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Expert Opinion on Drug Delivery

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https://www.readbyqxmd.com/read/29206056/ease-of-use-of-two-autoinjectors-in-patients-with-multiple-sclerosis-treated-with-interferon-beta-1a-subcutaneously-three-times-weekly-results-of-the-randomized-crossover-redefine-study
#1
Sibyl Wray, Brooke Hayward, Fernando Dangond, Barry Singer
BACKGROUND: For interferon beta-1a subcutaneously three times weekly (IFN β-1a SC tiw), administration options include manually injected prefilled syringes; a preassembled, single-use autoinjector; and a reusable autoinjector. This study evaluated patient-perceived ease of use of two injection devices. RESEARCH DESIGN AND METHODS: REDEFINE, a Phase IV, multicenter crossover study, randomized patients with multiple sclerosis and ≥5 weeks' IFN β-1a 44 μg SC tiw use to 4 weeks using a single-use autoinjector, then 4 weeks using a reusable autoinjector, or vice versa...
December 5, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29198148/us-human-factors-engineering-evaluation-of-an-updated-follitropin-alfa-pen-injector-gonal-f%C3%A2-rff-redi-ject%C3%A2-and-instructions-for-use
#2
Mary Mahony, Andrea Dwyer, Raschelle Barkume, Allison Strochlic, Fabien Jeannerot, Thomas Stüdeli
OBJECTIVES: The multi-dose, pre-filled GONAL-f® RFF Redi-ject® (follitropin alfa injection) pen injector was updated following feedback on user experience and pen functionality, as part of a continuous assessment program. Human-factors engineering (HFE) evaluations were conducted to confirm that the updated pen injector could be used by intended users to safely and effectively perform critical tasks identified by the risk-management plan. METHODS: Five rounds of formative evaluation and a simulated-use summative evaluation of the pen injector, instructions for use (IFU), and training video were conducted by HFE specialists or the intended users of the pen injector...
December 4, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29169288/human-studies-with-microneedles-for-evaluation-of-their-efficacy-and-safety
#3
Thuy Trang Nguyen, Jung Hwan Park
During the past two decades, many studies have documented the development of microneedles (MNs) as a feasible technique for the effective administration of drugs. More and more human studies have been done with MNs to bridge the gap between research and market applications that provide efficacious techniques for clinical implementation. Areas covered: The aim of this review is provide a brief description of the status of human study with MNs and to demonstrate progress for the right use of microneedle arrays in clinical settings...
November 23, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29149574/transscleral-passive-and-iontophoretic-transport-theory-and-analysis
#4
S Kevin Li, Jinsong Hao
INTRODUCTION: The sclera is considered the "static barrier," a main barrier for transscleral drug delivery. The characterization of passive and iontophoretic transport across the sclera in vitro is the first step towards our ability to predict transscleral drug delivery. Although previous studies have investigated this topic, the quantitative structure permeation relationships (QSPR) for passive and iontophoretic transscleral transport are not available. AREAS COVERED: This review evaluated previous passive permeation and iontophoresis results of transscleral transport in vitro and examined QSPR for transscleral permeation of small permeants and macromolecules...
November 17, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29148851/airway-geometry-airway-flow-and-particle-measurement-methods-implications-on-pulmonary-drug-delivery
#5
A Kourmatzis, S Cheng, H-K Chan
The effectiveness of drug delivery to the lungs is inextricably linked to the fundamental interactions that occur between particles and flow in the extrathoracic airway. Research in this field requires time resolved in-vivo and in-vitro measurements of three separate, yet intricately linked parameters: i) airway flow, ii) airway geometry, and iii) drug particle characteristics. A number of recent significant developments have been made in the experimental diagnostic tools used to characterise these parameters...
November 17, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29111841/strategies-and-industrial-perspectives-to-improve-oral-absorption-of-biological-macromolecules
#6
Chang Liu, Yongqiang Kou, Xin Zhang, Hongbo Cheng, Xianzhi Chen, Shirui Mao
Therapeutic proteins have become a highly attractive drug of choice due to minimal toxicity, high activity and exquisite specificity. Oral delivery of protein drugs is a very interesting area for research, and, naturally, numerous technologies are required to improve the oral bioavailability of therapeutic proteins. Areas covered: This review article systemically generalized the major physiological barriers facing oral macromolecule delivery as well as the current approaches and novel developments in the field, including permeation enhancers, enzyme inhibitors, particulate drug delivery system, ligand delivery system, mucoadhesive delivery system, mucus penetration delivery system and other strategies...
