6^th Asia-Pacific Pharma Congress July 11-13, 2016 Kuala Lumpur, Malaysia

Yuh-Pyng Sher has completed her Ph.D. in cancer research from National Taiwan University at 2006. Supporting by 2007 NHRI Postdoctoral Fellowship Award, she had postdoctoral studies from Center for Molecular Medicine in China Medical University Hospital. Now, she is an associate professor in China Medical University and a deputy director in Research center for Chinese Herbal Medicine in China Medical University. She has published more than 30 papers in reputed journals and has two patents. Sher’s lab is focused on cancer translational medicine study to develop promising cancer treatments for clinical application.

Tumor associated antigen L6 (TAL6) is over-expressed in some epithelial cancer cells. We found that more than 80% of breast and lung cancer tissue highly expressed TAL6 as compared to adjacent normal breast tissue. To identify CTL epitopes from TAL6, we synthesized 18 peptides for the HLA-A2 binding assay based on the MHC-binding motif using four computer prediction programs. Positive binders identified by ELISA were immunized in HLA-A2 transgenic (A2 Tg) mice. One peptide induced cytolytic CD8+ T cell responses and inhibit the growth of TAL6-positive tumors (EL4/TAL6/HLA-A2) in A2 Tg mice but not in wild type mice. These results demonstrate that the TAL6-derived CTL epitope could induce HLA-A2-restricted immunity against TAL6-expressing tumor cells. Furthermore, we evaluated human CTL epitope-induced anti-tumor effects in human lung cancer xenograft models. TAL6 derived peptides strongly inhibited tumor growth, cancer metastasis and prolonged survival time in A2 Tg mice immunized with a formulation of T-helper (Th) peptide, synthetic CpG ODN, and adjuvant Montanide ISA-51 (ISA-51). Adoptive transfer of peptide-induced CTL cells from A2 Tg mice into human tumor xenograft SCID mice significantly inhibited tumor growth. The combination of CTL-peptide immunotherapy and gemcitabine additively improved the therapeutic effects. This pre-clinical evaluation model provides a useful platform to develop efficient immunotherapeutic drugs to treat cancer and demonstrates a promising strategy with a benefit of antitumor immune responses worthy of further development in clinical trials.

Gopal Natesan has completed his Doctoral degree (PhD) in Pharmaceutical Chemistry from Hamdard University (Jamia Hamdard) New Delhi, India in 2000 and currently serving as Professor of Medicinal Chemistry & Deputy Dean of Academic Affairs in Faculty of Pharmacy, MAHSA University, Kuala Lumpur, Malaysia. His research focuses on the synthesis of newer small chemical entities, quinazolinones heterocyclic pharmacophore and their preliminary screening in both in-vivo and in-vitro models mainly focusing on pain & inflammation and also for newer microbial agents. He has published >40 articles in indexed journals and presented >80 papers in conferences and received number of honors, recently received “Young Scientist Award” in 2013 by International Society of Nature & Health Care Inc, USA and University of Colombo & University of Kelaniya, Sri Lanka. He was invited speaker at international scientific meetings and conferences and serves as reviewer for several scientific international journals and also as Editorial/Advisory board of various journals.

Pain and inflammation are the main two intolerable health issues faced by healthcare professionals, but the use of modern medicine has associated with unwanted side effects like gastrointestinal bleeding, nephrotoxicity, and cardiovascular adverse effects. The side effects have prompted the discovery of novel analgesic alternatives from the natural sources. Rhizophora genus has been reported for its wide range of therapeutics uses; however there are limited scientific data on its therapeutic applications of Rhizophora stylosa. An attempt has been made to study the analgesic property of Rhizophora stylosa leaves. In this present investigation, different organic extracts of R.stylosa leaves were prepared and evaluated for their analgesic activity by acetic acid induced writhing method and tail immersion method. The powder of the R.stylos’s leaf was extracted using organic solvent in order of increasing polarity i.e.: petroleum ether, chloroform, and methanol by hot percolation method using soxhlet apparatus. The crude extracts were subjected to the biological evaluation at two different doses [100 mg/kg and 250 mg/kg (bw)] in animal model using Swiss Albino mice. All the data was statistically analysed by using one way ANOVA followed Tukey test. From the study, it has been observed that chloroform extracts exhibited good analgesic activity in comparison to other extracts. It has been concluded that the different organic extract of Rhizophora stylosa promised peripheral analgesic (P<0.05) effect with dose dependent manner except methanol extract and all the organic extracts were devoid of central analgesic activity.

