Drug Delivery
NapaJen Pharma & Astellas Pharma Establish Research Collaboration for Discovery & Development of Novel Oligonucleotides
NapaJen Pharma, Inc. recently announced it has entered into a research collaboration with Astellas Pharma Inc. for the discovery and development of novel oligonucleotide therapeutics.…
Nicox Initiates Phase 2 Trial of NCX 4251 in Blepharitis
Nicox SA recently announced the initiation of a Phase 2 clinical trial evaluating NCX 4251, its novel patented ophthalmic suspension of fluticasone propionate nanocrystals, being…
Altimmune Announces Positive Results From NasoVAX Extension Study
Altimmune, Inc. recently announced additional positive data from a Phase 2 extension study of its NasoVAX intranasal influenza vaccine candidate. Data from this study demonstrated…
Amphastar Pharmaceuticals Receives ANDA Approval for Multi Dose Vial Drug
Amphastar Pharmaceuticals, Inc. recently announced the US FDA granted approval of its Abbreviated New Drug Application (ANDA) for Enoxaparin Sodium Injection 300 mg/3 mL (100 mg/mL) Multiple Dose Vial (MDV).
Aptar Pharma’s Nasal Device Approved by FDA for Breakthrough Treatment
Aptar Pharma recently announce that its Bidose nasal spray device was recently approved by the US FDA for a breakthrough therapy in the field of depression.
SunGen Pharma & Athenex Pharmaceutical Division Announce Injection Product Launch
SunGen Pharma recently announced the launch of Busulfan Injection, the second product launch through their joint venture Peterson Athenex with Athenex Pharmaceuticals. The ownership of…
CURE Pharmaceutical Expands US DEA Approval to Manufacture Pharmaceuticals Using Whole Cannabis Plant
CURE Pharmaceutical recently announced it has broadened its US Drug Enforcement Administration (DEA) license as an authorized manufacturer of Schedule 1 substances to include both…
Proper Fill & Finish in Clinical Development Requires a Comprehensive Approach
For pharma and biotech companies both large and small, the challenges involved in the fill and finish process of drugs for clinical development and scale-up continue to present new challenges.
Lipomedix Announces Initiation of Phase 1b Trial
Lipomedix recently announced the initiation of a Phase 1b multicenter trial (LIPORAD-2018) to identify the optimal dose, safety, and efficacy of its lead compound Promitil…
Catalent Invests Over $27 Million to Commercialize ODT Technology
Catalent Pharma Solutions recently announced that it is to invest more than $27 million to commercialize its next-generation oral disintegrating tablet (ODT) technology, Zydis Ultra.
Nemera’s Preservative-Free Multidose Eye Dropper Approved for Santen’s Drug in 29 European Countries
Nemera recently announce its multidose eye dropper Novelia has been approved for the preservative-free formulation Cosopt iMulti (20 mg/ml dorzolamide + 5 mg/ml timolol eye drops, solution).
SPECIAL FEATURE - Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development
Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.
GLOBAL REPORT - 2018 Global Drug Delivery & Formulation Report: Part 1, a Global Review
In part 1 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on a global review of 2018 product approvals.
Foamix Announces Positive Results From Phase 3 Open-Label Safety Study Evaluating Topical Minocycline Foam
Foamix Pharmaceuticals Ltd. recently announced positive safety and efficacy data for its Phase 3 open-label safety study (FX2016-13), evaluating FMX103 in moderate-to-severe papulopustular rosacea for…
Eton Pharmaceuticals Enters Into License Agreement for Two Branded Hospital Product Candidates
Eton Pharmaceuticals, Inc. recently announced that it has entered into an exclusive licensing and supply agreement with Sintetica SA, a Swiss-based pharmaceutical company, to obtain…
Genocea Announces Private Placement Financing of Up to $39 Million
Genocea Biosciences, Inc. recently announced it has entered into a private placement with certain existing and new investors providing for the purchase of up to…
Despite Recent Setbacks, the Ophthalmology Market Still Offers Vast Potential
Despite the ophthalmology market experiencing several research and development (R&D) setbacks during 2018, the launch of three new drugs highlights that the market still offers…
argenx & Halozyme Enter Global Collaboration & License Agreement
argenx and Halozyme Therapeutics, Inc. recently announced a global collaboration and license agreement that enables use by argenx of Halozyme’s ENHANZE drug delivery technology to…
AIT Receives Milestone Payment From Commercialization Partner
AIT Therapeutics, Inc. recently announced it has received a milestone payment of $3.15 million from its commercialization partner Circassia Pharmaceuticals for the successful completion of…
West Annouces Significant Agreements With Swissfillon & scPharmaceuticals
West recently announced it has commenced discussions with two companies regarding the use of West’s proprietary SmartDose drug delivery platform for complex molecules.
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.