Day 1 :
Keynote Forum
Xi Hu
Pfizer, USA
Keynote: Development of Commercial-Ready Processes for Antibody Drug Conjugates
Time : TBD
Biography:
Xi Hu is a principal scientist working in Pfizer’s BioTherapeutics Pharmaceutical Sciences organization. she received B.S in chemistry from Peking University in China and Ph.D in bioorganic chemistry from Duke University. she have over 10 years of bio-pharmaceutical industry experience in process research and development of bioconjugates, including vaccine conjugates and antibody drug conjugates. My expertise includes late phase process development, quality by design/DOE, control strategy, technology transfer, process validation and regulatory filing.
Abstract:
As antibody drug conjugates (ADCs) move through clinical development, from phase 1 to pivotal studies, supported by clinical efficacy and appropriate safety, the development of late stage and commercial-ready processes and methods becomes a priority. During the development of commercial-ready processes, several key activities have contributed to the successful advancement of the inotuzumab ozogamicin program to late-stage development. Among these are the development of a control strategy that focuses on the control of quality attributes from raw materials through drug product, attention to proper scaling of unit operations, detailed understanding of the product through application of appropriate analytical tools, and studies of the effect of process parameters on quality attributes. In addition, planning for the complex supply chain and facility requirements for handling cytotoxic materials has been crucial. This ADC is particularly complex, but the approaches used are applicable universally
Keynote Forum
Saeed Qureshi
PharmacoMechanics, Canada
Keynote: The scientific basis of defining quality pharmaceutical products and their assessment
Time : TBD
Biography:
Dr. Qureshi has extensive (30+ years) working experience, as a research scientist, with a regulatory agency (Health Canada). He is an internationally known expert on the subject and maintains a full command in the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products. Specifically: (1) Quality assessment of pharmaceutical products based on pharmacokinetic studies (e.g. bioavailability/bioequivalence) in humans and animals, including validation of in vitro results with in vivo (bioavailability) studies. (2) In vitro drug release characterization of pharmaceutical products in particular oral and dermal using dissolution and/or diffusion (absorption/penetration through skin) techniques. (3) Analytical methods development/validation for drug disposition evaluation in humans and animals using chromatographic (e.g. HPLC, GC, TLC) and spectroscopic (e.g. UV, MS) techniques. (4) Data analysis using sophisticated (SAS) and general-purpose (e.g. MS Excel) software.
Dr. Qureshi has extensively published in peer-reviewed journals and given numerous national and international presentations on the subject. Dr. Qureshi is very well known for his innovative but simple and practical ideas. Since 2010, he has been contributing and moderating a weblog (www.drug-dissolution-testing.com) which has become a popular source of new and thought provoking ideas for addressing the issues of product evaluations.
Abstract:
It is important to note that patients and consumers need drugs or medicines but buy products such as tablet/capsule. In this respect, one must first clearly differentiate between the two – drugs/medicines from products. The capability of releasing or delivery of the drugs from the products as expected then becomes a quality attribute of the products from a patient’s perspective. A formal or regulatory recognition of this critical quality attribute (CQA) is lacking at present, at least in a measurable terms which causes significant hurdles in developing and manufacturing of the pharmaceutical products. This presentation will explain scientific rationale for defining the CQA for pharmaceutical products so that the development process for such products becomes effective, objective and efficient. Unlike the current practices and requirements, which lack scientific basis, the approach or technique for the assessment of quality, thus CQA, must be product independent for an unbiased assessment. Such a product independent evaluation approach is not only a scientific requirement but will hugely simplify product evaluations thus their development and manufacturing. Considering solid oral dosage forms (tablet/capsule) as an example, a new and simple approach based on a universal drug dissolution test will be presented for monitoring CQA. Scientific validity, simplicity and superiority of such an approach in comparison with the current practices will be highlighted.
Keynote Forum
Edit Hirsch
Keynote: High-speed electrospinning of aqueous polymer solutions for the solid formulation of biopharmaceuticals
Time : TBA
Biography:
Edit Hirsch completed her MSc at Budapest University of Technology and Economics (Hungary) and started her PhD studies in 2015 at the Department of Organic Chemistry and Technology of the same university in the field of pharmaceutical biotechnology. She is the member of the Technology of Pharmaceutical, Environmental and Safety Materials Research Group and a researcher of the Pharmatech Model Laboratory.
