Drug Delivery
ADVANCED DELIVERY DEVICES - Implantable Drug-Eluting Devices: A Novel Approach to Patient Care
Samuel D. Trohman, MBA, Joey L. Glassco, Elena Draganoiu, PhD, and Carey Boyum present developmental and commercial examples of non-biodegradable drug-eluting devices, along with the versatile properties of thermoplastic polyurethanes for the development of effective drug delivery systems.
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.
SYRINGE SYSTEM - The Credence Companion Syringe System Delivers on Safety & Usability Using Human Factors Studies
John A. Merhige, MEM, and Lisa Caparra, RN, explain how development of the Companion product line has been driven by these two constituents, the innovation driven by the end-users’ needs and the avoidance of change driven by needs of the drug manufacturer.
FORMULATION DEVELOPMENT TECHNOLOGY - A Novel Drug Delivery System That Offers Zero-Order/Near Zero-Order Release Profile of Low-Dosage Strength Tablets Containing Highly Soluble Actives
Thomas B. Gold, PhD, was awarded a US patent; the intellectual property centers on formulation development technology that allows for the steady, continuous release of API over a particular duration of time to mitigate variations or spikes in therapeutic benefit.
PRIMARY PACKAGING - Ophthalmic Squeeze Dispenser (OSD): Does One Size Fit All?
Degenhard Marx, PhD, and Matthias Birkhoff, discuss how the use of preservatives in eye drops is still controversial, but more and more evidence supports the use of unpreserved eye drops for treatment of chronic diseases.
EXECUTIVE INTERVIEW - Vetter: Helping Small Biotech Companies Execute a Successful Drug Development Process
Dr. Susanne Resatz, President of Vetter Development Services USA, Inc., discusses the many benefits to small biotech companies in utilizing a full-service CDMO, and what advanced services the Chicago-based facility offers its growing customer base.
SPRAY-DRIED DISPERSIONS - Developing Process Control Strategies for the Manufacture of Spray-Dried Dispersions
Devon DuBose, Dana Settell, Nathan Bennette, and Amber Broadbent, PhD, say drug pipelines increasingly feature new drug candidates that exhibit poor solubility and require well-established enabling technologies to address this critical issue.
EXECUTIVE INTERVIEW - Terumo: Innovating at the Speed of Life for Cutting-Edge Solutions in Medical Devices & Services
Mr. Juichi “Jim” Takeuchi, Terumo Corporation’s Executive Officer and President of Global Pharmaceutical Solutions, discusses his company’s innovative approach to parenteral drug delivery using integrated science and technology.
HOT MELT EXTRUSION - OptiMelt™ Hot Melt Extrusion Technology to Improve Bioavailability of Poorly Soluble Drugs
Sampada Upadhye, PhD, indicates bioavailability enhancement with formulation and dose form flexibility can be achieved through the application of HME technology to produce stable drug formulations and increased development success rates.
SYRINGE STUDY - Gerresheimer - Scrutinizing 20,000 Syringes, a Long-Term Study (2011-2015)
Bernd Zeiss provides study results that contribute to a clearer picture of the factors of influence that are crucial to syringe function. Several common hypotheses were verified, while others were refuted.
DNA VACCINE TECHNOLOGY - A Vaccine Breakthrough That Could Change Lives & Enable Vaccine Development Programs
William Hearl, PhD, asks what if there was the potential for a better and safer treatment for allergies, a less-toxic cancer therapy, or a breakthrough treatment to improve the health of a pet or valuable livestock? What if you could employ a new, patented technology that may make these treatments possible?
MARKET SURVEY - Dosage Forms: It's Time to Listen to Consumers
Thomas Hein, PhD, says in light of their huge success and widespread use, it is easy to assume that tablets and capsules are generally accepted by consumers and the industry.
GLOBAL FORMULATION REPORT
This Global Formulation Report is a joint initiative by Drug Development & Delivery and PharmaCircle LLC, covering several areas of significant interest in today’s ever-challenging pharmaceutical and biotechnology industries.
THERAPEUTIC FOCUS - Direct Effects(TM) Diabetic Neuropathy Therapy: Treating Symptoms & Modifying Disease
Ronald Aung-Din, MD, reports that by using a unique methodology, symptomatic and neural restorative therapies treat DPN in preparations applied directly to areas of pathology, and therapeutic benefit is obtained in much shorter time than through blood flow.
IONTOPHORESIS - Captisol-Enabled(TM) Lipophilic Drug Complex Delivered Transdermally by Iontophoresis
Abhishek Juluri, PhD, Fahimeh Ghasemi, MS, Horacio Pérez-Sánchez, PhD, et al provide results obtained from in vitro studies clearly demonstrating the transport enhancement ability of CAP in solution as well as in gel formulations.
CAPSULE TECHNOLOGY - Enteric Capsule Drug Delivery Technology - Achieving Protection Without Coating
Hassan Benameur, PhD, says ECDDT represents a new, faster, and easier means for oral delivery of labile entities, such as peptides, nucleotides, live biopharmaceutical products, and vaccines.
SPECIAL FEATURE - Excipients: Enhancing the New, Poorly Soluble APIs
Contributor Cindy H. Dubin interviews several excipient manufacturers who share their insights about the role excipients play in formulating and manufacturing drugs for improved bioavailability, solubility, and delivery.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Contract Manufacturing: Anticipating the Needs of the Future
Contributor Cindy H. Dubin speaks with several companies in the prefilled syringe and parenteral manufacturing market that are offering a range of services and systems that cater to today’s issues as well as anticipating the needs of the future.
ADVANCED DELIVERY DEVICES - Design & Evaluation of a Polymer-Based Prefillable Syringe for Biopharmaceuticals With Improved Functionality & Performance
Sagarika Bose, PhD, and Kevin Constable address the design of a new commercially available polymer-based prefillable syringe with enhanced performance features when combined with complex biopharmaceutical drug products.
EXECUTIVE INTERVIEW - SOLIZE: 3D Data-Based Engineering & Manufacturing to Accelerate Delivery Device Development
Yoshiki Matsuda, Director of SOLIZE, discusses how his company can create new and innovative solutions to accelerate the development of devices and combination products built thereon.
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.