Introduction & Objectives: Naloxone hydrochloride (NHCL) is a semisynthetic opiate-receptor antagonist and is used to reverse the clinical effects of opiate analgesics. The drug is extensively metabolized in the liver. The objective of this study was to prepare sublingual tablet dosage form of NHCL for the purposes:1- quick therapeutic effect, 2-by pass liver metabolism, 3- easy to manage with certain patients including pediatrics. Methods: Direct compression technique was applied to prepare 150 mg sublingual tablets each containing 2mg drug. Pharmatose DLL-21, avicel pH 102, pregelatinized cornstarch, mannitol, talc, magnesium stearate and color (lake pigment HT red) were used as tablet excipients. The prepared tablets were evaluate for their physical characteristics, viz. uniformity of weight, thickness, hardness, disintegration time, content uniformity and in-vitro drug release in distilled water. The optimized formulation was subjected to shelf-life stability testing for two months. Results: The average values ± SD of weight, thickness, hardness, disintegration time and content uniformity for tablets were 149.415 ± 1.041(mg), 4.97 ± 0.008 (mm), 3.55 ± 0.438 (kg), 0.86 ± 0.12 (min) and 102.325 ± 2.256 (%), respectively. In dissolution study, 100% of drug appeared in the dissolution medium after 40 min. The results of stability study showed no significant difference compared with the fresh formulations when stored on shelf (P> 0.05). Conclusions: The results confirmed that NHCL sublingual tablets were successfully developed, in-vitro evaluated and could be a potential drug delivery system to quickly reverse the clinical effects of opiate analgesics after in-vivo assessment.

Doaa B.Farag completed her PhD in Medicinal Chemistry in November 2014 from Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. Her primary research goals are directed towards application of organic synthetic chemistry and computational techniques towards the broad goals of drug discovery and optimization. Her previous research projects started in University of South Carolina, USA in 2008, Department of Pharmaceutical and Biomedical Sciences. Another research project for the PhD was held in Egypt, which involved multistep synthetic procedures, purifi cation and characterization steps for small novel molecules as promising anti-infl ammatory activities. Several molecular modeling techniques were employed as docking, 3D pharmacophore and QSAR.

The mitogen activated protein kinase “Transforming growth factor β receptor-associated kinase 1 or TAK-1” has emerged as an interesting therapeutic target for infl ammatory diseases and cancer. TAK-1 is a member of the mitogen-activated protein kinase (MAPK) family and has been implicated in various signaling pathways. Identifi cation of small molecule inhibitors of TAK1 may represent an exciting therapeutic approach for both infl ammatory disease and cancer. In this study, the main focus was to use Multiple Linear Regression (MLR) analysis was employed to search for optimal 2D-QSAR model for activity prediction as well as valid 3D pharmacophore models for TAK-1 antagonists, using it in virtual screening of 50,000 compounds from ChemBridge for new lead compounds and fi nd their interactions with catalytic residues of TAK-1 by molecular docking.

Inas A. Abdallah is a Faculty of Pharmacy in Misr International University, Cairo, Egypt.

