Drug Delivery
Synairgen Announces Dosing Has Commenced With Its Inhaled Interferon Beta Product in US Government-Funded NIH ACTIV-2 Trial in COVID-19 Outpatients
Synairgen plc recently announced that dosing has begun in the inhaled interferon beta formulation (SNG001) sub-study of the ACTIV-2 Phase 2/3 trial evaluating patients with…
Progenity Initiates Safety & Tolerability Study of its Smart Capsule-Based Oral Drug Delivery System for GI Diseases
Progenity, Inc. recently announced the initiation of a clinical study for their Drug Delivery System (DDS) capsule, an ingestible and self-guided drug delivery device. The…
Stevanato Group Leads First Industry Discussion Paper on Primary Container Traceability
With years of experience in unit-level traceability of containers, Stevanato Group has been the lead in drafting this document. Having a standard for the unique…
Celon Pharma Announces Successful Completion of Phase 1A Trial of CPL’116, JAK-ROCK Inhibitor
Celon Pharma S.A. recently announced the successful completion of its Phase 1A trial of its JAK/ROCK kinases dual inhibitor, CPL’116. CPL’116 was administered orally in….
Melt Pharmaceuticals Completes Phase 1 Study for Sublingual, Non-Opioid Pain & Sedation Drug Candidate
Melt Pharmaceuticals, Inc. recently announced results from its MELT Phase 1 study, a comparative bioavailability study with the objective of characterizing the pharmacokinetic parameters of…
ProPerma™ Oral Formulation Technology
ProPerma™ uniquely improves both permeability and bioavailability of BCS III and BCS IV compounds by deploying an innovative and bespoke combination of GRAS and novel enhancing excipients…
Noble Launches Human Factors Engineering Services to Support Product Development and US FDA Approval of Medical Devices & Combination Products
Noble, an Aptar Pharma company and world leader in providing drug delivery training device programs for pharmaceutical companies and original equipment manufacturers, recently announced the launch of Human Factors Plus (HF+), an expanded service to further….
Biogen Announces FDA Approval of PLEGRIDY (Peginterferon Beta-1a) Intramuscular Administration for Multiple Sclerosis
Biogen Inc. recently announced the US FDA has approved a new intramuscular (IM) injection route of administration for PLEGRIDY (peginterferon beta-1a) for the treatment of….
Patent on Improved Particle Size Testing Method Granted to Hovione Will Impact Market
Grants for a patent describing an innovative method to improve particle size analysis methods by laser diffraction have been recently announced by Hovione Technology Ltd,…
Venthera Doses First Patient With Topical Therapy Targeting Genetic Drivers of Rare Vascular Anomalies
BridgeBio Pharma, Inc. and affiliate Venthera recently announced the first subject has been dosed in its Phase 1/2 clinical trial of BBP-681 (also known as…
Pacira BioSciences Announces Equity Investment in GeneQuine Biotherapeutics
Pacira BioSciences, Inc. recently announced that the company will lead an equity investment in GeneQuine Biotherapeutics GmbH…..
DURECT Corporation Announces First Patient Dosed in Phase 2b AHFIRM Study
DURECT Corporation recently announced it has dosed the first patient in its AHFIRM randomized, double-blind, placebo-controlled, multi-center Phase 2b study to evaluate the safety and efficacy of DUR-928…
Stevanato Group Launches After-Sales Service Offering for Technologies & Manufacturing Equipment by Establishing a Global Network
Stevanato Group has launched an updated comprehensive, global after-sales service offering for pharmaceutical customers. Effective from January this year,….
Credence MedSystems Receives Strategic Investment From Novartis
Credence MedSystems recently announced that Novartis has made a strategic investment in the company. The investment will advance ongoing development and scaling of Credence’s innovative drug delivery systems….
Clene Nanomedicine Receives Patent Notice of Allowance for using Gold Nanocrystals for Treating MS
Clene Inc. recently announced its wholly owned subsidiary Clene Nanomedicine, Inc., a clinical-stage biopharmaceutical company, was issued a Notice of Allowance from the US Patent and Trademark Office (USPTO) for its invention for….
Catalent Agrees to Acquire Dry Powder Inhaler Spray Drying, Capsule Manufacturing & Packaging Capabilities From Acorda Therapeutics
Catalent recently announced it has entered into a definitive agreement to acquire the manufacturing and packaging operations of Acorda Therapeutics, Inc. The acquisition complements Catalent’s…
FORMULATION FORUM - Oral Controlled Delivery of Poorly Water-Soluble Drugs
Jim Huang, PhD, discusses how understanding key biopharmaceutical properties in relationship to drug absorption and elimination plays a critical role in successful design of CR dosage forms from discovery to first-in-human with a shorter timeline and lower development costs.
TUB PACKAGING - Why Double-Bagged Tubs Are an Issue for High-Speed Filling
Tilman Roedle says variation in tub packaging continues to create financial and operational challenges for the entire downstream supply chain, and it’s time for the industry to align on packaging configuration requirements that make tubs fully processable on automated lines.
FORMULATION DEVELOPMENT - The Role of Excipient Selection in the Development of Orally Disintegrating Tablets
Torkel Gren, PhD, reviews the benefits that orally disintegrating products can bring to patients and developers and assesses the impact that excipient selection can have on the development of successful products.
Gerresheimer Builds New Production Plant for Plastic Containers in India
With Triveni Polymers Pvt. Ltd. in Kundli, Gerresheimer has already been well positioned in India for many years. A second production plant in Kosamba (Gujarat)…
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.