21^st Annual European Pharma Congress May 20-22, 2019 Mövenpick Hotel Zürich Regensdorf, Switzerland

Biography:

Judith Miklossy has received her MD, PhD degrees and Board certificates in neurology FRCP(H), then in psychiatry and psychotherapy with EU and AELE conform certificates, from the Faculty of Medicine of the University of Debrecen, and the National Board of specialization in Hungary. She has received the university degrees of Privatdozent (DSc, assistant professor) and Master of Education and Research (MER) and Board certification in Neuropathology FRCP(CH) at the University of Lausanne and the Swiss Medical Federation (FMH) in Switzerland. She was head of the Neurodegeneration research group at the University Institute of Pathology (CHUV, Lausanne), Switzerland, for over ten years. She has done molecular biology research and participated in the introduction of Alzheimer’s research in Temple University, Philadelphia, USA. She headed the neuropathology division of Kinsmen Laboratory of Neurological Research, in The University of British Columbia, Vancouver, Canada. She is actively involved in research on Alzheimer's disease, other neurodegenerative diseases and Lyme disease for more than 25 years. Presently she is director of the Prevention Alzheimer International Foundation and International Alzheimer Research Center in Switzerland. Her presentations on international meetings and her publications were repeatedly considered for CME and press releases.

Abstract:

Strong epidemiologic evidence and common molecular mechanisms support an association between Alzheimer’s disease (AD), type 2‐diabetes and several other chronic inflammatory disoders. Local inflammation and amyloidosis occur in both diseases and are associated with periodontitis and various infectious agents. Here we discuss accumulated evidence for the presence of local inflammation and bacteria in Alzheimer’s disease and type 2 diabetes and discuss host pathogen interactions in chronic inflammatory disorders. Spirochetes, Chlamydophyla pneumoniae and Helicobacter pylori are demonstrated in association with dementia and brain lesions in AD and islet lesions in type 2 diabetes. The presence of pathogens in host tissues activates immune responses through Toll‐like receptor signaling pathways. Evasion of pathogens from complement‐mediated attack results in persistent infection, inflammation and amyloidosis. Amyloid beta and the pancreatic amyloid called amylin bind to lipid bilayers and produce Ca(2+) influx and bacteriolysis. Similarly to AD, accumulation of amylin deposits in type 2 diabetes may result from an innate immune response to chronic bacterial infection, which are known to be associated with amyloidosis. Further research based on an infectious origin of both AD and type 2 diabetes will lead to novel treatment strategies.

Biography:

Fenghua Xu got her Ph.D. degree in Pharmaceutics in Peking University Health Science Center. She has her expertise in anti-cancer drug development and novel drug delivery system. She dedicate herself to develop therapeutic drugs with low adverse effect and easygoing administration method to relieve the patients and provide them better care. Her study involves natural entities, nanoscale and self-regulated drug delivery system. She has finished the preclinical studies of several new drug and hospital preparations for cancer treatment, four of which have got approval for clinical trial. She also practices in the manufacture and quality control of drug preparations and has set up a series of product quality standard.

Abstract:

Objective:  To evaluate the efficacy and safety of compound aluminum sulfate injection (CASI) in the treatment of non-muscle invasive bladder cancer(NMIBC) in patients. Methods:  A multi-center, open and non-controlled phase I/II clinical trial was designed. We enrolled 101 patients (age ≥18 years) with NMIBC at three clinical trial centers. CASI was directly injected into the root of NMIBC through catheter needle. Injection dose was determined by tumor size: <1cm: 2-6ml; 1-2cm: 4-8ml; 2-3cm: 6-10ml; >3cm: 8-16ml. Therapeutic effects was evaluated by effective rate (patients with complete tumor necrosis or tumor necrosis > 2/3) / all patients × 100%). Electrocardiogram, blood routine, urine routine and blood biochemistry examination were performed for safety evaluation. All data were input by EPI DATA 3.0 and analyzed by SASÒ 9.13. Results:  Eight of the 101 patients were detected blood aluminum concentration to evaluate the absorbance of aluminum sulfate after local administration. Only two patients in the middle dosage group showed significant elevation of aluminum concentration after injection, which decreased to the concentration around baseline within 24 hours. The rich blood supplement of the injection site might explain the aluminum absorption. The overall effective rate was 97.03% (98/101 patients), including 93.07% tumor necrosis completely (94/101 patients). Treatment-related adverse events (AE) occurred in 20 patients (19.80%). Nine patients (8.91%) experienced AE related to drug administration, including local pain, abdominal pain and anal irritation in. Other AE were related to urethral injury caused by cystoscopy. All AE were endurable and disappeared within 2-3 days without any treatment. The maximum tolerated single dose of CASI was 21ml. Conclusion:  As a convenient and compliant regimen, CASI had good efficacy and safety in the treatment of NMIBC. Key Words:  Compound aluminum sulfate injection, non-muscle invasive bladder cancer, efficacy, adverse effect, clinical trial

Biography:

Shinya Uchida received his PhD degree from University of Shizuoka in 1999. Dr. Uchida served as a clinical pharmacist at University Hospital of Hamamatsu School of Medicine. He is associate professor at University of Shizuoka and his major interests include clinical pharmaceutical science, clinical pharmacology and pharmacokinetics. He has published more than 50 papers in reputed journals.

Abstract:

Among the various types of drug formulations available, such as tablets, capsules, and granules, tablets are the most widely used because of ease of handling, as well as convenience for carrying and storage. However, many patients have noted difficulties with swallowing tablets with a large diameter. Mini-tablets with a diameter ≤4 mm have been widely studied and developed, and are considered to be easier to swallow as compared to conventional tablets. Decreased tablet diameter may improve patient adherence to medication and reduce the risk of aspiration of tablets. On the other hand, as tablet diameter is reduced, patients have more difficulties with picking them up and handling. Thus, in regard to tablet diameter, ease of swallowing is countered by more difficulties with handling, both of which can have effects on prescription adherence. In this study, we evaluated the ease of taking and handling on placebo tablets of 2–8 mm in diameter with the aim of clarifying the acceptable tablet diameter for patients. We manufactured tablets with 7 different sizes (2, 3, 4, 5, 6, 7, 8 mm). The study protocol was approved by the Ethics Committee of the University of Shizuoka. We conducted two clinical randomized crossover trials (swallowing trial and handling trial). To evaluate ease of swallowing (swallowing trial), 17 healthy young volunteers were asked to use the minimum volume of water required to smoothly consume each tablet, and to evaluate ease of swallowing using a visual analogue scale (VAS). In handling trial, 25 elderly patients participated. Each patient was asked to pick up 10 tablets from a dish and place them in a medication cup 30 cm distant from the dish, one by one. After finishing, they were asked to evaluate the ease of handling the tablets using a VAS. For the swallowing trial, VAS scores for ease of swallowing were also decreased for tablets 5 mm as compared to those 8 mm in diameter. For tablets <5 mm in diameter, VAS scores were nearly the same. As for the handling trial, the time required for the elderly patients to transfer all tablets was reduced from 32.8–22.2 seconds when the diameter of the tablets was from 2–4 mm. With tablets >5 mm, the time for handling was nearly the same regardless of size. VAS results for handling tablets was similar to the evaluation of handling time. The present results indicate that tablets <5 mm in diameter are easy to swallow, while those >5 mm offer good handling. Thus, a 5-mm tablet seems to adequately fulfill needs in regard to both swallowing and handling. 