A simple, rapid and accurate zero crossing derivative spectrophotometric method was developed and validated for the simultaneous determination of Paracetamol (PA), Ibuprofen (IB) and Caffeine (CAF). The derivative spectra of standard solutions of each compound were obtained at different orders to find out the suitable zero crossing points. Under the optimized conditions, determination of PA was performed at wavelength 271 nm using the first order (D1) (∆ λ = 10.0). IB and CAF were determined a wavelengths of 255 nm and 264 nm using first order (D1) (∆ λ = 10.0) and third order (D3) (∆ λ = 20.0) derivative spectra. The method was found to be linear in the range of 2.5 – 15 µg/mL for both PA and IB and in the range of 0.4 – 2.4 µg/mL for CAF. The method was successfully applied for the simultaneous determination of PA, IB and CAF in pharmaceutical dosage form (Cetafen® plus tablets) without any interference from excipients.

Nada Hazem is working as an Assistant Lecturer in Pharmacy Practice & Clinical Pharmacy Department in Misr International University, Cairo, Egypt.

In 2014, mobile applications had been widely used by the healthcare providers to improve pharmaceutical care and health care services. Generally, in our daily life mobile applications became involved at which there is over 100 billion people had downloaded these applications all over the world, where statistics showed 138 billion downloaded, 137 billion was free. It had become a general trend to use these applications as a medical and pharmaceutical source of drug information mainly because; they are easy to use, rapid and available at any time; but like any other technology, it showed disadvantage at which they are dated, difficult to use by some health care providers and summarized. It is recommended to be used by all health care providers, where it will help them in dose adjustment in accord to the patient disease status, decrease the medications risk by minimizing its adverse effects and predicting different type of interactions like drug, food and herbal interactions, in addition to easy conduction of all the pharmaceutical and medical calculations. Moreover, it is a very useful tool when dealing with special population (pregnancy, lactation and elderly). Mobile Applications have also provided a good source of information for patient counseling and education for optimal disease control. From our point of view, we will measure the impact of smart devices applications on the pharmaceutical care services provided in the Egyptian community.

Yun-wei Lai has worked in Taipei City Hospital, Ren-ai branch after graduated from China Medical University, Department of Pharmacy since 2007.

Pain-control is an important factor to improve life quality, especially in patients with chronic non-cancer pain. According to the research of the American Geriatrics Society, fibromyalgia syndrome is one of the most common and easily misdiagnosed conditions which cause chronic pain in the elderly. Opioids would be a choice when other treatments failed. However, clinicians should concern the risks, including overdose poisoning, misuse or addiction and evaluate it regularly. Although the evidence of chronic opioid therapy is rare in fibromyalgia, life quality got improved obviously in this case. A 65-year-old male had 10 years history of hypertension and 5 years history of benign prostatic hyperplasia. He suffered persistent severe left chest wall pain treated by orthopedic clinic (VAS 9) and fibromyalgia was highly suspected in Nov. 2012. Since conventional medical treatments didn’t work, the neurosurgeon decided to use opioid (fentanyl 25mcg/hour patch, 1 patch Q3D) with tramadol 37.5mg/acetaminophen 325mg to relieve his pain (VAS 3-4) and he also visited psychiatrist twice per year. In 2014, the doctor prescribed duloxetine 30mg and tapered the dosage of fentanyl (from 25mcg/H Q3D to 12mcg/H Q3D) which helps him in a relatively stable condition. The evidence of chronic opioid therapy (COT) in fibromyalgia is rare; even some guidelines are not recommended. However, opioids have the strongest analgesic effect in the treatment of chronic pain. The American Pain Society and the American Academy of Pain Medicine concluded that COT can be an effective therapy for carefully selected and monitored patients with persistent pain to improve pain control.

Doaa B.Farag completed her PhD in Medicinal Chemistry in November 2014 from Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. Her primary research goals are directed towards application of organic synthetic chemistry and computational techniques towards the broad goals of drug discovery and optimization. Her previous research projects started in University of South Carolina, USA in 2008, Department of Pharmaceutical and Biomedical Sciences. Another research project for the PhD was held in Egypt, which involved multistep synthetic procedures, purifi cation and characterization steps for small novel molecules as promising anti-infl ammatory activities. Several molecular modeling techniques were employed as docking, 3D pharmacophore and QSAR.

