Scientific Program

Day 1 :

Keynote Forum

Juergen Lademann

Director Center of Experimental and Applied Cutaneous Physiology, Germany

Keynote: Topical drug delivery with nanoparticles: Science fiction or reality?

Time : 10:00-10:40

Biography:

Jurgen Lademann graduated from the Moscow Lomonosov State University in 1980. 1991 he received the Assistant Professorship from the University of Jena, Germany. From 1993 to 1995 he headed the Medical Center of Sensor Technology at the University of the Armed Forces Germany. In 1996 Jurgen Lademann joined the Charite Universitatsmedizin Berlin and was appointed Director of the Center of Experimental and Applied Cutaneous Physiology. In 2001 the Charite appointed him full professor of Dermatology. He is the Vice President of the IFSCC and the editor of the Journal Skin Pharmacology and Physiology. He authored more than 600 peer-reviewed articles.

Abstract:

The demands on nanoparticles for use in dermatology and cosmetics are very different. While nanoparticles widely applied in sunscreens, like TiO2 and ZnO, shall remain on the skin surface or in the upper cell layers of the stratum corneum, nanoparticles intended for drug delivery shall penetrate through the skin barrier to the target structures in the living cells.

At the Charité - Universitätsmedizin Berlin various laser scanning microscopy methods are used to investigate the penetration and storage of nanoparticles in the skin, hair follicles being in the focus of attention. Human hair follicles are ideal target structures for drug delivery. Hosting both the stem and dendritic cells, they are surrounded by a dense network of blood vessels. Investigating nanoparticles of different size and materials, it was found that particles of approximately 600nm diameter penetrate most efficiently into the hair follicles and can be stored there for ca. 10 days. Their retention time in the hair follicles exceeds that in the stratum corneum by almost one order of magnitude.

 

Keynote Forum

Michael J O Rourke

President Re-Vana Therapeutics, USA

Keynote: The Development and Commercialisation of Sustained Release Ocular Drug Delivery Systems

Time : 10:40-11:20

Biography:

Michael O'Rourke has over 30 years drug delivery experience across ophthalmology, periodontal and pulmonary markets in sales, marketing, product launch, strategy development and global commercialization. In 2009 he founded Scotia Vision, a specialized ophthalmic consulting company with extensive expertise in global ocular drug delivery commercial and product development strategies. Career experience includes senior positions with several global leading organizations and start-ups, including 3M, Alza, Chiron Vision, Bausch + Lomb, GrayBug and Re-Vana Therapeutics. His unique global ocular drug delivery experience includes launching the world’s first intra ocular drug delivery technology in Europe, Vitrasert, and the world’s second, Retisert, in the USA. He’s managed 28 brands, led 13 product launches, structured/negotiated 12 strategic business deals and has been a team member in 18 device/drug approvals. Michael is from Glasgow Scotland but is now based in Tampa Florida. He was recently elected into the Global Scot "Hall of Fame”, for supporting and advising Scottish start ups and existing organisations in the Life Sciences and other sectors including music with the Royal Scottish National Orchestra.

Abstract:

The global ophthalmic pharmaceutical industry is estimated to reach $29 billion by 2022 with a growing elderly population and the increasing incidence of diabetic eye disease, due in part to increasing obesity rates in both adults and children. The number of people visually impaired in the world is approx. 295 million, with at least 39 million blind and 256 million having low vision. 65% of people visually impaired and 82% of all blind are 50 years and older. There is urgent need to develop new therapeutics and ocular drug delivery systems, providing controlled release for 4-6 months or longer for the treatment of chronic and blinding eye diseases. These will increase patient' s and doctor' s convenience by reducing the dosing frequency including the ability to minimize frequent intra vitreal injections for chronic conditions of the retina. Currently there are only 4 sustained release ocular drug delivery systems ever approved worldwide, treating blinding eye diseases. There is a significant need for both new delivery systems and therapeutics for both small and large molecules. This presentation will cover the development of systems to date, discuss new technologies under current development, the challenges to overcome and how they can ultimately successfully commercialized.

