Special Issue "Drug Delivery Technology Development in Canada"

A special issue of Pharmaceutics (ISSN 1999-4923).

Deadline for manuscript submissions: closed (5 February 2019)

Special Issue Editors

Guest Editor
Prof. Dr. Kishor M. Wasan

1. College of Pharmacy and Nutrition, University of Saskatchewan, E3122-104 Clinic Place, Saskatoon, SK, Canada
2.Faculty of Pharmaceutical Sciences, University of British Columbia, Vancouver, BC, Canada
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Interests: pharmaceutics; drug delivery; formulation, drug development, translational pharmacotherapy, lipid and lipoprotein metabolism, pharmacokinetics
Guest Editor
Prof. Dr. Ildiko Badea

College of Pharmacy and Nutrition, University of Saskatchewan, 3D01.5-107 Wiggins Road, Saskatoon, SK, Canada
Website | E-Mail
Interests: cationic lipid gene delivery; non-invasive drug delivery; functionalized nanodiamonds as gene delivery agents
Guest Editor
Prof. Dr. Christine Allen

Leslie Dan Faculty of Pharmacy, University of Toronto, 144 College St. Toronto, ON, Canada
Website | E-Mail
Interests: drug delivery; nanomedicines; imaging; polymeric nanoparticles; liposomes; cancer therapy; hyperthermia

Special Issue Information

Dear Colleagues,

Canada continues to have a rich history of ground-breaking research in drug delivery within academic institutions, pharmaceutical industry and the biotechnology community. Drug delivery refers to approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. It may involve scientific site-targeting within the body, or facilitating systemic pharmacokinetics; in any case, it is typically concerned with both quantity and duration of drug presence. Drug delivery is often approached through a drug's chemical formulation, medical devices or drug-device combination products. Drug delivery is a concept heavily integrated with dosage form and route of administration, the latter sometimes even being considered part of the definition.

Drug delivery technologies modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety, as well as patient convenience and compliance

Over the past 25 years, numerous Canadian-based biotechnology companies have been formed from the inventions conceived and developed within academic institutions that have led to the development of important drug delivery products that have enhanced the landscape of drug therapy in the treatment of cancer to infectious diseases. 

This Special Issue serves to highlight and capture the contemporary progress of drug delivery within the prevailing Canadian context. We invite articles on all aspects of drug delivery sciences from pre-clinical formulation development to human clinical trials that bring to light the world-class research currently undertaken in Canada for this Special Issue.

Prof. Dr. Kishor M. Wasan
Prof. Dr. Ildiko Badea
Prof. Dr. Christine Allen
Guest Editors

Manuscript Submission Information

Manuscripts should be submitted online at www.mdpi.com by registering and logging in to this website. Once you are registered, click here to go to the submission form. Manuscripts can be submitted until the deadline. All papers will be peer-reviewed. Accepted papers will be published continuously in the journal (as soon as accepted) and will be listed together on the special issue website. Research articles, review articles as well as short communications are invited. For planned papers, a title and short abstract (about 100 words) can be sent to the Editorial Office for announcement on this website.

Submitted manuscripts should not have been published previously, nor be under consideration for publication elsewhere (except conference proceedings papers). All manuscripts are thoroughly refereed through a single-blind peer-review process. A guide for authors and other relevant information for submission of manuscripts is available on the Instructions for Authors page. Pharmaceutics is an international peer-reviewed open access monthly journal published by MDPI.

Please visit the Instructions for Authors page before submitting a manuscript. The Article Processing Charge (APC) for publication in this open access journal is 1000 CHF (Swiss Francs). Submitted papers should be well formatted and use good English. Authors may use MDPI's English editing service prior to publication or during author revisions.

