Drug Delivery
Vyluma Announces Marketing Authorization Application Validation for the European Union
Vyluma, Inc. recently announced the European Medicines Agency (EMA) has validated the Marketing Authorisation Application (MAA) for its lead compound, NVK002. The application is confirmed…
TFF Pharmaceuticals & Leidos to Advance Next-Generation Biodefense Countermeasures Under the DARPA PPB Program Into Preclinical Testing
TFF Pharmaceuticals, Inc. recently announced the government will be advancing several next-generation medical countermeasures (MCMs) formulated with its Thin Film Freezing technology into advanced preclinical…
Pneumagen Presents Positive Phase 2 Influenza Human Challenge Study Data
Pneumagen recently presented positive results from its Phase 2, proof-of-concept, Controlled Human Infection Model (CHIM) study in which healthy volunteers were challenged with influenza virus…
Metoject Subcutaneous Injection Pen (Methotrexate) Pen-Type Autoinjector Launched In Japan
Eisai Co., Ltd. and nippon medac Co., Ltd., a subsidiary of medac group, recently announced they have launched the anti-rheumatic agent Metoject Subcutaneous Injection 7.5…
TFF Pharmaceuticals & Cleveland Clinic to Advance Multivalent Universal Influenza Vaccine Candidates into Preclinical Testing
TFF Pharmaceuticals, Inc recently announced that, in collaboration with Cleveland Clinic, the company is advancing multiple multivalent universal influenza vaccines to protect against seasonal and…
TFF Pharmaceuticals Provides Update on Tacrolimus Inhalation Powder Phase 2 Trial for the Prevention of Lung Transplant Rejection
TFF Pharmaceuticals, Inc. provided an update from the its ongoing Phase 2 trial of Tacrolimus Inhalation Powder (TFF TAC) for the prevention of lung transplant…
Enable Injections & Serina Therapeutics Announce Agreement to Develop SER-252 in Combination With enFuse for Advanced Parkinson’s Disease
Enable Injections, Inc. and Serina Therapeutics recently announced a partnership to develop and commercialize SER-252 (POZ-apomorphine) in combination with enFuse for the treatment of Parkinson’s…
Roquette Unlocks the Power of Flexibility With Launch of New Flex Softgel Capsule Shell System
Roquette recently announced the launch of its new LYCAGEL Flex hydroxypropyl pea starch premix for nutraceutical and pharmaceutical softgel capsules. Built on Roquette’s market-first LYCAGEL pea…
ElevateBio Announces New US Patents for Lead Life Edit CRISPR Systems & Adenine Deaminases Enabling Advanced Gene Editing Techniques
ElevateBio is building a robust portfolio of patents protecting its novel technologies while the Company scales as the world’s first integrated genetic medicine foundry….
IMUNON Announces Site Activation for IMNN-101 Phase 1 Vaccine Study
IMUNON, Inc. recently announced DM Clinical Research in Philadelphia is the first site activated and ready for patient recruitment for its Phase 1 study with…
Arecor & Medtronic Diabetes Establish Collaboration to Develop Novel Thermostable Insulin for Implantable Pump Delivery
Medtronic to fund Arecor’s development of Arestat-enabled novel, high concentration, thermostable insulin, specifically tailored for use in combination….
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.
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.