23^rd International Conference and Exhibition on Pharmaceutical Formulations July 27-28, 2020 Zurich, Switzerland

Biography:

Alptug Karakucuk was born in Turkey in 1988. He was graduated at Gazi University Faculty of Pharmacy in year 2012. He also took his Ph.D at Gazi University, Department of Pharmaceutical Technology in 2017 as a research and teaching assistant. He is still Ph.D., instructer at the same department. He is also co-founder and general manager of Fiber Pharma Drug, Cosmetics and Consulting Co. He published or presented several scientific studies in international areas, patented and commercialized some products, participated in scientific projects as researcher or coordinator.

Abstract:

The poor aqueous solubility issues of drug molecules limit drug absorption through oral or dermal route and evantually, lower bioavailability due to hydrophobicity. Moreover, it is a big challange to formulate poorly soluble drugs to increase solubility to obtain sufficient activity. Several new drug candidates, which are coming in regard to target-receptor geometry by high throughput screening, have high molecular mass and high Log P value that contributes to insolubility. According to Biopharmaceutical Classification System, the Class II and IV drugs consider as poorly soluble. Physical modifications (micronization, polymorph formation, solid dispersions, cyclodextrin complexes, use of organic solvent), chemical modifications (prodrug preparation, salt forms) or nanotechnological approaches (micelles, lipsomes, nanoemulsions, etc.) are considered to overcome low water solubility problems. Physical and chemical modifications have several disadvantages such as not applicable to each drug active substance, not providing sufficient increased saturation solubility or causing loss of activity. In the last years, it is considered that drug nanosuspensions are one the most successful approaches to formulate poorly soluble compounds. Nanosuspensions are dispersed systems which have nanometer range, typically 200-600 nm, pure drug particles. They contain minimum amount of stabilizing agents such as surfactants and/or polymers. Nanosuspensions can be produced by precipitation, wet milling, high pressure homogenization, or combination of these methods.  With unique properties of nanosuspensions by providing increased surface area of drug articles, they can improve saturation solubility and dissolution rate of poorly soluble drugs and hence oral or dermal bioavailability. The spesific function of Qality by Design is known as Design of Experiment (DoE). The DoE approach statistically examines the interactions between variables within the design area and enables the development of formulations by taking into account the optimum product characteristics. DoE approach helps to develop nanosuspension formulation by reducing the number of experiments which brings cost and time saving.

Biography:

Andrew Ebenazer has his expertise in Nanoencapsulation/ Nanoformulation of active compounds, toxicity studies on target and non-target organisms and biosafety studies. Further have a hands on expertise in developing the rapid qualitative, and quantitative analytical methods. Proficiency in handling, troubleshooting LCMS, Preparative HPLC, Analytical HPLC, UPLC, UHPLC, flash chromatography systems. A consultant in providing ecosafety solutions and industry oriented training workshops.

Abstract:

The majority of the active pharmaceutical ingredients (API) are poorly soluble in water, thus require the formulation process for improving bioavailability. Conventionally, the addition of excipients was in common practice, however, higher bioavailability could be affected due to lack of dose proportionality. As to overcome this, encapsulation techniques have provided answers to entrap the API inside the hydrodispersive capsule as a safe carrier. The capsule chosen should serve the purpose of biocompatibility, dispersion stability, and targeted bioavailability. i) Emulsions: Encapsulate is a micelle system of surfactants. A simple emulsification technique along with essential oils, an easier and effectual formulation. Emulsification is carried out by a high energy process aided by the mechanical devices or low energy process aided by the internal physical property of the system. The emulsion system poses the advantage of blending multiple components into a single system for combinational drug delivery. (ii) Polymeric encapsulation: The utilization of polymers for encapsulation has gained upper hand over the emulsion system as most of them are hard colloidal particles, unlike emulsions. Mostly preferred ones are natural polymers such as gelatin, chitosan, agarose, alginate for entrapment of API. These polymeric capsules can be additionally coated with other polymers or adjuvants or other functional groups for the benefit of sustained and controlled release applications. (iii) Lipid encapsulation: The encapsulate is typically a lipid such as triglycerides, fatty acids, steroids. The formulation is typically carried out by hot or cold homogenization or spray drying. The lipid encapsulation provides good stability for lipophilic drugs with an added advantage in topical applications. Overall encapsulation of the API provides the possibility of formulating customized delivery vehicles for the targeted applications. Also, all these formulations can be converted into nanometric form by altering the surfactant concentration or system components or by altering the energy intensity, which further aids the dispersity and bioavailability

