Search results for: pharmaceutical%20industry.

Authors: Blandina Šramová, Gabriela Kučeráková

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The paper is intended to declare and apply ethics, i. e. moral principles, rules in marketing environment. Ethical behavior of selected pharmaceutical companies in the Slovak Republic is the object of our research. The aim of our research is to determine perception of ethical behavior of the pharmaceutical industry in Slovakia by the medicine representatives in comparison with the assessment of doctors and patients. The experimental sample included 90 participants who were divided into three groups: medicine representatives of the pharmaceutical companies (N=30), doctors (N=30) and patients (N=30). The research method was a Questionnaire of ethical behavior, created by us, that describes individual areas included in the Code of ethics of the pharmaceutical industry in Slovakia. The results showed influence of professional status on ethical behavior perception, not gender. Higher perception was indicated at patients rather than doctors and medicine representatives.

Keywords: Ethics, corporate social responsibility, marketing, pharmaceutical industry.

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Authors: A. Abu-Safa, S. Abu-Salah, M. Mosa, S. Gharaibeh

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Pharmaceutical industries and effluents of sewage treatment plants are the main sources of residual pharmaceuticals in water resources. These emergent pollutants may adversely impact the biophysical environment. Pharmaceutical industries often generate wastewater that changes in characteristics and quantity depending on the used manufacturing processes. Carbamazepine (CBZ), {5Hdibenzo [b,f]azepine-5-carboxamide, (C15H12N2O)}, is a significant non-biodegradable pharmaceutical contaminant in the Jordanian pharmaceutical wastewater, which is not removed by the activated sludge processes in treatment plants. Activated carbon may potentially remove that pollutant from effluents, but the high cost involved suggests that more attention should be given to the potential use of low-cost materials in order to reduce cost and environmental contamination. Powders of Jordanian non-metallic raw materials namely, Azraq Bentonite (AB), Kaolinite (K), and Zeolite (Zeo) were activated (acid and thermal treatment) and evaluated by removing CBZ. The results of batch and column techniques experiments showed around 46% and 67% removal of CBZ respectively.

Keywords: Azraq bentonite, carbamazepine, pharmaceutical wastewater, zeolite.

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Authors: Zeeshan Hamid, Asher Ramish

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The purpose of this paper is to focus on security and safety issues facing by pharmaceutical industry globally when counterfeit drugs are in question. Hence, there is an intense need to secure and authenticate pharmaceutical products in the emerging counterfeit product market. This paper will elaborate the application of radio frequency identification (RFID) in pharmaceutical industry and to identify its key benefits for patient’s care. The benefits are: help to co-ordinate the stream of supplies, accuracy in chains of supplies, maintaining trustworthy information, to manage the operations in appropriate and timely manners and finally deliver the genuine drug to patient. It is discussed that how RFID supported supply chain information sharing (SCIS) helps to combat against counterfeit drugs. And a solution how to tag pharmaceutical products; since, some products prevent RFID implementation in this industry. In this paper, a proposed model for pharma industry distribution suggested to combat against the counterfeit drugs when they are in supply chain.

Keywords: Supply chain, RFID, pharmaceutical industry, counterfeit drugs, patients care.

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Authors: Merita Dauti, Edita Alili-Idrizi, Sihana Ahmeti–Lika, Ledjan Malaj

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The extermination and proper disposal of pharmaceutical wastes from expired and unused medications remains a disputable issue due to their specific nature and characteristics. Even though the hazards from these wastes are already well known in terms of environment and human health, people still treat them as usual wastes. At a national level, in many countries the management of pharmaceutical and medical wastes has been one of the main objectives in order to protect people’s health and the environment. Even though many legal regulations exist in this respect, there has not been a single law that would clearly explain the procedures of returning medicines, ways of selection, treatment and extermination of pharmaceutical wastes. This paper aims at analyzing the practices of pharmaceutical waste management and treatment in some European countries as well as a review of the legislation and official guidelines in managing these kinds of wastes and protecting the environment and human health. A suitable treatment and management of expired medications and other similar wastes would be in the interest of public health in the first place, as well as in the interest of healthcare institutions and other bodies engaged in environment protection.

Keywords: Pharmaceutical waste, legal regulation, proper disposal, environment pollution.

