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Expert Opinion on Drug Delivery

Gregor Anderson, Neil Johnson, Aruni Mulgirigama, Bhumika Aggarwal
Spacers offer a multitude of benefits by reducing the requirement to coordinate inhalation with actuation and improving inhaler technique in patients using a pressurized metered dose inhaler (pMDI). Spacers improve drug targeting by retaining within the spacer large particles normally deposited in the oropharynx, and by creating a prolonged aerosol cloud of fine particles to give the user increased time to inhale after actuation. This is particularly important in young children and the elderly to effectively deliver medication to the airways...
February 8, 2018: Expert Opinion on Drug Delivery
Luigi Battaglia, Pier Paolo Panciani, Elisabetta Muntoni, Maria Teresa Capucchio, Elena Biasibetti, Pasquale De Bonis, Silvia Mioletti, Marco Fontanella, Shankar Swaminathan
The blood brain barrier is a functional barrier allowing the entry into the brain of only essential nutrients, excluding other molecules. Its structure, although essential to keep the harmful entities out, is also a major roadblock for pharmacological treatment of brain diseases. Several alternative invasive drug delivery approaches, such as transcranial drug delivery and disruption of blood brain barrier have been explored, with limited success and several challenges. Intranasal delivery is a non-invasive methodology, which bypasses the systemic circulation, and, through the intra- and extra- neuronal pathways, provides direct brain drug delivery...
January 17, 2018: Expert Opinion on Drug Delivery
Peter Noymer, Assaf Shaked, Kay Newell
BACKGROUND: SMT-101, a novel, proprietary, water-resistant wearable infusion pump prefilled with a preset dosage of treprostinil, was designed to address many of the administration-related shortcomings of existing parenteral therapy for pulmonary arterial hypertension (PAH). The objective of the human factors (HF) program was to demonstrate that the SMT-101 system is safe and effective when used by patients with PAH, their caregivers, or healthcare providers. METHODS: The HF program for SMT-101 consisted of 8 studies (148 participants): an ethnographic study, an online survey of patients with PAH, 4 formative studies, a study of the instructions for use (IFU), and a summative study for validation...
January 9, 2018: Expert Opinion on Drug Delivery
Chintan Bhavsar, Munira Momin, Tabassum Khan, Abdelwahab Omri
A tumor is a heterogeneous mass of malignant cells that co-exists with non-malignant cells. The co-existence evolves from the initial developmental stages of the tumor and is one of the hallmarks of cancer. The presence of non-malignant cells provides a pro-tumorigenic niche known as the tumor microenvironment (TME). Proliferation, invasiveness, metastatic potential and maintenance of stemness through cross-talk between tumors and tumor associated stromal cells (TASCs) forms the basis of TME. Areas covered: The article highlights the developmental phases of a tumor from dysplasia to an invasive condition leading to formation of clinically detectable tumors...
January 4, 2018: Expert Opinion on Drug Delivery
Yasmin Thabet, Marta Slavkova, Jörg Breitkreutz
Child-appropriate drug formulations are mandatory for an efficient and safe drug therapy in children. Since the implementation of supportive legislations development of novel drug formulations has significantly been enforced despite the fact that children are a heterogeneous group of patients with varying needs according to age, maturation and disease. Areas covered: In this review, recent advances and current strategies are evaluated how to overcome the specific hurdles in pediatric drug development. For cardiovascular diseases as an example, EMA's decisions on pediatric investigation plans (PIPs) have been evaluated...
December 28, 2017: Expert Opinion on Drug Delivery
Rahul Mittal, Amit P Patel, Vasanti M Jhaveri, Sae-In Samantha Kay, Luca H Debs, James M Parrish, Debbie R Pan, Desiree Nguyen, Jeenu Mittal, Rahul Dev Jayant
The emergent field of nanoparticles has presented a wealth of opportunities for improving the treatment of human diseases. Recent advances have allowed for promising developments in drug delivery, diagnostics, and therapeutics. Modified delivery systems allow improved drug delivery over traditional pH, microbe, or receptor dependent models, while antibody association allows for more advanced imaging modalities. Nanoparticles have potential clinical application in the field of gastroenterology as they offer several advantages compared to the conventional treatment systems including target drug delivery, enhanced treatment efficacy, and reduced side effects...
