Middleeast Pharmacy and Pharmaceutical conference September 24-25, 2018 Abu Dhabi, UAE

Dimitrios A Lamprou is professor in pharmaceutical engineering and MSc Director at the School of Pharmacy in Queen's University Belfast, UK; a member of the prestigious Russell Group and Visiting Professor at University of Strathclyde, Glasgow, UK with experience of teaching in higher education, conducting research (60+ publications, 200+ conference abstracts, 55+ invited presentations). His group research interests focused on five distinct areas: Biosurface engineering, electrospinning, microfluidics, nanoanalysis, and printing of medicines.

This seminar will cover the challenges and opportunities in pharmaceutics by adopting new formulation technologies to bring new products into the market. Thermal and electrohydrodynamic processes including Fused Deposition Modeling (FDM) 3D printing and electrospinning are an example of technologies that have been widely used in other industries, however are new to pharmaceutical manufacturing. Therefore, the use of these techniques in drug delivery and tissue engineering applications, including the use of state-of-the-art techniques (e.g. FastScanAFM, ToFSIMS, nanoCT) will discussed in this seminar. The first part will focus on the preparation of drug-loaded polymeric electrospun nanofibers. The purpose of this study is to examine any potential effects, chemical and mechanically, of drug loaded electrospun nanofiber scaffolds. Biodegradable polyesters that commonly used in biomedical applications for controlled release and targeted drug delivery was loaded and electrospun with different types of drugs. The electrospun fibers were characterized through various methods in order to measure the drug efficacy, antibacterial properties and drug-polymer interactions. There are a number of different applications within medicine that require materials to be developed with the optimal characteristics, such as their strength, rate of degradation and porosity, as well as their shapes and sizes. 3D printing process was patented in 1986, however only recently have been utilized in the field of pharmaceutical printing. Therefore, in the second part, 3D printed systems (e.g. microneedles, rings, tablets) of various designs with high drug payloads that have be formulated using advanced additive technologies and characterized using advanced characterization techniques will be discussed.

Dighe Santosh B has completed his PhD from Jawaharlal Nehru Technological University, Hyderabad. He is currently working as the Head, Department of Pharmacology and IAEC In-Charge in Pravara Rural College of Pharmacy, India. He has published more than 30 papers in reputed journals. He is also serving in the field of animal welfare division as a CPCSEA Nominee, Ministry of Environment and Forest, Government of India, New Delhi from last 04 years.

Oxalis corniculata Linn. (Family: Oxalidaceae) is a medicinal plant which is used traditionally to cure various diseases in India. The present investigation was undertaken to evaluate the effect of Oxalis corniculata extracts on pentobarbital-induced sleeping time in carbon tetrachloride-induced hepatotoxicity in male Wistar rats. The petroleum ether (PEOC), chloroform (CFOC), ethyl acetate (EAOC), methanol (MEOC) extracts were prepared and evaluated at doses of 100, 200 and 400 mg/kg for effect on pentobarbital-induced sleeping time in hepatotoxic rats. Silymarin (100 mg/kg) was used as reference standard drug. Group-I was normal control and received feed and drinking water ad libitum throughout the experimental period. Group-II served as a hepatotoxic control and received carbon tetrachloride treatment. Group-III was reference standard drug treated group and received silymarin (100 mg/kg). The rats of Group-IV to XV were extracted treated groups and received PEOC, CFOC, EAOC and MEOC at a dose of 100, 200 and 400 mg/kg. Standard drug and plant extracts were given once daily for six days. On the sixth day, all the animals were challenged with sodium pentobarbital (50 mg/kg, IP) 30 minutes after extract and carbon tetrachloride administration. Sleeping time in the different groups of animals was recorded as the time between the loss and gain of the righting reflex. The carbon tetrachloride-induced liver injury was delaying the metabolism of barbiturates, thereby, slowing their excretion rate and leading to an increase in the duration of barbiturate-induced hypnosis, from 145±14 min in normal control to 229 ±38 min in carbon tetrachloride-induced hepatotoxicity group. Treatment of animals with EAOC and MEOC stimulated the effect of carbon tetrachloride and shortened the sleeping time close to the normal control.

