…..
ABITEC Corporation Acquires Larodan AB Research-Grade Lipids
ABITEC Corporation, an ABF Ingredients company, announced today that it has acquired Larodan AB, a manufacturer and international marketer of state of the art, high-purity research grade lipids…..
FORMULATION FORUM - Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19
James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.
FORMULATION DEVELOPMENT - Formulating Immediate-Release Tablets for Poorly Soluble Drugs
Gayatri Khanvilkar, MPharm, Ajit Bhagat, Sangmesh Torne, PhD, Tejas Gunjikar, PhD, and Amina Faham, PhD, present a case study showing that previously unviable APIs can be successfully processed with the right methods, which should give hope to formulators facing similar difficulties.
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.