December 22, 2017: Expert Opinion on Drug Delivery
G Borchard, D J A Crommelin
This review discusses the challenges to characterize and evaluate the peptide based drug glatiramer acetate (GA) and its follow-on products used for treatment of multiple sclerosis patients. Areas covered: GA is a highly complex mixture of peptides consisting of four amino acids. The various (physico)-chemical approaches and bioassays used for characterizing this complex drug product are described. It is not possible to link data from preclinical performance to outcomes observed in clinical trials as no critical attributes suitable for predicting the clinical performance in MS patients have been identified yet...
December 22, 2017: Expert Opinion on Drug Delivery
Zhen Wang, Zimei Wu, Jianping Liu, Wenli Zhang
Efficient delivery of drugs by nanoparticles deep into solid tumors is the precondition of valid cancer therapy. Despite profound understanding of the delivery of spherical nanoparticles into solid tumor attained, insufficient attention was paid to anisotropic particles. Actually, owing to their structural asymmetry, some non-spherical particles exhibit significant advantages over their spherical counterparts. Areas covered: This review will focus on particles with different shapes (discoidal particle, nanorod, filamentous particle, single-walled carbon nanotube) and the influence of their morphological characteristics (size, aspect ratio, rigidity) on the process of drug delivery to solid tumor in view of systemic circulation, transport from circulation system to tumor tissue, intratumoral transport and uptake by tumor cells, on the basis of introduction of challenges for drug delivery to solid tumor...
December 21, 2017: Expert Opinion on Drug Delivery
Hanan Al-Lawati, Hamidreza Montazeri Aliabadi, Behzad Sharif MakhmalZadeh, Afsaneh Lavasanifar
Immunosuppression has been the mainstay therapy in organ transplantation and autoimmune diseases. Different classes of drugs have been used in such disease conditions, but their effective clinical application has been limited by the emergence of systemic immunosuppression and/or individual drug side effects. Nanotechnology approaches may be used to modify the mentioned shortcomings of immunosuppressive therapy by enhancing the delivery of immunosuppressant to target cells of the immune system, thus reducing the required dose for function, and/or reducing drug distribution to non-target tissues...
December 20, 2017: Expert Opinion on Drug Delivery
Débora Sgorla, Anna Lechanteur, Andreia Almeida, Flávia Sousa, Eduardo Melo, Élcio Bunhak, Rubiana Mainardes, Najeh Khalil, Osvaldo Cavalcanti, Bruno Sarmento
The oral route is widely accepted as the most physiological path for exogenous administration of insulin, as it closely mimic the endogenous insulin pathway. Thus, in this work it is proposed an innovative lipid-polymeric nanocarrier to delivery insulin orally. Areas covered: Nanoparticles were produced through a modified solvent emulsification-evaporation method, using ethyl palmitate and hydroxypropylmethylcellulose acetate succinate as matrix. Lipid-polymeric nanoparticles were around 300 nm in size, negatively charged (-20 mV) and associated insulin with efficiency higher than 80%...
December 19, 2017: Expert Opinion on Drug Delivery
Andreas E Schneider, Jakob Lange
OBJECTIVES: Past research has emphasized injection force as a clinically highly relevant technical attribute of pen devices. However, little work has been conducted to relate these results to in-use studies. This article explores whether and how differences in pen injection force profiles influence users' self-reported perceived ease of injection and preferences. METHODS: Three different pen systems were subjected to measurements of injection force using an automated mechanical set-up followed by a simulated use study where users assessed perceived ease of injection...
December 9, 2017: Expert Opinion on Drug Delivery
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
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
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...
January 2018: Expert Opinion on Drug Delivery
Tushar Kumeria, Steven J P McInnes, Shaheer Maher, Abel Santos
Porous silicon (pSi) engineered by electrochemical etching has been used as a drug delivery vehicle to address the intrinsic limitations of traditional therapeutics. Biodegradability, biocompatibility, and optoelectronic properties make pSi a unique candidate for developing biomaterials for theranostics and photodynamic therapies. This review presents an updated overview about the recent therapeutic systems based on pSi, with a critical analysis on the problems and opportunities that this technology faces as well as highlighting pSi's growing potential...
December 2017: Expert Opinion on Drug Delivery
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
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
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
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
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
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