 

Keynote Forum

Istvan Toth

Professor, The University of Queensland, St. Lucia, Queensland, Australia

Keynote: Lipophilic vaccine delivery systems

Time :

Biography:

Professor Istvan TOTH is Chair in Biological Chemistry & Professor of Pharmacy, The University of Queensland (UQ), Brisbane, Australia; Affiliated Professorial Research Fellow and Group Leader, Institute of Molecular Biosciences, UQ. He graduated with a degree in Chemical Engineering from the Technical University, Budapest, Hungary in 1969 and was awarded his PhD in 1972 for research in Alkaloid Chemistry. In 1994 he was awarded a DSc for his work on drug delivery. Prof. Toth moved from the School of Pharmacy at the University of London to the University of Queensland in 1998, and leads a productive medicinal chemistry research group (presently 30 members). He is an elected RACI Fellow, Fellow of the Queensland Academy of Arts and Sciences and Fellow (External) of the Hungarian Academy of Sciences. In 2009 he was awarded the Adrian Albert award for sustained and outstanding research in medicinal biochemistry. He has over 400 peer-reviewed publications (>500 citations/year since 2012), 44 patents, and a strong record in research commercialization.His research has attracted over $84 million in competitive grants, research contracts and investment funds in the past 10 years, including an NHMRC Program grant, which is now in its fourth successive 5-year term and a recent NHMRC Project Grant.

Abstract:

Infection with group A streptococci (Streptococcus pyogenes, GAS), one of the common and widespread human pathogens, can result in a broad range of diseases, with the potential of acute and post-infectious rheumatic fever and rheumatic heart disease. Immunity to GAS relies on the production of opsonic antibodies specific to the hypervariable N-terminal and conserved C-terminal regions of the coiled-coil α-helical M protein, the major virulent factor in GAS. The development of an effective vaccine for GAS has been challenged by the induced autoimmunity of epitopes derived from the C-terminal regions, unsuitable B-cell epitopes that have been shown to react with human heart tissue, and the minimal B-cell epitopes, which believed to be safe, shows little or no immunogenicity unless bound to a delivery platform. For vaccine delivery, self-adjuvanting lipid core peptide (LCP) and polymer coated liposome systems including antigen, carrier and adjuvant within the same molecular entity has been developed. The systems allow the attachment of multiple copies of antigens.

  • Targeted Drug Delivery System

Session Introduction

Yasunori Iwao

Associate Professor School of Pharmaceutical Sciences,University of Shizuoka, Japan

Title: Inflamed site-specific drug delivery system using human serum albumin nanoparticles
Speaker
Biography:

Abstract:

To develop a new strategy for inflamed site-specific drug delivery in the colon for the treatment of ulcerative colitis (UC), we focused on the interaction between myeloperoxidase (MPO) and human serum albumin (HSA) and prepared nanoparticles (HSA NPs) conjugated with 5-aminosalicylic acid (5-ASA), an anti-inflammatory drug. The 5-ASA-HSA NPs (nine molecules of 5-ASA per HSA molecule) were uniform particles with an average particle size of 190 nm, a zeta potential of -11.8 mV, and a polydispersity index of 0.35. This was considered a suitable particle characteristic to pass through the mucus layer and accumulate into the mucosa. The specific interaction between the 5-ASA-HSA NPs and MPO was observed using quartz crystal microbalance analysis in vitro. In addition, the 5-ASA-HSA NPs group containing one thousandth of the dose of the 5-ASA (75 μg/kg) showed significantly lower disease activity index values and colon weight/length ratios in UC model mice as similar to large amount of neat 5-ASA group (75 mg/kg), indicating that the therapeutic effect of the 5-ASA-HSA NP formulation was confirmed in vivo. Microscopic images of tissue sections of colon extracted from UC model mice demonstrated that HSA NPs and MPO were both localized in the colon, and this specific interaction between HSA NPs and MPO would be involved the in the therapeutic effect in vivo. Furthermore, in the 5-ASA and 5-ASA-HSA NPs groups, some inflammatory damage was observed in the colon, but the degree of damage was mild compared with the control and HSA NPs groups, suggesting mucosal repair and replacement with fibrous granulation tissue had occurred. Therefore, these data demonstrated for the first time, that an HSA NP formulation has the potential to specifically deliver 5-ASA to an inflamed site where MPO is highly expressed.

 

 

Surangi Jayawardena

Assistant professor The University of Alabama in Huntsville USA

Title: Targeted Drug Delivery -Nanoantibiotics for Targeted Antibiotic Delivery for Bacteria
Speaker
Biography:

Abstract:

The work demonstrates the use of carbohydrate-conjugated nanomaterial (glyconanomaterial) to target bacterial pathogens. A collection of systematic studies done by several groups has demonstrated that bacteria can be specifically targeted using various oligosaccharides. Through our preliminary investigations we have discovered that oligosaccharide conjugated nanoparticles (glyconanoparticles) could be used to target strain specific bacteria. For example D-maltoheptaose (G7) and trehalose conjugated nanoparticle used to effectively target Escherichia coli and Mycobacterium spp. Antibiotic resistance in pathogenic bacterial strains is a growing global concern. We have demonstrated that these glyconanoparticles have been used as a carrier for antibiotics that would help target bacteria and reduce minimum inhibitory concentration of a conventional antibiotic. Antibiotic streptomycin (Str) is a broad range aminoglycoside typically used in the treatment of tuberculosis. We have bi-functionalized a nanoparticle using carbohydrate-G7 antibiotic-Str to produce glyconanoantibiotics (GNAs). As proof of concept for active targeting GNAs are used against a highly Str resistant E. coli strain. The GNAs demonstrated size dependent increased antibacterial efficacy few log folds improvement over the free the free antibiotic (Str).

