Search results for: pharmaceutical supplement

Authors: Radia Chemlal, Youcef Hamidi, Nabil Mameri

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This study deals with the production of biosurfactant by the Pseudomonas luteola strain on three different culture media (semi-synthetic medium M1, whey, and pharmaceutical reject) in the presence of gasoil. The monitoring of bacterial growth by measuring the optical density at 600 nm by spectrophotometer and the surface tension clearly showed the ability of Pseudomonas luteola to produce biosurfactants at various conditions of the culture medium. The biosurfactant produced in the pharmaceutical reject medium generated a decrease in the surface tension with a percentage of 19.4% greater than the percentage obtained when using whey which is 7.0%. The pharmaceutical rejection is diluted at various percentages ranging from 5% to 100% in order to study the effect of the concentration on the biosurfactant production. The best result inducing the great reduction of the surface tension value is obtained at the dilution of 30% with the pharmaceutical reject.

Keywords: biosurfactant, pseudomonas luteola, whey, antiscorpionic serum, gas oil

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Authors: J. D. Villanueva, N. Peyraube, I. Allan, G. D. Salvosa, M. Reid, C. Harman, K. D. Salvosa, J. M. V. Castro, M. V. O. Espaldon, J. B. Sevilla-Nastor, P. Le Coustumer

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The main objectives of this research are to (1) assess the occurrence of the pharmaceutical compounds and (2) present the environmental challenges posed by the existence of these pharmaceutical compounds in the surface water. These pharmaceuticals were measured in Napindan Lake, Philippines. This lake is not only a major tributary of the Pasig River (an estuary) and Laguna Lake (freshwater). It also joins these two important surface waters of the National Capital Region. Pharmaceutical compounds such as Atenolol, Carbamazepine, and two other over the counter medicines: Cetirizine, and Ibuprofen were measured in Napindan Lake. Atenolol is a beta blocker that helps in lowering hypertensions. Carbamazepine is an anticonvulsant used as treatment for epilepsy and neuropathic pain. Cetirizine is an antihistamine that can relieve allergies. Ibuprofen is a non-steroidal anti-inflammatory drug normally used to relieve pains. Three different climatological conditions with corresponding hydro physico chemical characteristics were considered. First, was during a dry season with a simultaneous dredging. Second was during a transition period from dry to wet season. Finally, the third was during a continuous wet event. Based from the results of the study, most of these pharmaceuticals can be found in Napindan Lake. This is a proof that these pharmaceutical compounds are being released to a natural surface water. Even though climatological conditions were different, concentrations of these pharmaceuticals can still be detected. This implies that there is an incessant supply of these pharmaceutical compounds in Napindan Lake. Chronic exposure to these compounds even at low concentrations can lead to possible environmental and health risks. Given this information and since consistent occurrence of these compounds can be expected, the main challenge, at present, is on how to control the sources of these pharmaceutical compounds. Primarily, there is a need to manage the disposal of the pharmaceutical compounds. Yet, the main question is how to? This study would like to present the challenges and institutional roles in helping manage the pharmaceutical disposals in a developing country like the Philippines.

Keywords: atenolol, carbamazepine, cetirizine, ibuprofen, institutional roles, Napindan lake, pharmaceutical compound disposal management, surface water, urban lake

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Authors: Sameena Malik, Ghosh Prakash, Sandeep Mudliar, Vishal Waindeskar, Atul Vaidya

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In this study, the biodegradability enhancement along with COD color and toxicity removal of pharmaceutical effluent by O₃, O₃/Fe²⁺, O₃/nZVI processes has been evaluated. The nZVI particles were synthesized and characterized by XRD and SEM analysis. Kinetic model was reasonably developed to select the ozone doses to be applied based on the ozonation kinetic and mass transfer coefficient values. Nano catalytic ozonation process (O₃/nZVI) effectively enhanced the biodegradability (BI=BOD₅/COD) of pharmaceutical effluent up to 0.63 from 0.18 of control with a COD, color and toxicity removal of 62.3%, 93%, and 75% respectively compared to O₃, O₃/Fe²⁺ pretreatment processes. From the GC-MS analysis, 8 foremost organic compounds were predominantly detected in the pharmaceutical effluent. The disappearance of the corresponding GC-MS spectral peaks during catalyzed ozonation process indicated the degradation of the effluent. The changes in the FTIR spectra confirms the transformation/destruction of the organic compounds present in the effluent to new compounds. Subsequent aerobic biodegradation of pretreated effluent resulted in biodegradation rate enhancement by 5.31, 2.97, and 1.22 times for O₃, O₃/Fe²⁺ and O₃/nZVI processes respectively.