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Authors: M. Bernasconi, M. Grothkopp, T. Friedli

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The objective of this paper is to examine the relationships between technical and social lean bundles as well as operational performance in the context of the pharmaceutical industry. We investigate the direct and mediating effects of the lean bundles Total Productive Maintenance (TPM), Total Quality Management (TQM), Just-In-Time (JIT), and Human Resource Management (HRM) on operational performance. Our analysis relies on 113 manufacturing facilities from the St.Gallen OPEX benchmarking database. The results show that HRM has a positive indirect effect on operational performance mediated by the technical lean bundles.

Keywords: Human resource management, operational performance, pharmaceutical industry, technical lean practices.

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Authors: Ilham Benali, Nasser Hajji, Nawfal Acha

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Given the fact that the pharmaceutical industry is a commonly studied sector in the context of innovation, the majority of innovation research is devoted to the developed markets known by high research and development (R&D) assets and intensive innovation. In contrast, in developing countries where R&D assets are very low, there is relatively little research to mention in the area of pharmaceutical sector innovation, characterized mainly by two principal elements which are the presence of foreign-owned firms and licensed manufacturing agreements between local firms and multinationals. With the scarcity of research in this field, this paper attempts to study the effect of these two elements on the firms’ innovation tendencies. Other traditional factors that influence innovation, which are the age and the size of the firm, the R&D activities and the market structure, revealed in the literature review, will be included in the study in order to try to make this work more exhaustive. The study starts by examining innovation tendency in pharmaceutical firms located in developing countries before analyzing the effect of foreign-owned firms and licensed manufacturing agreements between local firms and multinationals on technological, organizational and marketing innovation. Based on the related work and on the theoretical framework developed, there is a probability that foreign-owned firms and licensed manufacturing agreements between local firms and multinationals have a negative influence on technological innovation. The opposite effect is possible in the case of organizational and marketing innovation.

Keywords: Developing countries, foreign owned firms, innovation, licensed manufacturing agreements, pharmaceutical industry.

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Authors: Faisal Ali, Mansoor Shuakat, Lirong Cui, Helena Uhde, Rabia Riasat, Janeth J. Marwa

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HR is a department that enhances the power of employee performance in regard with their services, and to make the organization strategic objectives. The main concern of HR department is to organize people, focus on policies and their system. The empirical study shows the relationship between HRM (Human Resource Management practices) and their Job Satisfaction. The Hypothesis is testing on a sample of overall 320 employees of 5 different Pharmaceutical departments of different organizations in Pakistan. The important thing as Relationship of Job satisfaction with HR Practices, Impact on Job Satisfaction with HR Practices, Participation of Staff of Different Departments, HR Practices effects the Job satisfaction, Recruitment or Hiring and Selection effects the Job satisfaction, Training and Development, Performance and Appraisals, Compensation affects the Job satisfaction , and Industrial Relationships affects the Job satisfaction. After finishing all data analysis, the conclusion is that lots of Job related activities raise the confidence of Job satisfaction of employees with their salary and other benefits.

Keywords: HRM, HR practices, job satisfaction, TQM.

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Authors: M. Kumpugdee-Vollrath, T. Subongkot, T. Ngawhirunpat

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In this project we are interested in studying different kinds of shed snake skins in order to apply them as a model membrane for pharmaceutical purposes instead of human stratum corneum. Many types of shed snake skins as well as model drugs were studied by different techniques. The data will give deeper understanding about the interaction between drugs and model membranes and may allow us to choose the suitable model membrane for studying the effect of pharmaceutical products.

Keywords: DSC, FTIR, permeation, SAXS, shed snake skin.

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Authors: Jingming Wu, Junqi Yue, Ruikang Hu, Zhaoguang Yang, Lifeng Zhang

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Fecal coliform bacteria are widely used as indicators of sewage contamination in surface water. However, there are some disadvantages in these microbial techniques including time consuming (18-48h) and inability in discriminating between human and animal fecal material sources. Therefore, it is necessary to seek a more specific indicator of human sanitary waste. In this study, the feasibility was investigated to apply caffeine and human pharmaceutical compounds to identify the human-source contamination. The correlation between caffeine and fecal coliform was also explored. Surface water samples were collected from upstream, middle-stream and downstream points respectively, along Rochor Canal, as well as 8 locations of Marina Bay. Results indicate that caffeine is a suitable chemical tracer in Singapore because of its easy detection (in the range of 0.30-2.0 ng/mL), compared with other chemicals monitored. Relative low concentrations of human pharmaceutical compounds (< 0.07 ng/mL) in Rochor Canal and Marina Bay water samples make them hard to be detected and difficult to be chemical tracer. However, their existence can help to validate sewage contamination. In addition, it was discovered the high correlation exists between caffeine concentration and fecal coliform density in the Rochor Canal water samples, demonstrating that caffeine is highly related to the human-source contamination.