Keywords

  • Drug Delivery
  • Pharmaceutics
  • Drug Development
  • Formulation and Dosage Form Development
  • Translational Research
  • Biologicals
  • Small Molecules
  • Clinical Trials
  • Pharmacokinetics
  • Medical Devices
  • Route of Administration

Published Papers (12 papers)

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Research

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Open AccessArticle
Drug Delivery Technology to the CNS in the Treatment of Brain Tumors: The Sherbrooke Experience
Pharmaceutics 2019, 11(5), 248; https://doi.org/10.3390/pharmaceutics11050248
Received: 8 April 2019 / Revised: 21 May 2019 / Accepted: 22 May 2019 / Published: 27 May 2019
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Abstract
Drug delivery to the central nervous system (CNS) remains a challenge in neuro-oncology. Despite decades of research in this field, no consensus has emerged as to the best approach to tackle this physiological limitation. Moreover, the relevance of doing so is still sometimes [...] Read more.
Drug delivery to the central nervous system (CNS) remains a challenge in neuro-oncology. Despite decades of research in this field, no consensus has emerged as to the best approach to tackle this physiological limitation. Moreover, the relevance of doing so is still sometimes questioned in the community. In this paper, we present our experience with CNS delivery strategies that have been developed in the laboratory and have made their way to the clinic in a continuum of translational research. Using the intra-arterial (IA) route as an avenue to deliver chemotherapeutics in the treatment of brain tumors, complemented by an osmotic breach of the blood-brain barrier (BBB) in specific situations, we have developed over the years a comprehensive research effort on this specialized topic. Looking at pre-clinical work supporting the rationale for this approach, and presenting results discussing the safety of the strategy, as well as results obtained in the treatment of malignant gliomas and primary CNS lymphomas, this paper intends to comprehensively summarize our work in this field. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Open AccessArticle
Development and Characterization of Liposomal Formulations Containing Phytosterols Extracted from Canola Oil Deodorizer Distillate along with Tocopherols as Food Additives
Pharmaceutics 2019, 11(4), 185; https://doi.org/10.3390/pharmaceutics11040185
Received: 28 February 2019 / Revised: 2 April 2019 / Accepted: 9 April 2019 / Published: 16 April 2019
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Abstract
Phytosterols are plant sterols recommended as adjuvant therapy for hypercholesterolemia and tocopherols are well-established anti-oxidants. However, thermo-sensitivity, lipophilicity and formulation-dependent efficacy bring challenges in the development of functional foods, enriched with phytosterols and tocopherols. To address this, we developed liposomes containing brassicasterol, campesterol [...] Read more.
Phytosterols are plant sterols recommended as adjuvant therapy for hypercholesterolemia and tocopherols are well-established anti-oxidants. However, thermo-sensitivity, lipophilicity and formulation-dependent efficacy bring challenges in the development of functional foods, enriched with phytosterols and tocopherols. To address this, we developed liposomes containing brassicasterol, campesterol and β-sitosterol obtained from canola oil deodorizer distillate, along with alpha, gamma and delta tocopherol. Three approaches; thin film hydration-homogenization, thin film hydration-ultrasonication and Mozafari method were used for formulation. Validated liquid chromatographic tandem mass spectrometry (LC-MS/MS) was utilized to determine the entrapment efficiency of bioactives. Stability studies of liposomal formulations were conducted before and after pasteurization using high temperature short time (HTST) technique for a month. Vesicle size after homogenization and ultrasonication (<200 nm) was significantly lower than by Mozafari method (>200 nm). However, zeta potential (−9 to −14 mV) was comparable which was adequate for colloidal stability. Entrapment efficiencies were greater than 89% for all the phytosterols and tocopherols formulated by all three methods. Liposomes with optimum particle size and zeta potential were incorporated in model orange juice, showing adequate stability after pasteurization (72 °C for 15 s) for a month. Liposomes containing phytosterols obtained from canola waste along with tocopherols were developed and successfully applied as a food additive using model orange juice. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Open AccessArticle
