Drug Delivery
DRUG DEVELOPMENT - Softgel Technology for Fast-Tracked Development Programs
Jeff Browne, PhD, and Ronak Savla, PharmD, PhD, believe given the accelerated timelines associated with expedited programs, lipid-based drug formulations, encapsulated in softgel capsules, provide an attractive option for addressing the challenges facing formulators.
FORMULATION FORUM - Formulation Development From Preclinical to First-In-Human
Jim Huang, PhD, says when a compound enters preclinical development for a GLP tox study from the drug discovery stage, formulators have innovative options on how to develop a tox and clinical formulation that ensures the success of IND and first dose in human.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 3: Notable Drug Delivery and Formulation Transactions and Technologies of 2018
In part 3 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, offers a short overview of drug delivery and formulation transactions and includes some of the numbers that color the trends of 2018 along with some thoughts on notable transactions and technologies.
ChemioCare Announces Initiation of PETT-Based (Permeation Enhanced Transdermal Technology) Lenalidomide Program
ChemioCare USA Inc. recently announced it is initiating development of a transdermal formulation of lenalidomide, which is currently marketed in an oral form. ChemioCare believes…
Catalent Invests $14 Million at its Softgel Facility
Catalent recently announced that work is underway to expand integrated turnkey softgel capabilities at its facility in Eberbach, Germany. The $14-million expansion, which is scheduled…
Enesi Pharma & BARDA Drive Enter Public-Private Partnership to Develop Solid Dose Vaccine Delivery Technology
Enesi Pharma recently announced it has entered a public-private partnership with the US Biomedical Advanced Research and Development Authority’s (BARDA) DRIVe (Division of Research, Innovation,…
Hovione Technology Announces Acquisition of Global Rights to New Pulmonary Inhaler Device
Hovione Technology, a specialist in development of innovative inhalation device technology, recently announced it has secured global rights to develop and commercialize a new ultra-affordable, multi-use blister-based dry powder inhaler patented by inventor Dr. Klaus-Dieter Beller.
Paragon Bioservices to be Acquired for $1.2 Billion
Catalent, Inc. and Paragon Bioservices, Inc. and Catalent Inc. recently announced they have entered into a definitive agreement under which Catalent will acquire Paragon for $1.2 billion.
Bellerophon Announces Agreement With FDA on Regulatory Approval Pathway for INOpulse
Bellerophon Therapeutics, Inc. recently announced it has reached agreement with the US FDA on the regulatory approval pathway for INOpulse in patients with Pulmonary Hypertension…
Industry Trends: Vigilance is Critical for Future Success
Peter Soelkner says there will always be a wide variety of trends influencing our industry and we see no reason why this will not continue well into the future.
CURE Pharmaceutical to Acquire Chemistry Holdings Inc.
CURE Pharmaceutical, an innovative drug delivery and development company, recently announced that it has agreed to acquire Chemistry Holdings Inc., a formulation technology company that is developing innovative delivery systems for a variety of industries, in an all-stock transaction.
SMART DEVICES - Add-On Connectivity Facilitates New Generation of Smart Inhalers
Contributor Cindy H. Dubin reviews how the addition of electronic and connectivity to inhalers may improve patient adherence and, consequently, treatment efficacy.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 2, Notable Product Drug Delivery and Formulation Approvals of 2018
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on how the pharmaceutical industry has harnessed well validated drug delivery and formulation technologies to deliver important product approvals in 2018.
SPECIAL FEATURE - Excipients: Formulators Want Excipients for Solubility & Beyond
Contributor Cindy H. Dubin speaks with leading excipient companies to discuss the current role excipients are playing in continuous manufacturing, biopharma formulation, and controlled- and immediate-release 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…
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.