Keywords: iron nanoparticles, pharmaceutical effluent, ozonation, kinetics, mass transfer

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Authors: Ilham Benali, Nasser Hajji, Nawfel Acha

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The pharmaceutical sector is ongoing different constraints related to the Research and Development (R&D) costs, the patents extinction, the demand pressing, the regulatory requirement and the generics development, which drive leading firms in the sector to undergo technological change and to shift to biotechnological paradigm. Based on a large literature review, we present a background of innovation trajectory in pharmaceutical industry and reasons behind this technological transformation. Then we investigate the role that Information and Communication Technology (ICT) is playing in this revolution. In order to situate pharmaceutical firms in developing countries in this trajectory, and to examine the degree of their involvement in the innovation process, we did not find any previous empirical work or sources generating gathered data that allow us to analyze this phenomenon. Therefore, and for the case of Morocco, we tried to do it from scratch by gathering relevant data of the last five years from different sources. As a result, only about 4% of all innovative drugs that have access to the local market in the mentioned period are made locally which substantiates that the industrial model in pharmaceutical sector in developing countries is based on the 'license model'. Finally, we present another alternative, based on ICT use and big data tools that can allow developing countries to shift from status of simple consumers to active actors in the innovation process.

Keywords: biotechnologies, developing countries, innovation, information and communication technology, pharmaceutical firms

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Authors: G. O. Fakunmoju, F. A. Fakunmoju

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The experiment was conducted to evaluate the growth response of African giant catfish (Clarias gariepinus) fed with varying levels of Galawaste based diet, 300 clarias gariepinus fingerlings with mean body weight 10 ± 0.1g were assigned to five (treatment levels in which Gala waste meal replaced maize at 0, 25, 50, 75, 100% respectively in a completely randomized design. The trial fish were fed at 5% body weight daily for a period of 84 days. Data collected showed that body weight gain increased with an increase gala waste meal in the diet (P<0.05). The similar observation was recorded for feed intake but there was no significant (P>0.05) difference in feed conversion ratio among the treatments. All the fish fed the test ingredients performed better than the control groups hence, Gala waste meal could be recommended as a dietary supplement in the diet of African Giant Catfish.

Keywords: Galawaste meal, Clarias gariepinus, replacement, growth performance, diets

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Authors: Shahin Mirshekari, Mohammadreza Moradi, Hossein Jafari, Mehdi Jafari, Mohammad Ensaf

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This research employs Gaussian Process Regression (GPR) with an ensemble kernel, integrating Exponential Squared, Revised Matern, and Rational Quadratic kernels to analyze pharmaceutical sales data. Bayesian optimization was used to identify optimal kernel weights: 0.76 for Exponential Squared, 0.21 for Revised Matern, and 0.13 for Rational Quadratic. The ensemble kernel demonstrated superior performance in predictive accuracy, achieving an R² score near 1.0, and significantly lower values in MSE, MAE, and RMSE. These findings highlight the efficacy of ensemble kernels in GPR for predictive analytics in complex pharmaceutical sales datasets.

Keywords: Gaussian process regression, ensemble kernels, bayesian optimization, pharmaceutical sales analysis, time series forecasting, data analysis

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Authors: Ivan Zupan, Tomislav Saric, Suzana Tkalcic