November 7, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29032713/intravenous-iron-treatments-for-iron-deficiency-anemia-in-inflammatory-bowel-disease-a-budget-impact-analysis-of-iron-isomaltoside-1000-monofer-in-the-uk
#7
R F Pollock, G Muduma
Iron deficiency is the leading cause of anemia in patients with inflammatory bowel disease (IBD). Intravenous iron is the first-line treatment for clinically active IBD or previous oral iron intolerance. The aim of the present study was to develop a comparative model of iron deficiency and delivery for iron isomaltoside (IIM), ferric carboxymaltose (FCM), low molecular weight iron dextran (LMWID), and iron sucrose (IS) in the treatment of iron deficiency anemia associated with IBD. Areas covered: A model was developed to evaluate iron delivery characteristics, resource use and costs associated with IIM, FCM, LMWID and IS...
October 24, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/29041861/in-vitro-evaluation-of-aerosol-delivery-of-aztreonam-lysine-azli-an-adult-mechanical-ventilation-model
#8
Alejandro Rodríguez, María Cabrera, Luis F Reyes, María Bodí, Sandra Trefler, Laura Canadell, Diego Barahona, Stepham Ehrmann, Ignacio Martin-Loeches, Marcos I Restrepo, Laurent Vecellio
BACKGROUND: The delivery profile of Aztreonam lysine (AZLI) during mechanical ventilation (MV) is unknown. We evaluated the amount of AZLI drug delivered using an in vitro model of adult MV. METHODS: An adult lung model designed to mimic current clinical practice was used. Both nebulizers were placed before a Y-piece and 4 settings were tested: A) Aeroneb solo® [AS] with a t-piece; B) AS with the spacer; C) M-Neb® [MN] with a t-piece and D) MN with the spacer...
October 23, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28988504/low-colonic-absorption-drugs-risks-and-opportunities-in-the-development-of-oral-extended-release-products
#9
Jin Xu, Yiqing Lin, Pierre Boulas, Matthew L Peterson
Introduction Currently numerous drugs have been observed with lower colonic absorption than small intestine absorption, which can significantly impact in vivo performance of their oral extended release (ER) products. Areas covered We reviewed over 300 publications, patents, book chapters, and commercial reports of drug products from regulatory agencies for low colonic absorption (LCA) drugs and critical findings are discussed. The focuses of this article are (1) current findings on the causes of low colonic absorption to support early assessment of LCA candidates, and (2) current knowledge on successful ER strategies and technical platforms used for LCA drugs in commercial drug products to facilitate oral ER product development...
October 9, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28944694/tissue-plasminogen-activator-based-nanothrombolysis-for-ischemic-stroke
#10
Shan Liu, Xiaozhou Feng, Rong Jin, Guohong Li
Thrombolysis with intravenous tissue plasminogen activator (tPA) is the only FDA approved treatment for patients with acute ischemic stroke, but its use is limited by narrow therapeutic window, selective efficacy, and hemorrhagic complication. In the past two decades, extensive efforts have been undertaken to extend its therapeutic time window and explore alternative thrombolytic agents, but both show little progress. Nanotechnology has emerged as a promising strategy to improve the efficacy and safety of tPA...
September 28, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28918665/considerations-in-establishing-bioequivalence-of-inhaled-compounds
#11
Irvin Mayers, Mohit Bhutani
Generic inhalers are often perceived as inferior to their branded counterparts; however, they are safe and effective if they can meet the regulatory requirements. The approach to assess bioequivalence (BE) in oral dosage form products is not sufficient to address the complexities of inhalational products (e.g., patient-device interface); hence, more considerations are needed and caution should be applied in determining BE of inhaled compounds. Areas covered: This review outlines the evaluation process for generic inhalers, explores the regulatory approaches in BE assessment, and highlights the considerations and challenges in the current in vitro and in vivo approaches (lung deposition, pharmacokinetic, pharmacodynamic/clinical studies, and patient-device interface) for establishing BE of inhaled compounds...
September 21, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28128004/long-acting-slow-effective-release-antiretroviral-therapy
#12
Benson Edagwa, JoEllyn McMillan, Brady Sillman, Howard E Gendelman
Advances in long-acting antiretroviral therapy (ART) can revolutionize current HIV/AIDS treatments. We coined the term 'long-acting slow effective release ART' (LASER ART) to highlight the required formulation properties of slow drug dissolution, poor water-solubility, bioavailability, little-to-no off-target toxicities and improved regimen adherence. Drug carrier technologies characterized by high antiretroviral drug (ARV) payloads in a single carrier improve the pharmacokinetic and pharmacodynamic profiles...
November 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/27591122/microneedle-mediated-delivery-of-viral-vectored-vaccines
#13
Marija Zaric, Bárbara Ibarzo Yus, Petya Petrova Kalcheva, Linda Sylvia Klavinskis
Microneedle array platforms are a promising technology for vaccine delivery, due to their ease of administration with no sharp waste generated, small size, possibility of targeted delivery to the specified skin depth and efficacious delivery of different vaccine formulations, including viral vectors. Areas covered: Attributes and challenges of the most promising viral vector candidates that have advanced to the clinic and that have been leveraged for skin delivery by microneedles; The importance of understanding the immunobiology of antigen-presenting cells in the skin, in particular dendritic cells, in order to generate further improved skin vaccination strategies; recent studies where viral vectors expressing various antigens have been coupled with microneedle technology to examine their potential for improved vaccination...
