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Expert Opinion on Drug Delivery

Vijay Mishra, Sourav Thakur, Akshay Patil, Anshuman Shukla
Quality by design (QbD) encourages the pharmaceutical industry to use risk management and science-based manufacturing principles to gain process and product understanding and thus assures quality of the product. With the objective to curb the rising costs for development and regulatory barriers to innovation and creativity, QbD is being widely promoted by Food and Drug Administration (FDA) and International Conference on Harmonization (ICH). Areas covered: This review describes the elements, different design and tools of QbD as well as multidimensional applications of QbD ranging from dosage form and method development to meeting latest regulatory requirements...
August 3, 2018: Expert Opinion on Drug Delivery
Sarah A El-Lakany, Nazik A Elgindy, Maged W Helmy, Marwa M Abu-Serie, Ahmed O Elzoghby
OBJECTIVES: Herein, we propose combined aromatase inhibitor and herbal therapy of breast cancer as a synergistic therapeutic modality. METHODS: Zein nanospheres were prepared by phase separation for co-delivery of exemestane and luteolin. To enhance their tumor-targeting capability, the nanospheres were coated with PEGylated phospholipids and lactoferrin for passive and active targeting, respectively. RESULTS: The developed nanospheres demonstrated a small particle size and controlled drug release...
August 1, 2018: Expert Opinion on Drug Delivery
Aoife Maria Rodgers, Ana Sara Cordeiro, Adrien Kissenpfennig, Ryan F Donnelly
Vaccination is one of the greatest breakthroughs of modern preventative medicine. Despite this, there remain problems surrounding delivery, efficacy and compliance. Thus, there is a pressing need to develop cost-effective vaccine delivery systems that could expand the use of vaccines, particularly within developing countries. Microneedle (MN) arrays, given their ease of use, painlessness and ability to target skin antigen presenting cells, provide an attractive platform for improved vaccine delivery and efficacy...
August 1, 2018: Expert Opinion on Drug Delivery
Huiling Mu, René Holm
Solid lipid nanoparticles are promising drug carriers for systemic circulations as well as local applications. One of the major challenges for drug delivery is designing nanocarriers for efficient delivery of active substances to the target site and facilitating drug absorption. Areas covered: In this article, the effects of excipients and particle preparation methods on the properties of solid lipid nanocarriers and their impact on drug absorption and efficacies related to different administration routes are reviewed and discussed...
July 31, 2018: Expert Opinion on Drug Delivery
Driton Vllasaliu, Maya Thanou, Snjezana Stolnik, Robyn Fowler
Research into oral delivery of biologics has a long and rich history but has not produced technologies used in the clinic. The area has evolved in terms of strategies to promote oral biologics delivery from early chemical absorption enhancers to nanomedicine to devices. Continued activity in this area is justifiable considering the remarkable proliferation of biologics. Areas covered: The article discusses some physiological barriers to oral delivery of biologics, with a special focus on less characterized barriers such as the basement membrane...
July 27, 2018: Expert Opinion on Drug Delivery
Elsa Bodier-Montagutelli, Alexie Mayor, Laurent Vecellio, Renaud Respaud, Nathalie Heuzé-Vourc'h
No abstract text is available yet for this article.
July 27, 2018: Expert Opinion on Drug Delivery
Renuka Suresh Managuli, Sushil Yadaorao Raut, Meka Sreenivasa Reddy, Srinivas Mutalik
The major challenge of first pass metabolism in oral drug delivery can be surmounted by directing delivery toward intestinal lymphatic system (ILS). ILS circumvents the liver and transports drug directly into systemic circulation via thoracic duct. Lipid and polymeric nanoparticles are transported into ILS through lacteal and Peyer's patches. Moreover, surface modification of nanoparticles with ligand which is specific for Peyer's patches enhances the uptake of drugs into ILS. Bioavailability enhancement by lymphatic uptake is an advantageous approach adopted by scientists today...