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IMUNO-2865® is a commercially available, β–glucan based, natural hemicellulose compound with proven immunostimulative properties in people, domestic and some aquatic animals. During the experimental feeding trial with IMUNO-2865® in juvenile wild-caught chub under laboratory conditions, supplementation resulted in overall higher growth performance for all experimental groups regardless of the concentration of the added compound. The maximum, 5% concentration of the supplement, resulted in highest weight gain and calculated specific growth rate. In sea bream, as economically most important species in the Mediterranean aquaculture, significant increases in numbers of monocytes and heterophils were observed in the group supplemented with 2.5 % of IMUNO-2865® in the feed. An overall increase of erythrocytes was noted by the end of the experiment, although with variable distribution among groups. Blood Ca++ levels, total proteins, and total NH₃ were significantly higher after 60 days of feeding in all treatment groups compared to the control and remained elevated in the treated group following the secession of supplementation. Superoxide dismutase (SOD), glutathione peroxidase (GSH-Px) and serum paraoxonase PON1 (U/L) showed similar trends. All these parameters are playing a significant role in either oxygen supplementation of tissues, or anabolic and catabolic processes that on molecular levels contribute to the overall health and immune-building capacity of cells and tissues. The complete lack of mortality in sea bream and presented increases in cellular, biochemical and oxidative stress parameters in the blood suggest that the IMUNO-2865® represents a safe dietary supplement for in aquaculture, with an overall positive and potentially immunostimulative effect on farmed fish.

Keywords: IMUNO-2865®, β–glucans, Mediterranean aquaculture, fish imunnostimulans

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Authors: Bernasconi Matteo, Grothkopp Mark, Friedli Thomas

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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: P. Pasomboon, P. Chumnanpuen, T. E-kobon

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Hyaluronic acid (HA) consists of linear heteropolysaccharides repeat of D-glucuronic acid and N-acetyl-D-glucosamine. HA has various useful properties to maintain skin elasticity and moisture, reduce inflammation, and lubricate the movement of various body parts without causing immunogenic allergy. HA can be found in several animal tissues as well as in the capsule component of some bacteria including Pasteurella multocida. This study aimed to modify a genome-scale metabolic model of Escherichia coli using computational simulation and flux analysis methods to predict HA productivity under different carbon sources and nitrogen supplement by the addition of two enzymes (GLMU2 and HYAD) from P. multocida to improve the HA production under the specified amount of carbon sources and nitrogen supplements. Result revealed that threonine and aspartate supplement raised the HA production by 12.186%. Our analyses proposed the genome-scale metabolic model is useful for improving the HA production and narrows the number of conditions to be tested further.

Keywords: Pasteurella multocida, Escherichia coli, hyaluronic acid, genome-scale metabolic model, bioinformatics

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Authors: Mohammad Salem Abdullah Alhwaiti

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This study was conducted to assess the physical, chemical, and radionuclide concentrations of pharmaceutical industrial wastewater effluents. Fourteen wastewater samples were collected from pharmaceutical industries. The results showed a marked reduction in the levels of TH, Mg, and Ca concentration in wastewater limit for properties and criteria for discharge of wastewater to streams or wadies or water bodies in the effluent, whereas TSS and TDS showed higher concentration allowable for discharge of wastewater to streams or wadies or water bodies. The gross α activity in all the wastewater samples ranged between (0.086-0.234 Bq/L) lowered the 0.1 Bq/L limit set by World Health Organization (WHO), whereas gross β activity in few samples ranged between (2.565-4.800 Bq/L), indicating the higher limit set by WHO. Gamma spectroscopy revealed that K-40, Cr-51, Co-60, I-131, Cs-137, and U-238 activity are ≤0.114 Bq/L, ≤0.062 Bq/L, ≤0.00815Bq/L, ≤0.00792Bq/L, ≤0.00956 Bq/L, and ≤0.151 Bq/L, respectively, indicating lowest concentrations of these radionuclides in the pharmaceutical industrial wastewater effluents.

Keywords: pharmaceutical wastewater, gross α/β activity, radionuclides, Jordan

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Authors: Johann Valentowitsch, Wolfgang Burr

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In organizational research, strategies of exploration and exploitation are often considered to be contradictory. Building on the tradeoff argument, many authors have assumed that a company's market performance should be positively dependent on its strategic balance between exploration and exploitation over time. In this study, we apply this reasoning to the pharmaceutical industry. Using exploratory regression analysis we show that the long-term market performance of a pharmaceutical company is linked to both its ability to carry out exploratory projects and its ability to develop exploitative competencies. In particular, our findings demonstrate that, on average, the company's annual sales performance is higher the better the strategic alignment between exploration and exploitation is balanced. The contribution of our research is twofold. On the one hand, we provide empirical evidence for the initial tradeoff hypothesis and thus support the theoretical position of those who understand exploration and exploitation as strategic substitutes. On the other hand, our findings show that a balanced relationship between exploration and exploitation is also important in research-intensive industries, which naturally tend to place more emphasis on exploration.