 

  • Application of polymers for drug delivery

Session Introduction

Jayalakshmi Sridhar

Xavier University of Louisiana, USA

Title: Discovery of a synthetic method to form 2,2’-bis(naphthoquinone) compounds
Biography:

Abstract:

Quinones are key structural components in many natural products, and therapeutic drugs impacting many disease conditions, viz antimicrobial, antiparasitic, anti-tumor, inhibition of PGE2 biosynthesis and anti-cardiovascular disease. As part of our efforts in the design and development of kinase inhibitors as potential therapeutics for cancer and Alzheimer’s disease, the synthesis of monohydroxynaphthoquinones using Diels-Alder reaction was pursued. This lead to the discovery of a novel method for the synthesis of 2,2’-bis(naphthoquinones)  using conjugated ketene silyl acetals with benzoquinone. The analysis of the reaction conditions and the product structures using NMR and X-ray lead to the elucidation of a credible mechanism of dimer formation. The control of reactant stoichiometry to yield either the monomer of the dimer product is explored. 

Mariusz Skwarczynski

Associate Professor The University of Queensland, St. Lucia, Queensland, Australia

Title: Polyacrylate-based Vaccine Delivery System
Speaker
Biography:

Abstract:

Classical vaccines incorporating live or attenuated microorganisms possess several disadvantages and cannot be applied against cancer and some pathogens. Modern vaccines utilizing immunogenic subunits derived from a particular pathogen are able to overcome these obstacles but need a specific delivery system for their efficacy. Nanotechnology has opened a new window into these delivery methodologies. Particles-based subunit vaccine formulations have been proven to be very effective in inducing cellular and humoral immune responses.

We synthesized polymeric constructs consisting of polyacrylate cores and peptide epitopes derived from bacterial or cancer antigens. The peptide epitopes were synthesized using solid phase peptide synthesis, whereas polymeric cores were synthesized by successive atom transfer radical polymerization. Unprotected peptide epitopes containing an N-terminus azide moiety were conjugated to core structures via copper-catalyzed alkyne-azide 1,3-dipolar cycloaddition “click” reaction. The self-adjuvanting vaccine particles were formed under aqueous conditions and purified by dialysis. The particles were characterized by dynamic light scattering, transmission electron microscopy and elemental analysis to determine size and conjugation efficacy between polymer and peptides. Ability of nanoparticles to induce humoral immune responses against Group A Streptoccocus was examined in mice. To test the efficacy of polymer-peptide conjugates as a therapeutic vaccine against established tumors, in vivo tumor treatment experiments were performed based on well-established procedures with C57BL/6 mice using TC-1 tumor model.

The designed new delivery system based on the polyacrylate polymer with self-assembled properties induced humoral immune responses which were dependent on the particle size. The strong immune responses were observed even after single subcutaneous immunization. The produced antibodies were able to recognize and kill clinical isolated bacterial strains. The polymer-peptide conjugates were also used for the design of therapeutic vaccine against cervical cancer. Treatment with these conjugates led to significantly better survival compared to treatment with any other immunogens including IFA-adjuvanted positive control. Our findings suggested that this delivery system is a promising strategy for the design of prophylactic vaccines to induce humoral immunity as well as therapeutic peptide-based vaccines that induce adequate cellular immunity against a target disease. This delivery system also removes the use of incompletely defined and ordinarily toxic immune adjuvants, producing a safe and effective for potential vaccines for human use.

 

  • Herbal drug formulations and evaluations

Session Introduction

Rohit P. Dugar

Formulation Scientist Nutrilite Health Institute, Amway Greater Los Angeles Area

Title: Effect of granulation and tableting process parameters on microbial bio-burden in tablets containing plant based ingredients: A case study
Speaker
Biography:

Abstract:

Strict guidelines are enforced by governing bodies of different countries for the APC of dietary and natural products. In the current study, effect of processing parameters on microbial bio-burden is explored. Effect of process parameters of high shear (HS) and fluidized top spray (TS) granulation on microbial bio-burden of tablets containing natural products was studied. Components of formulation were accurately weighed and blended using a V-blender to prepare 6 kg batches each for HS and TS processes. 24 full factorial design was created using Minitab® as shown in Table 1. High shear wet granulation was carried out in a GEA PMA™ using starch slurry in de-ionized water. Wet mass was passed through a co-mill and then dried in a fluidized bed drier until constant LOD values were obtained. Fluidized top spray granulation was carried out in a GEA MP1™. Inlet air temperature and velocity were modified as per Table 1. Post drying, granules were milled at two different speeds and then compressed on a rotary tablet press at two different main compression forces. Aerobic plate count (APC) swabs, loss on drying and water activity were performed before each processing stage through final tableting. Initial dry blend APC was an average 50000 CFU/g. Figure 1 shows a 1.3-fold decrease in APC after the milling step post high shear granulation while a 3.5-fold kill after the drying step in fluidized bed drier. Post tableting, a 47-fold APC decrease was observed for low compression forces while a 50-fold for high forces. High rate of microbial kill during tableting could be attributed to the high shear forces and localized heating while the press is running. This work takes a deep dive into identification and optimization of each processing step involved in tableting in regard to the microbial load of the final formulations.

  • Novel Drug Delivery System

Session Introduction

Eckart Ruehl

Freie Universität Berlin, Germany

Title: Topical Drug Delivery into Skin by Polymer Nanocarriers
Biography:

Abstract:

Novel concepts of topical drug delivery into skin by polymer nanocarriers are presented. This work results from an interdisciplinary approach, which involves the large multidisciplinary research consortium of the Collaborative Research Center 1112 (SFB 1112). The research program includes: (i) nanocarrier synthesis, (ii) optimization of drug uptake into the polymers, (iii) evaluation of the physical and toxicological properties of polymer nanocarriers, (iv) exposure of these nanoscopic drug delivery systems to healthy and inflamed skin samples, and (v) probing the nanocarriers and drugs in the skin as a function of depth and penetration time. This allows us to evaluate the concept of polymer nanocarriers for efficient dermal drug delivery compared to standard formulations. Specific emphasis will be put on the detection of drugs and nanocarriers in skin samples with high spatial resolution far below the diffraction limit of optical microscopy along with selective and quantitative detection of drug penetration profiles. This is accomplished most advantageously by label-free approaches, in which the intrinsic spectroscopic properties of the drugs and nanocarriers are exploited for sensitive detection. Selected examples using X-ray microscopy and Raman-based approaches as well as results from numerical modeling, yielding the crucial parameters of drug penetration, will be discussed. Furthermore, recent results from atomic force microscopy-based techniques, such as optical near-field microscopy
and photothermal expansion will be shown, which can reach at chemical selectivity a spatial resolution below 10 nm. Such developments will contribute to develop a molecular understanding of dermal drug penetration processes.

GozdeKabay

TOBB University of Economics and Technology, Turkey

Title: Melanin Functionalized Protein Nanofibers: A Bio-inspired Platform for Drug Release
Speaker
Biography:

Abstract:

A recent approach for controlled release of drugs comprise natural-derived biopolymers since they show superior biodegradable/biocompatible features. In this study, nanofibers containing natural melanin and amyloid-like bovine serum albumin (mel/BSA) were produced by single-needle electrospinning to investigate drug release behavior of water soluble model drug, namely ampicillin. Prior to electrospinning, natural melanin was extracted from cuttle fish ink to prepare electrospinning solution. 20%, 10% and %5 (w:w) ampicilling:BSA including nanofibers were produced under 21 kV, 0.3 ml/h for 4 hours. Nanofiber formation and morphology for different drug formulations was observed by scanning electron microscope. Fourier transform infrared spectroscopy analysis showed that some compatibility exists between ampicillin and mel/BSA nanofibers. Moreover, drug release tests were conducted to explain the relationship between the drug release behavior and carrier morphology. For single electrospun nanofibers, 87% of the loaded drug was released within the 96 hours. Together, these imply that drug release vehicles could be extended to melanin functionalized biopolymer carriers.

 

Abdullah Abubakre

Academic Writer

Title: Biodegradable In Situ Forming Hydrogel for Intraocular Drug Delivery
Speaker
Biography:

Abstract:

The eye is an intricate organ, it consists of many barriers that help to protect and maintain its normal function. It is made up of two segments, the anterior segment – which includes the cornea, ciliary body, conjunctiva, sclera, and anterior uvea – and the posterior segment – which includes the retina and vitreous body. The protective design of the eye makes delivery of drugs to the back of the eye (posterior segment) difficult. However, with an ageing population, there is an increased number of blinding conditions that occur in the posterior segment that requires more effective and long-acting drug delivery systems (Mashaghi et al., 2016; Marshal, 1987).