July 26, 2018: Expert Opinion on Drug Delivery
Nashwa Osman, Kan Kaneko, Valeria Carini, Imran Saleem
Macromolecules with unique effects and potency are increasingly being considered for application in lung pathologies. Numerous delivery strategies for these macromolecules through the lung have been investigated to improve the targeting and overall efficacy. Areas covered: Targeting approaches from delivery devices, formulation strategies and specific targets are discussed. Expert opinion: Although macromolecules are a heterogeneous group of molecules, a number of strategies have been investigated at the macro, micro, and nanoscopic scale for the delivery of macromolecules to specific sites and cells of lung tissues...
July 26, 2018: Expert Opinion on Drug Delivery
Xinyi Tan, Xiaolin Liu, Yan Zhang, Hongjuan Zhang, Xiaoyang Lin, Chenguang Pu, Jingxin Gou, Haibing He, Tian Yin, Yu Zhang, Xing Tang
When intravenous or subcutaneous administration of insulin, various side effects or possible risks have been reported. Oral administration of insulin has significant advantages of convenience, painless and mimetic endogenous insulin pathway, and thus it presents patients compliance, protects pancreatic β cells and lessens adverse effects caused by long-term injection. This challenging oral delivery of insulin can be achieved by promising silica nanoparticles (SNs), especially mesoporous silica nanoparticles (MSNs), with controllable morphology and high loading efficiency...
July 25, 2018: Expert Opinion on Drug Delivery
Yanyan Wang, Xiaoyue Xu, Yan Gu, Yanju Cheng, Feng Cao
Considering that the number of patients afflicted by posterior eye diseases is increasing, effective drug delivery is currently in high clinical demand. Topical administration has been identified as the preferred option, while sufferingfrom multiple barriers. The development of nanoparticle-based drug delivery system provides an option, which would enhance the drug permeability across the barriers and achieve the desired drug level in the targeted tissue. Areas covered: This review highlights the barrier to the posterior segment of the eye via topical administration...
July 2018: Expert Opinion on Drug Delivery
Norman D Goldstuck, Hung P Le
Subdermal and intrauterine progestin releasing systems are two types of long-acting reversible contraceptive systems (LARC). Their use has transformed current contraceptive practice management. There is not much objective evidence to help decide which method is preferable and in which particular circumstance using objective criteria. Areas covered: MEDLINE, POPLINE, PubMed, and were searched using the terms "implant" vs "IUS" and then adding the terms "levonorgestrel" and "etonogestrel" to the implant arm and "levonorgestrel" to the IUS arm...
July 2018: Expert Opinion on Drug Delivery
Dechun Huang, Hongliang Qian, Haishi Qiao, Wei Chen, Jan Feijen, Zhiyuan Zhong
INTRODUCTION: Bioresponsive nanogels with a crosslinked three-dimensional structure and an aqueous environment that undergo physical or chemical changes including swelling and dissociation in response to biological signals such as mild acidity, hyperthermia, enzymes, reducing agents, reactive oxygen species (ROS), and adenosine-5'-triphosphate (ATP) present in tumor microenvironments or inside cancer cells have emerged as an appealing platform for targeted drug delivery and cancer therapy...
July 2018: Expert Opinion on Drug Delivery
Chintan Bhavsar, Munira Momin, Tabassum Khan, Abdelwahab Omri
Tumor is a heterogeneous mass of malignant cells co-existing with non-malignant cells. This co-existence evolves from the initial developmental stages of the tumor and is one of the hallmarks of cancer providing a protumorigenic niche known as tumor microenvironment (TME). Proliferation, invasiveness, metastatic potential and maintenance of stemness through cross-talk between tumors and its stroma forms the basis of TME. Areas covered: The article highlights the developmental phases of a tumor from dysplasia to the formation of clinically detectable tumors...
July 2018: Expert Opinion on Drug Delivery
Andrea Della Bella, Enrico Salomi, Francesca Buttini, Ruggero Bettini
Direct administration of drugs to the lung is commonly used for the treatment of local respiratory diseases, but it can also be employed to obtain a systemic effect. Besides the advantages offered in terms of higher therapeutic efficacy, this administration route raised specific drug delivery issues. In fact, to obtain a suitable bioavailability and therapeutic effect, the drug has to be efficiently deposited in the lower airways. Formulation is required to render the drug respirable. Area covered: The present paper deals with dry powders formulations, in particular it reviews the literature of the last two decades with respect to the role of the solid-state characteristics of the excipients used as carriers in adhesive mixture toward respirability of the active ingredient...