Keywords: Caffeine, Human Pharmaceutical Compounds, Chemical Tracer, Sewage Contamination.

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Authors: Shilpi Tyagi, D. K. Nauriyal

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This study investigates the firm level determinants of profitability of Indian drug and pharmaceutical industry. The study uses inflation adjusted panel data for a period 2000-2013 and applies OLS regression model with Driscoll-Kraay standard errors. It has been found that export intensity, A&M intensity, firm’s market power and stronger patent regime dummy have exercised positive influence on profitability. The negative and statistically significant influence of R&D intensity and raw material import intensity points to the need for firms to adopt suitable investment strategies. The study suggests that firms are required to pay far more attention to optimize their operating expenditures, advertisement and marketing expenditures and improve their export orientation, as part of the long term strategy.

Keywords: Indian drug and pharmaceutical industry, trade related intellectual property rights, research and development, food and drug administration.

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Authors: Almudena Aguinaco, Olga Gimeno, Fernando J. Beltrán, Juan José P. Sagasti

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A sequential treatment of ozonation followed by a Fenton or photo-Fenton process, using black light lamps (365 nm) in this latter case, has been applied to remove a mixture of pharmaceutical compounds and the generated by-products both in ultrapure and secondary treated wastewater. The scientifictechnological innovation of this study stems from the in situ generation of hydrogen peroxide from the direct ozonation of pharmaceuticals, and can later be used in the application of Fenton and photo-Fenton processes. The compounds selected as models were sulfamethoxazol and acetaminophen. It should be remarked that the use of a second process is necessary as a result of the low mineralization yield reached by the exclusive application of ozone. Therefore, the influence of the water matrix has been studied in terms of hydrogen peroxide concentration, individual compound concentration and total organic carbon removed. Moreover, the concentration of different iron species in solution has been measured.

Keywords: Fenton, photo-Fenton, ozone, pharmaceutical compounds, hydrogen peroxide, water treatment

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Authors: Emil Crişan, Matthias Klumpp

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This paper discusses the theory behind the existence of an idealistic model for business network governance and uses a clarifying case-study, containing governance structures and processes within a business network framework. The case study from a German pharmaceutical industry company complements existing literature by providing a comprehensive explanation of the relations between supply chains and business networks, and also between supply chain management and business network governance. Supply chains and supply chain management are only one side of the interorganizational relationships and ensure short-term performance, while real-world governance structures are needed for ensuring the long-term existence of a supply chain. Within this context, a comprehensive model for business governance is presented. An interesting finding from the case study is that multiple business network governance systems co-exist within the evaluated supply chain.

Keywords: Business network, pharmaceutical industry, supply chain governance, supply chain management.

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Authors: Balasubramanian P, Ligy Philip, S. Murty Bhallamudi

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In this study, cometabolic biodegradation of chloroform was experimented with mixed cultures in the presence of various organic solvents like methanol, ethanol, isopropanol, acetone, acetonitrile and toluene as these are predominant discharges in pharmaceutical industries. Toluene and acetone showed higher specific chloroform degradation rate when compared to other compounds. Cometabolic degradation of chloroform was further confirmed by observation of free chloride ions in the medium. An extended Haldane model, incorporating the inhibition due to chloroform and the competitive inhibition between primary substrates, was developed to predict the biodegradation of primary substrates, cometabolic degradation of chloroform and the biomass growth. The proposed model is based on the use of biokinetic parameters obtained from single substrate degradation studies. The model was able to satisfactorily predict the experimental results of ternary and quaternary mixtures. The proposed model can be used for predicting the performance of bioreactors treating discharges from pharmaceutical industries.

Keywords: Chloroform, Cometabolic biodegradation, Competitive inhibition, Extended Haldane model, Pharmaceuticalindustry.

