International Conference and Expo on Parenterals & Injectables August 17-19, 2015 Chicago, USA

Ji-Geng Yan MD, PhD is an Associate Professor and Director of Research Laboratory and Reconstructive Surgery at Medical College of Wisconsin, USA.

After a nerve injury, calcium concentration in the intra-nerve fiber drastically increases. The purpose of our study was to test an implantable micro-osmotic pump to deliver medications to accelerate calcium absorption, thereby greatly improving nerve regeneration. Twenty-four SD rats were divided into four groups of six each: 1) Sham control: crush injury to sciatic nerve only; 2) Crush injury with a Nifedipine pump; 3) Crush injury with a Calcitonin pump; 4) Crush injury with a Saline pump. Each rat’s right sciatic nerve was crushed. The micro-osmotic pump was implanted in the neck, and the dripping tube was routed to the injured nerve. After four weeks of survival time, compound muscle action potential (CMAP), tetanic muscle force (TMF), myelinated nerve fiber area (NFA), nerve calcium concentration (NCC), and calcified spots (CS) were evaluated. The calcium absorption rate (CAR) was also determined. The order from highest to lowest recovery rate was Nifedipine> Calcitonin > Sham control > Saline. Differences among the groups were statistically significant (P < 0.001, ANOVA Test), and the difference between Nifedipine/Calcitonin and Saline/Sham control were all statistically significant (P< 0.001, t-test). The correlation rate of NCC with CMAP/TMF and with NFA/CS and CAR were calculated to be 0.99 (all P < 0.001, Pearson’s Correlation). We conclude from this study that nerve regeneration strongly correlated with calcium absorption; our new data has shown greatly improved nerve functional recovery, and this can potentially be translated into clinical applications.

Nesrine M Hegazi has completed her MSc in 2008 and PhD in 2014 from the Faculty of Pharmacy, Ain Shams University, in Egypt. She joined a research team in the National Research Center in Cairo, and has participated in various conjoint products with German Universities. She has participated in various international conferences and workshops and published in reputable journals in addition to being a reviewer in the Arabian Journal of Chemistry.

Phenolics and their glycosides have received during the last few decades, an increasing attention from chemists and pharmacologists. Previous comprehensive studies proved that plant phenols possess diverse effect on biological systems. The diversity of their structures is the basis of the recent increase in the detection of the various biological and pharmacological activities which have been extensively researched such as antitumor, antibacterial, enzyme inhibitory, anti-hepatotoxic, antioxidant, anti-allergic, anti-inflammatory, anti-osteoporotic, analgesic, antiviral and immunomodulating. These abilities make polyphenols interesting for the treatment of various diseases like inflammation or cancer, but also for anti-ageing purposes in cosmetic formulations, or for nutraceutical applications. Unfortunately, these compounds lack long-term stability as they are very sensitive to light and heat. Moreover, polyphenols often present a poor biodisponibility mainly due to low water solubility. Lastly, many of these molecules possess a very astringent and bitter taste, which limits their use in food or in oral medications. To circumvent these drawbacks, delivery systems have been developed, and among them, encapsulation would appear to be a promising approach. Therefore, the administration of phenolic compounds requires the formulation of a finished protecting product able to maintain the structural integrity of the polyphenol until the consumption or the administration, mask its taste, increase its water solubility and bioavailability, and convey it precisely towards a physiological target. Among the existing stabilization methods, encapsulation is an interesting means. The use of encapsulated polyphenols instead of free compounds was the source of numerous works.

Dorota Watrobska-Swietlikowska completed his Ph.D. at the age of 28 years from Medical University of Gdansk. She is the Scientist at Department of Pharmaceutical Technology of Medical University. She has published 4 papers wherein two of them are in reputed journals. She collaborated with hospitals for studying the physical stability of parenteral admixtures with high electrolyte concentrations.

