Drug Delivery
SPECIAL FEATURE - Excipients: Exciting Expansion & Innovation
Contributor Cindy H. Dubin speaks with several companies and presents a unique look at how excipients are being used to support current and future innovative active pharmaceutical ingredients.
FORMULATION FORUM - Oral Formulation Approaches for Different Stages of Clinical Studies
Jim Huang, PhD, says it is of the utmost important task to utilize a phase-appropriate formulation development approach for early and later-stage commercial development of oral dosage forms.
SUPPLY CHAIN MANAGEMENT- Are Supply Chains Up for the Post-Pandemic Challenge?
John Swift believes each medical device manufacturer will discover different patterns of risk as a result of COVID-19. It is therefore imperative that businesses carry out an in-depth and urgent re-appraisal of their supply chain, as failing to do so may cause commercial damage.
Proveris Expands Product Portfolio With New Kinaero Cx pMDI Collection System for Delivered Dose Uniformity & Aerodynamic Particle Size Distribution Testing
Proveris Scientific Corporation recently introduced the Kinaero Cx pMDI Collection System to automate the pMDI shaking, priming, dose sample collection, and fire-down for….
Starton Therapeutics Announces FDA Clearance of IND Application
Starton Therapeutics Inc. recently announced the US FDA has cleared an investigational new drug (IND) application for STAR-OLZ in Chemotherapy Induced Nausea and Vomiting (CINV). STAR-OLZ is a multi-day transdermal….
Lonza Joins IPAC-RS, an International Consortium Advancing the Regulatory Science of Inhalation Products
Lonza recently announced its membership in the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS). Through this consortium, Lonza will collaborate with other industry…
Outlook Therapeutics Submits BLA to FDA for ONS-5010 as a Treatment for Wet AMD
Outlook Therapeutics, Inc. recently announced it has submitted its Biologics License Application (BLA) to the US FDA for ONS-5010, an investigational therapy which, if approved,…
Mapi Pharma Receives US Patent Covering Methods of Suppressing or Alleviating Primary or Secondary Progressive MS With a Sustained-Release Glatiramer Acetate Depot
Mapi Pharma Ltd. recently announced it has been granted US Patent No. 11,167,003 titled Methods for suppressing or alleviating primary or secondary progressive multiple sclerosis….
Owen Mumford & Noble International Announce Collaboration
Owen Mumford Pharmaceutical Services recently announces its alliance with Noble International, an Aptar Pharma company and world leader in providing drug delivery….
eTheRNA Manufacturing Announces New LNP Formulation Development & Production Service
eTheRNA Manufacturing recently introduced a new Lipid Nanoparticle (LNP) formulation development and production service to support the discovery and early preclinical development of RNA-based….
Gb Sciences' Nanoparticle Encapsulation Technology Improves the Efficacy of Terpenes for Use in Chronic Pain Formulations
Gb Sciences, Inc. recently announced its sponsored study investigating the effect of nanoparticle encapsulation of three cannabis-based terpenes on their potential efficacy in pain management was….
DFE Pharma, Harro Höfliger & Sterling Announce Unique Partnership to Provide Formulation Services for Respiratory Products
Three leading companies in their respective fields – DFE Pharma (excipients solution provider), Harro Höfliger (equipment supplier), and Sterling (API manufacturer) recently announced a unique partnership….
WHITE PAPER: Tackling a Changing Climate; Metered Dose Inhalers | Recipharm
Are you prepared for the HFA phasedown? With many industries switching to more environmentally friendly propellants, pMDI developers need to be ready. Recipharm explore alternative…
Gerresheimer Opens a New Plant to Produce Pharmaceutical Container Solutions
Gerresheimer ceremoniously took over a new building in Berlin, Ohio. In the future, the square plastic containers of the Duma Twist-Off Q brand with a 40-ml filling volume….
Rani Therapeutics Announces Initiation of Phase 1 Study for Osteoporosis
Rani Therapeutics Holdings, Inc. recently announced the initiation of a Phase 1 study of RT-102, an oral formulation of the human parathyroid hormone analog PTH(1-34)…
Vallon Pharmaceuticals Announces Topline Results of its Pivotal SEAL Study for Lead Program
Vallon Pharmaceuticals, Inc. recently announced topline results from its pivotal SEAL study evaluating ADAIR, a proprietary abuse-deterrent formulation of immediate release (IR) dextroamphetamine for the…
Gerresheimer Establishes Small Series Production in the US
Pharma and medical technology specialist Gerresheimer has established small series production at its Technical Competence Center at its Peachtree City, GA, location. Small quantities of…
PAVmed Announces Successful First-in-Human Implantations of its Intraosseous Infusion System
PAVmed Inc. recently announced physicians at the Clinica Porto Azul in Barranquilla, Colombia, successfully implanted the company’s PortIO Intraosseous Infusion System in three….
Viatris Announces Receipt of First FDA Approval for Generic Version of Symbicort Inhalation Aerosol in Partnership With Kindeva
Viatris Inc. and Kindeva Drug Delivery L.P. recently announced Mylan Pharmaceuticals Inc., a Viatris subsidiary, has received approval from the US FDA for its Abbreviated New Drug…
KemPharm Earns $1.975 Million From Corium Following FDA Approval of Donepezil Transdermal System
KemPharm, Inc. recently announced it has earned a $1.975 million fee from Corium, Inc. following the approval of Corium’s product ADLARITY (donepezil transdermal system) by…
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.