Drug Delivery
FDA Approves FENSOLVI for Injectable Suspension for Pediatric Patients with Central Precocious Puberty
Tolmar Pharmaceuticals, Inc. recently announced the US FDA has approved its New Drug Application for FENSOLVI (leuprolide acetate) for injectable suspension for the treatment of…
3M Drug Delivery Systems Launches as Independent Company, Kindeva Drug Delivery
Kindeva Drug Delivery, formerly 3M Drug Delivery Systems, recently announced its launch as an independent company following the acquisition by Altaris Capital Partners in a transaction valued at….
Adare Pharmaceuticals Acquires Orbis Biosciences
Adare Pharmaceuticals, Inc. recently announced it has acquired the pharmaceutical technology company, Orbis Biosciences, Inc. The acquisition of Orbis will….
SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions
Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.
FORMULATION FORUM - Application of Nano-Emulsion Technology to Address Unmet Medical Needs: A Case Study of Clopidogrel IV by 505(b)(2) Pathway
Jim Huang, PhD, presents a case study on how the EmulSol technology produces stable, optically clear nano-emulsions without the use of organic solvents and with minimal use of surfactants using a high-pressure or microfluidic homogenization process.
GLOBAL REPORT - 2019 Global Drug Delivery & Formulation Report: Part 3, Notable Drug Delivery & Formulation Transactions & Technologies of 2019
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on several notable drug delivery and formulation transactions and technologies.
WEBINAR - Developing an Oral Modified-Release (MR) Formulation: Challenges & Considerations for Achieving Success
Please join Quotient Sciences’ Vice President of Pharmaceutical Sciences, Dr. Andy Lewis, on May 20 at 10 AM London/11 AM Brussels or 6 PM London/1 PM New York for a live webinar on modified-release formulation…
Stevanato Group Announces Product Development Collaboration With Cambridge Design Partnership on Pen-Injector Technology
Stevanato Group, a leading producer of glass primary packaging and provider of integrated capabilities for combination products and Cambridge Design Partnership (CDP), a UK- and US-based leading technology and product design partner, recently….
Avadel Pharmaceuticals Announces Positive Topline Results from its Pivotal Phase 3 REST-ON Trial
Avadel Pharmaceuticals plc recently announced positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly…
Amphastar Pharmaceuticals Receives FDA Approval for Epinephrine Injection
Amphastar Pharmaceuticals, Inc. recently announced the US FDA has granted approval of its Abbreviated New Drug Application (ANDA) for Epinephrine Injection, USP 30 mg/30 mL…
Esperion Announces Development & Commercialization Agreement With Otsuka Pharmaceutical
Esperion recently announced it has entered into a collaboration agreement with Otsuka Pharmaceutical Co., Ltd. for the development and commercialization of….
Ascendia Joins the Fight Against COVID-19; Developing Formulations
Ascendia Pharmaceuticals, a specialty CDMO company engaged in the design, formulation, optimization, and manufacture of poorly soluble molecules for various dosage forms with patent-protected technology…
Arcutis Announces Enrollment of First Patient in Phase 1/2b Study
Arcutis Biotherapeutics, Inc. recently announced it has enrolled the first patient in Phase 1/2b study of ARQ-252, a potent and highly selective topical small molecule…
Hovione's Inhaler for High-Dose Delivery Earns Product Design Award
Hovione Technology recently announced its innovative 8Shot Dry Powder Inhaler (DPI) enabling high-dose drug delivery to the lungs has received the Red Dot 2020 Product…
Celsion Reports Sufficient Events Have Been Reached for the Second Interim Analysis of the Phase 3 OPTIMA Study
Celsion Corporation recently announced the prescribed minimum number of events of 158 patient deaths has been reached for the second pre-specified interim analysis of the…
Proveris to Present: The Effect of Ethanol Concentration on pMDI Evaporation Fraction
Proveris Scientific Corporation, a leading provider of services and technology to advance the science of spray and aerosol products, recently announced that on April 26…
Roquette Launches Online Technical Platform for Researchers & Drug Developers
As virtual collaboration and knowledge-sharing have reached a new level of urgency within the scientific community, Roquette, a trusted global supplier to life science companies…
Emisphere Announces Novo Nordisk Development Update
Novo Nordisk recently announced the European Commission (EC) has granted marketing authorization for Rybelsus, (oral semaglutide), for the treatment of adults with insufficiently controlled type…
SPECIAL FEATURE - Excipients: Matching Ingredients to Molecules Improves Functionality
Contributor Cindy Dubin speaks with several leading excipient manufacturers on how their excipient offerings are improving drug release, solubility, taste, physical characteristics, viscosity, and more for a range of molecules.
FORMULATION FORUM - Rational Design & Development of Lipid-Filled Hard Capsules
Jim Huang, PhD, says with ever increasing percentage of water-insoluble or low permeable new therapeutic entities among drug pipelines, lipid-based delivery systems, together with other main delivery technologies, have become an important tool for the development of those compounds.
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.