Investigating the Phospholipid Effect on the Bioaccessibility of Rosmarinic Acid-Phospholipid Complex through a Dynamic Gastrointestinal in Vitro Model
Pharmaceutics 2019, 11(4), 156; https://doi.org/10.3390/pharmaceutics11040156
Received: 30 January 2019 / Revised: 20 March 2019 / Accepted: 29 March 2019 / Published: 2 April 2019
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Abstract
Phyto-phospholipid complexes have been developed as a common way of improving the oral bioavailability of poorly absorbable phyto-pharmaceuticals; however, the complexation with phospholipids can induce positive or negative effects on the bioaccessibility of such plant-derived active ingredients in different parts of the gastrointestinal [...] Read more.
Phyto-phospholipid complexes have been developed as a common way of improving the oral bioavailability of poorly absorbable phyto-pharmaceuticals; however, the complexation with phospholipids can induce positive or negative effects on the bioaccessibility of such plant-derived active ingredients in different parts of the gastrointestinal tract (GIT). The purpose of this study was to investigate the effects of phospholipid complexation on the bioaccessibility of a rosmarinic acid-phospholipid complex (RA-PLC) using the TNO dynamic intestinal model-1 (TIM-1). Preparation of RA-PLC was confirmed using X-ray diffraction, Fourier-transform infrared spectroscopy, partition coefficient measurement, and Caco-2 monolayer permeation test. Bioaccessibility parameters in different GIT compartments were investigated. Complexation by phospholipids reduced the bioaccessibility of RA in jejunum compartment, while maintaining the ileum bioaccessibility. The overall bioaccessibility of RA-PLC was lower than the unformulated drug, suggesting that the improved oral absorption from a previous animal study could be considered as a net result of decreased bioaccessibility overwhelmed by enhanced intestinal permeability. This study provides insights into the effects of phospholipid on the bioaccessibility of hydrophilic compounds, and analyzes them based on the relationship between bioaccessibility, membrane permeability, and bioavailability. Additionally, TIM-1 shows promise in the evaluation of dosage forms containing materials with complicated effects on bioaccessibility. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Open AccessCommunication
Biodistribution of a Radiolabeled Antibody in Mice as an Approach to Evaluating Antibody Pharmacokinetics
Pharmaceutics 2018, 10(4), 262; https://doi.org/10.3390/pharmaceutics10040262
Received: 29 October 2018 / Revised: 21 November 2018 / Accepted: 1 December 2018 / Published: 5 December 2018
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Abstract
(1) Background: Monoclonal antibodies are used in the treatment of multiple conditions including cancer, autoimmune disorders, and infectious diseases. One of the initial steps in the selection of an antibody candidate for further pre-clinical development is determining its pharmacokinetics in small animal models. [...] Read more.
(1) Background: Monoclonal antibodies are used in the treatment of multiple conditions including cancer, autoimmune disorders, and infectious diseases. One of the initial steps in the selection of an antibody candidate for further pre-clinical development is determining its pharmacokinetics in small animal models. The use of mass spectrometry and other techniques to determine the fate of these antibodies is laborious and expensive. Here we describe a straightforward and highly reproducible methodology for utilizing radiolabeled antibodies for pharmacokinetics studies. (2) Methods: Commercially available bifunctional linker CHXA” and 111Indium radionuclide were used. A melanin-specific chimeric antibody A1 and an isotype matching irrelevant control A2 were conjugated with the CHXA”, and then radiolabeled with 111In. The biodistribution was performed at 4 and 24 h time points in melanoma tumor-bearing and healthy C57BL/6 female mice. (3) The biodistribution of the melanin-binding antibody showed the significant uptake in the tumor, which increased with time, and very low uptake in healthy melanin-containing tissues such as the retina of the eye and melanized skin. This biodistribution pattern in healthy tissues was very close to that of the isotype matching control antibody. (4) Conclusions: The biodistribution experiment allows us to assess the pharmacokinetics of both antibodies side by side and to make a conclusion regarding the suitability of specific antibodies for further development. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Open AccessArticle