Biography:

Abstract:

Gummi drugs are dried jelly formulations prepared by the addition of a gelling agent to saccharides, which are then cooled and solidified. Epinastine hydrochloride (Epi), which is commonly used as an allergy medicine for conditions such as allergic rhinitis, is used as a medicinal drug and an over-the-counter drug (OTC) for self-medication in Japan. The very bitter taste of Epi may affect its acceptability among patients. In this study, we aimed to improve the palatability of gummi drug containing Epi by using organoleptic masking (sweetener and flavor). Epi gummi formulations (Epi-G, 10 mg of Epi/3.5 g of gummi drug), and two other types of Epi-G were prepared by organoleptic masking with aspartame, cocoa powder, and chocolate flavoring (C-Epi-G); and a formulation with aspartame, L-menthol, and lemon flavor (L-Epi-G). A gustatory sensation test was performed on six healthy adult volunteers (age, 23.3±1.8 years). We used a visual analog scale (VAS) to evaluate bitterness, sweetness, and the overall palatability of each Epi-G during chewing and immediately after spitting out the drugs. This study was approved by Ethics Committee of the Hamamatsu University School of Medicine. We developed three types of gummi formulations containing Epi: Epi-G, C-Epi-G, and L-Epi-G. In the gustatory sensation test, the VAS scores for overall palatability while chewing for C-Epi-G and L-Epi-G, with organoleptic masking, were 130% and 100%, respectively, of the value for Epi-G without masking. The score after spitting out for C-Epi-G was 130% that of the value for Epi-G. The use of gummi drugs of medicinal drugs to treat infant and geriatric patients allows them to swallow the drugs more easily while chewing, and improves palatability compared with other oral formulations. Therefore, gummi drugs may improve patient adherence to medication. We believe that gummi drugs represent an attractive formulation for both medicinal drugs and OTC.

Biography:

Dr. Savita D. Patil has her expertise in pharmacological evaluation of pharmaceutical dosage form and passion in improving the asthmatic patients health. Her experience on pharmacological screening of herbal formulation and potent active compounds collaboration with other departments  make it responsive constructive researcher for improving healthcare of patients.

Abstract:

The current study was aim to developed extended release (ER) pellets formulations containing zaltoprofen as a model drug and glyoxal treated starch hydrogel composite as a binder and extended release polymer. The glyoxal treated starch hydrogel composites were prepared using a 3² full factorial design approach and characterized by FTIR, DSC, XRD and SEM analysis. The matrix pellets were prepared by extrusion-spheronization technique and characterized production yield, FTIR, DSC, XRPD, SEM, optical microscopy, flow characteristics, mucoadhesiveness, in-vitro dissolution and in-vivo pharmacokinetic parameter.  The FTIR interpretation of glyoxal treated starch hydrogel composite provides the significant result as a formation of hemiacetal group and keton group of glyoxal is abolished; hence it could be satisfied that star-κ-carr cross-linked hydrogel composite was formed. The optimized formulation (G5) was contained 4:8 ratio of glyoxal treated starch hydrogel composite showed in-vitro drug release up to 99.15 ± 2.20 %, 16h, respectively and in-vivo parameter were showed decrease in C max and increase in t_1/2 significantly and drug release more than 12h. Hence it was concluded that optimized formulation (G5) showed acceptable release pattern, hence would be the viable alternative to ER type formulations.

Biography:

Mr. Tesfaye Zerihun graduated in Chemistry Diploma from Kotebe teaching college on JUN, 2006 and Bachelor of pharmacy on July 2011 from Addis Ababa University and employed at Addis Ababa university aklilu Lema institution of path biology Research center on September 2007 as Technical Assistance and served for the past 5 years. Giving Technical support for Master and PhD students both on the field and Laboratory. Currently, He is working as a Senior Clinical Pharmacist at Addis Ababa University, college of Health Science, Black lion specialized Teaching Hospital in Mentoring under graduate pharmacy students who are coming to the hospital for clinical attachment both at the ward and dispensary area .I am also participating in some of Clinical research which is under go in the Hospital beside the routine work.