Abstract:
The application of biopharmaceuticals for oral administration is a topic of great interest in the pharmaceutical industry due to the inherent advantages of oral delivery. Electrospinning is a promising drying technology providing a rapid and gentle drying at ambient temperature due to the large surface area. Considering the sensitivity of biopharmaceuticals, the use of aqueous solutions during electrospinning is preferred. The commonly used single needle electrospinning equipment does not have adequate productivity, thus in order to satisfy the industrial requirements the scale-up of electrospinning is necessary. High-speed electrospinning (HSES) is a suitable technology for mass production of fibres in the sub-micron range. The scaled up electrospinning of water-soluble polymers such as polyvinyl polypyrrolidone (PVP) K17, PVP K90, polyvinyl alcohol (PVA), hydroxypropyl β-cyclodextrin (HPβCD), and hydroxypropyl methylcellulose (HPMC) were achieved using HSES. Simultaneously the optimization of these systems were accomplished considering the feasibility of downstream processing (e.g. grinding) of the nanofibrous mat. High molecular weight polyethylene oxide (PEO) was added to enhance fiber formation of PVA and HPMC while sugar type “grindability-aiding” excipients were used to improve grindability of the dried product. PVA and PEO based samples containing sugar type excipients (glucose, mannitol, lactose, saccharose, trehalose) were ground and characterized. The physical state of the polymers and excipients impacts the properties of the nanofibers such as downstream processability and in addition it could affect the biomolecule stability. The results demonstrate the successful scale-up process to HSES which is a suitable production method for formulations of water-soluble polymers for oral delivery of biopharmaceuticals.
Keynote Forum
Ahmed I Ismail
Keynote: Identification of Bifidobacterium Animalis Ssp. Lactis from Egyptian Women Breast Milk and Feces of Breast Fed Infant Based on Molecular Level
Time : TBA
Biography:
Updating Soon...
Abstract:
Bifidobacterium represent one of the major genera of the intestinal tract of human and animals used as probiotics in dairy and nondairy foods for restore the intestinal microflora which confers a health benefit. The identification of Bifidobacterium by phenotypic features is commonly unreliable, time, money, and effort consuming. We sought to improve the Bifidobacterium identification method based on molecular level to identify probiotic bacteria in complex microbial communities. The application of 16S-23S rRNA oligonucleotide primers is the best and most reliable, rapid, and precise species and sub species identification approach. The ribosomal intergenic spacer region (ISR) located between the highly conserved 16S rRNA and 23S rRNA shows a high degree of variation in length and sequence and potential for intra species discrimination and providing the phylogenetic Relationship of the Genus Bifidobacterium spp. Results showed that one of the two primer sets Bflac2-Bflac5 species specific gives positive results differentiating between B. animalis ssp. Lactis isolated from breast fed infants milk of human and that isolated from feces of breast fed infant and detecting reference strain for B. animalis ssp. Lactis DSM10140. DNA sequences of the two strains were submitted to the Genbank NCBI under accession number (KT758845) named as B. animalis ssp. Lactis Egm1 (Egyptian milk) and accession number (KT758846) named as Egf1 Egyptian feces while the second primer give false positive result. Also, we aim to obtain patent protection under Intellectual property rights (IPRs) for B. animalis ssp.Lactis which was isolated from Egyptian resources to be used for a better and healthier food and dairy products.
Keynote Forum
Mai Khanfar
Keynote: Enhancement Of The Release Of Curcumin By Freeze Drying Technique Using Inulin And Neusilin As Carriers
Time : TBA
Biography:
Mai Khanfar is an associate professor of Pharmaceutical Technology ,she has completed her PhD from Jordan University of Science And Technology. She has published more than 22 papers in reputed journals she has interest in enhancing the solubility of poorly soluble drugs using various techniques like spray drying , liquisolid , solid state characterization , exciients and preformulaion
Abstract:
Curcumin solubility at physiological pH (6.8) was significantly increased by preparing solid dispersion (SD) with Inulin and Neusilin US2 at different ratios using Freeze-dry technique. Based on the results of differential scanning calorimetry and X-ray diffraction studies, Curcumin was presented in its amorphous state in formulations containing Neusilin US2. Formulation that contain Curcumin, Inulin and Neusilin US2 at ratio (1:5:1) gave the best enhancement in Curcumin dissolution, about 98% of Curcumin was released compared with 21% from raw material. Moreover, physical stability tests showed that Curcumin remained in its amorphous form after 3 months.
Keynote Forum
Nidhi P. Sapkal
Keynote: Technology Development of Bi/Multilayer Thin Films
Time : TBA
Biography:
Dr. Nidhi Sapkal is an academician and industrial consultant. She has done M.Pharm from Gujarat University and PhD from Nagpur University. She started her career 22 years ago as an academician. Presently she is working as Professor in Department of Pharmaceutical chemistry, Gurunank College of Pharmacy. She is also Principal Research Coordinator at Zim Laboratories limited, Nagpur. At Zim, she is actively contributing to research and development activities involving novel products and process technologies. She has about 25 research papers and 19 patent applications to her credit. She has delivered many invited lectures in various international conferences
Abstract:
Thin films are ideal dosage form for pediatric, geriatric, dysphagic, mentally challenged and bed ridden patients. These films are thin, flat, elegant, rectangular shaped dosage forms that can be delivered by either oral, sublingual or buccal route. In the market, most of the available products are single layered and belong to category of orally dissolving films. A few belong to sublingual and buccal category. The present technology yeilds monolayer films containing single or multiple actives but is not capable of delivering fixed dose combinations that are incompatible with each other. The present investigation describes technology development of thin films consisting of more than one layer. The final product looks like a single thin layer with different colours/shades/textures on both the sides. The method is capable of producing films with two, three or more layers depending upon the need of the product. These films are inseparable from each other during storage, handling and use and importantly, do not interact physically or chemically at the same time. The technology can also be used to deliver actives with different release profiles in thin film form or to deliver single active with different release profiles. This technology can be applied to many buccal or oral care products which require to maintain unidirectional flow of active into a particular direction. Thus, this is an important way to add more attributes to thin film technology.