Introduction: Lipid emulsions stabilized mainly withegg lecithin are used as drug carriers and as a one of components of parenteral admixtures. Size of oily droplets of submicron emulsion is about 300 nm. Two significant parameters in lipidemulsion preparation are particle size and particle size distribution. Intravenous administration of fat droplets with diameters larger than 5 µm has been reported to be associated with severe adverse effects, such as emboli in the lungs. Appropriate container is mainly factor which determine stable lipid emulsion. Contact PCV with lipid emulsion given parenteral is considered as extremely unsafe. Physicochemical properties of lipid parenteral emulsions with contact of non-PVC plastic containers such as ethylvinylacetate (EVA), polipropylene (PP), low density polyethylene (LDPE), polyethyene (PE) were examined (immersion test).

Mark J. Hayward has done his BS Chemistry, Physics, Mathematics, and Computer Science-Univ of West Georgia Ph.D Analytical Chemistry and Chemical Engineering-Purdue Univ Classically trained chromatographer and mass spectrometrist, practicing for 3 decades Built and managed significant analytical and bioanalytical labs at Wyeth, Novartis, and Lundbeck Currently working as a consultant to build new labs and address some the most challenging technical problem in the chemical, consumer products, clinical diagnostic and pharma industries Well known for giving back to the scientific community through collaboration, teaching, and engagement in the interactive dissemination of best practices within scientific societies and at scientific conferences

In our work in pharma, we use UV, ELSD, and/or MS detection for many tens of thousands of analyses per year, and frequently, all 3 of these detection approaches are used simultaneously with each chromatographic instrument. At the same time, we have great need to focus on the polar parts of the molecules to achieve sufficient separation Often reversed phase (RP) separations are insufficient when the polar part of the molecules is the focus. Normal phase (NP) LC can achieve sufficient separations, but tends to be slow, intolerant of high sample loading, and not readily interfaced to MS. In contrast, using CO2 as a solvent (SFC) is fast, green, facilitates much easier method development, and tolerates a greater range of sample load than NP-LC while generally delivering the same or better NP separation. While SFC has been long used with a variety of LC detectors, the performance of these detectors with SFC has generally been notably lower than commonly achieved with LC. This is particularly true for MS detection. Clearly, more progress is needed in adapting SFC to the more common LC detection approaches. This has led us to study the interfacing of each of these detectors to SFC individually and in combined set ups with split flows in order to achieve optimal separations (SFC) and detection (MS, ELSD, & UV) simultaneously. The outcome of the study for detector performance is that essentially identical detector performance can be achieved with SFC as is observed with RP-LC, even when using cold ESI-MS. These principles are explained and demonstrated for high sensitivity SFC bioanalysis using cold ESI-MS/MS detection as well as Open Access SFC/MS also incorporating UV and ELSD detection. Our findings are that SFC (w/ UV, ELSD, and/or MS) is not only applicable to polar and/or chiral compounds, but also a broad logP range of analytes where RP-LC is commonly used across many business needs. In this large middle range of compounds (>80% of analytes), SFC provides identical results to LC (except reverse elution order). Thus, it is feasible to shift LC analyses to SFC and achieve a green result: a 75% reduction in solvent waste. We have demonstrated this by shifting 1000s of RP-LC samples to SFC to meet timeline and capacity needs.

Ajit S Narang works for the Drug Product Science & Technology Department of Bristol-Myers Squibb, Co. (BMS) in New Brunswick, NJ. He is a Principal Scientist involved in the development of oral solid dosage forms of small molecule drugs and parenteral solution dosage forms of antibodies and antibody-drug conjugates. He also serves as Adjunct Faculty at the Universities of Tennessee and Phoenix; Industrial Advisory Board member of Western Michigan University; Editor of Pharmaceutical Journals; and a panel member of the Biopharmaceutics Technical Committee (BTC) of the Pharmaceutical Quality Research Institute (PQRI) in Arlington, VA. He earned his PhD from the University of Tennessee in Memphis. He has over 12 years of pharmaceutical industry experience working for BMS, Ranabxy, and Morton Grove Pharmaceuticals in different capacities and has contributed to several commercialized drug products. He has published over 40 peer reviewed articles; 2 books; 7 patent applications; 20 invited talks; 60 presentations at various scientific meetings.