Keywords: exploitation, exploration, market performance, pharmaceutical industry, strategy

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Authors: Kanika Saxena, Sunita Balani

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Purpose - The aim of the study is to compare the reported sustainability activities in areas of emission, water management and gender equality, currently undertaken by the seven major pharmaceutical companies. Methodology: The published corporate sustainability activity reports for the year 2017 for seven pharmaceutical companies have been studied. The two main criteria for the inclusion of pharmaceutical companies in this study are that they are globally recognized and active in the field of sustainability reporting. Company’s actions and initiatives have been grouped under three categories: (i) Emissions (ii) Water management (iii) Gender Equality in terms of employee workforce. Findings: Based on the sustainability reports, quantification and grading of the companies showed interesting results. Johnson & Johnson and Bayer are leading their activities under emissions and water management categories. The number of activities under emission and water management in case of Eli Lily, Roche, Sanofi, Pfizer and GlaxoSmithKline were 19, 16, 16, 11 and 6 respectively. Johnson & Johnson and Eli Lily are leading in taking the initiatives to curb the problem of emissions as compared with other 5 companies. Under the category of gender equality in terms of employee workforce, Eli Lily is leading the group of sampled companies with 47% of women employee workforce globally followed by Sanofi with 46.2% (42.2% of managers) female employees. It has also been observed that in some of the reports, gender diversification in the workforce has not been mentioned though the total number of employees were mentioned. Conclusion: This study could serve as the informative material for future in-depth industry-specific studies in order to find out the participation of the pharmaceutical companies in the reporting of the sustainability activities especially in reference to emission, water management and gender equality in the workforce. In addition to it, this can be helpful as a reference point for other companies in the pharmaceutical sector who are yet to explore the field of sustainability initiatives and reporting. Due to the limited scope of this study, only seven major players of the pharmaceutical sector who are active in the field of sustainability have been considered.

Keywords: emission, gender equality workforce, pharmaceutical, sustainability, water management

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Authors: Mohd Sukri Hassan, Ahlam Inayatullah Badrul Munir, M. Husaini A. Rahman

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Halal authentication and verification in supplement capsules are highly required as the gelatine available in the market can be from halal or non-halal sources. It is an obligation for Muslim to consume and use the halal consumer goods. At present, real-time polymerase chain reaction (RT-PCR) is the most common technique being used for the detection of porcine and bovine DNA in gelatine due to high sensitivity of the technique and higher stability of DNA compared to protein. In this study, twenty samples of supplements capsules from different products with different Halal logos were analyzed for porcine and bovine DNA using RT-PCR. Standard bovine and porcine gelatine from eurofins at a range of concentration from 10^-1 to 10^-5 ng/µl were used to determine the linearity range, limit of detection and specificity on RT-PCR (SYBR Green method). RT-PCR detected porcine (two samples), bovine (four samples) and mixture of porcine and bovine (six samples). The samples were also tested using FT-IR technique where normalized peak of IR spectra were pre-processed using Savitsky Golay method before Principal Components Analysis (PCA) was performed on the database. Scores plot of PCA shows three clusters of samples; bovine, porcine and mixture (bovine and porcine). The RT-PCR and FT-IR with chemometrics technique were found to give same results for porcine gelatine samples which can be used for Halal authentication.

