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Advanced Drug Delivery Reviews

Dave Anderson, Roger Liu, J Anand Subramony, Jon Cammack
Combination products are therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another. Historically, biologics development involved identifying efficacious doses administered to patients intravenously or perhaps by a syringe. Until fairly recently, there has been limited focus on developing an accompanying medical device, such as a prefilled syringe or auto-injector, to enable easy and more efficient delivery. For the last several years, and looking forward, where there may be little to distinguish biologics medicines with relatively similar efficacy profiles, the biotechnology market is beginning to differentiate products by patient-focused, biologic-device based combination products...
January 11, 2017: Advanced Drug Delivery Reviews
Uche C Anozie, Paul Dalhaimer
For nanoparticles to be successful in combating diseases in the clinic in the 21st century and beyond, they must localize to target areas of the body and avoid damaging non-target, healthy tissues. Both soft and stiff, bio-degradable and non-biodegradable nanoparticles are anticipated to be used to this end. It has been shown that stiff, non-biodegradable nanoparticles cause reactive oxygen species (ROS) generation and autophagy in a variety of cell lines in vitro. Both responses can lead to significant remodeling of the cytosol and even apoptosis...
January 5, 2017: Advanced Drug Delivery Reviews
Roy Biran, Daniel Pond
Blood contact with biomaterials triggers activation of multiple reactive mechanisms that can impair the performance of implantable medical devices and potentially cause serious adverse clinical events. This includes thrombosis and thromboembolic complications due to activation of platelets and the coagulation cascade, activation of the complement system, and inflammation. Numerous surface coatings have been developed to improve blood compatibility of biomaterials. For more than thirty years, the anticoagulant drug heparin has been employed as a covalently immobilized surface coating on a variety of medical devices...
December 29, 2016: Advanced Drug Delivery Reviews
Kenjirou Higashi, Keisuke Ueda, Kunikazu Moribe
This review considers advances in the understanding of active pharmaceutical ingredient polymorphism since around 2010 mainly from a structural view point, with a focus on twelve model drugs. New polymorphs of most of these drugs have been identified despite that the polymorphism of these old drugs has been extensively studied so far. In addition to the conventional modifications of preparative solvents, temperatures, and pressure, more strategic structure-based methods have successfully yielded new polymorphs...
December 7, 2016: Advanced Drug Delivery Reviews
Michael R Folkert, Robert D Timmerman
While conventional treatment relies on protracted courses of therapy using relatively small dose-per-fraction sizes of 1.8-2Gy, there is substantial evidence gathered over decades that this may not be the optimal approach for all targetable disease. Stereotactic ablative body radiosurgery (SABR) or stereotactic body radiation therapy (SBRT) is a technique which uses precise targeting to deliver high doses of radiation capable of ablating tumors directly. In this review, we will discuss the justification for and techniques used to deliver ablative doses to improve treatment outcomes, interactions with biological and immunologic therapy, and special procedures to spare normal tissue, which have facilitated the expanding role for these techniques in the management of a wide range of malignant histologies and disease states...
December 5, 2016: Advanced Drug Delivery Reviews
Radhe Mohan, David Grosshans
In principle, proton therapy offers a substantial clinical advantage over conventional photon therapy. This is because of the unique depth-dose characteristics of protons, which can be exploited to achieve significant reductions in normal tissue doses proximal and distal to the target volume. These may, in turn, allow escalation of tumor doses and greater sparing of normal tissues, thus potentially improving local control and survival while at the same time reducing toxicity and improving quality of life. Protons, accelerated to therapeutic energies ranging from 70 to 250MeV, typically with a cyclotron or a synchrotron, are transported to the treatment room where they enter the treatment head mounted on a rotating gantry...
December 3, 2016: Advanced Drug Delivery Reviews
Zehra Elgundi, Mouhamad Reslan, Esteban Cruz, Vicki Sifniotis, Veysel Kayser
It has been over four decades since the development of monoclonal antibodies (mAbs) using a hybridoma cell line was first reported. Since then more than thirty therapeutic antibodies have been marketed, mostly as oncology, autoimmune and inflammatory therapeutics. While antibodies are very efficient, their cost-effectiveness has always been discussed owing to their high costs, accumulating to more than one billion dollars from preclinical development through to market approval. Because of this, therapeutic antibodies are inaccessible to some patients in both developed and developing countries...