Emerging data suggests that aggregation instability of a ready-to-use protein solution drug product may be linked to the shear forces experienced by the protein during downstream purification. Sustained conformational changes due to shear during processing may contribute to long-range hydrophobic protein-protein interactions in protein solutions. These interactions manifest in changes in the physicochemical properties of proteins including viscosity and hydrodynamic diameter, in addition to protein aggregation during accelerated stability testing. These observations provide an experimental framework to develop an early predictor of aggregation instability.

Mathilde Gosselin is the CEO and Founder of Materium bringing more than 15 years of experience in the industry working as manager, an engineer and a project manager. She has a Chemical Engineering degree and a Masters in Mechanical Engineering from Sherbrooke University, completed with IBM, focused on characterisation of Thermal Interface Material (TIM) used in microelectronics.

Historically, fermentation has been done in suspended growth and increased productivity was obtained via bioreactor operational parameters optimization, microbial strain selection and genetic engineering. Similarly, enzymatic reactor productivity was increased via reactor and enzyme optimization. One area that has been too often overlooked in both fermentation and enzymatic processes is the possibility to increase productivity via adsorption to a mobile media support. Materium Innovation has developed a hollow mesoporous silica microsphere (MATSPHERES Series) that can be used as both a microorganisms’ carrier and as an immobilization support for enzymes. MATSPHERES’ high specific surface area and surface chemistry are well suited for microorganism or enzyme adsorption. Results demonstrate that fermentation incubation time is reduced by several hours and productivity is increased up to 30%. Results also shows that immobilized enzymes activity is increased compared to free enzyme. Furthermore, immobilized enzymes are protected against pH and temperature changes. Finally, immobilization has an advantageous impact on process costs since it reduce microorganism’s washout and allow enzymes recycling.

Amit Bandyopadhyay has completed his PhD in the year 2004 from the University of Calcutta. He served as Assistant Professor of Physiology in the Institute of Dental Sciences, Bareilly, UP, India (September 2003 to June 2006) and School of Health Sciences, Universiti Sains Malaysia (June 2006 – June 2009). Currently he is an Assistant Professor of Physiology at University of Calcutta since 30th June 2009. His field of Research Interest is Sports and Exercise Physiology and published 71 papers (including 7 Review Articles) in reputed journals. He is also editorial Board Member in the Journals of National and International repute.

Dietary supplements are used by athletes not only to avoid Doping but also to improve athletic performance. Chronic supplementation of caffeine and Panax ginseng (PG) improves sports performance. The present study was aimed to evaluate the effects of acute supplementation caffeine and PG on endurance running performance in young male university students. Nineteen recreational male runners who were nonusers of caffeine and PG were recruited in this placebo-controlled double-blind randomized study. Caffeine (5mg-1.kg-1 body weight), PG (200mg) or placebo was supplemented in encapsulated form one hour prior to the treadmill running exercise trial at 70% of VO2max. Oxygen uptake was determined every 20min while heart rate, body and skin temperatures, and ratings of perceived exertion (RPE) were recorded every 10min during the trials. Blood samples were drawn every 20min for the analysis of glucose, lactate, insulin and free fatty acids. Analysis of data by ANOVA indicated that endurance time was significantly (P<0.05) higher in the caffeine trial whereas cardiorespiratory parameters, skin and core body temperature, blood parameters and RPE did not show any significant variation among the trials. Even the combined supplementation of caffeine and PG did not influence the parameters measured in the study. Study showed that ingestion of 5mg of caffeine per kg of body weight improved the endurance running performance but did not impose any significant effect on other studied parameters. Supplementation of PG or combined supplementation of caffeine and PG did not influence the endurance performance.

Prof. Bhambere Deepak Sunil has completed his PhD at the age of 30 years from Jaipur National University and. He is the Assistant professor of Pharmaceutics at MET’s Institute of pharmacy, a premier pharmacy institute in India. He has enormous experience in Targeted drug delivery system. He has published number of papers in reputed journals and attended national and international conferences. He had visited Malaysia for poster competition at Kuala Lampur and he will present poster at Internal national conference at Philadelphia, USA in April 2015.