Biography:

She started working in Olive medical Laboratory and now she is currently working as a Resident Doctor in Biochemistry Institute Skopje, North Macedonia

Abstract:

Introduction:

The  purpose for  research  is  inspiration from one child  with autism in my family, from  heteroanamnesis  and  symptoms, I decided  to  do  the  test-the  first daughter of my sister  with diagnosis; autism,  she  had  multi  food  intolerance, than with  prof.Blyta  we  started  with  follow  up  panel (a  big  panel  with more  analysis: blood, urine, faecal, biochemistry also microbiology) but the first  test  was food intolerance  for those patients. The  connection  between Autism and food intolerances is likely  to lie  in the  higher  prevalence  of  intestinal  permeability that it  seen  in  autistic   patients. They  have  intestinal  permeability, the  largest   protein  undigested  into  the  blood, from  this  process  can  develop food  intolerance and  food  allergy. For  food  intolerance  is  responsible IgG or IgG4 and  those  antibodies   reacted   as  adaptive  immune  system. The IgG antibodies then fix to the food proteins to form an immune complex in the blood stream. If the immune complex fixes to a tissue it will eventually lead to tissue damage from inflammation and specific symptoms which vary from person to person is  the most  important  casein intolerance and gluten intolerance because  from casein has a pathological mechanism of casomorphine formation also  from gluten intolerance to gliadinmorphine, these findings are  specific for pathologies such as Autism, delays in psychomotor, delays in speech, mood, anxiety, hyperactivity, etc. but it is another of my  research on gliadinomorphine and casomorphine with Autistic children’s.

Method:

About 50 patients with autism diagnosis, aged from 5-9 years, have been tested in rapid blood tests for determination of specific IgG4(human) or Nutri Smart-test, DST-diagnostische system and  technologien  GmbH –Germany.

Results & Conclusion:

The results of tests were positive 99% and those are from food intolerance Casein, Gluten, Cow’s milk, Sheep  milk, Goat’s  milk, Egg white, Egg yellow, Soy, Wheat, Peanut, Banana, Tomato, Potato, Meat mix, Legume, Almun, Hazelnut, Apple, Pineapple, Kiwi, Rye, Fish mix, Mustard, Cacao, Grain  mix, Tuna, Veg  mix, Lamb etc.  those  are  the  most  frequent  positive results with IgG 4 concentration  in  level 2 and 3(3 is the  high  level concentration). Also they  have  and  clinic  information’s for   gastrointestinal  symptoms excessive  production  of  gas, belching and  abdominal pain, diarrhoea, gastric  reflux, high  rates  or  inflammatory bowel disease etc. Cause of food intolerance are digestive enzymes deficiency, but it can also be a secondary problem as a consequence other diseases.

Biography:

Aymen has received Bachelor Degree of Pharmaceutical Sciences at King Saud University and undergone Military Training Courses for Post Graduate Medical Students with excellent grade. Completed Master’s degree of Pharmaceutical Sciences at King Saud University and as well as received Ph.D. Currently working in Military Price Sultan Cardiac Center, Saudi Arabia.