The mitogen activated protein kinase “Transforming growth factor β receptor-associated kinase 1 or TAK-1” has emerged as an interesting therapeutic target for infl ammatory diseases and cancer. TAK-1 is a member of the mitogen-activated protein kinase (MAPK) family and has been implicated in various signaling pathways. Identifi cation of small molecule inhibitors of TAK1 may represent an exciting therapeutic approach for both infl ammatory disease and cancer. In this study, the main focus was to use Multiple Linear Regression (MLR) analysis was employed to search for optimal 2D-QSAR model for activity prediction as well as valid 3D pharmacophore models for TAK-1 antagonists, using it in virtual screening of 50,000 compounds from Princeton for new lead compounds and fi nd their interactions with catalytic residues of TAK-1 by molecular docking.

Audrey Kow is a current PhD student at the University of Putra Malaysia under the supervision of Dr Tham Chau Ling in Immunopharmacology. She has completed her Honours in Medical Biosciences from Monash University, Malaysia and Masters in Biomedical Sciences from Curtin University, Western Australia.

Introduction: Anaphylaxis is a serious, rapid and potentially life-threatening allergic response2 involving IgE or IgG4. Clinacanthus nutans - a small native shrub found in tropical Asia possess analgesic, anti-inflammatory and anti-viral activities and traditionally used for skin rashes, insect and snake-bites3. In Thailand, alcoholic C. nutans extracts has been used topically for skin rashes, a symptom of allergy1. Aim: To justify that C. nutans can treat skin rashes; this study investigated the anti-allergenicity of C. nutans extracts. Methods: Cytotoxicity of C. nutans extracts was evaluated by MTT on RBL-2H3. The most active C. nutans extract was determined by IgE-mediated mast cell degranulation. Acute toxicity of C. nutans aqueous extract was evaluated using female Sprague Dawley rats at 5000 mg/kg. Anti-allergenicity of C. nutans aqueous extract was studied by IgE-mediated passive systemic anaphylaxis (PSA). The release of preformed mediator (β-hexosaminidase) as well as newly synthesised mediators (TNF-α, IL-4 and LTC4) was evaluated. Results: C. nutans extracts were not cytotoxic up to 1 mg/ml (ethanolic) and 6 mg/ml (aqueous). In vitro, C. nutans aqueous extract was able to inhibit the release of preformed mediators but not newly synthesised mediators at 5 mg/ml. The ethanolic extracts were not able to inhibit all mediators tested. At 5000 mg/kg, C. nutans aqueous extract was non-toxic to the rats; no significant difference observed haematologically and biochemically. In vivo, C. nutans aqueous extract did not inhibit mediators of IgE-mediated PSA at 500 mg/kg and 2000 mg/kg. Conclusion: C. nutans aqueous extract was most active but could not inhibit mediators of IgE-mediated PSA. As anaphylaxis could be mediated by IgE or IgG, we postulate that C. nutans aqueous extract may exhibit its anti-allergenicity in IgG-mediated pathway.

Aurapa Sakulpanich graduated in Bachelor of Pharmacy degree from Faculty of Pharmacy, Silpakorn University and Master of Pharmacy degree (Pharmacognosy) from Faculty of Pharmacy, Mahidol Universtiy. She is interested in pharmacognosy and phytochemistry including the development of phytopharmaceutical products from plant. Recently, she is studying in Doctoral degree (Phytopharmaceutical Sciences) at Faculty of Pharmacy, Mahidol University which had been spending years to study insecticidal activity of Thai plant and attempt to develop the phytopharmaceutical products.