December 2, 2016: Advanced Drug Delivery Reviews
Jayoung Kim, Adam C Mirando, Aleksander S Popel, Jordan J Green
Angiogenesis is naturally balanced by many pro- and anti-angiogenic factors while an imbalance of these factors leads to aberrant angiogenesis, which is closely associated with many diseases. Gene therapy has become a promising strategy for the treatment of such a disordered state through the introduction of exogenous nucleic acids that express or silence the target agents, thereby engineering neovascularization in both directions. Numerous non-viral gene delivery nanoparticles have been investigated towards this goal, but their clinical translation has been hampered by issues associated with safety, delivery efficiency, and therapeutic effect...
November 30, 2016: Advanced Drug Delivery Reviews
Julia Wang, Jonah A Kaplan, Yolonda L Colson, Mark W Grinstaff
Mechanically-activated delivery systems harness existing physiological and/or externally-applied forces to provide spatiotemporal control over the release of active agents. Current strategies to deliver therapeutic proteins and drugs use three types of mechanical stimuli: compression, tension, and shear. Based on the intended application, each stimulus requires specific material selection, in terms of substrate composition and size (e.g., macrostructured materials and nanomaterials), for optimal in vitro and in vivo performance...
November 14, 2016: Advanced Drug Delivery Reviews
Robert Langer, Arijit Basu, Abraham J Domb
No abstract text is available yet for this article.
December 15, 2016: Advanced Drug Delivery Reviews
Harivardhan Reddy Lakkireddy, Didier Bazile
The design of the first polymeric nanoparticles could be traced back to the 1970s, and has thereafter received considerable attention, as evidenced by the significant increase of the number of articles and patents in this area. This review article is an attempt to take advantage of the existing literature on the clinically tested and commercialized biodegradable PLA(G)A-PEG nanotechnology as a model to propose quality building and outline translation and development principles for polymeric nano-medicines. We built such an approach from various building blocks including material design, nano-assembly - i...
December 15, 2016: Advanced Drug Delivery Reviews
Arijit Basu, Konda Reddy Kunduru, Joshua Katzhendler, Abraham J Domb
Polyesters derived from the α-hydroxy acids, lactic acid, and glycolic acid, are the most common biodegradable polymers in clinical use. These polymers have been tailored for a range of applications that require a physical material possessing. The physical and mechanical properties of these polymers fit the specific application and also safely biodegrade. These polymers are hydrophobic and do not possess functional side groups. This does not allow hydrophilic or hydrophobic manipulation, conjugation of active agents along the polymer chain, etc...
December 15, 2016: Advanced Drug Delivery Reviews
Patrina S P Poh, Mohit P Chhaya, Felix M Wunner, Elena M De-Juan-Pardo, Arndt F Schilling, Jan-Thorsten Schantz, Martijn van Griensven, Dietmar W Hutmacher
New advanced manufacturing technologies under the alias of additive biomanufacturing allow the design and fabrication of a range of products from pre-operative models, cutting guides and medical devices to scaffolds. The process of printing in 3 dimensions of cells, extracellular matrix (ECM) and biomaterials (bioinks, powders, etc.) to generate in vitro and/or in vivo tissue analogue structures has been termed bioprinting. To further advance in additive biomanufacturing, there are many aspects that we can learn from the wider additive manufacturing (AM) industry, which have progressed tremendously since its introduction into the manufacturing sector...
December 15, 2016: Advanced Drug Delivery Reviews
Arijit Basu, Konda Reddy Kunduru, Sindhu Doppalapudi, Abraham J Domb, Wahid Khan
Polylactide (PLA) and its copolymers are hydrophobic polyesters used for biomedical applications. Hydrogel medicinal implants have been used as drug delivery vehicles and scaffolds for tissue engineering, tissue augmentation and more. Since lactides are non-functional, they are copolymerized with hydrophilic monomers or conjugated to a hydrophilic moiety to form hydrogels. Copolymers of lactic and glycolic acids with poly(ethylene glycol) (PEG) provide thermo-responsive hydrogels. Physical crosslinking mechanisms of PEG-PLA or PLA-polysaccharides include: lactic acid segment hydrophobic interactions, stereocomplexation of D and L-lactic acid segments, ionic interactions, and chemical bond formation by radical or photo crosslinking...