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Authors: Hossein Tavallali, Mohammad Ali Karimi, Gohar Deilamy-Rad

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The proposed method for speciation, preconcentration and determination of Fe(II) and Fe(III) in pharmaceutical products was developed using of alumina-coated magnetite nanoparticles (Fe₃O₄/Al₂O₃ NPs) as solid phase extraction (SPE) sorbent in magnetic mixed hemimicell solid phase extraction (MMHSPE) technique followed by flame atomic absorption spectrometry analysis. The procedure is based on complexation of Fe(II) with 1, 10-phenanthroline (OP) as complexing reagent for Fe(II) that immobilized on the modified Fe₃O₄/Al₂O₃ NPs. The extraction and concentration process for pharmaceutical sample was carried out in a single step by mixing the extraction solvent, magnetic adsorbents under ultrasonic action. Then, the adsorbents were isolated from the complicated matrix easily with an external magnetic field. Fe(III) ions determined after facility reduced to Fe(II) by added a proper reduction agent to sample solutions. Compared with traditional methods, the MMHSPE method simplified the operation procedure and reduced the analysis time. Various influencing parameters on the speciation and preconcentration of trace iron, such as pH, sample volume, amount of sorbent, type and concentration of eluent, were studied. Under the optimized operating conditions, the preconcentration factor of the modified nano magnetite for Fe(II) 167 sample was obtained. The detection limits and linear range of this method for iron were 1.0 and 9.0 - 175 ng.mL⁻¹, respectively. Also the relative standard deviation for five replicate determinations of 30.00 ng.mL^-1 Fe²⁺ was 2.3%.

Keywords: Alumina-coated magnetite nanoparticles, magnetic mixed hemimicell solid-phase extraction, Fe(ΙΙ) and Fe(ΙΙΙ), pharmaceutical sample.

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Authors: S. N. H. Azmi, B. Iqbal, J. K. Al Mamari, K. A. Al Hattali, W. N. Al Hadhrami

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A simple, accurate and precise direct spectrophotometric method has been developed for the determination of cefixime in tablets and capsules. The method is based on the reaction of cefixime with a mixture of potassium iodide and potassium iodate to form yellow coloured product in ethanol-distilled water medium at room temperature which absorbed maximally at 352 nm. The factors affecting the reaction product were carefully studied and optimized. The validation parameters based on International Conference on Harmonisation (ICH, USA) guidelines were followed. The effect of common excipients used as additives has been tested and the tolerance limit was calculated for the determination of cefixime. Beer’s law is obeyed in the concentration range of 4 – 24 ug mL-1 with apparent molar absorptivity of 1.52 × 104 L mol-1cm-1 and Sandell’s sensitivity of 0.033 ug/cm2/ 0.001 absorbance unit. The limits of detection and quantitation for the proposed method are 0.32 and 1.06 ug mL-1, respectively. The proposed method has been successfully applied for the determination of cefixime in pharmaceutical formulations. The results obtained by the proposed method were statistically compared with the reference method using t- and F- values and found no significant difference between the two methods. The proposed method can be used as an alternate method for routine quality control analysis of cefixime in pharmaceutical formulations.

Keywords: Spectrophotometry, cefixime, validation, pharmaceutical formulations.

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Authors: F. Isada, Y. Isada

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The aim of this research is to clarify the difference by industry segment or product characteristics as regards organisation management for an open innovation to raise R&D performance. In particular, the trait of the pharmaceutical industry is defined in comparison with IT component industry segment. In considering open innovation, both inter-organisational relation and the management in an organisation are important issues. As methodology, a questionnaire was conducted. In conclusion, suitable organisation management according to the difference in industry segment or product characteristics became clear.

Keywords: Empirical study, industry segment, open innovation, product-development organisation pattern.

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Authors: V.Bharathi, Jamila Patterson, R.Rajendiran

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Optimization of extraction of phenolic compounds from Avicennia marina using response surface methodology was carried out during the present study. Five levels, three factors rotatable design (CCRD) was utilized to examine the optimum combination of extraction variables based on the TPC of Avicennia marina leaves. The best combination of response function was 78.41 °C, drying temperature; 26.18°C; extraction temperature and 36.53 minutes of extraction time. However, the procedure can be promptly extended to the study of several others pharmaceutical processes like purification of bioactive substances, drying of extracts and development of the pharmaceutical dosage forms for the benefit of consumers.