Modulation of Hypoxia-Induced Chemoresistance to Polymeric Micellar Cisplatin: The Effect of Ligand Modification of Micellar Carrier Versus Inhibition of the Mediators of Drug Resistance
Pharmaceutics 2018, 10(4), 196; https://doi.org/10.3390/pharmaceutics10040196
Received: 13 September 2018 / Revised: 14 October 2018 / Accepted: 19 October 2018 / Published: 21 October 2018
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Abstract
Hypoxia can induce chemoresistance, which is a significant clinical obstacle in cancer therapy. Here, we assessed development of hypoxia-induced chemoresistance (HICR) against free versus polymeric cisplatin micelles in a triple negative breast cancer cell line, MDA-MB-231. We then explored two strategies for the [...] Read more.
Hypoxia can induce chemoresistance, which is a significant clinical obstacle in cancer therapy. Here, we assessed development of hypoxia-induced chemoresistance (HICR) against free versus polymeric cisplatin micelles in a triple negative breast cancer cell line, MDA-MB-231. We then explored two strategies for the modulation of HICR against cisplatin micelles: a) the development of actively targeted micelles; and b) combination therapy with modulators of HICR in MDA-MB-231 cells. Actively targeted cisplatin micelles were prepared through surface modification of acetal-poly(ethylene oxide)-poly(α-carboxyl-ε-caprolactone) (acetal-PEO-PCCL) micelles with epidermal growth factor receptor (EGFR)-targeting peptide, GE11 (YHWYGYTPQNVI). Our results showed that hypoxia induced resistance against free and cisplatin micelles in MDA-MB-231 cells. A significant increase in micellar cisplatin uptake was observed in MDA-MB-231 cells that overexpress EGFR, following surface modification of micelles with GE11. This did not lead to increased cytotoxicity of micellar cisplatin, however. On the other hand, the addition of pharmacological inhibitors of key molecules involved in HICR in MDA-MB-231 cells, i.e., inhibitors of hypoxia inducing factor-1 (HIF-1) and signal transducer and activator of transcription 3 (STAT3), substantially enhanced the cytotoxicity of free and cisplatin micelles. The results indicated the potential benefit of combination therapy with HIF-1 and STAT3 inhibitors in overcoming HICR to free or micellar cisplatin. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Open AccessArticle
DOX-Vit D, a Novel Doxorubicin Delivery Approach, Inhibits Human Osteosarcoma Cell Proliferation by Inducing Apoptosis While Inhibiting Akt and mTOR Signaling Pathways
Pharmaceutics 2018, 10(3), 144; https://doi.org/10.3390/pharmaceutics10030144
Received: 3 August 2018 / Revised: 29 August 2018 / Accepted: 31 August 2018 / Published: 4 September 2018
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Abstract
Doxorubicin (DOX) is a very potent and effective anticancer agent. However, the effectiveness of DOX in osteosarcoma is usually limited by the acquired drug resistance. Recently, Vitamin D (Vit-D) was shown to suppress the growth of many human cancer cells. Taken together, we [...] Read more.
Doxorubicin (DOX) is a very potent and effective anticancer agent. However, the effectiveness of DOX in osteosarcoma is usually limited by the acquired drug resistance. Recently, Vitamin D (Vit-D) was shown to suppress the growth of many human cancer cells. Taken together, we synthesized DOX-Vit D by conjugating Vit-D to DOX in order to increase the delivery of DOX into cancer cells and mitigate the chemoresistance associated with DOX. For this purpose, MG63 cells were treated with 10 µM DOX or DOX-Vit D for 24 h. Thereafter, MTT, real-time PCR and western blot analysis were used to determine cell proliferation, genes and proteins expression, respectively. Our results showed that DOX-Vit D, but not DOX, significantly elicited an apoptotic signal in MG63 cells as evidenced by induction of death receptor, Caspase-3 and BCLxs genes. Mechanistically, the DOX-Vit D-induced apoptogens were credited to the activation of p-JNK and p-p38 signaling pathway and the inhibition of proliferative proteins, p-Akt and p-mTOR. Our findings propose that DOX-Vit D suppressed the growth of MG63 cells by inducing apoptosis while inhibiting cell survival and proliferative signaling pathways. DOX-Vit D may serve as a novel drug delivery approach to potentiate the delivery of DOX into cancer cells. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Review