Chrysomya megacephala (Diptera: Calliphoridae) is a fly promoting wide spreading of pathogenic bacteria, fungi, virus and parasites based on both indirect and direct mechanical transmission. These pathogens produced the vector-borned diseases such as cholera, food poisoning, fungal and parasitic diseases in human and animals. These annoying flies are a sign of unhygienic status and unclean environment. Thus, chemical insecticides have been used for fly controling. The chemical insecticides promote high persistent bioaccumulation and toxicity in mammals while biopesticides from plants display a fast degradation, short half-life, and low toxicity. Thus, biopesticides are interested and there are many insecticidal plants in Thailand including Stemona (Stemonaceae). Stemona spp. have long been traditionally used as an insecticide in plantation. Recently, the Stemona collinsiae root extract was reported a good inhibitory activity against Spodoptera litura. S. collinsiae contains a high content of didehydrostemofoline alkaloid. Thus, the evaluation of S. collinsiae extract against C. megacephala was studied using the bait containing 70% ethanol root extract of S. collinsiae and glucose in various ratios and then fed to adult stage of C. megacephala. The S. collinsiae extract possessed adulticidal activity with correct mortality at 24, 48 and 96 days equal to 7.3-11.0, 13.5-49.9 and 75.3-94.4%, respectively. The S. collinsiae extract showed LD50 value at a concentration of 0.035 mg/mg insect. The abnormal symptoms of C. megacephala, after receiving the bait, showed motionless followed by ataxia, frequently and quickly movement of front legs and probocis, tip over, convulsion, stretching of hind or front legs, and finally died. The glucose-treated group showed no dead fly and no previous symptoms.

Shokoufeh Ghavamian is the last semester student of general biology (B.Sc.) in University of Tabriz, Iran.

Plants have been the basis for medical treatments through much of human history. Even though active compounds of many herbal drugs were unknown, they have been widely prescribed by the practitioners of the traditional medicines due to their beneficial effects and low cost. Although the primary feather of diabetes is hyperglycemia, but diabetic disease can cause damage in several organs like hepatic tissue in the long term period so the present study was conducted to determine the hepatoprotective activity of Lavandula officinalis L. ethanolic extract in the alloxan-induced diabetic rats. Twenty-eight male wistar rats [200 - 250g weight] were randomly divided into four groups as follows: Healthy control group (HC) received saline (0.9% i.p.) in all experimental days, diabetic control group (DC) received single dose of alloxan (120mg/kg b.w., i.p.), First treatment group (FT) received single dose of alloxan and 100mg/kg (LOE) i.p. for 21 days in the diabetic rats, second treatment group (ST) received single dose of alloxan and 200 mg/kg LOE i.p. for 21 days. After termination of experimental days’ liver tissue dissected to measure activity of some antioxidant enzymes such as superoxide dismutase (SOD), catalase (CAT) and lipid peroxidation (MDA) by spectrophotometer. Blood samples collected to measure Aspartate transaminase (AST) and Alanine transaminase (ALT) in the serum by using commercially available diagnostic kits. This study revealed that intraperitoneal administration of LOE for 21 days, afforded significant hepatoprotection against alloxan-induced elevation in serum marker enzymes AST (38%) and ALT (38.65%) P<0.05, liver antioxidant enzymes activities SOD (68.61%) P<0.01, CAT (41.53%) and liver lipid peroxidation (44.74%) P<0.05 compared to DC. The present study indicated the hepatoprotective effect of LOE in diabetic rats.

Samy Emara is a Professor of Pharmaceutical Chemistry and Vice Dean of Community Services and Environment Development Affairs at Faculty of Pharmacy, Misr International University (Egypt). Emara has completed his PhD experiments in cooperation with Hiroshima University (Japan) from April 1991 to July1993 and earned the degree in December 1993 from Assiut University (Egypt). His research interests lie in the area of direct injection HPLC techniques for drug monitoring in biological fl uids using protein-coated columns. In recent years, he has focused on mass spectrometric techniques for single cell metabolomics in collaboration with Single Cell Mass Spectrometry Laboratory (Riken, Osaka, Japan).