Keywords: Avicennia marina, Central Composite RotatableDesign (CCRD), Response Surface Methodology, Total Phenoliccontents (TPC)

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Authors: Tommaso Adamo, Gianpaolo Ghiani, Antonio D. Grieco, Emanuela Guerriero

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Batch production plants provide a wide range of scheduling problems. In pharmaceutical industries a batch process is usually described by a recipe, consisting of an ordering of tasks to produce the desired product. In this research work we focused on pharmaceutical production processes requiring the culture of a microorganism population (i.e. bacteria, yeasts or antibiotics). Several sources of uncertainty may influence the yield of the culture processes, including (i) low performance and quality of the cultured microorganism population or (ii) microbial contamination. For these reasons, robustness is a valuable property for the considered application context. In particular, a robust schedule will not collapse immediately when a cell of microorganisms has to be thrown away due to a microbial contamination. Indeed, a robust schedule should change locally in small proportions and the overall performance measure (i.e. makespan, lateness) should change a little if at all. In this research work we formulated a constraint programming optimization (COP) model for the robust planning of antibiotics production. We developed a discrete-time model with a multi-criteria objective, ordering the different criteria and performing a lexicographic optimization. A feasible solution of the proposed COP model is a schedule of a given set of tasks onto available resources. The schedule has to satisfy tasks precedence constraints, resource capacity constraints and time constraints. In particular time constraints model tasks duedates and resource availability time windows constraints. To improve the schedule robustness, we modeled the concept of (a, b) super-solutions, where (a, b) are input parameters of the COP model. An (a, b) super-solution is one in which if a variables (i.e. the completion times of a culture tasks) lose their values (i.e. cultures are contaminated), the solution can be repaired by assigning these variables values with a new values (i.e. the completion times of a backup culture tasks) and at most b other variables (i.e. delaying the completion of at most b other tasks). The efficiency and applicability of the proposed model is demonstrated by solving instances taken from a real-life pharmaceutical company. Computational results showed that the determined super-solutions are near-optimal.

Keywords: Constraint programming, super-solutions, robust scheduling, batch process, pharmaceutical industries.

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Authors: Patiparn Punyapalakul, Thitikamon Sitthisorn

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Ciprofloxacin (CIP) and Carbamazepine (CBZ), nonbiodegradable pharmaceutical residues, were become emerging pollutants in several aquatic environments. The objectives of this research were to study the possibility to recover these pharmaceuticals residues from pharmaceutical wastewater by increasing the selective adsorption on synthesized functionalized porous silicate, comparing with powdered activated carbon (PAC). Hexagonal mesoporous silicate (HMS), functionalized HMSs (3- aminopropyltriethoxy, 3- mercaptopropyltrimethoxy and noctyldimethyl) were synthesized and characterized physico-chemical characteristics. Obtained adsorption kinetics and isotherms showed that 3-mercaptopropyltrimethoxy functional groups grafted on HMS provided highest CIP and CBZ adsorption capacities; however, it was still lower than that of PAC. The kinetic results were compatible with pseudo-second order. The hydrophobicity and hydrogen bonding might play a key role on the adsorption. Furthermore, the capacities were affected by varying pH values due to the strength of hydrogen bonding between targeted compounds and adsorbents. Electrostatic interaction might not affect the adsorption capacities.

Keywords: Adsorption, Carbamazepine, Ciprofloxazin, Mesoporous Silicates, Surface functional groups

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Authors: M. A. Okezue, K. L. Clase, S. R. Byrn, P. Shivanand

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Medicines regulatory authorities expect pharmaceutical companies and contract research organizations to seek ways to certify that their laboratory control measurements are reliable. Establishing and maintaining laboratory quality standards are essential in ensuring the accuracy of test results. ‘ISO/IEC 17025:2017’ and ‘WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL)’ are two quality standards commonly employed in developing laboratory quality systems. A review was conducted on the two standards to elaborate on areas on convergence and divergence. The goal was to understand how differences in each standard's requirements may influence laboratories' choices as to which document is easier to adopt for quality systems. A qualitative review method compared similar items in the two standards while mapping out areas where there were specific differences in the requirements of the two documents. The review also provided a detailed description of the clauses and parts covering management and technical requirements in these laboratory standards. The review showed that both documents share requirements for over ten critical areas covering objectives, infrastructure, management systems, and laboratory processes. There were, however, differences in standard expectations where GPPQCL emphasizes system procedures for planning and future budgets that will ensure continuity. Conversely, ISO 17025 was more focused on the risk management approach to establish laboratory quality systems. Elements in the two documents form common standard requirements to assure the validity of laboratory test results that promote mutual recognition. The ISO standard currently has more global patronage than GPPQCL.