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Open AccessReview
A Snapshot of Transdermal and Topical Drug Delivery Research in Canada
Pharmaceutics 2019, 11(6), 256; https://doi.org/10.3390/pharmaceutics11060256
Received: 1 May 2019 / Revised: 28 May 2019 / Accepted: 30 May 2019 / Published: 1 June 2019
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Abstract
The minimally- or non-invasive delivery of therapeutic agents through the skin has several advantages compared to other delivery routes and plays an important role in medical care routines. The development and refinement of new technologies is leading to a drastic expansion of the [...] Read more.
The minimally- or non-invasive delivery of therapeutic agents through the skin has several advantages compared to other delivery routes and plays an important role in medical care routines. The development and refinement of new technologies is leading to a drastic expansion of the arsenal of drugs that can benefit from this delivery strategy and is further intensifying its impact in medicine. Within Canada, as well, a few research groups have worked on the development of state-of-the-art transdermal delivery technologies. Within this short review, we aim to provide a critical overview of the development of these technologies in the Canadian environment. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Open AccessReview
Plant/Bacterial Virus-Based Drug Discovery, Drug Delivery, and Therapeutics
Pharmaceutics 2019, 11(5), 211; https://doi.org/10.3390/pharmaceutics11050211
Received: 22 March 2019 / Revised: 23 April 2019 / Accepted: 25 April 2019 / Published: 3 May 2019
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Abstract
Viruses have recently emerged as promising nanomaterials for biotechnological applications. One of the most important applications of viruses is phage display, which has already been employed to identify a broad range of potential therapeutic peptides and antibodies, as well as other biotechnologically relevant [...] Read more.
Viruses have recently emerged as promising nanomaterials for biotechnological applications. One of the most important applications of viruses is phage display, which has already been employed to identify a broad range of potential therapeutic peptides and antibodies, as well as other biotechnologically relevant polypeptides (including protease inhibitors, minimizing proteins, and cell/organ targeting peptides). Additionally, their high stability, easily modifiable surface, and enormous diversity in shape and size, distinguish viruses from synthetic nanocarriers used for drug delivery. Indeed, several plant and bacterial viruses (e.g., phages) have been investigated and applied as drug carriers. The ability to remove the genetic material within the capsids of some plant viruses and phages produces empty viral-like particles that are replication-deficient and can be loaded with therapeutic agents. This review summarizes the current applications of plant viruses and phages in drug discovery and as drug delivery systems and includes a discussion of the present status of virus-based materials in clinical research, alongside the observed challenges and opportunities. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Open AccessReview
Challenges and Recent Progress in Oral Drug Delivery Systems for Biopharmaceuticals
Pharmaceutics 2019, 11(3), 129; https://doi.org/10.3390/pharmaceutics11030129
Received: 6 February 2019 / Revised: 9 March 2019 / Accepted: 14 March 2019 / Published: 19 March 2019
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Abstract
Routes of drug administration and the corresponding physicochemical characteristics of a given route play significant roles in therapeutic efficacy and short term/long term biological effects. Each delivery method has favorable aspects and limitations, each requiring a specific delivery vehicles design. Among various routes, [...] Read more.
Routes of drug administration and the corresponding physicochemical characteristics of a given route play significant roles in therapeutic efficacy and short term/long term biological effects. Each delivery method has favorable aspects and limitations, each requiring a specific delivery vehicles design. Among various routes, oral delivery has been recognized as the most attractive method, mainly due to its potential for solid formulations with long shelf life, sustained delivery, ease of administration and intensified immune response. At the same time, a few challenges exist in oral delivery, which have been the main research focus in the field in the past few years. The present work concisely reviews different administration routes as well as the advantages and disadvantages of each method, highlighting why oral delivery is currently the most promising approach. Subsequently, the present work discusses the main obstacles for oral systems and explains the most recent solutions proposed to deal with each issue. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Open AccessReview
Spatially Specific Liposomal Cancer Therapy Triggered by Clinical External Sources of Energy
Pharmaceutics 2019, 11(3), 125; https://doi.org/10.3390/pharmaceutics11030125