December 15, 2016: Advanced Drug Delivery Reviews
Betty Tyler, David Gullotti, Antonella Mangraviti, Tadanobu Utsuki, Henry Brem
Polylactic acid (PLA) and its copolymers have a long history of safety in humans and an extensive range of applications. PLA is biocompatible, biodegradable by hydrolysis and enzymatic activity, has a large range of mechanical and physical properties that can be engineered appropriately to suit multiple applications, and has low immunogenicity. Formulations containing PLA have also been Food and Drug Administration (FDA)-approved for multiple applications making PLA suitable for expedited clinical translatability...
December 15, 2016: Advanced Drug Delivery Reviews
Anjali Jain, Konda Reddy Kunduru, Arijit Basu, Boaz Mizrahi, Abraham J Domb, Wahid Khan
Poly(lactic acid) and its copolymers have revolutionized the field of drug delivery due to their excellent biocompatibility and tunable physico-chemical properties. These copolymers have served the healthcare sector by contributing many products to combat various diseases and for biomedical applications. This article provides a comprehensive overview of clinically used products of poly(lactic acid) and its copolymers. Multi-dimension information covering product approval, formulation aspects and clinical status is described to provide a panoramic overview of each product...
December 15, 2016: Advanced Drug Delivery Reviews
P Saini, M Arora, M N V Ravi Kumar
Poly(lactic acid) (PLA) has become a "material of choice" in biomedical applications for its ability to fulfill complex needs that typically include properties such as biocompatibility, biodegradability, mechanical strength, and processability. Despite the advantages of pure PLA in a wider spectrum of applications, it is limited by its hydrophobicity, low impact toughness, and slow degradation rate. Blending PLA with other polymers offers a convenient option to enhance its properties or generate novel properties for target applications without the need to develop new materials...
December 15, 2016: Advanced Drug Delivery Reviews
Roshan James, Ohan S Manoukian, Sangamesh G Kumbar
Therapeutic biomolecules often require frequent administration and supramolecular dosing to achieve therapeutic efficiencies and direct infusion into treatment or defect sites results in inadequate physiological response and at times severe side effects or mis-targeting. Delivery systems serve several purposes such as increased circulatory time, increased biomolecule half-life, and incorporation of new innovations can enable highly specific cell targeting and improved cell and nucleus permeability. Poly(lactic acid) (PLA) has become a "material of choice" due to wide availability, reproducible synthetic route, customization, versatility, biodegradability and biocompatibility...
December 15, 2016: Advanced Drug Delivery Reviews
Maria Balk, Marc Behl, Christian Wischke, Jörg Zotzmann, Andreas Lendlein
Biodegradable polymers are versatile polymeric materials that have a high potential in biomedical applications avoiding subsequent surgeries to remove, for example, an implanted device. In the past decade, significant advances have been achieved with poly(lactide acid) (PLA)-based materials, as they can be equipped with an additional functionality, that is, a shape-memory effect (SME). Shape-memory polymers (SMPs) can switch their shape in a predefined manner upon application of a specific external stimulus...
December 15, 2016: Advanced Drug Delivery Reviews
Byung Kook Lee, Yeonhee Yun, Kinam Park
Poly(d,l-lactic acid) (PLA) has been widely used for various biomedical applications for its biodegradable, biocompatible, and nontoxic properties. Various methods, such as emulsion, salting out, and precipitation, have been used to make better PLA micro- and nano-particle formulations. They are widely used as controlled drug delivery systems of therapeutic molecules, including proteins, genes, vaccines, and anticancer drugs. Even though PLA-based particles have challenges to overcome, such as low drug loading capacity, low encapsulation efficiency, and terminal sterilization, continuous innovations in particulate formulations will lead to development of clinically useful formulations...
December 15, 2016: Advanced Drug Delivery Reviews
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