A simple, rapid and environmentally friendly direct injection high-performance liquid chromatography (HPLC) method for the determination of levodopa (LD) and carbidopa (CD) in human serum has been developed and validated. Th e method was based on extracting and separating LD and CD from human serum using a single protein-coated TSK gel ODS-80 TM analytical column (50×4.0 mm i.d., 5 μm). Th e protein-coated column functioned in two chromatographic modes: Size-exclusion chromatography [i.e., solid-phase extraction (SPE) for serum proteins] and reversed-phase chromatography for the fi nal separation of LD and CD. SPE and HPLC separation were carried out simultaneously with a green mobile phase consisting of acetate buff er (0.1 M, pH 2.4) at a fl ow rate of 1 mL/min and at ambient temperature. Th e eluents were monitored fl uorometrically at emission and excitation wavelengths of 320 and 270 nm, respectively.

Doaa B.Farag completed her PhD in Medicinal Chemistry in November 2014 from Faculty of Pharmacy, Ain Shams University, Cairo, Egypt. Her primary research goals are directed towards application of organic synthetic chemistry and computational techniques towards the broad goals of drug discovery and optimization. Her previous research projects started in University of South Carolina, USA in 2008, Department of Pharmaceutical and Biomedical Sciences. Another research project for the PhD was held in Egypt, which involved multistep synthetic procedures, purifi cation and characterization steps for small novel molecules as promising anti-infl ammatory activities. Several molecular modeling techniques were employed as docking, 3D pharmacophore and QSAR.

The mitogen activated protein kinase “Transforming growth factor β receptor-associated kinase 1 or TAK-1” has emerged as an interesting therapeutic target for infl ammatory diseases and cancer. TAK-1 is a member of the mitogen-activated protein kinase (MAPK) family and has been implicated in various signaling pathways. Identifi cation of small molecule inhibitors of TAK1 may represent an exciting therapeutic approach for both infl ammatory disease and cancer. In this study, the main focus was to use Multiple Linear Regression (MLR) analysis was employed to search for optimal 2D-QSAR model for activity prediction as well as valid 3D pharmacophore models for TAK-1 antagonists, using it in virtual screening of 50,000 compounds from MayBridge for new lead compounds and fi nd their interactions with catalytic residues of TAK-1 by molecular docking.

Lobna Kormod is working in Pharmaceutical Chemistry Department at Faculty of Pharmacy, Misr International University, Cairo, Egypt.

A simple spectrophotometric method is proposed for determination of a binary mixture of paracetamol and caffeine in laboratory prepared mixtures and pharmaceutical dosage forms without prior separation. Preparations including paracetamol and caffeine were used as examples showing overlapping absorption spectra. The method, known as ratio subtraction method (RSM), is used to construct calibration curves for the two drugs where both showed reasonable linearity. The results were compared to results obtained by high performance liquid chromatography (HPLC). The methods proved to be rapid, simple and money saving compared to HPLC. So it can be used in routine analysis of these drug combinations.

Ki Yong Lee has completed her PhD at the age of 31 years from Seoul National University and postdoctoral studies from Michigan State University. She is the associate professor of College of Pharmacy, Korea University. She has published more than 66 papers in reputed journals.

Five new alkyl phloroglucinol derivatives, characterized as (Z)-15-hydroxy-1-(2,4,6-trihydroxyphenyl)-9-octadecen-1-one (named trichocarpol A, 1), (Z)-15-hydroxy-1-(2,6-dihydroxy-4-methoxyphenyl)-9-octadecen-1-one (named trichocarpol B, 2), (Z)-17-hydroxy-1-(2,4,6-trihydroxyphenyl)-9-octadecen-1-one (named trichocarpol C, 3), (Z)-18-hydroxy-1-(2,4,6-trihydroxyphenyl)-9-octadecen-1-one (named trichocarpol D, 4), and (9Z,12Z)-18-hydroxy-1-(2,4,6-trihydroxyphenyl)-9,12-octadecadien-1-one (named trichocarpol E, 5) were isolated from the roots of Rhus trichocarpa together with a known compound, 4-(2,6-dihydroxy-4-methoxyphenyl)-4-oxobutanoic acid (6). The cytotoxic activity of compounds 1‒6 was evaluated in human gastric adenocarcinoma AGS cells and compounds 1‒5 showed significant cytotoxicity. Our results suggest that R. trichocarpa, especially the alkyl phloroglucinol derivatives in it, is a good source of natural agents for the treatment of gastric cancer.