Keynote Forum
Ying Li
Keynote: Current use of oral contraceptives and the risk of first-ever ischemic stroke: A meta-analysis of observational studies
Time : TBA
Biography:
Ying LI, MD/PhD, is a professor at Nanjing Medical University School of Public Health. She completed over 20 granted studies in reproductive and pharmaceutical epidemiology, with over 100 papers and several patents. She studied at CDC under WHO scholarships on reproductive health surveillance and post market surveillance for the safety of drugs in 1996 and 2000. Recognized by dozens awards and professional honors, she also serves as associate editors for three professional journals.
Abstract:
To evaluate the risk of first-ever ischemic stroke associated with current use of oral contraceptive pills (OCPs), and to describe how the risk was influenced by estrogen dose, progestin type, and study characteristics. We obtained relevant articles published between 1970 and March 2014 by conducting a search of Pubmed, Embase and the Cochrane Library. Two investigators independently identified eligible studies based on selection criteria in a two-step method. The quality of studies was assessed with the Newcastle-Ottawa scale. Pooled odds ratios were calculated with a random-effects meta-analysis model. A total of 18 independent studies (3 cohort studies and 15 case-control studies) were identified. The overall summary odds ratio for first-ever ischemic stroke risk associated with current OCP use compared with noncurrent OCP use was 2.47 [95% confidence interval (CI), 2.04-2.99]. The risk of ischemic stroke among current OCP users decreased significantlywith decreasing estrogen dose: OCPs of≥50 μg ethinyl estradiol (EE), 30-40 ug EE, 20 ug EE and progestin only pills implied odds ratios of 3.28 (95%CI, 2.49-4.32), 1.75 (95%CI, 1.61-1.89), 1.56 (95%CI, 1.36-1.79), and 0.99 (95%CI, 0.71-1.37), respectively. All four generations of progestin were associated with an elevated risk of ischemic stroke, and the risk of ischemic stroke among users of the fourth-generation progestins seemed to be slightly lower than those of other generations of progestins. Data from observational studies suggest that current use of modern OCPs is associated with an increased risk of first-ever ischemic stroke.
Keynote Forum
Vaishali Kilor
Keynote: Drug printed Oral Thin Films: Future trend in drug delivery technology
Time : TBA
Biography:
Dr. Vaishali Kilor is working as an Associate Professor at Gurunanak College of Pharmacy, Nagpur. She has 24 years of experience in academics. She has about 15 original research papers published in peer reviewed journals. She is reviewer of many reputed journals. She has worked on many industrial projects. Presently, she is working as a consultant for Zim Laboratories Ltd. Dr. Kilor has attended several national and international conferences. Her research interests include developing novel drug delivery systems using novel technologies.
Abstract:
Thin films are relatively a recent addition in the pharmaceutical dosage forms. These can be used to administer drugs via various routes like oral, buccal, sublingual, transdermal, vaginal, rectal etc. When given by oral route these are meant for rapid disintegration and release of the drug in the oral cavity for quick therapeutic effect without use of water for swallowing. These are gaining popularity amongst the patient population of all ages, specially paediatric and geriatric patients. Though overcoming drawbacks of many oral solid dosage forms thin film technology faces certain limitations for drugs prone to hydrolytic and thermal degradation. Many drugs when loaded onto thin films using the conventional casting method results in films with poor mechanical properties. Manufacturing thin films by printing actives onto placebo substrates can overcome these limitations increasing the production yield and quality. The technology has the ability to process actives which are otherwise restricted to be formulated as thin film formulations. In the present investigation Drop On Demand printing technology was used for the printing of OTF of model drug Cholecalciferol which is prone to degradation in solvent casted films. Drug loaded printing ink was developed with optimised properties and printing was carried out on the placebo substrate. Stability studies of solvent casted Vitamin D3 films as well as printed Vitamin D3 films were carried out to observe significant improvement in the stability of printed films as compared to solvent casted films which showed up to 50% degradation.
Keynote Forum
Ahmed R Awd
Keynote: Effects of some lactobacillus strains on plasma lipids of rats and fecal microflora
Time : TBA
Biography:
Updating soon...
