Drug Delivery
INHALATION DELIVERY - Inhaled Drug Development: Optimizing Delivery
Sandy Munro, PhD, Nikki Willis, and Geraldine Venthoye, PhD, believe selecting the delivery device/platform on the basis of patient needs, nature of disease, and opportunities for accelerating the proof-of-concept or early clinical stages by using fast-to-clinic approaches can help to accelerate the project through later-stage development by combining the approach with seamless scalability, designing in manufacturability, and an appropriate manufacturing strategy.
BIOSIMILAR DEVELOPMENT - Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices
Darren Mansell says as early experience in following this guidance has recently matured, some issues have arisen that may impede best available outcomes for patients, one of which is the question of whether “interchangeability” guidance may stifle innovation (and therefore improved patient experience) in drug delivery devices.
OPEN INNOVATION PLATFORM - Incentivizing Drug Delivery Research Using an Open Sharing Platform
Keith R. Horspool, PhD, Shirlynn Chen, PhD, and Markus Koester, PhD, discuss an open innovation platform to stimulate scientific understanding, and development of potential new technologies, for delivery of compounds with challenging solubility by offering a set of more contemporary poorly soluble drugs free-of-charge for independent research activities.
PRODUCT DEVELOPMENT STRATEGY - ESCP, Estimating Product Performance Part 2 – Choosing a Seesaw
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
EXECUTIVE INTERVIEW - Celanese: Better Therapeutic Outcomes From Better Drug Delivery
Laura Brand, Vice President of Celanese’s Medical & Pharmaceutical Business, discusses her company’s drug delivery platform and the value it brings to the industry.
Catalent Signs Drug Development Agreement With Cybin Inc
Catalent recently announced it has signed an agreement with Cybin Inc. to apply Catalent’s proprietary Zydis orally disintegrating tablet (ODT) technology for the delivery of…
Aptar Pharma & Noble Partner With dne pharma on its Nasal Naloxone Treatment
Aptar Pharma and Noble, an Aptar Pharma company, recently announced their collaboration with dne pharma. Both companies are providing their nasal drug delivery….
Vetter Establishes Office in China to Better Serve the Needs of its Growing Customer Base Worldwide
Vetter, one of the global leaders in prefilled drug-delivery systems, recently announced the opening of a new business entity in Shanghai, China…..
Vectura Expands Dry Powder Inhaler Development & Manufacturing Capabilities
Vectura Group plc, an industry leading inhalation CDMO, recently announced an expansion of its dry powder inhaler (DPI) development and manufacturing capabilities at its facility in Chippenham, UK…..
AIM ImmunoTech Announces First Healthy Subjects Dosed in Phase 1 Intranasal Ampligen Clinical Study
AIM ImmunoTech Inc. recently announced it has dosed the first healthy subjects in its Phase 1 clinical study on the safety of AIM’s drug Ampligen…
VYNE Therapeutics Announces Development Program for Combination Topical Gel
VYNE Therapeutics Inc. recently announced development plans for FMX114, a fixed combination of pan-JAK inhibitor tofacitinib and sphingosine 1-phosphate receptor modulator fingolimod in a topical…
Silo Pharma Enters Exclusive Option Agreement With the University of Maryland
Silo Pharma, Inc. recently announced it has executed an exclusive option agreement with the University of Maryland, Baltimore to explore a novel invention generally known…
Aptamer Group Extends Collaboration With AstraZeneca to Explore Next-Generation Drug Delivery Approaches
Aptamer Group, the developer of Optimer reagents and therapeutics, recently announced the extension of its current agreement with AstraZeneca, a global biopharmaceutical company. This agreement…
FORMULATION FORUM - Considerations in Development & Manufacturing of Complex Injectables for Early Phase Studies
Jim Huang, PhD, explains how a niche CDMO, which has specialized technologies in complex injectable development and adopts GMP practice with a “laboratory setting,” will have greater flexibility regarding changes, timing, and cost for successful manufacture of complex injectables in early phase development of therapeutic drugs.
MICROFLUIDIC ENCAPSULATION TECHNOLOGY - Achieving Reliable siRNA Drug Delivery for Inflammatory Diseases & Tumor Targeting by Nanoencapsulation
Olivia Merkel, PhD, and Christoph Zimmermann, PhD student, discuss the benefits of microfluidic encapsulation technology for gene silencing applications in cancer immunology and inflammatory diseases, where siRNA can potentially be used to downregulate genes associated with these pathologies.
