Drug Delivery
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.
PROTEIN CRYSTALS - Reshaping Traditional Biotherapeutic Formulations
Don Paul Kovarcik, MBA, and William Wittbold, MS, indicate that while protein therapeutics have enjoyed considerable commercial success throughout the past 3 decades, there still remain formulation and delivery challenges.
THERAPEUTIC FOCUS - Direct Effects™ Cannabinoid Therapy: Medical Cannabis Without Psychoactive & Systemic Effects
Ronald Aung-Din, MD, reports topical CBD is beneficial in treating symptoms of a number of neuropathic and psychiatric conditions. Individual clinical response varied depending on condition treated and on severity and longevity of symptoms, and overall, topical CBD therapy was well tolerated.
LIPOPHILIC SALTS - Opportunities & Applications in Oral Drug Delivery
Hywel Williams, PhD, Annabel Igonin, PhD, David Vodak, PhD, and Hassan Benameur, PhD, believe lipophilic salts are being explored in a number of different areas and one interesting application is their potential to boost API loading in lipid formulations.
CARBON NANOTUBES - MGMR™ - A Medical-Grade Carbon Nanotube Designed for Medical Applications
Joseph S. Dillon, PhD, MBA, and Lainie Mulvanny discuss the transformation of CNTs into a unique composition of matter, marking a complete departure from the dirty, tangled micron bundles of CNTs that frustrated medical researchers for years.
COMBINATION CORNER - How to Approach OTS Devices for Your Combination Product
Lilli Zakarija, MSME, MBA, cautions that while OTS devices are already “developed” and on the market, they should still go through the device development design control process from the perspective of the combination product, and then let the design control process determine if the device meets the specific requirements of the CP.
PULMONARY DELIVERY - Pulmonary Delivery of Insulin to Treat Diabetes - A Debacle
T.R. Shantha, MD, PhD, FACA, says the market for new anti-diabetic therapeutic agents and their painless delivery is enormous and is sure drug companies and research scientists are in a race to develop a safer method other than the pulmonary and oral routes to deliver insulin.
EXECUTIVE INTERVIEW - Transdermal Specialties: A New Dimension in Transdermal Drug Delivery
Bruce K. Redding, Jr, CEO and Founder of TSI, discusses the importance of developing a new tool for enhanced drug delivery, but also a means to reduce the time-to-market for new formulations while also expanding the number of drugs that can be delivered transdermally.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Biologics Present a New Set of Challenges
Contributor Cindy H. Dubin speaks with leading syringe developers and contract manufacturers to discuss how they are overcoming industry challenges and provides a look at some of the innovative advancements in prefilled syringe technology.
NANOPARTICLE CHARACTERIZATION - One Size Does Not Fit All: Nanoparticle Size Analysis for Nanomedicine Applications
Andrew N. Cleland, PhD, Jean-Luc Fraikin, PhD, Peter Meinhold, PhD, and Franklin Monzon, PhD, describe a new diagnostic instrument able to rapidly and accurately report detailed nanoparticle size distributions for a wide variety of nanoparticle types and concentrations in a range of different solutions.
DRUG DELIVERY - PLEX(TM) Local Drug Delivery Platform Enables Prolonged, Controlled-Release Medications
Noam Emanuel, PhD, reviews how PLEX is a unique local drug delivery platform that brings numerous innovative solutions to the market in various fields, such as infections, inflammations, and cancer.
EXECUTIVE INTERVIEW - Gerresheimer in the US - Fully Focused on Core Business
Roger Kurinsky, Senior Vice President of Tubular Glass Americas talks about recent strategy shifts, the importance of the US pharma market, and how Gerresheimer’s investments in the US can benefit pharma companies.
LIPID NANOPARTICLES - EnCore(TM): Facilitating Delivery of RNAi Therapeutics to Treat Cancer
Marc T. Abrams, PhD, and Bob D. Brown, PhD, explain how nanoparticle technology has the potential to enable tumor bioavailability even in the absence of a targeting ligand.
LYOPHILIZATION - The Key to Creating Acceptable & Effective Fast-Dissolving Oral Formulations
Leon Grother says multiple products are on the market made using a controlled lyophilization process. The fast-dissolving characteristics it can impart have enabled the demands of several challenging patient populations to be met with formulations of important medicines that work well for them.
PULMONARY DELIVERY - Afrezza – Another Lesson for Drug Delivery Professionals?
Josef Bossart, PhD, believes Mannkind’s recent announcement that Sanofi has decided to return the marketing rights for Afrezza may not exactly be history repeating itself, but it certainly feels as though it rhymes.
SPECIAL FEATURE - Advancements in Drug Delivery Technologies Tackle Solubility & Bioavailability Challenges
Contributor Cindy H. Dubin speaks with several innovator companies to learn more about the latest advances in drug delivery to address the challenging issues of solubility and bioavailability today
EXECUTIVE INTERVIEW - Cardax Inc: Delivering Nature-Identical Astaxanthin to the Market
David G. Watumull, President and CEO of Cardax, Inc, discusses the company’s plans to create a new platform for products in the consumer health and pharmaceutical markets based on the delivery of nature-identical astaxanthin.
ADVANCED DELIVERY DEVICES - How Data Hubs & Smart Devices Are Enabling the Rise of Therapeutic Ecosystems
Stephen Allan discusses how unique collaborations between tech and biotech reflect a new paradigm in how therapeutics are being commercialized and marketed under the new pay-for-performance healthcare model.
EXECUTIVE INTERVIEW - Enable Injections: Revolutionizing Treatment With a New Class of Devices
Michael Hooven, CEO of Enable Injections, discusses his vision for the company and how it intends to create marketleading biologics delivery devices that meet the most pressing needs of pharmaceutical companies while enabling easy patient self-administration for significant cost-savings.
NANOSCALE COMPLEXES - A Novel Nanotechnology-Based Platform to Optimize Combination Cancer Therapies: Rational Development & Improved Delivery Using CombiPlex®
Barry D. Liboiron, PhD; Arthur C. Louie, MD; et al describe how CombiPlex addresses the challenges facing the traditional development path of many contemporary drug combinations and provide clinical proof-of-principle evidence that this approach can yield marked improvements in efficacy and patient outcomes.
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.