Drug Delivery
Catalent to be Added to S&P 500 Index
Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer…
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….
Alimera Sciences Announces Enrollment of First Patient in Landmark NEW DAY Clinical Trial
Alimera Sciences, Inc. recently announced it has enrolled the first patient in the company’s NEW DAY clinical trial, a randomized, controlled, multi-center study designed to…
Chiasma Announces US Commercial Launch & Availability of the First & Only Oral Somatostatin Analog
Chiasma, Inc. recently announced the commercial launch and availability of MYCAPSSA (octreotide) capsules in the US for patients with acromegaly. MYCAPSSA, the first and only….
LSNE-León Receives Approval From AEMPS to Manufacture Biotechnology-Based Therapeutic Products
LSNE Contract Manufacturing recently announced that the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the manufacturing of clinical-stage biotechnology-based therapeutic products at…
Catalent Biologics Invests $50 Million to Add Third High-Speed Vial Line
Catalent recently announced it is investing $50 million to install an additional high-speed vial filling line at its Bloomington, IN, facility. The new line is…
Micron Biomedical Progresses With Clinical Evaluation of its Technology for Measles-Rubella Vaccination
Micron Biomedical, Inc. (Micron) recently received a second tranche of funding ($2.6 million) to continue clinical development of its microneedle-based technology for measles and rubella…
SPECIAL FEATURE - Injection Devices: Will COVID-19 Deliver Growth to the Market?
Contributor Cindy H. Dubin interviews several leading companies and highlights trends in autoinjectors, pen injectors, wearable devices and connectivity, and prefilled syringes.
FORMULATION FORUM - Formulation Development Strategy for Early Phase Human Studies
Jim Huang, PhD, says successful translation of discovery compounds into first-in-human and first-in-patient is one of the key challenges facing the pharmaceutical industry, and to achieve this, a rational formulation development strategy will be critical to avoid costly development failures, while speeding up the development timeline in a cost-effective manner.
DEVICE DEVELOPMENT - Mapping the Regulatory Strategy to Better Navigate Electronic Drug Delivery Device Development for Patient Safety & Security
Ahmed Mallek, Hadrien Gremillet, and Audrey Chandra say that along with technology advancement in the medical industry, the behaviors and needs of different stakeholders also evolve, resulting in a clear interest in electronic drug delivery devices for a variety of reasons.
PEPTIDE THERAPEUTICS - Oral Peptide Therapeutics – Opportunities Abound as Barriers Fall
John S. Vrettos, PhD, says numerous technologies are currently in development that are designed to enable the oral delivery of peptides. Though each has its unique set of properties and capabilities, all must overcome key obstacles to successfully deliver peptides via the oral route.
COMBINATION PRODUCTS - Development Challenges & Solutions
Tom McLean says combination drug development pipelines continue to rapidly expand and diversify with differentiated molecules and formulations, which can call for nuanced as well as significant packaging and delivery system requirements.
TFF Pharmaceuticals Enters into Worldwide Licensing Agreement With UNION Therapeutics
TFF Pharmaceuticals, Inc. recently announced it has entered into a worldwide exclusive licensing agreement with UNION therapeutics A/S (UNION) for its TFF technology used in…
Eyenovia & Arctic Vision Announce Exclusive Collaboration & License Agreement
Eyenovia, Inc. and Arctic Vision recently announced they have entered into an exclusive license agreement for Arctic Vision to develop and commercialize MicroPine for the…
Clearside Biomedical Announces US FDA Acceptance of IND Application
Clearside Biomedical, Inc. recently announced the US FDA has accepted its Investigational New Drug (IND) application for CLS-AX (axitinib injectable suspension), enabling initiation of a…
Arcturus Therapeutics Announces Dosing of its COVID-19 Vaccine Candidate in Phase 1/2 Study
Arcturus Therapeutics Holdings Inc. recently announced that all subjects in the first cohort have been dosed in the Phase 1/2 clinical study with its ARCT-021…
Wearable Drug Delivery Provider Sorrel Medical Partners With Leading Global Pharmaceutical Manufacturer
Sorrel Medical recently announced it has entered into a strategic partnership with one of the world’s leading pharmaceutical companies to advance the development and introduction of next-generation wearable drug delivery solutions….
Emerald Health Pharmaceuticals Begins Enrollment in Phase 2a Study
Emerald Health Pharmaceuticals Inc. has recently begun enrollment and has dosed its first patients with diffuse cutaneous systemic sclerosis (dcSSc) in its Phase 2a clinical…
Daré Bioscience Announces Initiation of Phase 1 Clinical Trial of Novel Intravaginal Ring Designed to Deliver Non-oral, Bio-identical Hormone Therapy
Daré Bioscience, Inc. recently announced the initiation of a Phase 1 clinical trial of DARE-HRT1, designed to deliver bio-identical 17β-estradiol and bio-identical progesterone continuously over…
Oculis Announces Successful End-of-Phase 2 Meeting With the FDA
Oculis S.A. recently announced it has successfully completed an End-of-Phase 2 meeting with the US FDA for OCS-01 in two indications: for the treatment of…
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.