Drug Delivery
EXECUTIVE INTERVIEW - NanOlogy: Submicron Particle Platform Transforms Systemic Chemotherapy Into Local Delivery
Marc Iacobucci, Managing Director of NanOlogy, discusses his company’s technology, clinical program, and efforts to transform cancer therapy.
GAS-POWERED DELIVERY - Innovating Injectable Devices to Deliver Today’s Pharmaceuticals
Steven Kaufman believes that with autoinjectors in high demand by the biopharma industry, gas-powered delivery systems may have the solution to many of the difficulties the industry is facing.
GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, focuses on the macro aspects of the 2017 product approvals.
INTRADERMAL DELIVERY - New Technology Brings Simplicity & Scalability to Intradermal Drug Delivery
Boris Stoeber, PhD, Sahan Ranamukha, PhD, and Rory St. Clair describe the Microdermics technology and its improvements over the conventional subcutaneous route of administration.
SPECIAL FEATURE - Injection Devices: Manufacturers Focus on 21st Century Technology While Still Tackling Traditional Challenges
Contributor Cindy H. Dubin highlights some of the key companies in the injectable delivery market that are focusing on advanced technology as well as the more traditional challenges related to breakage, leaching, and needlestick prevention.
NANOMEDICINES - V-Smart® Nanomedicines: Non-Invasive Targeted Brain Therapeutics for CNS Diseases
Susan Rosenbaum, JD, and Irwin Hollander, PhD, present a unique and novel solution to this greatest challenge in medicine for brain disease treatment, considered the “Holy Grail of Neuroscience,” with their breakthrough innovation.
NASAL DELIVERY - A Promising Route of Drug Delivery to the Brain: Scientific Considerations
Vinayak Pathak, MPharm, MBA, indicates after reviewing clinical experiments published in this area, it is evident that formulation design, altering the physico-chemical properties of the drug, addition of absorption enhancers, and mucoadhesive polymers did result in higher bioavailability of drugs in animal models via the nasal route when compared to parenteral administration of the same drug.
DEVICE TRAINING - Maximizing Patient Adherence by Minimizing the Forgetting Curve
Chris Evans explains how it is important that pharmaceutical companies and their drug delivery system partners proactively address the forgetting curve by rethinking how patients learn to use self-administration systems.
FOAMED SILICONE - Molded Porous Silicone for Delivery of Macromolecules & Low-Solubility APIs
James Arps, PhD, and Matt Petersen, PhD, investigate how foamed silicone is capable of sustained, controlled elution of hydrophobic small molecule and large macromolecular payloads.
PACKAGING - Child-Resistant Features for Container Closure Systems
Stefan Hellbardt, PhD, Guenter Nadler, and Degenhard Marx, PhD, highlight the successful introduction of Aptar’s first CR/SF nasal spray pump and the first dermal dispenser on the US market.
DEVICE REGULATIONS - Early Preparation Will Pay Big Dividends as EU Enacts New EU Device Regulations
Joanne Emmett says current directives are giving way to new regulations that require Class III and implantable devices to undergo clinical investigation to show that they are equal or superior to other products on the market.
TECHNOLOGY-ENABLED HEALTH - Digitally Connected Health Technologies: Blazing Meaningful Trails in Healthcare
Daniel Spors and Kyle Dolbow, PhD, say the overall digital health market is currently $76 billion, and is estimated to grow at 21%, and this space includes life sciences and medical device companies that are incorporating digital technology into their products and services, such as smart inhalers and remote therapy devices.
INTRABODY DELIVERY - The Feldan Shuttle Technology: A Peptide-Based Method to Deliver Antibodies
Thomas Del’Guidice, PhD, Nancy Messier, PhD, and David Guay, PhD, present the Feldan Shuttle technology, a peptide-based delivery method that could provide efficient and safe intrabody delivery in mammalian cells.
TABLET FORMULATION - Reformulation of Tablets to Resolve Sticking & Picking Issues Faced on Compression: A Case Study
Smruti P. Chaudhari, PhD, and Anshul Gupte, PhD, successfully reformulated tablets using the potassium-salt form of Compound XY without adding any new excipient. Through the reformulation, they also resolved earlier issues faced during tablet compression.
OPHTHALMIC SQUEEZE DISPENSER - Eliminating the Need for Additives in Multidose Preservative-Free Eyecare Formulations
Degenhard Marx, PhD, and Matthias Birkhoff highlight their company’s Ophthalmic Squeeze Dispenser (OSD), a multi-dose dropper that relies solely on mechanical measures to prevent microbial contamination of the bottle content.
GENE & CELL THERAPY - Its Growing Potential to Disrupt Drug Research & Healthcare Delivery
Jeff Galvin believes as the pace of gene and cell therapies accelerates over this next decade, potential cures for chronic diseases, cancer cures, and autosomal defect cures will result, and the efficacy of new therapeutics may move as much as $500 billion from traditional pharmaceuticals to gene technologies.
ADVANCED DELIVERY DEVICES - The Staked Needle Pre-Filled Syringe: Benefits, Conventional Limitations & a New Approach
Horst Koller and John A. Merhige, MEM, say the advantages of a Staked Needle Pre-Filled Syringe are clear and well documented, but significant risks remain. A new alternative is now available that addresses the known challenges and adds critical usability and safety features while preserving existing components and processes.
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.
EXECUTIVE INTERVIEW - Particle Sciences: Experts in Development & Manufacturing of Complex Dosage Forms
Dr. Mark Mitchnick, CEO of Particle Sciences and CMO of Lubrizol, discusses the rise of complex drug products, the capabilities needed to develop and manufacture these products, and the company’s expansion in this area.
EXECUTIVE INTERVIEW - Aptar Pharma: Quality Will Inject Real Growth Into the Injectables Market
Bas van Buijtenen, President of the Aptar Pharma Injectable Division, reviews the past 12 months and assesses what will drive the market in the future.
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.