Abstract:

A stereo selective high-performance liquid chromatographic (HPLC) method was developed and validated to determine S-( )- and R-(+)-propranolol in rat serum. Enantio-meric resolution was achieved on cellulose tris (3,5-dimethylphenylcarbamate) immobilized onto spherical porous silica chiral stationary phase (CSP) known as Chiralpak IB. A simple analytical method was validated using a mobile phase consisted of n-hexane-ethanol-triethylamine (95:5:0.4%, v/v/v) at a flow rate of 0.6 mL min and fluorescence detection set at excitation/emission wavelengths 290/375 nm. The calibration curves were linear over the range of 10–400 ng mL-1 (R = 0.999) for each enantiomer with a detection limit of 3 ng mL-1. The proposed method was validated in compliance with ICH guidelines in terms of linearity, accuracy, precision, limits of detection and quantitation, and other aspects of analytical validation. Actual quantification could be made for propranolol isomers in serum obtained from rats that had been intraperitoneally (i.p.) administered a single dose of the drug. The proposed method established in this study is simple and sensitive enough to be adopted in the fields of clinical and forensic toxicology. Molecular modelling studies including energy minimization and docking studies were first performed to illustrate the mechanism by which the active enantiomer binds to the β-adrenergic receptor and second to find a suitable interpretation of how both enantiomers are interacting with cellulose tris(3,5-dimethylphenylcarbamate) CSP during the process of resolution. The latter interaction was demonstrated by calculating the binding affinities and interaction distances between propranolol enantiomers and chiral selector.

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.

Notes/Comments:

The study reveals the need for further research to find out how efficient the regulatory authorities at both federal and state levels are. The research also needed to discover whether or not counterfeit medicines are sold on the Sudanese market. From the data obtained in this article some general inferences could be made:

• The broad outlines remain intact, but preventing drug smuggling across national borders (Sudan shares frontiers

with 9 countries) is hard to police.

• The enforcement of the Act and its regulation governing the manufacture, importation, sale, distribution and exportation of medicines are not adequate enough to control the illegal importation and sale of medicines in Sudan.

• The splitting of the drug regulatory authority between two ministries and the marketing of unregistered medicines by public drug suppliers (namely the CMSPO, and RDFs), and NGOs undermine the quality of medicines and ultimately jeopardise the health of the people taking medication.

Biography:

I earned my Ph.D. from the Faculty of Pharmacy, Cairo University in 2008. I was the winner of Best Ph.D. thesis award in Pharmaceutical Sciences, National Research Center (NRC), 2008 and winner of the Scientific Excellence award from the NRC, 2011. I earned a post graduate certificate in higher education from the University of Greenwich, UK. I am currently working as a Professor, Pharmaceutical Technology Department, NRC and the supervisor of scientific networks, ASRT. I’m a member of the National drug committee, ASRT. I shared as a team member in 7 research projects and as a co-principal investigator in a research project granted by the Science and Technology Development Fund (STDF). Editorial board member and reviewer for a number of peer reviewed international journals as the Journal of American Association of Pharmaceutical Scientists, International Journal of Pharmacy and Pharmaceutical Sciences, Journal of inclusion phenomena, etc. Speaker and poster presenter in many national and international conferences

Abstract:

This study is meant to design a novel system for the treatment of diabetic ulcer. The prepared system took advantages of insulin as a localized gold standard healing therapeutic.  The main aim of the presented work is to design an effective topical dual mechanistic treatment for diabetic foot ulcer through designing and preparing insulin-ethosomes-loaded electrospun fibrous mats as a sustained and efficient platform of therapy.  The biodegradable electrospun mat would serve as an ideal matrix for the handling and administration of the designed system .The designed system is composed of flexible ethosomal vesicles loaded with insulin for local treatment of foot ulcer. The prepared system offered controlled  rate and profile of insulin releases through duals mechanism; first; the system benefited from the excellent reported flexibility of ethosomal vesicles to pass deep along skin layers allowing gradual drug release in all affected layers and second, the fibrous mat served as an efficient and accurate mode of applying the drug carrier system and providing  a new generation of the wound dressing materials which was able  to alleviate much of the painful repetitive procedures of frequent changes of dressing materials. The designed system was tested in vivo on experimental animals after inducing skin wounds.