Keywords: ISO/IEC 17025:2017, laboratory standards, quality control, WHO GPPQCL

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Authors: R. S. Chandan, M. Vasudevan, Deecaraman, B. M. Gurupadayya

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In Pharmaceutical industries, it is very important to remove drug residues from the equipment and areas used. The cleaning procedure must be validated, so special attention must be devoted to the methods used for analysis of trace amounts of drugs. A rapid, sensitive and specific reverse phase ultra performance liquid chromatographic (UPLC) method was developed for the quantitative determination of Albendazole in cleaning validation swab samples. The method was validated using an ACQUITY HSS C₁₈, 50 x 2.1mm, 1.8μ column with a isocratic mobile phase containing a mixture of 1.36g of Potassium dihydrogenphosphate in 1000mL MilliQ water, 2mL of triethylamine and pH adjusted to 2.3 ± 0.05 with ortho-phosphoric acid, Acetonitrile and Methanol (50:40:10 v/v). The flow rate of the mobile phase was 0.5 mL min^-1 with a column temperature of 35⁰C and detection wavelength at 254nm using PDA detector. The injection volume was 2µl. Cotton swabs, moisten with acetonitrile were used to remove any residue of drug from stainless steel, teflon, rubber and silicon plates which mimic the production equipment surface and the mean extraction-recovery was found to be 91.8. The selected chromatographic condition was found to effectively elute Albendazole with retention time of 0.67min. The proposed method was found to be linear over the range of 0.2 to 150µg/mL and correlation coefficient obtained is 0.9992. The proposed method was found to be accurate, precise, reproducible and specific and it can also be used for routine quality control analysis of these drugs in biological samples either alone or in combined pharmaceutical dosage forms.

Keywords: Cleaning validation, Albendazole, residues, swab analysis, UPLC.

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Authors: Bita Mashayekhi, Seyed Meisam Tabatabaie Nasab

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Intellectual capital is one of the most valuable and important parts of the intangible assets of enterprises especially in knowledge-based enterprises. With respect to increasing gap between the market value and the book value of the companies, intellectual capital is one of the components that can be placed in this gap. This paper uses the value added efficiency of the three components, capital employed, human capital and structural capital, to measure the intellectual capital efficiency of Iranian industries groups, listed in the Tehran Stock Exchange (TSE), using a 8 years period data set from 2005 to 2012. In order to analyze the effect of intellectual capital on the market-to-book value ratio of the companies, the data set was divided into 10 industries, Banking, Pharmaceutical, Metals & Mineral Nonmetallic, Food, Computer, Building, Investments, Chemical, Cement and Automotive, and the panel data method was applied to estimating pooled OLS. The results exhibited that value added of capital employed has a positive significant relation with increasing market value in the industries, Banking, Metals & Mineral Nonmetallic, Food, Computer, Chemical and Cement, and also, showed that value added efficiency of structural capital has a positive significant relation with increasing market value in the Banking, Pharmaceutical and Computer industries groups. The results of the value added showed a negative relation with the Banking and Pharmaceutical industries groups and a positive relation with computer and Automotive industries groups. Among the studied industries, computer industry has placed the widest gap between the market value and book value in its intellectual capital.

Keywords: Capital Employed, Human Capital, Intellectual Capital, Market-to-Book Value, Structural Capital, Value Added Efficiency.

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Authors: Nikola Vlahovic, Blazenka Knezevic, Petra Batalic

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In this paper, we will present a research about feasibility of implementing unmanned aerial vehicles, also known as 'drones', in logistics. Research is based on available information about current incentives and experiments in application of delivery drones in commercial use. Overview of current pilot projects and literature, as well as an overview of detected challenges, will be compiled and presented. Based on these findings, we will present a conceptual model of business process that implements delivery drones in business to business logistic operations. Business scenario is based on a pharmaceutical supply chain. Simulation modeling will be used to create models for running experiments and collecting performance data. Comparative study of the presented conceptual model will be given. The work will outline the main advantages and disadvantages of implementing unmanned aerial vehicles in delivery services as a supplementary distribution channel along the supply chain.