Lenka Varinska has completed her PhD at the age of 27 years from Pavol Jozef Safarik University in Kosice, Slovak Republic. She is the postdoctoral researcher at the Department of Pharmacology, Faculty of Medicine, Kosice, Slovak Republic. She has published more than 19 papers in reputed journals.

The tumor microenvironment is formed by both malignant and non-malignant cells as well as by extracellular matrix (ECM) components. Stromal cells located in the tumor are primarily considered as sources of promalignant factors. Toward this end, we here address the issue of testing whether ECM affects vessel growth, considering the impact of a potent effector for conversion of fibroblasts to myofibroblasts and ECM production, i.e. the adhesion/growth-regulatory galectin-1. This endogenous lectin, known for triggering diverse cellular responses such as growth modulation, invasion or motility and production of vascular endothelial growth factor-C, is here studied for its impact on the qualities of ECM to sustain proliferation of human umbilical vein endothelial cells (HUVECs). Fibroblasts had been cultured for 10 days with the lectin, followed by removing cellular constituents after an osmotic shock. Freshly isolated HUVECs were placed on the ECM. In parallel, HUVECs were seeded on untreated and gelatin-coated surfaces as controls. A positive control for growth of HUVECs culture using medium supplemented with vascular endothelial growth factor completed the test panel. Cells were kept in contact to the substratum for two days and then processed for immunocytochemistry. HUVECs seeded on fibroblast-generated ECM presented a comparatively high degree of proliferation. Furthermore, contact to substratum produced by tumor-associated fibroblasts led to generation a meshwork especially rich in fibronectin. Galetctin-1 is apparently capable to trigger ECM production favorable for growth of HUVECs, prompting further work on characterizing structural features of the ECM and in situ correlation of lectin presence, ECM constitution and neo-angiogenesis.

Tien Yew TANG completed his B. Pharm (Hons.) degree at the UCSI University in 2013. He has been a biotherapeutic product evaluator at the Biologics Section, Centre for Product Registration, National Pharmaceutical Control Bureau, Ministry of Health Malaysia since February 2015. Prior to his present position, he completed pharmacy training at Hospital Pakar Sultanah Fatimah, Muar.

Biotherapeutics are medicinal products made by or derived from living organisms and may be produced by biotechnology. Due to its structure and complex manufacturing process, every biotherapeutic product (BTP) is considered ‘high risk’ and must therefore adhere to stringent quality assurance and control requirements. Similarly, copy products of original biotherapeutics (termed as ‘biosimilars’) are subjected to equally strict regulatory control. BTPs have been registered in Malaysia since 1990’s. Registration of biosimilars started only in 2008. This research aims to compare evaluation practice on biosimilar and novel BTPs at the Biological Product Registration Section in Malaysia. Evaluation activities were studied in terms of evaluation questions, evaluation timeline, nonclinical and clinical requirements, and local requirements on product label (including package insert). Six biosimilar product dossiers and six novel BTP dossiers evaluated in 2013-2015 were sampled. Parameters for comparison were determined and analysed using data collection forms. Specific to the biosimilar products, the evaluation practice on labels and package inserts were dissected and described in a qualitative arm of this research. The analysis on findings revealed some similarities and differences in current evaluation practice (timeline and requirements) for biosimilar vs. novel BTPs. The findings of this research also provide an insight on current evaluation practice on biosimilar product labelling.

Erna Sulistyowati has been pursuing her PhD program at Kaohsiung Medical University, Taiwan since 2014. She graduated M.D (Doctor of medicine) from University of Brawijaya, Indonesia. She received Master degree in Biomedics from University of Brawijaya. Currently, she is one of the research team on KMUP-treatment in diabetes-related cardiovascular disease in Department of Pharmacology, School of Medicine, Kaohsiung medical University, Taiwan.