Biography:

Zenia Pardo-Ruiz has expertise in the development and application of alternative methods in the quality control of vaccines and other biopharmaceuticals as part of the Biochemistry team at the Center for Pharmaceuticals Research and Development, where she reach her PhD degree. Currently, she is a reviewer of biological products, specialized in vaccines, at the Cuban Regulatory Authority (Center for State Control of Drugs, Equipment and Medical Devices).

Abstract:

The use of alternative methods to animal testing has been encouraged, thus during the last decade an increasing number of alternative approaches in the biopharmaceutical industry have been formally adopted. In this context, there are an ethical, scientific and economic discussion worldwide in relation to the reliability of the application of the General Safety Test and the Rabbit Pyrogen Test in the quality control of biopharmaceuticals. The application of the former has been questioned because no reliable conclusions can be drawn from this test. For this reason, this assay has been removed from some pharmacopeias and it is no longer mandatory for several Regulatory Agencies, especially after the introduction of Good Manufacturing Practices and the use of other stringent methods. In addition, in vitro alternatives for pyrogens control, such as the Monocyte Activation Test, have been developed. This alternative method mimics the human fever reactions and detects the enhancing pro-inflammatory effect of substances that are commonly found in the biopharmaceutical industry, increasing the product safety. It is known that the position of a Regulatory Authority is focused in the assurance on the safety of products; however, Cuban regulations have not yet specifically ruled on the usefulness of both tests. This work offers a scientific basis on the reliability of these tests and their role to increase or not the safety of biological products. In addition, the position of the Cuban Regulatory Authority with respect to its application in the quality control of biological products is exposed.

Biography:

Dr. Michael U. Uhumwangho is currently working as Associate Professor at Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmacy, University of Benin, Nigeria. He has completed his Ph.D. in Pharmaceutics and Pharmaceutical Technology from same University. His main area of expertise includes Tabletting, Controlled Drug Delivery System, Floating Drug Delivery Systems, Novel Drug Delivery Systems, and Pharmaceutical Formulations. He has published 70 research articles in journals as author/co-author.

Abstract:

Purpose:

This study was carried out to formulate effervescent and non-effervescent gastro-floating matrix tablets (GFMTs) of metronidazole using Azadirachta indica (Neem) gum (AIG).

Method:

Neem gum was extracted by method previously described. Granules were prepared by wet granulation technique using the extracted neemgum at varying concentrations (2, 4, 6 and 8% w/w). The granules were compressed at an optimized compression pressure of 30 arbitrary unit on the tableting machine load scale. Tablets were evaluated for hardness, friability, floating lag time, in vitro buoyancy test and drug release profiles. Drug-excipient compatibility study was done using Fourier Transform Infra-red Spectroscopy (FTIR) and Differential Scanning Calorimetry (DSC). Scanning Electron Microscope (SEM) was used to analyze the pores and morphology of the tablets.

Results:

All formulated floating matrix granules were free flowing with angle of repose and Carr’s index ≤ 33.2º and ≤ 15.5% respectively. All floating matrix granules were compressible with tablet hardness ≤ 9.0 Kg/cm2.Generally, GFMTs percentage friability decreased with increase in binder concentration (≤ 0.99%). The floating lag time for the effervescent FMTs tablets ranged from 2-7 min while the non-effervescent FMTs had zero floating lag time. FTIR and DSC studies showed that the excipients and the Active Pharmaceutical Ingredient (API) i.e. metronidazole were compatible. SEM reveals the presence of pores and rough surface on the non-effervescent GFMTs while smooth surface with no pores was revealed in the effervescent formulations.

Conclusion:

Gastro-floating matrix tablets of metronidazole were successfully formulated in this study using the effervescent and non-effervescent techniques and Azadirachta indica gum as a natural polymer. There was significant difference in the floating lag times (P >0.05) while there was no significant difference in the in vitro buoyancy studies of the tablets formulated using both the effervescent and non-effervescent methods (P <0.05)