ORAL MUCOSAL IMMUNOTHERAPY - Oral Mucosal Delivery of Allergenic Proteins for Inducing Tolerance in Food Allergic Individuals
William R. Reisacher, MD, highlights some of the differences between food allergy immunotherapy via the oral mucosal route versus exposure through the stomach and intestines.
PRODUCT DEVELOPMENT STRATEGY - ESCP, Estimating Product Performance Part 1 - Playground Physics
Josef Bossart, PhD, introduces, in a series of short articles, a qualitative model to help understand and visualize the potential of a product with prescribers, patients, and payors. This simple model can help weed out product ideas that may at first glance seem attractive but offer little potential in the real world.
Celsion Corporation Receives FDA Fast Track Designation for GEN-1 in Advanced Ovarian Cancer
Celsion Corporation recently announced that it has received Fast Track designation from the US FDA for GEN-1, its DNA-mediated interleukin-12 (IL-12) immunotherapy currently in Phase…
Catalent Announces Commercial Supply Agreement With Aurinia Pharmaceuticals
Catalent recently announced it recently signed a multi-year commercial supply agreement with Aurinia Pharmaceuticals, a biopharmaceutical company focused on delivering therapies to treat targeted patient…
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…
What are Drug Delivery Systems?
Drug delivery systems are engineered technologies for the targeted delivery and/or controlled release of therapeutic agents. The practice of drug delivery has changed significantly in the past few decades and even greater changes are anticipated in the near future. Drug delivery includes but is not limited to oral delivery, gene/cell delivery, topical/transdermal delivery, inhalation deliver, parenteral delivery, respiratory delivery, capsules, particle design technology, buccal delivery, etc.
The Evolution of Drug Delivery Systems
Drug delivery systems have greatly evolved over the past 6 decades. In the past 12 years specifically, there have been huge advancements in drug delivery technology. For instance, advanced medication delivery systems, such as transdermal patches, are able to deliver a drug more selectively to a specific site, which frequently leads to easier, more accurate, and less dosing overall. Devices such as these can also lead to a drug absorption that is more consistent with the site and mechanism of action. There are other drug delivery systems used in both medical and homecare settings that were developed because of various patient needs and researchers continue to develop new methods.
Drug Delivery System Market Size
The pharmaceutical drug delivery market size is studied on the basis of route of administration, application, and region to provide a detailed assessment of the market. On the basis of route of administration, it is segmented into oral delivery, pulmonary delivery, injectable delivery, nasal delivery, ocular delivery, topical delivery, and others.
The estimated global market size of drug delivery products was $1.4 trillion in 2020. Unfortunately, 40% of marketed drugs and 90% of pipeline drugs (mostly small molecules) are poorly soluble in water, which makes parenteral, topical, and oral delivery difficult or impossible. In relation, poor solubility often leads to low drug efficacy. Add in the fact that many other hurdles exist in the form of drug loading, stability, controlled release, toxicity, and absorption – it’s not hard to understand the difficulties in bringing new drug products to market. Additionally, biopharmaceuticals (proteins, peptides, nucleic acids, etc) and combination drug products possess many of these same problematic obstacles that affect efficacy. These challenges, coupled with the complexity and diversity of new pharmaceuticals, have fueled the development of a novel drug delivery platforms that overcome a great many bioavailability and delivery obstacles. By leveraging these platforms, pharmaceutical and biopharmaceutical companies can improve dosing accuracy, efficacy, and reproducibility in their drug discovery and drug delivery research.
Drug Delivery System Demand
The demand for pharmaceutical products worldwide is only going to increase in the coming years, as old and emerging diseases continue to threaten the well-being of people globally. Drug discovery efforts are expected to intensify, generating a large variety of active compounds with vastly different structures and properties. However, it is well known that despite tremendous output of the drug discovery process, the success rate of a candidate compound becoming an approved drug product is extremely low. The majority of candidate compounds are discarded due to various hurdles in formulation and preclinical testing (such as issues with solubility, stability, manufacturing, storage, and bioavailability) before even entering into clinical studies. Therefore, advances in formulation and drug delivery, especially the development of new and versatile biomaterial platforms as effective excipients, may salvage many “difficult,” otherwise triaged, drug compounds, and significantly enhance their chance of becoming viable products. Furthermore, breakthroughs in biomaterial platform technologies will also facilitate life cycle management of existing APIs through reformulation, repurposing of existing APIs for new indications, and development of combination products consisting of multiple APIs.