 

Pedram Ebrahimnejad

Assistant Professor Mazandaran University of Medical Sciences, Iran

Title: Formulation of a novel antibacterial polymeric composite for delivery of curcumin
Speaker
Biography:

Abstract:

A a novel antibacterial nanocomposite was developed for delivery of curcumin through a completely green and environmentally friendly route (without using any organic solvents, hazardous chemicals and even harsh procedure). To achieve this, natural biopolymers Sodium Alginate, Chitosan and Carboxymethylcellulose sodium were used. Curcumin and magnetic nanoparticles were encapsulated into the Alginate nanocapsules by formation of Alginate-Ca2+ complex. To modify the drawbacks of Alginate nanocapsules like porosity and burst drug release, they were coated with Chitosan and Carboxymethylcellulose through inter-ionic interactions between oppositely charged biopolymers. After coating with these natural polymers, porosity was reduced and burst drug releases were modified. The synthesized nanocarrier was characterized by zetasizer, FTIR, 1H NMR, DSC and SEM. Its antibacterial activity was assessed by determining minimum inhibitory concentration (MIC) values. It was concluded that this novel drug delivery vehicle makes antibacterial processes proceed, representing more efficient drug delivery system in nanomedicine.

 

Day 2 :

Keynote Forum

Robert Lee

Executive Vice President Particle Sciences USA

Keynote: Development and Characterization of Sterile Nanoparticulate Suspensions

Time : 10:00-10:40

Biography:

Dr. Lee is Executive Vice President of Pharmaceutical Development Services at Particle Sciences, a Lubrizol Advanced Materials, Inc. company, a pharmaceutical contract development and manufacturing organization (www.particlesciences.com). He provides direction and is involved with product and business development. Before joining Particle Sciences, Rob held senior management positions at Novavax, Inc., Lyotropic Therapeutics, Inc., and Imcor Pharmaceutical Co. He holds BSs in Biology and Chemistry from the University of Washington and a PhD in Physical Bioorganic Chemistry from the University of California, Santa Barbara. Rob has published articles in numerous peer-reviewed journals and five book chapters plus holds over two dozen issued patents or provisional patent applications.

Abstract:

Many active pharmaceutical ingredients are poorly water soluble and may suffer from low oral bioavailability, if formulated in unmodified form.  These compounds are also challenging to formulate for other routes of administration, especially parenteral.  The prevalence of low solubility compounds has led to intensive research and has generated many technologies to address formulation.  For BCS II molecules, there are other drug delivery approaches besides nanoparticulate suspensions (NSs) used for oral administration but many feel the higher value of this technology is for parenteral delivery.  This technology has been used for several marketed products including oral tablets, oral liquid NSs, and parenteral liquid NSs.  There continues to be a strong interest in employing NS formulations, particularly for parenteral dosage forms.  An overview of the history and product development of NSs with an emphasis on sterile products will be presented

 

I look forward to the meeting.  It looks like my talk may be appropriate for tracks 1, 5, 6, and 9 – probably track 6 may be the best fit.  Please get back to me as soon as possible on what session, date, and time my presentation is scheduled for along with when I need to be there to chair my session (and what session).  Let me know if you need any additional information.  Once I know what date my session is, I’ll make my hotel reservations.

 

 

 

Keynote Forum

Behzad Nili

Executive Nano Drug Delivery USA

Keynote: Are we the medical researchers enslaved by an antique established status quo and a rigid system that can compromise the outcome of our research conclusions or even the efficiency of final treatments/drugs?

Time : 10:40-11:20

Biography:

Behzad Nili has completed his PharmD/PhD at the age of 27 years from Turin University, School of Pharmcey, Italy and thought at SUMS Shiraz University School of Medical Sciences, in both Departments of Pharmaceutics and Medicinal Chemistry, for several years. He has been working for Nano Drug Delivery, since 2004.

Abstract:

TBA

Keynote Forum

Ahmed Mamun

Editorial Board Member Asian journal of Lifesciences Cairo University Egypt

Keynote: Real-time potentiometric sensor; an innovative tool for monitoring hydrolysis of chemo/bio-degradable drugs in pharmaceutical sciences

Time : 11:40-12:30

Biography:

Researcher in analytical chemistry of faculty of pharmacy cairo university and Quality control supervisor in orchidia pharmaceuticals for ophthalmic..Editorial board member in Asian journal of Lifesciences

Abstract:

In recent years, the whole field of ion-selective electrodes(ISEs) in pharmaceutical sciences has expanded far beyond its original roots. The diverse range of opportunities offered by ISEs was broadly used in a number of pharmaceutical applications, with topics presented ranging from bioanalysis of drugs and metabolites, to protein binding studies, green analytical chemistry, impurity profiling, and drug dissolution in biorelevant media. Inspired from these advances and with the aim of extending the functional capabilities of ISEs, the primary focus of the present paper is the utilization of ISE as a tool in personalized medicine. Given the opportunity to explore biological events in real-time (such as drug metabolism) could be central to personalized medicine. (ATR) is a chemo-degradable and bio-degradable pharmaceutically active drug. Laudanosine (LDS) is the major degradation product and metabolite of ATR and is potentially toxic and reported to possess epileptogenic activity which increases the risk of convulsive effects. In this work, ATR have been subjected to both chemical and biological hydrolysis, and the course ofthe reactions is monitored by means of a ISE. In this study, we have designed an efficient real-time tracking strategy which substantially resolve the challenges of the ATR chemical and biological degradation kinetics. By utilizing a potentiometric sensor, tracking of ATR chemical and biological degradation kinetics can be performed in a very short time with excellent accuracy. The LOD was calculated to be 0.23 mol L−1, the potential drift was investigated over a period of 60 min and the value was 0.25 mVh−1. Real serum samples for measurement the rate of in vitro metabolism of ATR was performed. Furthermore, a full description of the fabricated screen-printed sensor was presented. 

Keynote Forum

Syed H Askari

Maculus Therapeutix, USA

Keynote: Medical Devices as Tools for drug delivery: Challenges and opportunities

Time :

Biography:

Syed Askari, PhD, is the Founder, President and CEO of Maculus Therapeutix, an ENT medical device/drug delivery company. Previously he founded Medicus Biosciences, and launched two wound healing products, SutureSeal and HyFlex.Syed holds more than 25 patents/patents applications. Syed has a PhD in Organic Chemistry from the University of British Columbia and has completed his post doctoral work at UCLA and UCSB under Prof Wudl and Prof Heeger Nobel Laureate (year 2000) labs.

Abstract:

Medical device with drug delivery technology has improved over the last 20 years to address issues with ease of application or implantation, biocompatibility, durability, bioabsorbability and drug dosage control. These developments have been applied to stents and lenses, heart valves and seats, vascular stents and shunts, hemostasis and embolization, post-surgical closure, liquid bandages, and other areas. The devices have also been used as drug delivery vehicles. New technologies must be tailored to the target physiologic environment since materials that function well in one environment may fail in another. Research has brought about a much greater understanding of the importance of the surfaces of medical devices in terms of the reaction to contact with bodily fluids and tissues, and novel materials have been developed that resist attachment to cells, platelets, calcium deposits, etc.  Overall, greater understanding of the specific environment in which a device will be deployed leads to more reliable, durable and functional designs with fewer complications over time. This talk will explore some of the advancements in polymer chemistry and hydrogel-based materials and how these technologies have been applied to medical devices and drug delivery in numerous settings. Significant challenges remain in the medical device and delivery arena, and potential future advancements will be discussed.

 

 

  • Use of Nanoparticles in DDS and newer methodologies

Session Introduction

Vaishnavi Parikh

Genus Lifesciences Inc., USA

Title: Significance of Structure Elucidation of Protein At The Interface In Designing Polymer Nanoparticle Mediated Protein Delivery System
Speaker
Biography:

Abstract:

It is of utmost importance to deliver protein in safe and efficacious form from the nano particulate delivery system knowing that adsorption of proteins on to nanoparticle surfaces involves complex interactions including hydrophobic interaction, electrostatic interaction and/or interaction between adsorbed protein molecules which may lead to loss of protein stability. However, adsorption based drug delivery systems for protein drugs would be one of the simplest and most effective forms of drug if the mechanistic understanding of adsorption of proteins at solid/liquid interfaces is obtained. Evaluation of the changes in structure of recombinant human growth hormone (r-hGH) upon adsorption at biodegradable Poly (lactide-co-glycolide)PLGA nanoparticles of different hydrophobicity as a function of pH revealed the polymer grades suitable for delivery system.  The comprehension of structural stability and polymer grade is extremely useful in developing sustained delivery of protein like r-hGH. This kind of dosage form is currently lacking in the market despite the facts that r-hGH was first approved for use by FDA in 1995, the conventional dosage form in the market has a limitation of daily subcutaneous injections, a long-acting dosage form of r-hGH; Nutropin depot was discontinued in 2004, about 5 years after its approval from FDA and since then continued research has been focused in this area. Thus, direct evaluation of secondary and tertiary structural conformations of the adsorbed proteins on the polymer surface with the analytical techniques such as dynamic light scattering Spectroscopy, fluorescence spectroscopy and circular dichroism spectroscopy will help understand the nature of the interactions that govern the adsorption of the protein on the polymer, leading to successful design of nano particulate delivery systems.

