Drug Delivery
MannKind Receives FDA Fast Track Designation for Clofazimine Inhalation Suspension for the Treatment of Nontuberculous Mycobacterial Lung Disease
MannKind Corporation recently announced the US FDA has granted Fast Track designation of Clofazimine Inhalation Suspension (MNKD-101) for the treatment of nontuberculous mycobacterial (NTM) lung…
Enable Injections Expands Strategic Partnership With Roche
Enable Injections, Inc. recently announced it has expanded its partnership with Roche through a collaboration, allowing Roche to develop and apply Enable’s expertise….
DevPro Biopharma & Bespak Complete Early Feasibility Studies for New Groundbreaking Albuterol Inhaler
DevPro Biopharma and Bespak have recently announced the completion of early feasibility studies on DP007, a new formulation of albuterol in a pressurized metered dose….
Bespak & H&T Presspart Enter Collaboration Agreement to Advance Transition to Low GWP Propellants in pMDIs
Partnership will provide GMP filling capabilities and development support for clinical trial programs with low GWP propellants….
Bespak & Medicines Evaluation Unit Collaborate to Accelerate Clinical Trials on Climate-Friendly Inhalers
Bespak and The Medicines Evaluation Unit (MEU) recently announced a collaboration to further accelerate the pharmaceutical industry’s transition from existing pressurized Metered Dose Inhaler (pMDI)…
Guangzhou Bio-gene Technologies Announces Initiation of Phase 1 Clinical Trial for CAR-T Targeting CLL-1
Guangzhou Bio-gene Technologies recently announced the first patient was treated with BG1805, an investigational autologous CAR-T cell therapy targeting CLL-1, a member of the C-type…
SPECIAL FEATURE - Prefilled Syringes & Parenteral Delivery: Next-Gen Injections Feature Technology & Reconstitution
Contributor Cindy H. Dubin highlights innovations from key players in parenteral delivery and prefilled syringes, with focuses on safety, meeting regulatory requirements, cost, fill/finish, and dosing.
SCALING MANUFACTURING - Collaboration Between a Device Supplier & Equipment Manufacturer to Meet the Needs of Patients, End-Users & Pharma Manufacturers
John Merhige and William (“Bill”) Jaworski present how their two companies have worked closely together, using creative manufacturing strategies to produce a wide array of problem-solving drug delivery systems.
EXECUTIVE INTERVIEW - Adare Pharma Solutions: Expanding Capabilities to Exceed Customer Expectations
Tom Sellig, CEO of Adare Pharma Solutions, discusses how he has realized various achievements and about the company’s focus on addressing special needs in the market, its global expansion, and where he expects to take the company in the future.
DRUG & DEVICE DEVELOPMENT - Integration of siRNA, Nanoparticles & Capsule Endoscopy for Treatment of Inflammatory Bowel Disease
Nila Murali, Leia Jiang, and Ravali Bhavaraju highlight a promising technology that can change the way IBD is treated. Current imaging technology can successfully identify inflammation, and current treatments can address active inflammation and manage symptoms.
MannKind to Proceed With Phase 1 Nintedanib DPI Study for Pulmonary Fibrotic Diseases
MannKind Corporation recently announced it will proceed with a first-in-human Phase 1 study of nintedanib DPI (MNKD-201) for pulmonary fibrotic diseases, including idiopathic pulmonary fibrosis…
Biora Therapeutics Announces Completion of Multiple-Ascending Dose Cohorts for Clinical Trial of BT-600
Biora Therapeutics, Inc. recently announced completion of dosing for the multiple-ascending dose cohorts for its clinical study of BT-600, a drug-device combination consisting of the…
Biotts Becomes First Company to Successfully Deliver Insulin Through Skin
Patients with Type 1 diabetes could replace up to 20 insulin injections over a period of five days….
DRY POWDER FORMULATION - Preparing to Deliver the Next Generation of Inhaled Therapeutics
Richard Johnson, PhD, outlines the trends and challenges within the inhaled drug delivery market. Specifically, DPI delivery will be explored, including how the challenges with dry powder formulation can be overcome and what the future holds for DPIs.
ENA Respiratory Announces FDA IND Clearance for First-in-Class Antiviral Innate Immunomodulator
ENA Respiratory recently announced the US FDA has issued a "safe to proceed" notice for its investigational new drug (IND) application for a Phase 1b…
Tiziana Life Sciences Announces Study Results From Intranasal Anti-CD3 Foralumab in Multiple Sclerosis Patients
Tiziana Life Sciences, Ltd. recently announced a study related to its lead candidate, foralumab, was highlighted in Neurology Today, the official news source of the…
Regeneration Biomedical Doses First Patient in a First-in-Human Phase 1 Clinical Trial of Stem Cell Therapy Delivered Directly Into the Brain of Patients With Alzheimer’s Disease
Regeneration Biomedical, Inc. recently announced the first patient has been dosed in an FDA-cleared, first-in-human Phase 1 clinical trial of autologous, Wnt-Activated Adipose-Derived Stem Cells…
New Drug Delivery System Developed by Hebrew University Researchers Simultaneously Delivers Diverse Therapeutic Agents in a Single Carrier
A new drug delivery system that overcomes previous limitations in delivering diverse therapeutic compounds in a single carrier has been developed by Hebrew University of…
Asahi Kasei Bioprocess & Axolabs Announce Strategic Partnership to Accelerate Oligonucleotide Therapeutics Development
Asahi Kasei Bioprocess (AKB), part of the Asahi Kasei Group, and Axolabs have recently announced a strategic partnership in the burgeoning field of oligonucleotide….
NeuroSense Collaborates With Lonza to Identify Exosome-Based Biomarkers to Advance Neurodegenerative Disease Treatments & Diagnostics
Lonza and NeuroSense Therapeutics Ltd. recently announced a collaboration to evaluate biological changes occurring in people with neurodegenerative diseases, including ALS. This agreement provides NeuroSense…
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.