Received: 26 February 2019 / Revised: 12 March 2019 / Accepted: 13 March 2019 / Published: 16 March 2019
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Abstract
This review explores the use of energy sources, including ultrasound, magnetic fields, and external beam radiation, to trigger the delivery of drugs from liposomes in a tumor in a spatially-specific manner. Each section explores the mechanism(s) of drug release that can be achieved [...] Read more.
This review explores the use of energy sources, including ultrasound, magnetic fields, and external beam radiation, to trigger the delivery of drugs from liposomes in a tumor in a spatially-specific manner. Each section explores the mechanism(s) of drug release that can be achieved using liposomes in conjunction with the external trigger. Subsequently, the treatment’s formulation factors are discussed, highlighting the parameters of both the therapy and the medical device. Additionally, the pre-clinical and clinical trials of each triggered release method are explored. Lastly, the advantages and disadvantages, as well as the feasibility and future outlook of each triggered release method, are discussed. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Open AccessReview
What Drives Innovation: The Canadian Touch on Liposomal Therapeutics
Pharmaceutics 2019, 11(3), 124; https://doi.org/10.3390/pharmaceutics11030124
Received: 23 February 2019 / Revised: 11 March 2019 / Accepted: 12 March 2019 / Published: 16 March 2019
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Abstract
Liposomes are considered one of the most successful drug delivery systems (DDS) given their established utility and success in the clinic. In the past 40–50 years, Canadian scientists have made ground-breaking discoveries, many of which were successfully translated to the clinic, leading to [...] Read more.
Liposomes are considered one of the most successful drug delivery systems (DDS) given their established utility and success in the clinic. In the past 40–50 years, Canadian scientists have made ground-breaking discoveries, many of which were successfully translated to the clinic, leading to the formation of biotech companies, the creation of research tools, such as the Lipex Extruder and the NanoAssemblr™, as well as contributing significantly to the development of pharmaceutical products, such as Abelcet®, MyoCet®, Marqibo®, Vyxeos®, and Onpattro™, which are making positive impacts on patients’ health. This review highlights the Canadian contribution to the development of these and other important liposomal technologies that have touched patients. In this review, we try to address the question of what drives innovation: Is it the individual, the teams, the funding, and/or an entrepreneurial spirit that leads to success? From this perspective, it is possible to define how innovation will translate to meaningful commercial ventures and products with impact in the future. We begin with a brief history followed by descriptions of drug delivery technologies influenced by Canadian researchers. We will discuss recent advances in liposomal technologies, including the Metaplex technology from the author’s lab. The latter exemplifies how a nanotechnology platform can be designed based on multidisciplinary groups with expertise in coordination chemistry, nanomedicines, disease, and business to create new therapeutics that can effect better outcomes in patient populations. We conclude that the team is central to the effort; arguing if the team is entrepreneurial and well positioned, the funds needed will be found, but likely not solely in Canada. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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Other

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Open AccessPerspective
The Development of Oral Amphotericin B to Treat Systemic Fungal and Parasitic Infections: Has the Myth Been Finally Realized?
Pharmaceutics 2019, 11(3), 99; https://doi.org/10.3390/pharmaceutics11030099
Received: 30 January 2019 / Revised: 18 February 2019 / Accepted: 19 February 2019 / Published: 26 February 2019
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Abstract
Parenteral amphotericin B has been considered as first-line therapy in the treatment of systemic fungal and parasitic infections, however its use has been associated with a number of limitations including affordability, accessibility, and an array of systemic toxicities. Until very recently, it has [...] Read more.
Parenteral amphotericin B has been considered as first-line therapy in the treatment of systemic fungal and parasitic infections, however its use has been associated with a number of limitations including affordability, accessibility, and an array of systemic toxicities. Until very recently, it has been very challenging to develop a bioavailable formulation of amphotericin B due to its physical chemical properties, limited water and lipid solubility, and poor absorption. This perspective reviews several novel oral Amphotericin B formulations under development that are attempting to overcome these limitations. Full article
(This article belongs to the Special Issue Drug Delivery Technology Development in Canada)
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