Abstract:
Lactobacillus represent one of the major genera of the intestinal tract of human and animals and are used, as probiotics, in dairy and non-dairy foods to restore the intestinal microflora which confer a health benefit. After an adaptation period for 7 days, the first group was fed on basal diet (80 g- for each rat group /day) and served as control I, while the second group was offered basal diet plus standardized buffalo's milk (40 ml. for each rat group / day) and served as control II. The other groups were fed on 80 grams of basal diet for each rat group / day and 40 ml. / day for each rat group, buffalo's milk plus one of the following Lactobacillus strains respectively L.casei strain AZ1, L.rhamnosus strain AZ1 and L.gasseri strain AZ1. Furthermore, supplementation of diets with fermented milk products cultured with L. casei KY123805 or L. rhamnosus KY123789 resulted in noticeable decreases in Total cholesterol, HDL- cholesterol and triglycerides levels at the end of the experiment (28 days) as compared to dry diet (control I). Species of lactobacilli occurring in intestinal tract deconjugate both taurocholic and glycocholic acids, such serum cholesterol levels when it is considered that deconjugated bile acids function more poorly in supporting adsorption of lipids from the intestinal tract than deconjugated ones, this could result in reduce adsorption of cholesterol from the intestines and thus influence its serum level. Therefore, the main target of the present investigation was to isolate and identify some local isolates belonging to genera Lactobacillus. Also, the isolated strains have been screened in order to define their characteristics that would be as probiotic strains or not. Furthermore, the long-term goal of this work is to registering patent protection for some Lactobacillus spp. isolated from local Egyptian resources to increase the additive values of the Egyptian microbial wealth and well use it in the industrial healthy dairy products and pharmaceutical
- Pharmaceutical Research | Pharmaceutical Formulations
Session Introduction
Mai Khanfar
Jordan University of Science And Technology, Jordan.
Title: Enhancement of the Release of Curcumin by Freeze Drying Technique Using Inulin and Neusilin as Carriers
Biography:
Mai Khanfar is an associate professor of Pharmaceutical Technology ,she has completed her PhD from Jordan University of Science And Technology. She has published more than 22 papers in reputed journals she has interest in enhancing the solubility of poorly soluble drugs using various techniques like spray drying , liquisolid , solid state characterization , exciients and preformulaion
Abstract:
Curcumin solubility at physiological pH (6.8) was significantly increased by preparing solid dispersion (SD) with Inulin and Neusilin US2 at different ratios using Freeze-dry technique. Based on the results of differential scanning calorimetry and X-ray diffraction studies, Curcumin was presented in its amorphous state in formulations containing Neusilin US2. Formulation that contain Curcumin, Inulin and Neusilin US2 at ratio (1:5:1) gave the best enhancement in Curcumin dissolution, about 98% of Curcumin was released compared with 21% from raw material. Moreover, physical stability tests showed that Curcumin remained in its amorphous form after 3 months.
- Pharmaceutical Formulations
Location: Hyatt Regency Osaka
Session Introduction
Edit Hirsch
Budapest University of Technology and Economics, Hungary
Title: High-speed electrospinning of aqueous polymer solutions for the solid formulation of biopharmaceuticals
Biography:
Edit Hirsch completed her MSc at Budapest University of Technology and Economics (Hungary) and started her PhD studies in 2015 at the Department of Organic Chemistry and Technology of the same university in the field of pharmaceutical biotechnology. She is the member of the Technology of Pharmaceutical, Environmental and Safety Materials Research Group and a researcher of the Pharmatech Model Laboratory.
Abstract:
The application of biopharmaceuticals for oral administration is a topic of great interest in the pharmaceutical industry due to the inherent advantages of oral delivery. Electrospinning is a promising drying technology providing a rapid and gentle drying at ambient temperature due to the large surface area. Considering the sensitivity of biopharmaceuticals, the use of aqueous solutions during electrospinning is preferred. The commonly used single needle electrospinning equipment does not have adequate productivity, thus in order to satisfy the industrial requirements the scale-up of electrospinning is necessary. High-speed electrospinning (HSES) is a suitable technology for mass production of fibres in the sub-micron range. The scaled up electrospinning of water-soluble polymers such as polyvinyl polypyrrolidone (PVP) K17, PVP K90, polyvinyl alcohol (PVA), hydroxypropyl β-cyclodextrin (HPβCD), and hydroxypropyl methylcellulose (HPMC) were achieved using HSES. Simultaneously the optimization of these systems were accomplished considering the feasibility of downstream processing (e.g. grinding) of the nanofibrous mat. High molecular weight polyethylene oxide (PEO) was added to enhance fiber formation of PVA and HPMC while sugar type “grindability-aiding” excipients were used to improve grindability of the dried product. PVA and PEO based samples containing sugar type excipients (glucose, mannitol, lactose, saccharose, trehalose) were ground and characterized. The physical state of the polymers and excipients impacts the properties of the nanofibers such as downstream processability and in addition it could affect the biomolecule stability. The results demonstrate the successful scale-up process to HSES which is a suitable production method for formulations of water-soluble polymers for oral delivery of biopharmaceuticals.
