2^nd International Conference and Exhibition on Pharmaceutical Development and Technology May 11-12, 2018 Osaka, Japan

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

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.

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.

Biography:

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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.

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.

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.

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.

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.

Biography:

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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