Drug Delivery
Thomas H. Lee Partners & Frazier Healthcare Partners Acquire Adare
Thomas H. Lee Partners, L.P. and Frazier Healthcare Partners recently announced they have acquired Adare Pharmaceuticals, which will be rebranded Adare Pharma Solutions, a leading specialty contract development….
Oculis to Present Significant Corporate & Clinical Development Progress
Oculis S.A., a biopharmaceutical company focused on developing transformative topical ophthalmic treatments to improve the sight and lives of patients, recently announced that Dr. Marcia…
Gerresheimer Announces New Laboratory & Regulatory Services for Biotech Customers
Gerresheimer recently announced it has added essential laboratory and regulatory services to its broad portfolio of products, solutions, and services for biotech companies. Specialized laboratory…
Vectura Partners With Monash University to Support Development of Inhaled Oxytocin to Prevent Postpartum Haemorrhage
Vectura Group plc recently announced it has signed an agreement with Monash University’s Institute of Pharmaceutical Sciences (MIPS) to develop inhaled oxytocin delivered via a….
Orasis Raises $30 Million to Advance Clinical Development Program
Orasis Pharmaceuticals recently announced the closing of a $30-million Series C financing. The financing was co-led by new investor Bluestem Capital and returning investor Visionary…
Vaxart Announces FDA Clearance of IND Application for Oral COVID-19 Vaccine
Vaxart, Inc. recently announced the US FDA has completed its review of the company’s Investigational New Drug (IND) application for its Phase 1 clinical trial…
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…
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.