Said Abdel Karim is currently working as a Clinical Staff Lead Pharmacist with more than 8 years of experience as hospital Pharmacist. He has worked as a teaching aids at Al Ahram Canadian University, Egypt and drug control specialist in antibiotics department at NODCAR (The National Organization for Drug Control & Research). He is a certified American Board Pharmacotherapy Specialist (BCPS). He has completed his MSc in Clinical Pharmacy and MBA from Torrens University, Abu Dhabi.

Proton pump inhibitors (PPIs) are one of the most commonly prescribed medications. They are efficacious and useful in the management of a variety of conditions including Gastro Esophageal Reflux Disease (GERD), reflux esophagitis and Helicobacter pylori-associated peptic ulcer disease. Previous studies have demonstrated an association between chronic proton pump inhibitor (PPI) utilization and adverse events such as fractures, infections, hypomagnesaemia and vitamin B12 deficiency. Because patients taking PPIs for an extended period of time are more susceptible to these adverse events, an approach to tapering patients off PPIs is clinically warranted. This project contributes to existing knowledge by showing that the inclusion of clinical pharmacists to identify eligible candidates and recommend a PPI taper yields, a reduction in PPI use and medication cost savings in primary care.

Ripal Gharia has completed her MD in Pharmacology from Bhavnagar University in India. She is currently working as an assistant general manager, pharmacovigilance and medical Services at Cliantha Research Limited. She has experience in medical writing, regulatory affairs, pharmacovigilance and

clinical trial management.

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems. Conventionally, it involves reporting individual cases or aggregate reports. Within the last decade, there has been a growing awareness that the scope of pharmacovigilance should be extended beyond the strict confines of detecting new signals of safety concerns. It involves ongoing processes to monitor an always evolving benefit/risk profile, with a well-established safety governance model across the enterprise and a solid underlying process for signal detection and management. There is an inherent challenge in bringing pharmacovigilance expertise development phase into the medicinal products for the first time; the weight of the established practices has resulted in a dichotomy between safety management in the pre-marketing and in the post-marketing phase, with many negative impacts. Many companies still refer to drug safety for pre-marketing activities and pharmacovigilance for post-marketing activities, while the essence is same. Pharmacovigilance contributions are essential for the development or the review of key study documents and processes such as protocol, investigator’s brochure, safety management plan, core development safety label, DSUR/IND reports, safety signaling plan, etc. As per USFDA resources, from 2001 through 2010, the FDA approved 222 novel therapeutics (183 pharmaceuticals and 39 biologics). There were 123 new post-market safety events (3 withdrawals, 61 boxed warnings and 59 safety communications) during a median follow-up period of 11.7 years (Interquartile Range [IQR], 8.7-13.8 years), affecting 71 (32.0%) of the novel therapeutics. To reduce this, improvized strategies to collect safety data in premarketing stage is required for effective risk management post approval. Bringing the PV team early into the development phase team will create a critical continuum of safety expertise on the company’s product, with positive impacts during its whole lifecycle and enhance the regulatory compliance.

Sudhir Kumar Sharma has completed his Masters in Physics and MTech in Materials from Department of Physics, Barkatullah University Bhopal, India. He has completed his PhD from the Indian Institute of Science Bangalore, India. He as a Postdoctratral Fellow attended Centre for Nano Science and Engineering (CeNSE), IISc. Bangalore, India. He has worked as a research associate at New York University Abu Dhabi, UAE and is currently working as a research scientist.He has more than 90 international journals and conferences publications.

One of the major unsolved problems in pharmaceutical drug development is the poor water solubility of many active pharmaceutical ingredients (APIs) and hence reduced bioavailability. Researchers have attempted to minimize the