Migraine is a common, chronic, incapacitating neurovascular disorder, characterized by attacks of severe headache, autonomic nervous system dysfunction, and in some patients, an aura involving neurologic symptoms. Migraine is characterized by episodes of head pain that is often throbbing and frequently unilateral and may be severe. Studies on anti-migraine drugs showed that vasoconstriction from 5-HT, ergotamine and noradrenaline could reduce migraine attacks. Triptans are specific and selective agonists for the 5-HT1 receptors. Rizatriptan is a triptan that is rapidly absorbed and highly bioavailable with proven efficacy for treating migraine with rapid onset of effect after oral administration. Drugs that are easily absorbed from the stomach and have a short half-life are eliminated quickly from the blood circulation, require frequent dosing. To avoid this problem, the oral gastroretentive formulations have been developed in an attempt to release the drug slowly into the gastric region. By considering above need an attempt was made to prepare mucoadhesive microspheres containing Rizatriptan benzoate using 23 full factorial designs.

Mr. Ankitkumar Soni has completed his Diploma in Pharmacy from Gujarat University, Bachelor of Pharmacy and Master of Pharmacy (Pharmaceutics) from Gujarat Technological University. He has also completed certificate cource of Community Medical Service (CMC) and Essential Drugs for Primary Health Care of WHO from Indian Rural Medical Association, Bikaner Rajasthan. He is currently working as an Assistant Professor at Anand Pharmacy College, Anand, Gujarat, India.

The focus of this study was to develop and optimize in-situ injectable implant of Lornoxicam for long term treatment of arthritis and musculoskeletal inflammatory disorders, prepared with using different concentrations and ratios of PLGA. Drug-excipients interaction was characterized by DSC and FTIR. The different biocompatible solvents benzyl alcohol, poly ethylene glycol 400 and dimethyl sulfoxide were used in the formulation which were easily miscible in water and formed implant rapidly. The formulation was prepared by polymer precipitation method. The formulations were evaluated for drug entrapment efficiency, cumulative percentage drug release, surface morphology, rheological behaviour. The formulation was characterized by Scanning Electron Microscopy (SEM) showed crosslinking of polymer with uniform implant formation and porous surface by their degradation at different time intervals. The formulation with 35% PLGA 50:50 concentrations exhibited minimum burst release of drug and sustained the release of drug till 5 days by increase in the polymer concentration. Clarity and pH were found in acceptable range. Release kinetics revealed that all formulations followed zero order kinetic. The optimized formulation was subjected to in-vivo gelling study and pharmacokinetic study using Sprague-Dawley rats, and it persisted till 7 days without any tissue damage also Cmax, Tmax, AUC and t1/2 were significantly higher than marketed I.M injection. Clinical efficacy of prepared formulation was assessed by determining statistical analysis. Stability study of optimized formulation was performed at 25 ± 20C / 60 ± 5 % RH and40 ± 10 C and 75% RH showed no change in physical and chemical characteristics.

Dr. Muhammad Ali A. shah completed his PhD from Nanjing Agricultural University, China in 2009 with specialization in field of DNA vaccines. He has completed his Post Doctorate with distinction from Biomedical Engineering at School of Biological Sciences & Medical Engineering, Southeast University, China. During the Post Doctorate studies he had an opportunity to work with legend like Prof He Nongye. He worked on different possibilities of application of nanoparticles with drug delivery. There are almost 40 publications at his credit, which have been cited in 3, 00 plus publications by other research groups throughout the world. He has co-authored a couple of books as well and Editor of a couple of journals from the The Science Publishers. He is the recipient of 6 international R & D grants funded from Higher Education Commission, China Science Foundations, and Jiangsu Science Fund etc. He has 16 years of Research and teaching experience. Currently he is working as Chairman, Department of Pathobiology in Arid Agriculture University. His current research interests include immuno-therapeutics especially DNA vaccination and Nano vaccines against Infectious agents and their delivery.