July 2018: Expert Opinion on Drug Delivery
Ana Brotons-Canto, Nekane Martín-Arbella, Carlos Gamazo, Juan M Irache
Allergic diseases constitute one of the most common causes of chronic illness in developed countries. The main mechanism determining allergy is an imbalance between Th1 and Th2 response towards Th2. Areas covered: This review describes the mechanisms underlying the natural tolerance to food components and the development of an allergic response in sensitized individuals. Furthermore, therapeutic approaches proposed to manage these abnormal immunologic responses food are also presented and discussed. Expert opinion: In the past, management of food allergies has consisted of the education of patients to avoid the ingestion of the culprit food and to initiate the therapy (e...
July 2018: Expert Opinion on Drug Delivery
Estela R García, Stefanie Thalhauser, Hèctor R Loscertales, Pilar Modamio, Cecilia F Lastra, Eduardo L Mariño
As the elderly population and polypharmacy are increasing, it is predicted that interventions to enhance medication adherence, as dose administration aids (DAA), will grow. One of the limitations of repackaging medicines into DAA is to assure the stability of medicines, and, therefore, their quality, efficacy and safety. Area covered: This article collects and summarises data of all the stability studies of repackaged medicines into DAAs. Computerized search in databases: PubMed, Google Scholar, SciELO, and reference texts related to the field (keywords: drug stability, DAAs, compliance aids, and repackaging), open access databases and guidelines...
June 2018: Expert Opinion on Drug Delivery
Stanley Cohen, Piotr A Klimiuk, Tillmann Krahnke, Deepak Assudani
BACKGROUND: This study examined the patient handling experience and self-injection success of patients with rheumatoid arthritis (RA) administering BI 695501 using an AI. METHODS: This Phase II, 7-week, open-label, interventional study (NCT02636907) included adult patients with moderately to severely active RA not adequately controlled by DMARDs, with no experience of self-injecting with AI/pen. Patients self-injected BI 695501 via AI every 2 weeks in the AI Assessment Period (AAP)...
June 2018: Expert Opinion on Drug Delivery
Joseph V Pergolizzi, Robert Taylor, Jo Ann LeQuang, Robert B Raffa
There is no greater public health threat at this time in America than the opioid abuse crisis, and a systematic, level-headed, coherent, and unified approach is needed. Among the many things that have been proposed to help reduce opioid abuse is the development of opioid analgesic products in abuse-deterrent formulations (ADFs). This seems to make perfect sense. Areas covered: In this article, the viewpoints of 12 stakeholders (physicians, pain patients, payers, manufacturers, regulators, law enforcement, hospitals, first responders, elected officials, rehabilitation centers, opioid addicts, and the general public) were considered in terms of how ADF opioids are regarded and might contribute potential impediments to more widespread use...
June 2018: Expert Opinion on Drug Delivery
Jing Yu, Sachin Dubey, Yogeshvar N Kalia
BACKGROUND: Dermatological diseases, including most skin cancers and rare genetic conditions frequently originate in the epidermis. Targeted, topical cell-based therapy is a promising therapeutic strategy. Here, we present the first report demonstrating that fractional laser ablation enables local 'needle-free' intraepidermal delivery of living human cells. METHODS: The cells penetrated porcine ear skin via microchannels created by Er:YAG fractional laser ablation; cell delivery was quantified using a haemocytometer...
June 2018: Expert Opinion on Drug Delivery
Mukta Agrawal, Swarnlata Saraf, Shailendra Saraf, Sophia G Antimisiaris, Nobuhito Hamano, Shyh-Dar Li, Mahavir Chougule, Sunday A Shoyele, Umesh Gupta, Ajazuddin, Amit Alexander
Brain is supposed to be the most complicated part of the body which is very far from the reach of drug moieties. The drug entry in to the brain region depends upon various factors, and among those, the blood-brain-barrier remains the most prominent one. This barrier restricts the entry of almost all the drug and most of the essential biological components like proteins, peptides, etc. and hinders treatment of the CNS disorders. Alzheimer Disease (AD) is one such brain disorder, more specifically a neurodegenerative disorder which primarily affects the older adults...
June 2018: Expert Opinion on Drug Delivery
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