 

Ulrike Alexiev

Freie Universität Berlin, Germany

Title: Topical drug delivery and nanotoxicity as revealed by advanced fluorescence microscopy
Biography:

Abstract:

Fluorescence lifetime imaging microscopy (FLIM) provides new possibilities in the investigation of nanocarrier penetration and drug delivery, as the fluorescence lifetime is highly sensitive to the microenvironment. Using Cluster-FLIM, image contrast is enhanced and a clear-cut discrimination between different fluorescent species is feasible. This allows visualization of nanoparticles with an unprecedented precision and sensitivity in skin sections, skin biopsis, living cells and in living tissue. The latter is realized in a multiphoton FLIM setup. To further increase resolution and to resolve nanocarrier fine-structure we employed single molecule TIRF microscopy. Using this method, we were also able to show the penetration of individual nanoparticles into the viable epidermis, thereby adding new information to the debate of whether nanoparticles can cross the skin barrier. Since nanotoxicity is a major concern in the application of nanoparticles, we recently developed a novel FLIM-based imaging assay (FLIM-ROX) for reactive oxygen species detection. Using FLIM-ROX, we demonstrate the nanotoxicity of subcytotoxic amounts of nanoparticles by linking cellular adverse effects to low-level oxidative stress.

 

  • Formulation and evaluation of different drugs

Session Introduction

Paritosh Pande

IMA Life North America, USA

Title: Influence of formulation and lyophilization process variations on protein aggregation and chemical degradation: impact of scale up
Speaker
Biography:

Abstract:

Statement of the Problem:

Currently nearly half of the therapeutic proteins are freeze dried but the freeze-drying does not guarantee stability partly because the product temperature during a freeze drying cycle cannot be directly controlled. Variations in product temperature can significantly impact the product critical quality attributes (CQAs), even for biosimilars having the similar formulations. Therefore, a better understanding of product temperature variations and their impact on meaningful critical quality attributes (CQAs) will enable development of sampling strategies to better assess the influence of distribution in CQAs like protein chemical degradation and aggregation on the probability of releasing out of specification product.  

Methodology & Theoretical Orientation:

Currently, we are evaluating the variations in CQAs related to protein degradation by:

  1. Assessing the variations in key physical properties like phase composition (i.e. phase separation and crystallinity), specific surface area, and glass transition temperature (Tg) in the product vials, as well as levels of product degradation. Attempts are being made to identify the physical properties that are predictive of chemical degradation and aggregation.
  1. Quantify the position-dependent differences in product temperature history caused by differences in vial heat transfer coefficient (Kv) and assess whether or not these differences are likely to cause differences in stability, particularly aggregation (which can potentially generate adverse immune response).

Conclusion:

Preliminary results indicate that temperature history differences due to variations in Kv are not likely to result in significant differences in stability. Significant intra-batch variations in ice nucleation temperature result in modest variations in specific surface area with possible stability consequences, but current results indicate a large difference in ice nucleation temperature between laboratory and manufacturing with likely adverse stability consequences.

Significance:

Although, the current research focuses on proteins, the general scale-up technology will also apply to generics and vaccine products. An understanding of these variations in CQAs will reduce the probability of releasing out-of-specification product.

 

  • Herbal drug formulations and evaluations

Session Introduction

Willford Edem Dorglo

Pokupharma Co. Ltd, Ghana

Title: Problms facing herbal medicine delivery in Ghana
Biography:

Abstract:

Healthcare in Ghana is generally near the top of Sub-Saharan African rankings, but bottlenecks in delivery remain, along with certain gaps in policy and practice. Overcoming these challenges will involve policy-makers thinking out-of-the-box to create a space for the numerous micro-entrepreneurs who are the backbone of Ghana’s herbal medicine practice to thrive. This is an opportunity to support national equitable healthcare delivery goals as well as national economic development goals.  The continued advancement of herbal medicine practice promises significant opportunities for job creation across the herbal medicine value chain. Moreover, beyond their use at home, there are also significant opportunities to commercialize herbal medicine products in global markets.  Perhaps it is time to put herbal medicine on a more industrial footing. We at Pokupharma Company Limited are far advance to add to our wide range of drugs.  Antiretroviral herbal drugs to augment foreign imports.In my submission, I write on alternative system of medicines, the practice it faces in Ghana with reference to Antiretroviral herbal medicine.The human immunodeficiency virus has infected millions of people and the epidemic continues to grow rapidly in some parts of the Africa. Antiretroviral (ARV) therapy has provided improved treatment and prolonged the life expectancy of patients. Moreover, there is growing interest in using ARVs to protect against new infections. Hence, ARVs have emerged as our primary strategy in combating the virus. Unfortunately, several challenges limit the optimal performance of these drugs. First, ARVs often require life-long use and complex dosing regimens. This results in low patient adherence and periods of lapsed treatment manifesting in drug resistance. This has prompted the development of alternate dosage forms such as vaginal rings and long-acting injectables that stand to improve patient adherence. Another problem central to therapeutic failure is the inadequate penetration of drugs into infected tissues. This can lead to incomplete treatment, development of resistance, and viral rebound. Several strategies have been developed to improve drug penetration into these drug-free sanctuaries. These include encapsulation of drugs in nanoparticles, use of pharmacokinetic enhancers, and cell-based drug delivery platforms. In this review, we discuss issues surrounding ARV therapy and their impact on drug efficacy. We also describe various drug delivery–based approaches developed to overcome these issues. Ghanaian herbal medicine and health care practice systems are not well documented and characterized in writing. Herbal medicine practitioners are mainly illiterate and practice in the general community or in secret shrines which are mostly in rural areas. The mutual suspicion between herbal medicine practitioners on one hand, and allopathic medicine practitioners, academics and the educated elite on the other hand, is still rather strong. Herbal secrecy and the absence of effective specific protection of intellectual property rights are barriers to making knowledge easily available by the practitioners.  However, there are indications that some of the healers are prepared to divulge some the secrets. Lack of adequate financial support throughout the system limits rapid progress in developing herbal medicine. The systems for legal control and management of herbal medicine in Ghana are still weak. There is no legal or administrative instrument to control complementary medicine practice in this country. Although there is a growing interest in phyto-medicine research, there is no known organization or individuals in Ghana that conduct scientific research into the esotertic component of herbal medicine and the other healing modalities. Efficacy tests have not been done on virtually all of the herbal and complementary medicine products on the commercial market. There are no formal schools in Ghana for herbal medicine and any of the types of complementary medicine. Modalities for establishing useful working relationship between allopathic and herbal and other medicine practitioners are yet to be clearly defined. There is no national standard research protocol and no national ethical committee on TM. Poor agricultural practices, indiscriminate bush burning and uncontrolled harvesting are threatening the easy availability of some medicinal plants. There are many quacks and opportunists in the field of traditional and complementary medicine practice in this country. There has not been any formal or any real research, to the best of my knowledge, in any of the types of complementary medicine in Ghana. One still hears of professionals in allopathic/modern medicine who openly and severely rebuke patients and/or their relations for visiting a herbal medicine practitioner(s) during the course of an illness.  Because of fear of rebuke patients normally deny that they ever visited a herbal medicine practitioner(s). Herbal medicine grade has now been establishment in the Ministry of Health.  But it is taking much too long to establish the facilities in the various chosen institutions for them to start any meaningful work. Lack of specialization programs for these practitioners in the field as in India and other countries. There is therefore the need for collaboration in Ghana to transform the health system for instance, the Allopthic Medicine Practitioner by virtue of his/her training is in the best position to play a leading role in the team work for the development and practice of the herbal and complementary medicines in a holistic health care system in the advance world allopathic cancer centers.  In Ghana for instance the Centre in Mampong runs purely herbal medicine clinic.  Currently there is one medical practitioner in Ghana who have also specialized in herbal medicine and managing men with prostate disease using herbal medicine. National innovation policies typically focus on scientific and technological research and development. The future advancement and viabil8ity of Ghana’s herbal medicine sector, however, hinges on creating an operating environment that takes advantage of the informal nature of herbal medicine practice while continuing to encourage innovation and strengthen entrepreneurship for improved quality and efficacy of herbal medical product and practice.

 

 

 

 

  • Targeted Drug Delivery System

Session Introduction

Surangi Jayawardena

The University of Alabama in Huntsville, USA

Title: Targeted drug delivery -nanoantibiotics for targeted antibiotic delivery for bacteria
Speaker
Biography:

Abstract:

The work demonstrates the use of carbohydrate-conjugated nanomaterial (glyconanomaterial) to target bacterial pathogens. A collection of systematic studies done by several groups has demonstrated that bacteria can be specifically targeted using various oligosaccharides. Through our preliminary investigations we have discovered that oligosaccharide conjugated nanoparticles (glyconanoparticles) could be used to target strain specific bacteria. For example D-maltoheptaose (G7) and trehalose conjugated nanoparticle used to effectively target Escherichia coli and Mycobacterium spp. Antibiotic resistance in pathogenic bacterial strains is a growing global concern. We have demonstrated that these glyconanoparticles have been used as a carrier for antibiotics that would help target bacteria and reduce minimum inhibitory concentration of a conventional antibiotic. Antibiotic streptomycin (Str) is a broad range aminoglycoside typically used in the treatment of tuberculosis. We have bi-functionalized a nanoparticle using carbohydrate-G7 antibiotic-Str to produce glyconanoantibiotics (GNAs). As proof of concept for active targeting GNAs are used against a highly Str resistant E. coli strain. The GNAs demonstrated size dependent increased antibacterial efficacy few log folds improvement over the free the free antibiotic (Str).