problem by reducing the drug particle size. While, many of these platforms bring unique advantages to the field of drug delivery, an ideal solution would be to remove the problem of solubility entirely, by reducing the API size to clusters of a few molecules, bound by weak, Van der Waal’s forces that would readily dissociate into molecules, during enteral or parenteral drug delivery process. In order to have commercial impact, such molecular clusters should also be produced in sufficiently high yield. We have precipitated molecular clusters of two drug molecules, ibuprofen and naproxen, respectively, via supersonic jet expansion of the supercritical CO2 drug formulation into a collection vessel cooled to liquid N2 temperatures and capturing the clusters instantaneously in dry ice with up to 80% yield. Gradual dissolution of the dry ice in water, at room temperature, resulted in the true solubilization of these clusters. Drop casting and ambient drying of the solution on a substrate (e.g. silicon) resulted in a stable, viscous liquid film, which we refer to as a nanostructured molecular liquid. This is a significant observation, considering the fact that, normally, ibuprofen and naproxen are solid powder at room temperature and pressure, with melting points of 76 ºC and 154 ºC, respectively. In vitro cancer cell viability studies of water-solubilized ibuprofen and naproxen exhibit similar cytotoxicity to that of the original raw materials, thus retaining their potency. Besides its scientific importance, this invention is expected to open up new drug delivery platforms.

Lara Tutunji has completed her Bachelors in Pharmacy from the University of Jordan. She has completed her PhD from Temple University, USA. She has worked as an Assistant Professor at the Faculty of Pharmacy, University of Jordan between December 2005 and December 2017. She is currently working as an Assistant Professor at the Faculty of Pharmacy and Medical Sciences at Al-Ahliyya Amman University in Salt, Jordan. Her research interests include bioequivalence testing and evaluation of different drug delivery systems.

The objective of the current investigation was to evaluate the release of metformin from extended-release hydrophilic tablets and to assess their swelling, textural and erosional behavior. Drug release from the matrix tablets was assessed using USP 26 apparatus II (paddle) modified with the insertion of mesh. The swelling and erosion behavior was investigated by textural analysis of the swollen tablets using a TA.XT2i texture analyzer. The release of metformin was pH-independent with a burst effect observed during the first two hours of the release. The rapid increase in swelling initially may be responsible for the burst effect in drug release. In HCl/KCl buffer, the drug release followed non-Fickian (anomalous) release, while it followed Fickian (Case I) diffusion in phosphate buffer. The drug release was diffusion controlled rather than first-order kinetics. The rate of water uptake followed an anomalous or complex behavior. Increased swelling and water uptake increased the drug release, while decreased work of penetration through the polymeric matrix decreased the drug release. Erosion was also one of the mechanisms that occurred in HPMC-matrix tablets. It is interesting to note that swelling and water uptake played a more important role than erosion during drug release.

Fawzy Elbarbry has completed his PhD and Postdoctoral studies from University of Saskatchewan, Canada. He is the Director of Student Success at Pacific University, a premier institution in the Pacific Northwest of USA and a Clinical Pharmacist at Legacy Health System. He has published more than 50 papers in reputed journals and has been serving as an Editorial Board Member of several journals with high reputation.

Approximately 29% of US population were treated for hypertension with only 52% of them have their blood pressure under control. The direct health care spending to treat hypertension is approximately $46 billion, with almost half ($22.9 billion) in the form of prescription drugs. Thirty six percent (36%) of people in USA and Canada regularly use Complementary and Alternative Medicine (CAM) for the prevention and treatment of different diseases, including hypertension. Generally, majority of the hypertensive patients do not disclose the use of such remedies and also health care providers do not usually ask their hypertensive patients if they use CAM. The widespread consumption of CAM in hypertension requires clear understanding of their underlying mechanism of action, efficacy and safety. This chapter will provide a comprehensive list of CAM commonly used by Americans for the prevention and treatment of hypertension as well as their postulated mechanism of action. Modulation of drug metabolizing enzymes and their safety will also be covered

along with the clinical consequences, i.e., drug-herb or herb-disease interactions. While the information included in this chapter will show that simple dietary constituents have potential impact on human health and significantly reduce the cost in health care, patients and healthcare providers should also be careful with using CAM therapies, because not only is there minimal evidence that several CAM products work to treat hypertension, but their safety hasn't been well-established.

Fawzy Elbarbry has completed his PhD and Postdoctoral studies from University of Saskatchewan, Canada. He is the Director of Student Success at Pacific University, a premier institution in the Pacific Northwest of USA and a Clinical Pharmacist at Legacy Health System. He has published more than 50 papers in reputed journals and has been serving as an Editorial Board Member of several journals with high reputation.