- Pharmaceutical Biotechnology
Location: Hyatt Regency Osaka
Session Introduction
Ahmed Ismail
Department of Chemical Engineering, Egypt
Title: Identification of Bifidobacterium Animalis Ssp. Lactis from Egyptian Women Breast Milk and Feces of Breast Fed Infant Based on Molecular Level
Biography:
Dr. Ahmed Ismail is currently working as professor in Department of Chemical Engineering in Egypt.
Abstract:
Bifidobacterium represent one of the major genera of the intestinal tract of human and animals used as probiotics in dairy and nondairy foods for restore the intestinal microflora which confers a health benefit. The identification of Bifidobacterium by phenotypic features is commonly unreliable, time, money, and effort consuming. We sought to improve the Bifidobacterium identification method based on molecular level to identify probiotic bacteria in complex microbial communities. The application of 16S-23S rRNA oligonucleotide primers is the best and most reliable, rapid, and precise species and sub species identification approach. The ribosomal intergenic spacer region (ISR) located between the highly conserved 16S rRNA and 23S rRNA shows a high degree of variation in length and sequence and potential for intra species discrimination and providing the phylogenetic Relationship of the Genus Bifidobacterium spp. Results showed that one of the two primer sets Bflac2-Bflac5 species specific gives positive results differentiating between B. animalis ssp. Lactis isolated from breast fed infants milk of human and that isolated from feces of breast fed infant and detecting reference strain for B. animalis ssp. Lactis DSM10140. DNA sequences of the two strains were submitted to the Genbank NCBI under accession number (KT758845) named as B. animalis ssp. Lactis Egm1 (Egyptian milk) and accession number (KT758846) named as Egf1 Egyptian feces while the second primer give false positive result. Also, we aim to obtain patent protection under Intellectual property rights (IPRs) for B. animalis ssp.Lactis which was isolated from Egyptian resources to be used for a better and healthier food and dairy products.
Ahmed Awd
Department of Chemical Engineering, Egypt
Title: Effects of some lactobacillus strains on plasma lipids of rats and fecal microflora
Biography:
Ahmed Awd is currently working as professor in Department of Chemical Engineering in Egypt.
Abstract:
Lactobacillus represent one of the major genera of the intestinal tract of human and animals and are used, as probiotics, in dairy and non-dairy foods to restore the intestinal microflora which confer a health benefit. After an adaptation period for 7 days, the first group was fed on basal diet (80 g- for each rat group /day) and served as control I, while the second group was offered basal diet plus standardized buffalo's milk (40 ml. for each rat group / day) and served as control II. The other groups were fed on 80 grams of basal diet for each rat group / day and 40 ml. / day for each rat group, buffalo's milk plus one of the following Lactobacillus strains respectively L.casei strain AZ1, L.rhamnosus strain AZ1 and L.gasseri strain AZ1. Furthermore, supplementation of diets with fermented milk products cultured with L. casei KY123805 or L. rhamnosus KY123789 resulted in noticeable decreases in Total cholesterol, HDL- cholesterol and triglycerides levels at the end of the experiment (28 days) as compared to dry diet (control I). Species of lactobacilli occurring in intestinal tract deconjugate both taurocholic and glycocholic acids, such serum cholesterol levels when it is considered that deconjugated bile acids function more poorly in supporting adsorption of lipids from the intestinal tract than deconjugated ones, this could result in reduce adsorption of cholesterol from the intestines and thus influence its serum level. Therefore, the main target of the present investigation was to isolate and identify some local isolates belonging to genera Lactobacillus. Also, the isolated strains have been screened in order to define their characteristics that would be as probiotic strains or not. Furthermore, the long-term goal of this work is to registering patent protection for some Lactobacillus spp. isolated from local Egyptian resources to increase the additive values of the Egyptian microbial wealth and well use it in the industrial healthy dairy products and pharmaceutical
- Pharmaceutical Technology
Location: Hyatt Regency Osaka
Session Introduction
Mai Khanfar
Jordan University of Science And Technology, Jordan
Title: Enhancement Of The Release Of Curcumin By Freeze Drying Technique Using Inulin And Neusilin As Carriers
Biography:
Mai Khanfar is an associate professor of Pharmaceutical Technology ,she has completed her PhD from Jordan University of Science And Technology. She has published more than 22 papers in reputed journals she has interest in enhancing the solubility of poorly soluble drugs using various techniques like spray drying , liquisolid , solid state characterization , exciients and preformulaion
Abstract:
Curcumin solubility at physiological pH (6.8) was significantly increased by preparing solid dispersion (SD) with Inulin and Neusilin US2 at different ratios using Freeze-dry technique. Based on the results of differential scanning calorimetry and X-ray diffraction studies, Curcumin was presented in its amorphous state in formulations containing Neusilin US2. Formulation that contain Curcumin, Inulin and Neusilin US2 at ratio (1:5:1) gave the best enhancement in Curcumin dissolution, about 98% of Curcumin was released compared with 21% from raw material. Moreover, physical stability tests showed that Curcumin remained in its amorphous form after 3 months.