Diabetes Mellitus (DM)-related cardiomyopathy has been recognized as one of main problem in diabetes patient since it caused heart failure and raised its mortality risk. Currently studies showed that DM leads cardiac ventricle hypertrophy through mechanism of Cardiomyocytes induced apoptosis and cardiac autophagy suppression. Our previous study indicated that KMUP-3 was able to induce autophagy in cardiomyocytes. So that, in this study we investigated whether KMUP-3 promote autophagy activity, prevent high glucose (HG)-induce cardiac injury and also improve cardiac performance in DM rats. We generated diabetes-induced model by treating high glucose (HG) in neonatal rat cardiomyocytes. Cardiomyocytes were incubated in 30 mM glucose in the presence or absence of KMUP-3 (1 to 10 µM). An experimental diabetic rat model was induced by 65mg/kg of Streptozotocin (STZ) combined with high calorie intake on rats. Dose of KMUP-3 intraperitoneally injection was 1 mg/kg. Cardiac performances were evaluated by serial echocardiography. We found KMUP-3 attenuated HG-induced cell death by MTT assay. Furthermore, KMUP-3 inhibited HG-induced apoptosis which was associated with Bax protein decrease, Bcl-2 protein increase, and caspase-3 cleavage decline. Microtubule-associated protein I light chain 3-II (LC3-II) was the key protein associated with autophagy. KMUP-3 significantly enhanced generation of LC3-II and phosphorylation of AMPK in time-dependent manner. As expected, KMUP-3 pre-treatment dose-dependently reduced the HG-induced LC3- II, Atg7, and phosphor-AMPK expression. Fractional shortening (FS) and ejection fraction (EF), the index of left ventricular systolic function were significantly decreased in DM group. Compared with DM group, these changes were attenuated when diabetic rats were treated with KMUP-3 (p<0.05). In sum, KMUP-3 attenuates HG-induced cardiomyocytes apoptosis by inducing autophagy. These findings suggest that KMUP-3 may have great therapeutic potential in the treatment of diabetic cardiomyopathy.

Vishnu Vardhan Reddy Beeram pursuing PhD from Vignan’s University at Vadlamudi, Guntur in Andhra Pradesh, India. He has Completed Master of pharmacy in Pharmaceutics from Rajiv Gandhi University of Health and Sciences at Bengaluru in Karnataka, India. He has published more than 10 papers in reputed scientific journals.

Targeted drug delivery is also can called as Smart drug delivery. It is a method of delivering a drug or medication to a patient in a manner that increases the concentration of a medication in some parts of the body relative to others. The targeted drug delivery is largely founded on Nano medicine, which plans combat the major downfalls of the conventional drug delivery by employing Nano-particulate medicated drug delivery. The site targeted drug delivery works by targeting the specific cell/organs of the patient, to facilitate the release of the drug candidate at required quantity, rate and to avoid the unwanted adverse or side effects. Inhalation therapies have until now primarily provided fast acting treatment for respiratory illness such as asthma and chronic obstructive pulmonary disease (COPD). Relative to oral delivery, inhalation of therapeutic drugs to the airways often produces maximum therapeutic levels in the respiratory tract while maintaining low systemic concentrations and thereby minimizing side effects. The inhalation drug delivery has exposed an unmet need for the controlled release of inhaled drugs and also can benefit future therapies whose success depends critically on multiple daily dosing. A logical strategy to achieve sustained release of drugs in the respiratory tract involves encapsulating drugs in slowly degrading particles that can be inhaled. This strategy can however be foiled by the relatively rapid natural clearance of insoluble particles from the respiratory system. The Nanospheres embedded Micro particulates based dry powder inhaler therapy is gaining interest for most of the therapies like diabetes, tuberculosis, HIV associated tuberculosis and many other local or systemic infections with minimal dose of dug for prolonged time to avoid most side effects and emerging drug resistance.