Keywords: Business process, delivery drones, logistics, simulation modelling, unmanned aerial vehicles.

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Authors: M. Kumpugdee-Vollrath, J.-P. Krause, S. Bürk

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Most of the drugs used for pharmaceutical purposes are poorly water-soluble drugs. About 40% of all newly discovered drugs are lipophilic and the numbers of lipophilic drugs seem to increase more and more. Drug delivery systems such as nanoparticles, micelles or liposomes are applied to improve their solubility and thus their bioavailability. Besides various techniques of solubilization, oil-in-water emulsions are often used to incorporate lipophilic drugs into the oil phase. To stabilize emulsions surface active substances (surfactants) are generally used. An alternative method to avoid the application of surfactants was of great interest. One possibility is to develop O/W-emulsion without any addition of surface active agents or the so called “surfactant-free emulsion or SFE”. The aim of this study was to develop and characterize SFE as a drug carrier by varying the production conditions. Lidocaine base was used as a model drug. The injection method was developed. Effects of ultrasound as well as of temperature on the properties of the emulsion were studied. Particle sizes and release were determined. The long-term stability up to 30 days was performed. The results showed that the surfactant-free O/W emulsions with pharmaceutical oil as drug carrier can be produced.

Keywords: Emulsion, lidocaine, Miglyol, size, surfactant, light scattering, release, injection, ultrasound, stability.

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Authors: M. Peña Aguilar Juan, Ríos Hernández Ezequiel, R. Valencia Luis

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For certification, certain goods of public interest, such as medicines and food, it is required the preparation and delivery of a dossier. For its elaboration, legal and administrative knowledge must be taken, as well as organization of the documents of the process, and an order that allows the file verification. Therefore, a virtual platform was developed to support the process of management and elaboration of the dossier, providing accessibility to the information and interfaces that allow the user to know the status of projects. The development of dossier system on the cloud allows the inclusion of the technical requirements for the software management, including the validation and the manufacturing in the field industry. The platform guides and facilitates the dossier elaboration (report, file or history), considering Mexican legislation and regulations, it also has auxiliary tools for its management. This technological alternative provides organization support for documents and accessibility to the information required to specify the successful development of a dossier. The platform divides into the following modules: System control, catalog, dossier and enterprise management. The modules are designed per the structure required in a dossier in those areas. However, the structure allows for flexibility, as its goal is to become a tool that facilitates and does not obstruct processes. The architecture and development of the software allows flexibility for future work expansion to other fields, this would imply feeding the system with new regulations.

Keywords: Electronic dossier, technologies for management, web software, dossier elaboration, pharmaceutical industry.

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Authors: Taruna Katyal Arora, Geeta Kumari, Hari Shankar, Neelima Mishra

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Substandard and counterfeit antimalarials is a major problem in malaria endemic areas. The availability of counterfeit/ substandard medicines is not only decreasing the efficacy in patients, but it is also one of the contributing factors for developing antimalarial drug resistance. Owing to this, a pilot study was conducted to survey quality of drugs collected from different malaria endemic areas of India. Artesunate+Sulphadoxine-Pyrimethamine (AS+SP), Artemether-Lumefantrine (AL), Chloroquine (CQ) tablets were randomly picked from public health facilities in selected states of India. The quality of antimalarial drugs from these areas was assessed by using Global Pharma Health Fund Minilab test kit. This includes physical/visual inspection and disintegration test. Thin-layer chromatography (TLC) was carried out for semi-quantitative assessment of active pharmaceutical ingredients. A total of 45 brands, out of which 21 were for CQ, 14 for AL and 10 for AS+SP were tested from Uttar Pradesh (U.P.), Mizoram, Meghalaya and Gujrat states. One out of 45 samples showed variable disintegration and retension factor. The variable disintegration and retention factor which would have been due to substandard quality or other factors including storage. However, HPLC analysis confirms standard active pharmaceutical ingredient, but may be due to humid temperature and moisture in storage may account for the observed result.

Keywords: Antimalarial medicines, counterfeit, substandard, thin layer chromatography.