- Drug Delivery Technologies
Location: Hyatt Regency Osaka
Session Introduction
Nidhi Sapkal
Zim Laboratories limited, India
Title: Technology Development of Bi/Multilayer Thin Films
Biography:
Dr. Nidhi Sapkal is an academician and industrial consultant. She has done M.Pharm from Gujarat University and PhD from Nagpur University. She started her career 22 years ago as an academician. Presently she is working as Professor in Department of Pharmaceutical chemistry, Gurunank College of Pharmacy. She is also Principal Research Coordinator at Zim Laboratories limited, Nagpur. At Zim, she is actively contributing to research and development activities involving novel products and process technologies. She has about 25 research papers and 19 patent applications to her credit. She has delivered many invited lectures in various international conferences
Abstract:
Thin films are ideal dosage form for pediatric, geriatric, dysphagic, mentally challenged and bed ridden patients. These films are thin, flat, elegant, rectangular shaped dosage forms that can be delivered by either oral, sublingual or buccal route. In the market, most of the available products are single layered and belong to category of orally dissolving films. A few belong to sublingual and buccal category. The present technology yeilds monolayer films containing single or multiple actives but is not capable of delivering fixed dose combinations that are incompatible with each other. The present investigation describes technology development of thin films consisting of more than one layer. The final product looks like a single thin layer with different colours/shades/textures on both the sides. The method is capable of producing films with two, three or more layers depending upon the need of the product. These films are inseparable from each other during storage, handling and use and importantly, do not interact physically or chemically at the same time. The technology can also be used to deliver actives with different release profiles in thin film form or to deliver single active with different release profiles. This technology can be applied to many buccal or oral care products which require to maintain unidirectional flow of active into a particular direction. Thus, this is an important way to add more attributes to thin film technology.
Vaishali Kilor
Zim Laboratories Ltd, India
Title: Drug printed Oral Thin Films: Future trend in drug delivery technology
Biography:
Dr. Vaishali Kilor is working as an Associate Professor at Gurunanak College of Pharmacy, Nagpur. She has 24 years of experience in academics. She has about 15 original research papers published in peer reviewed journals. She is reviewer of many reputed journals. She has worked on many industrial projects. Presently, she is working as a consultant for Zim Laboratories Ltd. Dr. Kilor has attended several national and international conferences. Her research interests include developing novel drug delivery systems using novel technologies.
Abstract:
Thin films are relatively a recent addition in the pharmaceutical dosage forms. These can be used to administer drugs via various routes like oral, buccal, sublingual, transdermal, vaginal, rectal etc. When given by oral route these are meant for rapid disintegration and release of the drug in the oral cavity for quick therapeutic effect without use of water for swallowing. These are gaining popularity amongst the patient population of all ages, specially paediatric and geriatric patients. Though overcoming drawbacks of many oral solid dosage forms thin film technology faces certain limitations for drugs prone to hydrolytic and thermal degradation. Many drugs when loaded onto thin films using the conventional casting method results in films with poor mechanical properties. Manufacturing thin films by printing actives onto placebo substrates can overcome these limitations increasing the production yield and quality. The technology has the ability to process actives which are otherwise restricted to be formulated as thin film formulations. In the present investigation Drop On Demand printing technology was used for the printing of OTF of model drug Cholecalciferol which is prone to degradation in solvent casted films. Drug loaded printing ink was developed with optimised properties and printing was carried out on the placebo substrate. Stability studies of solvent casted Vitamin D3 films as well as printed Vitamin D3 films were carried out to observe significant improvement in the stability of printed films as compared to solvent casted films which showed up to 50% degradation.
- Pharmaceutical Research
Location: Hyatt Regency Osaka
Session Introduction
Ying Li
Nanjing Medical University, China
Title: Current use of oral contraceptives and the risk of first-ever ischemic stroke: A meta-analysis of observational studies
Biography:
Ying LI, MD/PhD, is a professor at Nanjing Medical University School of Public Health. She completed over 20 granted studies in reproductive and pharmaceutical epidemiology, with over 100 papers and several patents. She studied at CDC under WHO scholarships on reproductive health surveillance and post market surveillance for the safety of drugs in 1996 and 2000. Recognized by dozens awards and professional honors, she also serves as associate editors for three professional journals.