Hepatitis C Virus (HCV) infects approximately 3% of world’s population and more than 50% of people are at high risk. . Even after 25 years of its discovery, no specific treatment or vaccination is available. Moreover, current diagnostic tests are not efficient enough to be used proficiently. Considering to mutational properties HCV have number of quasispecies that must be addressed for effective dealing. Moreover these genomic level changes may impede conventional diagnostic method results. There is need for an orderly, sensitive, cost effective and quick method for screening of HCV. Fortunately, diverse, innovative and charismatic nanotechnology field provides an opportunity to develop such ideal diagnostic tools. Magnetic nanoparticles (MNP) are one of the cheapest and promising nanotechnology tools that have the potential to detect and isolate HCV. Their functional methodology is based on the attachment of virus or its constituent to the ligand conjugated with MNP. When MNP are attracted in a magnetic field, the whole complex can be isolated. The present exploration summarize the internal structure of HCV virus, available nanotechnologies for detection of different viruses with special reference to magnetic nanoparticles role in HCV detection.

She received her degree (M Sc Pharm) from Gazi University, Faculty of Pharmacy, Pharmaceutical Technology Dept (Ankara, TURKEY). Presently she has been conducting PhD studies at the same university and department. From 2007-2010 she worked as Project Manager in R&D at Drogsan Pharmaceuticals (Ankara,TURKEY) with main focus on generic drugs, new combinations as parenteral, oral solid and topical semisolid dosage forms. Presently she owns the position of R&D Specialist of Sanovel Pharmaceuticals with main focuses on statistical formulation development, QbD, PAT, DoE, SPC and Computer simulations. She has numerous patents and presentations at Turkey and international areas on QbD.

From the current reported numbers, FDA warning letters and drug recalls show a big increase in year, and sterile dosage forms are covering more than half of all the dosage forms, relate to manufacturing and quality issues. On the other hand, due to patent expirations on generic manufacturing, it is estimated that parenteral dosage forms will be the blockbuster drugs in ten years. Thus pharmaceutical industry need to change marketing approaches from volume to value. With Quality by Design (QbD) approach to drug development could increase efficiencies, decrease quality related failures and shortages, provide regulatory relief and flexibility, and offer important business benefits throughout the product’s life cycle. QbD is a systematic approach to development, which begins with predefined objectives and emphasizes product and process understanding and process control based on sound science and quality risk management. The holistic approach to QbD starts with the definition of a quality target product profile (QTPP) and Critical quality attributes (CQAs). Risk assessment is the next step and should be performed at each step of the implementation pathway. The next step involves development of design space and setting control strategy for product quality lifecycle management, which means management of all phases in the life of a product from the initial development through marketing until the product’s discontinuation. PAT is one of the other important tool of QbD for control strategy development at manufacturing area, which allows real time release. Therefore, quality is generated during process development rather than established in the end product.

Hartzel BIO – Bill Hartzel is the Director of Strategic Execution at Catalent Pharma Solutions, a global leader in development solutions and advanced drug delivery technologies. In this role he is responsible for the implementation of a full suite of advanced aseptic processing solutions for biologic and complex pharmaceutical liquid products. Bill provides a strong background in advanced aseptic processing in blow/fill/seal and plastics in which he has numerous publications and presentations on the topics. Additionally, Bill has been a leader in the single use “disposables” industry since 2006 for his background in materials of construction. Bill is on the Board of Directors for BPSA, a technical author for PDA –TR 66 on Single Use Manufacturing, and the former Chairman of the ASME BPE Task Group for Single Use. Bill has an undergraduate degree in Chemical Engineering and an MBA from Villanova University.

This presentation will focus on the use of the advanced aseptic filling techniques utilized in blow/fill/seal technology to create a glass free injectables platform for biologics. It will provide details on how the principles of QbD are leveraged in the equipment and process design to dramatically reduce the risk profile and particulate contamination in parenteral filling through control and automation. In addition, the presentation will provide a case study of a model mAb and its compatibility with the BFS vial compared to glass.