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Authors: Ching - Yi Lee, I-Hsiung Tseng, Feng-Chuan Pan

Abstract:

Environment today is featured with aging population, increasing prevalence of chronic disease and complex of medical treatment. Safe use of pharmaceutics relied very much on the efforts made by both the health- related organizations and as well as the government agencies. As far as the specialization concern in providing health services to the patients, the government actively issued and implemented the divisions of medical treatment and pharmaceutical to improve the quality of care and to reduce medication errors and ensure public health. Pharmaceutical sub-sector policy has been implemented for 13 years. This study attempts to explore the factors that affect the patients- behavior intention of refilling a prescription from a NHIB pharmacy. Samples were those patients refilling their prescriptions with the case NHIB pharmacies. A self-administered questionnaire was used to collect respondents- information while the patients or family members visit the pharmacy for the refilling. 1,200 questionnaires were dispatched in 37 pharmacies that randomly selected from Pingtung City, Dongkang, Chaozhou, Hengchun areas. 732 responses were gained with 604 valid samples for further analyses. Results of data analyses indicated that respondents- attitude, subjective norm, perceived behavior control and behavior intentions toward refilling behavior varied from some demographic variables to another. This research also suggested adding actual behavior, either by a self-report or observed, into the research.

Keywords: Separation of dispensing and prescribing, prescriptions refill slip, NHIB contracted pharmacy, drug safety, theory of planned behavior.

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Authors: Dmitriy Yu. Korulkin, Raissa A. Muzychkina

Abstract:

The Ramon preparation is received from a plant; it is destined for external treatment of inflammations in post-surgery period. The Ramon is a biogenic immune stimulator accelerating metabolism, contributing to improvement of blood indexes, having general tonic, anti-inflammatory and bactericidal effect.

Keywords: Anti-inflammatory, anthraquinones, bactericidal activity, Ramon.

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Authors: Syarifah Abd Rahim, Fatinah Ab Rahman, Engku N. E. M. Nasir, Noor A. Ramle

Abstract:

Co-crystal is believed to improve the solubility and dissolution rates and thus, enhanced the bioavailability of poor water soluble drugs particularly during the oral route of administration. With the existing of poorly soluble drugs in pharmaceutical industry, the screening of co-crystal formation using carbamazepine (CBZ) as a model drug compound with dicarboxylic acids co-crystal formers (CCF) namely fumaric (FA) and succinic (SA) acids in ethanol has been studied. The co-crystal formations were studied by varying the mol ratio values of CCF to CBZ to access the effect of CCF concentration on the formation of the co-crystal. Solvent evaporation, slurry and cooling crystallization which representing the solution based method co-crystal screening were used. Based on the differential scanning calorimetry (DSC) analysis, the melting point of CBZ-SA in different ratio was in the range between 188oC-189oC. For CBZ-FA form A and CBZ-FA form B the melting point in different ratio were in the range of 174oC-175oC and 185oC-186oC respectively. The product crystal from the screening was also characterized using X-ray powder diffraction (XRPD). The XRPD pattern profile analysis has shown that the CBZ co-crystals with FA and SA were successfully formed for all ratios studied. The findings revealed that CBZ-FA co-crystal were formed in two different polymorphs. It was found that CBZ-FA form A and form B were formed from evaporation and slurry crystallization methods respectively. On the other hand, in cooling crystallization method, CBZ-FA form A was formed at lower mol ratio of CCF to CBZ and vice versa. This study disclosed that different methods and mol ratios during the co-crystal screening can affect the outcome of co-crystal produced such as polymorphic forms of co-crystal and thereof. Thus, it was suggested that careful attentions is needed during the screening since the co-crystal formation is currently one of the promising approach to be considered in research and development for pharmaceutical industry to improve the poorly soluble drugs.

Keywords: Carbamazepine, co-crystal, co-crystal former, dicarboxylic acid.

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Authors: Luciana Montera

Abstract:

DNA shuffling is a powerful method used for in vitro evolute molecules with specific functions and has application in areas such as, for example, pharmaceutical, medical and agricultural research. The success of such experiments is dependent on a variety of parameters and conditions that, sometimes, can not be properly pre-established. Here, two computational models predicting DNA shuffling results is presented and their use and results are evaluated against an empirical experiment. The in silico and in vitro results show agreement indicating the importance of these two models and motivating the study and development of new models.

Keywords: Computer simulation, DNA shuffling, in silico andin vitro comparison.

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