Drug Delivery
Catalent & Grünenthal Announce Successful Collaboration to Facilitate Expedited Clinical Development Timelines
Catalent and Grünenthal recently announced their successful formulation design and clinical-phase manufacturing collaboration for an orally dosed small molecule in Grünenthal's pipeline. Positive preclinical results…
Roivant Reports Positive Topline Results From Phase 3 Trial of VTAMA (tapinarof) Cream, 1% Once Daily in Adults & Children as Young as 2
Dermavant Sciences, a Roivant Sciences (Nasdaq: ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology, recently announced positive results from ADORING 2, one…
Nemera & Nelson Labs Europe Strengthen Partnership to Offer Integrated Services to Customers
This strategic alliance will give a unique advantage to pharmaceutical & bio-tech customers – accelerating the go-to-market of their drug-device combination products by offering analytical chemistry, drug compatibility lab testing and expert advice….
Cingulate & Indegene Announce Joint Commercialization Agreement for Lead ADHD Candidate
Cingulate Inc. and Indegene recently announced a joint commercialization agreement to provide commercial support for Cingulate’s lead candidate CTx-1301 (dexmethylphenidate), a novel, investigational treatment….
First Wave BioPharma Announces First Patient Dosed in Phase 2 SPAN Clinical Trial of Enhanced Adrulipase Formulation
First Wave BioPharma, Inc. recently announced that the first patient was dosed in the Phase 2 SPAN clinical trial investigating an enhanced enteric microgranule delivery formulation of….
Evonik Opens New Facility for Pharmaceutical Lipids at Site in Germany
Evonik is opening a new GMP facility to manufacture lipids for advanced, pharmaceutical drug delivery applications. The lipid launch facility is located at the company’s site in Hanau, Germany and….
WHITEPAPER - Purity is Paramount: Assessing N-Oxide Impurities in Lipids Used in Lipid Nanoparticle Delivery Systems
This study demonstrates that Evonik is capable of manufacturing high-quality lipids with a purity greater than 99% and a consistently low level of the N-Oxide impurity.
NeOnc Technologies Engages Anova Enterprises to Pursue Pediatric Brain Tumor Indication & FDA Fast-Track Status
NeOnc Technologies Holdings, Inc. has recently expanded its engagement of Anova Enterprises to pursue a pediatric indication for NEO100, an enhanced method of delivering pharma-based…
SiSaf & the University of Leipzig Partner to Develop Bio-Courier Targeted miRNA for the Treatment of Pancreatic Cancer
SiSaf Ltd recently announced its collaboration with the University of Leipzig, Germany, to develop Bio-Courier targeted micro interfering RNAs (miRNA) for the treatment of….
SPECIAL FEATURE - Solubility & Bioavailability: Difficult Beasts to Tame
Contributor Cindy H. Dubin highlights the services many of these outsourced providers offer to enhance solubility and bioavailability and get their clients’ projects to market faster and cost effectively – while maintaining critical quality attributes.
DELIVERY TECHNOLOGY - NeuroDirect™ Ketamine: Novel, Non-Systemic Topical Therapy for PTSD & Associated Intractable Depression
Ronald Aung-Din, MD, and Chantelle G. Martin, MBChB, present scientific data demonstrating how with NeuroDirect technology, the benefits of psychedelic compounds may be achieved without concern for their potential systemic effects.
FORMULATION FORUM - Changing the Landscape of Nanoparticles for Long-Acting Injectable Drugs
Jim Huang, PhD, and Shaukat Ali, PhD, say recently, there has been continued interest in parenteral NPs with sustained-release characteristics as more drugs discovered are poorly soluble and less bioavailable, and these challenges have led to enormous opportunities and launch of many drug products to market.
MARKET TRENDS - Emerging Trends in Injectable Drug Formulation & Delivery
Martin Gonzalez, PhD, details current trends in sterile injectable formulations and delivery devices and highlights the challenges pharma and its CDMO partners are facing bringing emerging parenteral breakthroughs to patients.
QSAM Biosciences Completes Enrollment of Initial Cohort in its Phase 1 Study of CycloSam Targeting Metastatic Bone Cancer
QSAM Biosciences Inc. recently announced the completion of enrollment in the first participant grouping (cohort) of its Phase 1 study evaluating CycloSam in the treatment…
EyePoint & Rallybio Announce Research Collaboration
Rallybio Corporation and EyePoint Pharmaceuticals, Inc recently announced a research collaboration. The partnership will evaluate sustained delivery of Rallybio’s inhibitor of complement component….
PDS Biotech Completes Successful Meeting With FDA for Triple Combination of PDS0101, PDS0301 & a Commercial Immune Checkpoint Inhibitor
Received guidance on registrational path for combination in recurrent/metastatic, immune checkpoint inhibitor refractory head and neck cancer….
IMUNON & Break Through Cancer Commence Enrollment in a Phase 1/2 Clinical Study of IMNN-001 in Combination With Avastin in Advanced Ovarian Cancer
IMUNON, Inc. and Break Through Cancer recently announced the commencement of patient enrollment in a collaboration to evaluate IMUNON’s IMNN-001 (formerly GEN-1) in combination with…
Daré Bioscience Announces Start of a Phase 1 Study for its Potential First-in-Category Treatment for Primary Dysmenorrhea
Daré Bioscience, Inc. recently announced the start of a Phase 1 study evaluating its development program targeted at treating primary dysmenorrhea by delivering the active…
Cue Biopharma Enters Strategic Collaboration & Option Agreement With Ono Pharmaceutical
Cue Biopharma, Inc. recently announced a collaboration and option agreement with Ono Pharmaceutical Co., Ltd. for CUE-401, a bispecific protein designed to induce and expand regulatory….
Eterna Therapeutics Enters Option & License Agreement With Lineage Cell Therapeutics to Develop Hypoimmune Pluripotent Cell Lines for Multiple Neurology Indications
Eterna Therapeutics Inc. recently announced it has entered into an exclusive option and license agreement with Lineage Cell Therapeutics, Inc. for the development of novel induced…
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.