Abstract:

Objective: To evaluate antileishmanial activity of methanolic extract of Aloe otallensis (A. otallensis) on the promastigote stage of Leishmania donovani (L. donovani) as compared to standard drugs and to screen its phytochemical constituents. Methods: Phytochemical screening was done by using the method mentioned by Evans and Trease on methanolic extract of the exudates of Aloe otallensis leaves. The extract was also evaluated for in vitro antileishmanial activity against L. donavani which is found from the Parasitology Unit of Black Lion Hospital. The result was compared to standard drugs of sodium stibogluconate, milfostin and paramomycin. Results: The extract has a good antileishmanial activity with an IC50 of 0.123 0 μg/mL on L. donovani (AM 563). The experimental data showed that relatively it had better activity than paramomycin and milfostin but less activity than sodium stibogluconate. The data analyses were done by GraphPad Prism version 5 software after it was read by ELISA reader at the wave length of 650 nm. The phytochemical screening of the exudates of A. otallensis showed the presence of phenol, alkaloid and saponin. Conclusions: The methanol extract of the exudates of A.otallensis has a good anti- leishmaniasis activity and this may be attributed to phenol, alkaloid and saponin present in the plant. But it needs further analysis for the conformation of which constituent presents in high concentration to know which one has the strongest effect.

Biography:

Raffaele Pilla received his Master’s degree in Pharmacy at G. d’Annunzio University in Chieti-Pescara, Italy in 2005, where he also served internships at the Cell Physiology Laboratory and Molecular Biology Laboratory. Prior, he was an Erasmus Student at Faculté de Pharmacie de Reims in Reims, France. He received his Doctor Europaeus in 2010 from Pitié-Salpétrière Institute in Paris, France. Also in 2010, he received his Ph.D. in Biochemistry, Physiology, and Pathology of Muscle at G. d’Annunzio University in Chieti-Pescara, Italy. He was hired as a Postdoctoral Scholar in the Department of Pharmacology and Physiology at the University of South Florida in Tampa, on two research grants funded by the Office of Naval Research (US Navy) and Divers’ Alert Network. He has written and lectured widely worldwide. He has been involved in ongoing research at the University of South Florida with the use of ketone esters.

Abstract:

It has been recently shown that nutritional ketosis is effective against seizure disorders and various acute/chronic neurological disorders. Physiologically, glucose is the primary metabolic fuel for cells. However, many neurodegenerative disorders have been associated with impaired glucose transport/metabolism and with mitochondrial dysfunction, such as Alzheimer’s/Parkinson’s disease, general seizure disorders, and traumatic brain injury. Ketone bodies and tricarboxylic acid cycle intermediates represent alternative fuels for the brain and can bypass the rate- limiting steps associated with impaired neuronal glucose metabolism. Therefore, therapeutic ketosis can be considered as a metabolic therapy by providing alternative energy substrates. It has been estimated that the brain derives over 60% of its total energy from ketones when glucose availability is limited. In fact, after prolonged periods of fasting or ketogenic diet (KD), the body utilizes energy obtained from free fatty acids (FFAs) released from adipose tissue. Because the brain is unable to derive significant energy from FFAs, hepatic ketogenesis converts FFAs into ketone bodies-hydroxybutyrate (BHB) and acetoacetate (AcAc)-while a percentage of AcAc spontaneously decarboxylates to acetone. Large quantities of ketone bodies accumulate in the blood through this mechanism. This represents a state of normal physiological ketosis and can be therapeutic. Ketone bodies are transported across the blood-brain barrier by monocarboxylic acid transporters to fuel brain function. Starvation or nutritional ketosis is an essential survival mechanism that ensures metabolic flexibility during prolonged fasting or lack of carbohydrate ingestion. Therapeutic ketosis leads to metabolic adaptations that may improve brain metabolism, restore mitochondrial ATP production, decrease reactive oxygen species production, reduce inflammation, and increase neurotrophic factors’ function. It has been shown that KD mimics the effects of fasting and the lack of glucose/insulin signaling, promoting a metabolic shift towards fatty acid utilization. In this work, the author reports a number of successful case reports treated through metabolic ketosis.