Drug Delivery
Catalent & MigVax Sign Agreement to Develop an Orally Disintegrating Freeze-Dried Tablet Vaccine Against COVID-19
Catalent and MigVax recently announced they have signed a development agreement to leverage Catalent’s proprietary Zydis Bio orally disintegrating tablet (ODT) technology for delivering the…
SPECIAL ROUNDTABLE - Which Trends Will Have the Most Impact on Drug Development in 2022?
Drug Development & Delivery posed this question to life science leaders during a recent roundtable discussion. While their responses are varied, a common theme is that COVID-19 has left a lasting impact on the industry….
Zai Lab & Novocure Announce Phase 2 Pilot Study Evaluating Tumor Treating Fields Together With Standard-of-Care Chemotherapy Meets Primary Endpoint for First-Line Treatment of Gastric Cancer
Zai Lab and Novocure recently announced the EF-31 Phase 2 pilot study, testing the safety and efficacy of Tumor Treating Fields (TTFields) together with standard-of-care…
Evonik Invests $220 Million to Build New Lipid Production Facility for mRNA-based Therapies in the US
Evonik is building a new, highly flexible, global-scale production facility for pharmaceutical lipids in the US. The new plant at Evonik’s Tippecanoe site in Lafayette,…
Teon Therapeutics Announces FDA Acceptance of IND Application for Novel, Oral Immune Checkpoint Inhibitor
Teon Therapeutics recently announced the acceptance by the US FDA of Teon’s Investigational New Drug (IND) application for the study of TT-816. TT-816 is a novel, oral cannabinoid CB2 receptor….
Vaxart Reports Positive Preliminary Data from Phase 1b Trial of its Oral Norovirus Vaccine Candidates in Elderly Adults
Results of the trial show a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells (ASCs), consistent with previous…
PLATFORM TECHNOLOGY - Confident Silence: Delivering on the Promise of siRNA Therapies
Giles Campion, MD, says while the liver offers plenty of fertile ground for developing siRNAs therapies to treat many diseases, many disease-related genes are not highly expressed in the liver. For this reason, the next great challenge in the field is delivering siRNA to tissues outside the liver.
SPECIAL FEATURE - Outsourcing Formulation Development & Manufacturing: Understanding Critical Attributes Earlier in Development Leads to a More Robust Drug Product
Contributor Cindy H. Dubin speaks with industry leaders on how drug sponsors and CDMOs are collaborating earlier, and highlights how third-party contractors are navigating material shortages and how the industry is shifting to address different therapeutic targets and molecules, such as mRNA.
GLOBAL REPORT – 2021 Global Drug Delivery & Formulation Report: Part 3, Drug Delivery and Formulation Pipeline Trends
In part 3 of this 3-part series, PharmaCircle, in collaboration with Drug Development & Delivery, provides additional insights into the nature of the current pipeline in terms of development phase, delivery route, molecule type, and disease area taken from PharmaCircle’s Pipeline Dynamics module.
AUTOINJECTOR TECHNOLOGY - De-risking Biosimilar Development With a Clinically Validated & Commercially Proven Disposable Autoinjector
Victoria Meyer, MBA, explains how for many biopharmaceutical customers, BD and the BD Physioject™ Disposable Autoinjector have offered the appropriate combination of technology, documentation, and resources required for timely success.
CordenPharma Increases xRNA-based Capabilities with a Strategic Investment in LNP Formulation Services at its Caponago Injectable Facility
CordenPharma has recently increased its xRNA capabilities at its sterile injectable facility in Caponago, Italy. The company reports that it is investing over €10M in new Lipid Nanoparticle (LNP) formulation,….
BIORESORBABLE POLYMERIC MATRICES - Convergence of Materials Science & Drug Development to Treat Challenging ENT Diseases
Maria Palasis, PhD, and Robert Kern, MD, review how The XTreo platform represents a unique and powerful convergence of materials science, drug development, and formulation chemistry, enabling the local delivery of medication to anatomical spaces not accessible by conventional therapeutic approaches.
EXECUTIVE INTERVIEW - Catalent: Developing & Delivering Billions of Doses of Drugs Every Year
Alessandro Maselli, President and Chief Operating Officer of Catalent, talks about his company’s unique approach to drug development partnerships as he prepares to become the company’s new President and Chief Executive Officer on July 1, 2022.
Lonza Completes Dedicated Early Clinical Phase Development & Manufacturing Facility in Bend (OR)
Lonza has enhanced its offering for customers in the early phases of their clinical trials by adding a dedicated Early Phase Clinical Manufacturing facility at…
Gattefossé Strengthens its International Footprint & Breaks Ground on its Production Site in Texas
Gattefossé will break ground on its first North American manufacturing facility in Lufkin city, TX. Gattefossé as well as officials of Lufkin city will attend the ceremony. This asset will manufacture….
ISR Signs Agreement With Gerresheimer for Clinical-Scale Production of IcoOne Nasal Inhalers
The drug development company ISR has recently signed an agreement with Gerresheimer for large-scale production of the IcoOne nasal inhaler, for its Phase 3 study of its dry powder….
SciSparc to Collaborate With Polyrizon for Brain Targeting Using Intranasal Hydrogel Systems
SciSparc Ltd. recently announced it has signed a collaboration agreement with Polyrizon Ltd., a biotech company focused on the development of innovative medical device hydrogels delivered in….
Timber Pharmaceuticals Receives FDA Breakthrough Therapy Designation for the Treatment of Congenital Ichthyosis
Timber Pharmaceuticals, Inc. recently announced the US FDA has granted Breakthrough Therapy designation to TMB-001, a topical isotretinoin formulated using the company’s patented IPEG delivery…
DFE Pharma Opens New Center of Excellence in India to Provide Fast-Track Formulation Services
DFE Pharma recently announced the launch of its new Center of Excellence Closer to the Formulator (C2F) in Hyderabad, India. The C2F center is based in Genome Valley….
WHITE PAPER: Bring Quality OINDPs to Market Faster Than Ever Before | Proveris Scientific
Learn how the Proveris by Design(TM) approach is a proven tool for successfully developing nasal spray and inhalation drug products….
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.