Drug Delivery
WHITEPAPER - Accelerate Preclinical Developments & Improve Oral Bioavailability With Lipid-Based Formulation & Encapsulation Technology Combination
This paper covers the benefits of the LBF and capsules combination in dosage form developments, an efficient technology platform to bring efficient and differentiated products to the market.
Zealand Pharma Announces Designation of Priority Review by the US FDA for Dasiglucagon in Congenital Hyperinsulinism
Zealand Pharma A/S recently announced that the US FDA has granted priority review designation for dasiglucagon for the prevention and treatment of hypoglycemia in pediatric…
OKYO Pharma Achieves 90% Enrollment in 240-Patient Phase 2 Clinical Trial of OK-101 to treat Dry Eye Disease
OKYO Pharma Limited recently announced it has enrolled and randomized 90% of the patients in its 240-patient Phase 2 multi-center, double-masked, placebo-controlled clinical trial of…
Denali Therapeutics Announces New Interim Data From Phase 1/2 Study of DNL310 in MPS II (Hunter Syndrome)
Denali Therapeutics Inc. recently announced new interim data from the ongoing open-label, single-arm Phase 1/2 study of DNL310 (ETV:IDS) in children with MPS II (Hunter…
Certara Simcyp Group Awarded Two New Grants From US FDA
Programs focus on use of physiologically-based pharmacokinetic (PBPK) modeling for demonstrating virtual bioequivalence and predicting drug absorption of topical formulations…..
WHITEPAPER - Effect of Excipient Choices on Topical Formulations & Manufacturing Processes
In this whitepaper, we review the effect of excipient choice on the process of manufacturing topical products. The effect of the following excipient types will be discussed: surface active agents, preservatives, polymer choice and….
Ascendia Named to 2023 Inc. 5000 List of America’s Fastest-Growing Private Companies for the Fourth Consecutive Year
Ascendia Pharmaceuticals®, a leading specialty pharmaceutical contract development and manufacturing organization (CDMO) in North America, proudly announces it has been named to the prestigious 2023…
Vaxxas Opens World-Class Manufacturing Facility to Produce Proprietary Needle-Free Vaccine Patch For Late-Stage Clinical Trials & First Commercial Products
Vaxxas recently announced the opening of its first, state-of-the-art manufacturing facility in Brisbane, Queensland. The custom-built 60,000-sq-ft Vaxxas Biomedical Facility will serve as….
Revive Therapeutics Announces Initiation of Novel Bucillamine Formulation Development
Revive Therapeutics Ltd. recently announced it has initiated the development of a next-generation formulation of Bucillamine for the potential treatment of public health medical emergencies,…
Recipharm & Honeywell to Speed Development of Inhalers With Near-Zero Global Warming Potential Propellant
Partnership will reduce environmental footprint of pressurized metered dose inhalers and accelerate transition to lower greenhouse gas respiratory care….
Tiziana Life Sciences Announces FDA IND Clearance of Intranasal Foralumab for the Treatment of Alzheimer’s Disease
Tiziana Life Sciences Ltd. recently announced the US FDA has cleared the IND application for intranasal foralumab to be studied in Alzheimer’s disease. Foralumab could be a potentially….
BioCorRx Submits Expanded Access Treatment Protocol to FDA for Implantable Biodegradable Naltrexone Pellet for Opioid Use Disorder Treatment
Company hopes in 30 days to begin making its drug candidate available to help patients and address public health crisis….
Ketabon GmbH Reports Top-Line Results From Phase 2 Trial of Take-at-Home, Oral Ketamine Option for Treatment-Resistant Depression
Ketabon, a joint venture between HMNC Brain Health and Develco Pharma, recently announced top-line results from its Phase 2 KET01-02 Ketabon study with lead asset…
Comera Life Sciences Significantly Expands Intellectual Property Portfolio Strengthening the Proprietary SQore Platform
Comera Life Sciences Holdings, Inc. recently announced a significant expansion of its SQore patent portfolio with the issuance of four new patents and two new…
Silo Pharma Reaches Positive Milestone With Nasal Formulation for Anxiety, PTSD & Stress-Related Disorders
Silo Pharma, Inc. recently announced it has advanced the formulation development for its therapeutic drug, SPC-15. The liquid nasal formulation will be used in….
Preclinical Data Shows Strong Immunogenicity & Protection With IMUNON’s PlaCCine DNA-Based Vaccines Modality
IMUNON, Inc. recently announced a manuscript titled Strong immunogenicity & protection in mice with PlaCCine: A COVID-19 DNA vaccine formulated with a functional polymer is available…
WHITEPAPER - Addressing Regulatory Challenges for Ophthalmic Combination Products
Going forward, sponsors developing ophthalmic products formulated for delivery as eye drops must be prepared to pursue development programs that address the regulatory requirements for drug-device combination products. Partnering with a contract manufacturing organization (CMO) that has experience bringing such products to market is essential…..
First Patient Enrolled in Investigator-Initiated Trial With OCS-01 Eye Drops for the Treatment of Cystoid Macular Edema
Oculis Holding AG recently announced the first patient has been enrolled in the investigator-initiated LEOPARD trial evaluating the potential of OCS-01 eye drops, Oculis’ novel…
ProQR Therapeutics & Laboratoires Théa Announce Agreement for Théa to Acquire ProQR’s Sepofarsen & Ultevursen Ophthalmic Assets
ProQR Therapeutics N.V. and Laboratoires Théa recently announced an agreement in which ProQR will divest its late-stage ophthalmic assets, sepofarsen and….
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.