Abstract:
To evaluate the risk of first-ever ischemic stroke associated with current use of oral contraceptive pills (OCPs), and to describe how the risk was influenced by estrogen dose, progestin type, and study characteristics. We obtained relevant articles published between 1970 and March 2014 by conducting a search of Pubmed, Embase and the Cochrane Library. Two investigators independently identified eligible studies based on selection criteria in a two-step method. The quality of studies was assessed with the Newcastle-Ottawa scale. Pooled odds ratios were calculated with a random-effects meta-analysis model. A total of 18 independent studies (3 cohort studies and 15 case-control studies) were identified. The overall summary odds ratio for first-ever ischemic stroke risk associated with current OCP use compared with noncurrent OCP use was 2.47 [95% confidence interval (CI), 2.04-2.99]. The risk of ischemic stroke among current OCP users decreased significantlywith decreasing estrogen dose: OCPs of≥50 μg ethinyl estradiol (EE), 30-40 ug EE, 20 ug EE and progestin only pills implied odds ratios of 3.28 (95%CI, 2.49-4.32), 1.75 (95%CI, 1.61-1.89), 1.56 (95%CI, 1.36-1.79), and 0.99 (95%CI, 0.71-1.37), respectively. All four generations of progestin were associated with an elevated risk of ischemic stroke, and the risk of ischemic stroke among users of the fourth-generation progestins seemed to be slightly lower than those of other generations of progestins. Data from observational studies suggest that current use of modern OCPs is associated with an increased risk of first-ever ischemic stroke.
- Drug Regulatory Affairs
Location: Hyatt Regency Osaka
Session Introduction
Abdeen Omer
Ministry of Health and Social Welfare,Sudan
Title: Evaluation of medicine distribution, regulatory privatisation, social welfare services and its alternatives
Biography:
Abdeen Mustafa Omer (BSc, MSc, PhD) is an Associate Researcher at Occupational Health Administration, Ministry of Health and Social Welfare, Khartoum, Sudan. He has been listed in the book WHO’S WHO in the World 2005, 2006, 2007 and 2010. He has published over 300 papers in peer-reviewed journals, 200 review articles, 7 books and 150 chapters in books
Abstract:
The strategy of price liberalisation and privatisation had been implemented in Sudan over the last decade, and has had a positive result on government deficit. The investment law approved recently has good statements and rules on the above strategy in particular to pharmacy regulations. Under the pressure of the new privatisation policy, the government introduced radical changes in the pharmacy regulations. To improve the effectiveness of the public pharmacy, resources should be switched towards areas of need, reducing inequalities and promoting better health conditions. Medicines are financed either through cost sharing or full private. The role of the private services is significant. A review of reform of financing medicines in Sudan is given in this article. Also, it highlights the current drug supply system in the public sector, which is currently responsibility of the Central Medical Supplies Public Corporation (CMS). In Sudan, the researchers did not identify any rigorous evaluations or quantitative studies about the impact of drug regulations on the quality of medicines and how to protect public health against counterfeit or low quality medicines, although it is practically possible. However, the regulations must be continually evaluated to ensure the public health is protected against by marketing high quality medicines rather than commercial interests, and the drug companies are held accountable for their conducts.
- Pharmaceutical Research
Location: Hyatt Regency Osaka
Session Introduction
Katrin Mae
University Of Santo Tomas, Phillipines
Title: Antiangiogenic and AMP-Activated Protein Kinase Activities of Gracilaria coronopifolia J.G. Agardh Extracts
Biography:
Katrin Mae M. Ortega, a bonifide graduate in Master of Science in pharmacy at the age of 25 years from of University Of Santo Tomas last June 2017 wherein she was awarded a dsitinction of Cum Laude. During her graduate study, Ms Ortega exhibited top performance during written examination as well as oral examinations. She got a Meritus honor on her thesis entitled “Antiangiogenic and AMP-Activated Protein Kinase Activities of Gracilaria coronopifolia J.G. Agardh Extracts”. This study as awarded gold medal in the Technical Poster Competition during 2nd International Science Graduate Scholars” Conference in the theme “From Disccoveries Today to Innovating Tommorow” held at the Philippine International Convention Center Pasay City.
Abstract:
AMP-activated protein kinase (AMPK) is an intracellular energy sensor which is important in metabolic regulation, cell growth, and survival. Recently, dysfunction in AMPK is implicated to numerous angiogenesis-related diseases, however, the mechanism remains elusive. In this study, the antiangiogenic activity of the red alga, Gracilaria coronopifolia, was determined through cellular signaling pathway of AMPK. Chorioallantoic membrane (CAM) assay showed that all extracts of G. coronopifolia inhbited angiogenesis in a dose-dependent manner. Among them, dichloromethane extract exhibited the most potent antiangiogenic activity (IC50 =1.21 μg/mL, p=0.215) followed by hexane extract (IC50=3.08 μg/mL, p=0.479) and methanol extract (IC50=8.93 μg/mL, p= 0.042). Antiangiogenic activity was correlated to a low concentrations of Fe, Zn, and Cu of duck CAM determined using flame atomic absorption spectrometer (fAAS) and colorimetric assay. Likewise, In vitro AMPK signaling assay showed that all extracts activated AMPK, with dichloromethane extract having the lowest EC50 of 70.2 μg/mL. Thin layer chromatography (TLC) and gas chromatography-mass spectrometry (GC-MS) revealed the active component of each extracts. Notably, this is the first report on the AMPK activity of G. coronopifolia related to new blood vesselhttps://pharmatech.pharmaceuticalconferences.com/call-for-abstracts.php formation and a colorimetric-based correlation of angiogenesis based on Fe, Zn, and Cu concentration in the duck chorioallantoic membrane.