October 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28895435/intranasal-delivery-of-stem-cell-based-therapies-for-the-treatment-of-brain-malignancies
#14
Gina Li, Nicolas Bonamici, Mahua Dey, Maciej S Lesniak, Irina V Balyasnikova
Glioblastoma (GBM) is the most aggressive malignant brain cancer in adults, and its poor prognosis and resistance to the existing standard of care require the development of innovative therapeutic modalities. The local delivery of stem cells as therapeutic carriers against glioma has produced encouraging results, but encounters obstacles with regards to the repeatability and invasiveness of administration. Intranasal delivery of therapeutic stem cells could overcome these obstacles, among others, as a noninvasive and easily repeatable mode of administration...
September 12, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28893110/radioimmunotherapy-for-delivery-of-cytotoxic-radioisotopes-current-status-and-challenges
#15
Carlos Daniel Martins, Gabriela Kramer-Marek, Wim J G Oyen
Radioimmunotherapy (RIT) with monoclonal antibodies and their fragments labelled with radionuclides emitting α-particles, β-particles or Auger electrons have been used for many years in the development of anticancer strategies. While RIT has resulted in approved radiopharmaceuticals for the treatment of hematological malignancies, its use in solid tumors still remains challenging. Areas covered: In this review, we discuss the exciting progress towards elucidating the potential of current and novel radioimmunoconjugates and address the challenges for translation into clinical practice...
September 12, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28836459/3d-printing-of-oral-drugs-a-new-reality-or-hype
#16
Wen-Kai Hsiao, Barbara Lorber, Herbert Reitsamer, Johannes Khinast
No abstract text is available yet for this article.
September 5, 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/28774208/moving-beyond-subcutaneous-insulin-the-application-of-adjunctive-therapies-to-the-treatment-of-type-1-diabetes
#17
Kathleen H Ang, Jennifer L Sherr
With the discovery of insulin nearly a century ago, the diagnosis of Type 1 Diabetes (T1D) transformed from a death sentence to a chronic medical condition. Despite the advances that have been made, the vast majority of those living with T1D still struggle to achieve targeted control. Yet, a plethora of agents have been developed to treat those with Type 2 Diabetes. Exploration of how these agents may benefit those with T1D has been an area of intense investigation, especially due to the overweight/obesity epidemic, which now afflicts more than 60% of those living with T1D...
September 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/27911116/finding-the-right-route-for-insulin-delivery-an-overview-of-implantable-pump-therapy
#18
Lia Bally, Hood Thabit, Roman Hovorka
Implantable pump therapy adopting the intraperitoneal route of insulin delivery has been available for the past three decades. The key rationale for implantable pump therapy is the restoration of the portal-peripheral insulin gradient of the normal physiology. Uptake in clinical practice is limited to specialized centers and selected patient populations. Areas covered: Implantable pump therapy is discussed, including technical aspects, rationale for its use, and glycemic and non-glycemic effects. Target populations, summaries of clinical studies and issues related to implantable pump therapy are highlighted...
September 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/27897039/use-of-nanotechnology-for-improved-pharmacokinetics-and-activity-of-immunogenic-cell-death-inducers-used-in-cancer-chemotherapy
#19
Martyna Janicka, Jerzy Gubernator
Immunogenic cell death inducers (ICD inducers) are a diverse group of therapeutic molecules capable of eliciting an adaptive immune response against the antigens present on the surface of dying cancer cells. Most of these molecules suffer from low bioavailability, high toxicity and poor pharmacokinetics which limit their application. It is believed that nanotechnology, in particular nano-sized nanocarriers, can address most of the issues that limit the use of ICD inducers. Area covered: The mechanism of action of ICD inducers and their limitations is discussed...
September 2017: Expert Opinion on Drug Delivery
https://www.readbyqxmd.com/read/27892760/microbubble-mediated-ultrasound-drug-delivery-and-therapeutic-monitoring
#20
Charles A Sennoga, Emma Kanbar, Laurent Auboire, Paul-Armand Dujardin, Damien Fouan, Jean-Michel Escoffre, Ayache Bouakaz
Recent developments in ultrasound imaging and ultrasound contrast agents (UCAs) improved diagnostic confidence in echography and set into motion their combined use as a tool for drug delivery and therapeutic monitoring. Non-invasive, precise and targeted delivery of drug molecules to pathological tissues by employing different mechanisms of drug release is becoming feasible. Areas covered: We sought to describe: the nature and features of UCAs; outline current contrast-specific imaging modes; before describing a variety of strategies for using ultrasound and microbubbles as a drug delivery system...
September 2017: Expert Opinion on Drug Delivery
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