Dr. Lee is a Research Scientist in Baxter’s Drug Development group and is involved in early-stage formulation development for new injectable products, including developing formulations for large molecules, with a focus on the particular requirements of biologic therapeutics. She has expertise in analytical biochemistry, where she has driven impurity identification and quantification efforts for complex biomolecular therapeutics. Dr. Lee earned her Ph.D. in organic chemistry from the University of Wisconsin-Madison in 2006 and has authored several publications and patents.

As Biologics continue to evolve, the delivery platform/method plays an increasingly critical role. In parallel, clinical guidelines are also calling for increased safety and simplicity in medication delivery. Due to complexity related to heat-intolerance, Biologics requiring intravenous dosing are typically reconstituted just prior to use. Aseptic-filling is a method which does not involve the use of heat for sterilization, and is a proven sterilization approach for commercial-scale filling of Biologics and other heat-sensitive molecules. Baxter’s R&D scientists have performed stability, oxidation and agitation studies including the evaluation of aggregation and bioactivity for two monoclonal antibodies and a therapeutic protein (hormone). Data will be presented that demonstrates compatibility of Biologics in an aseptically-filled, flexible IV container using Baxter’s proprietary process/technology. This process/technology in flexible IV container presentation for Biologics and other heat-sensitive molecules is exclusive to Baxter. The presentation is intended to demonstrate the science behind delivering Biologics with a difference.

Least developed countries in general and Pakistan in particular has a massive population of almost 20 millions. For the last ten years plus it's largely affected by the activities of extremists and shift of inhabitants from affected areas. Moreover 70 present population is serving with low nutrition diet. This segment of the population has high child birth rate minimum 4-5 children per family. Low nutrition value not only affected the mother but also the born children. The one having wealth have 1-2 childern and have healthy nutrition. Because of economic policies, country health care implementation plan there are likely chances that country will lead to massive health disaster side because of low nation diet getting by major sector of the population. Currant rate of population increase vis-a vis-a nutrition and health care support available to them is not comparable to developed countries.
Aim of this work is to present a complete program level Nutrion Improvement methodology and implementation plan in order to save the mother and child suffering from low NETRUTION and save this country from Health Disaster. This will not only support deprived segments of the country but also help them to engage in productive work so that they can support themself economically and participate in improving family diet.

Parkinson’s disease is a common neurodegenerative disorder of the central nervous system. It is characterized by the loss of dopamine-generating neurons in the substantia nigra and corpus striatum (which leads to the decreasing level of dopamine) and accumulation of α-synuclein aggregates in the brain. Presently, commercial drugs in market altogether do not provide complete treatment for neuronal degradation however only treats the disease in a symptomatic way. Dopamine transporter (DAT) plays an important role in the termination of neurotransmission by rapid reuptake of dopamine (DA) from the synaptic cleft into presynaptic terminals where it will be degraded by monoamino oxidase. With the blockade of DAT, level of dopamine in synaptic cleft as well as dopaminergic neurotransmission will increase. We have modelled the human DAT based on a drosophila’s DAT X-ray crystal structure, and minimized it in the environment of the lipid bilayer and solvent water. The transporter was validated with known inhibitors downloaded from CHEMbl database, in Auto Dock 4.2. and GOLD 5 docking software. The obtained results correlated positively with the existing experimental results. The binding free energy for DA, according to preexistent experiments, is ΔGexperimental = -7,4 kcal/mol; while ΔGcalculated = -6,4 kcal/mol was obtained through our studies. The binding position of DA, also, coincides with previous literatures: interaction with Phe320, Asp79, Ser149, Ser422, and Thr156 amino acids. Thus, with the results collected, a new model was designed for potential inhibitors approached through De Novo and fragment based drug design. Novel selective DAT inhibitors, when alone or in combination with levodopa, may improve the quality of life in patients suffering from Parkinson’s disease.