Approximately 29% of US population were treated for hypertension with only 52% of them have their blood pressure under control. The direct health care spending to treat hypertension is approximately $46 billion, with almost half ($22.9 billion) in the form of prescription drugs. Thirty six percent (36%) of people in USA and Canada regularly use Complementary and Alternative Medicine (CAM) for the prevention and treatment of different diseases, including hypertension. Generally, majority of the hypertensive patients do not disclose the use of such remedies and also health care providers do not usually ask their hypertensive patients if they use CAM. The widespread consumption of CAM in hypertension requires clear understanding of their underlying mechanism of action, efficacy and safety. This chapter will provide a comprehensive list of CAM commonly used by Americans for the prevention and treatment of hypertension as well as their postulated mechanism of action. Modulation of drug metabolizing enzymes and their safety will also be covered

along with the clinical consequences, i.e., drug-herb or herb-disease interactions. While the information included in this chapter will show that simple dietary constituents have potential impact on human health and significantly reduce the cost in health care, patients and healthcare providers should also be careful with using CAM therapies, because not only is there minimal evidence that several CAM products work to treat hypertension, but their safety hasn't been well-established.

Dimitrios A Lamprou is professor in pharmaceutical engineering and MSc Director at the School of Pharmacy in Queen's University Belfast, UK; a member of the prestigious Russell Group and Visiting Professor at University of Strathclyde, Glasgow, UK with experience of teaching in higher education, conducting research (60+ publications, 200+ conference abstracts, 55+ invited presentations). His group research interests focused on five distinct areas: Biosurface engineering, electrospinning, microfluidics, nanoanalysis, and printing of medicines.

Progress in drug design has led to the development of new peptides, proteins and drug molecules. However, the limited ability to selectively deliver these molecules at well-defined dosing regimens and without invoking drug-resistance remains a significant challenge. Microfluidic devices provide many advantages for applications in drug delivery and crystallization; they require small sample volumes, provide high-throughput screening and allow control of the crystallization. Microfluidics is a multidisciplinary field of science based on the manipulation of fluids in submillimeter dimensions and the conditions that microfluidics offer are completely different from those of bulk set-ups. Other advantages include more thoughtful use of sample and reagent resources, the opportunity to carry out separations and detections with higher resolution and sensitivity, lower cost of the whole procedure, quicker analysis and small footprints for the analytical devices. The first part of the presentation

will focus in the formulation of liposomes that have been the centre of attention in research due to their potential to act as drug delivery systems. Although its versatility and manufacturing processes are still not scalable and reproducible. Therefore, the microfluidic method for liposomes preparation will be presented and the results from this preparation process will be compared with traditional methods (e.g. film hydration method and extrusion) in order to understand benefits and drawbacks of microfluidics. The second part will focus on other systems such as polymeric nanoparticles and also studies on continuous

microfluidic devices for crystallization.

Nanomedicine is a promising candidate for passive and targeted drug delivery. Doxil (Doxorubicin loaded stealth liposomes) and abraxane (human serum albumin nanoparticles conjugating paclitaxel) are commercially viable examples of nanomedicine. Despite favorable therapeutic applications as well as pharmacokinetic and pharmacodynamic attributes, fate of nanomedicine and its safety still need to be addressed. Certain factors such as route of administration, aggregation behavior and deposition of nanomedicine in body cavities should be considered for a successful treatment approach. Owing to absence of adequate data, multidisciplinary qualitative and quantitative tests should be incorporated to understand toxicity of nanomedicines. In this context, certain biomaterials have been approved by USFDA for engineering the next generation of medicines. Therefore, in present investigation, we have enlisted the toxicity and safety issues of nanomedicines. Moreover, attention has also been paid to various tests that can be employed for the assessment of next generation medicines. For collecting the data on safety and toxicity of nanomedicines, popular research websites like Science Direct and PubMed Central were used. In addition, various regulatory websites like USFDA were also explored for collecting the data on standards for nanomedicines. The outcome of literature survey indicated the presence of gaps between existing knowledge and specific areas which should be addressed in making the framework for the assessment of safety and toxicity of nanomedicines. A standard and stringent set of parameters should be framed for vigorously testing the safety and toxicity of nanomedicines.