Biography:
I, Sourav De, completed B. Pharmacy and M. Pharmacy in Pharmaceutical Chemistry from India at 2012. I have completed 5 yrs teaching and research experience in different University. I have already published few articles and two book chapters in different national and international journal. Now I am Pursuing PhD from VIT University, India. I am working on the basis on organometallic compounds, heterocyclic and QSAR modelling. I have already delivered oral and poster presentation in different national and international conference. I am attaching my CV on the basis of above information.
Abstract:
A series of Ruthenium-Quinolinol complexes (3a-d & 4a-d) has been synthesized by employing a simple, efficient and environmental friendly condition. Catalytic role of Amberlite IRA-120(H) has been demonstrated. The structures of the new compounds were elucidated by the analysis of spectroscopic data. The stability of these complexes was measured by UV spectroscopy & time dependent NMR spectroscopy. These newly developed complexes were represented as potential anticancer agent. Complex [(η6-hexamethylbenzene)RuCl(κ2-O,N-5-chloro-HyQ)]·Cl (4b), [(η6-hexamethylbenzene)RuCl(κ2-O,N-5,7-dibromo-HyQ)]·Cl (4c) and [(η6-hexamethylbenzene)RuCl(κ2-O,N-5-chloro-7-iodo-HyQ)]·Cl (4d) exhibited best cytotoxicity profiles in three reported human cancer cell lines (MCF-7, Hela, Caco-2). A high selectivity was observed with these newly developed organoruthenium compounds in human cancer cell lines. Compound 4c might be utilized for cancer theranostic agents because of its significant quantum yield in water, high potency, selectivity and high cellular uptake in cancer cell lines.
Biography:
Rashmi Saxena Pal , assistant professor in Pharmacy deptt, PSIT, pursuing Ph D from IFTM University. She has published more than 20 papers in reputed journals and has been serving as an editorial board member of reputed journals. She has attended many Conferences and Seminars and has e book publication in her account.She is life time member of APTI and have submitted many abstracts.
Abstract:
The poor air quality of indoors nowadays are responsible for the major health problems, especially in children. Asthma is considered the most common chronic disease in urban-dwelling children. Allergists consider indoor air filtration to be part of a comprehensive measure to improve respiratory health. Air purifiers with HEPA filters have been shown to improve symptoms of asthma, allergies and other air borne infections. However, filtration systems and air purifiers do not reduce levels of all indoor air pollutants, therefore there is a need of addition of houseplants. The use of plants can be uniquely useful in these environments where other kinds of remediation technology may be impractical or difficult to deploy. In addition to basic photosynthesis that removes carbon dioxide and returns oxygen to the air, plants can remove toxicants from air, soil, and water. For maximal control over the elevated levels of mercury vapours, formaldehyde etc, multiple species of houseplants are required. They should be planted at the sites to remove the relevant toxicants in a particular space. The houseplants are specific in the types of chemicals they are able to remove from the environment. The true potential of these indoor plants are yet to be explored and the awareness regarding their benefits is to be focussed upon. This review deals with the detailed study of some indoor plants such as Spider lily, Bamboo palm, Snake plant, Red edged Draceana,Boslon fern, Weeping fig, Rubber plant, Peace lily etc.
- Pharmaceutical Biotechnology
Location: Hyatt Regency Osaka
Session Introduction
Xiaoling Wang
Capital Medical University, China
Title: Association between HLA-B*15:02 and Oxcarbazepine induced cutaneous adverse reaction: a meta-analysis
Biography:
Xiaoling Wang is currently working as a associate professor in Capital Medical University located in Beijing the capital of China.
Abstract:
Introduction: HLA-B*15:02 has been demonstrated as a key risk factor for carbamazepine (CBZ) induced severe cutaneous adverse reaction (sCAR) especially in Asian population. Oxcarbazepine, a drug that has similar structure of CBZ. However, the HLA-B*15:02 is remained unknown for relationship of OXC induced cADR.
Method: 8 studies included for analysis, including 32 sCAR cases, 112 mild cutaneous adverse reaction (mcADR) cases, 281 OXC tolerant control, 946 population control.
Result: In tolerant control group, an association was between HLA-B*15:02 genotype and OXC induced sCAR (OR, 18.13; 95% CI, 6.77-48.56), but not in mcADR (OR, 1.43; 95% CI, 0.56-3.64). In population control group, the result is similar, in sCAR (OR, 8.22; 95% CI, 3.03-22.34), in mcADR (OR, 2.06; 95% CI, 0.91-4.67).
Discussion: Our study demonstrated that although OXC has a privilege compare to CBZ among sCAR, it might still share the similar genetic risk factor --HLA-B*15:02, on inducing sCAR.