Keywords: halal, real-time PCR, gelatine, chemometrics

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Authors: Amit Das

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Background and significance of the study: Generally investors and market forecasters use financial statement for investigation while it awakens contribute to investing. The main vicinity of financial accounting and reporting practices recommends a few basic financial performance indicators, namely, return on capital employed, return on assets and earnings per share, which is associated considerably with share prices. It is principally true in case of Indian pharmaceutical companies also. Share investing is intriguing a financial risk in addition to investors look for those financial evaluations which have noteworthy shock on share price. A crucial intention of financial statement analysis and reporting is to offer information which is helpful predominantly to exterior clients in creating credit as well as investment choices. Sound financial performance attracts the investors automatically and it will increase the share price of the respective companies. Keeping in view of this, this research work investigates the impact of financial performance indicators on share price of pharmaceutical companies in India which is listed in the Bombay Stock Exchange. Methodology: This research work is based on secondary data collected from moneycontrol database on September 28, 2015 of top 101 pharmaceutical companies in India. Since this study selects four financial performance indicators purposively and availability in the database, that is, earnings per share, return on capital employed, return on assets and net profits as independent variables and one dependent variable, share price of 101 pharmaceutical companies. While analysing the data, correlation statistics, multiple regression technique and appropriate test of significance have been used. Major findings: Correlation statistics show that four financial performance indicators of 101 pharmaceutical companies are associated positively and negatively with its share price and it is very much significant that more than 80 companies’ financial performances are related positively. Multiple correlation test results indicate that financial performance indicators are highly related with share prices of the selected pharmaceutical companies. Furthermore, multiple regression test results illustrate that when financial performances are good, share prices have been increased steadily in the Bombay stock exchange and all results are statistically significant. It is more important to note that sensitivity indices were changed slightly through financial performance indicators of selected pharmaceutical companies in India. Concluding statements: The share prices of pharmaceutical companies depend on the sound financial performances. It is very clear that share prices are changed with the movement of two important financial performance indicators, that is, earnings per share and return on assets. Since 101 pharmaceutical companies are listed in the Bombay stock exchange and Sensex are changed with this, it is obvious that Government of India has to take important decisions regarding production and exports of pharmaceutical products so that financial performance of all the pharmaceutical companies are improved and its share price are increased positively.

Keywords: financial performance indicators, share prices, pharmaceutical companies, India

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Authors: Asma Temagoult, Bariza Zitouni, Yassin Noui

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Cactus fruit contains different nutritional and functional components, which are used because of their benefits to human health, such as flavonoids, phenolic compounds, carotenoids and vitamins C. It has hypoglycemic and hypolipidemic action, and antioxidant properties related to anticarcinogenic, antiulcerogenic and immunomodulatory effects. The antioxidant and nutritional properties have been characterized in cactus prickly pear (Opuntia ficus-indica Mill.), cultivar yellow, grown in Arris area; Eastern of Algeria. The antioxidant properties of this cactus cultivar were higher than the others cactus cultivar in the world. The amount of fruit phenolic compounds revealed contents between 20.65 and 45.70 mg / 100 g of FW for total polyphenols and 0.519 - 0.591 mg / 100 g of FW for the flavonoids. The antioxidant activity was evaluated by DPPH radical scavenging and FRAP (ferric reducing antioxidant power) methods. The average recorded to the potassium content is about 1070 mg / 100 g of the fresh weight; sodium is 60.7 mg / 100 g of the fresh weight and 80 mg / 100g for the calcium. According to the high value of this cactus, it was considered as a good nutrient and important pharmaceutical resource. It could be used as a natural additive or substituted food supplement in many foodstuffs production, to benefit from these benefits.

Keywords: antioxidant properties, DPPH, FRAP, nutritional properties, Opuntia ficus indica

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Authors: Zeliha Ustun, Mustafa Ersoz

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In the study, a traditional herbal supplement black cumin seed (Nigella sativa) oil properties has been studied to protect the main quality parameters by a new supplement application. Black cumin seed and its oil is used as a dietary supplement and preferred traditional remedy in Africa, Asia and Middle East for centuries. Now it has been consuming by millions of people in America and Europe as natural supplements and/or phytotherapeutic agents to support immune system, asthma, allergic rinnitis etc. by the scientists’ advices. With the study, it is aimed to prove that soft gelatin capsules are a new and more practical way of usage for Nigella sativa oil that has a longer stability. With the study soft gelatin capsules formulation has been developed to protect cold pressed black cumin seed oil physicochemical properties for a longer period. The product design has been developed in laboratory and implemented in pilot scale soft gelatin capsule manufacturing. Physicochemical properties (peroxide value, free fatty acids, fatty acid composition, refractive index, iodine value, saponification value, unsaponifiable matters) of Nigella sativa oil soft gelatin capsules and Nigella sativa oil in liquid form in amber glass bottles have been compared and followed for 8 months. The main parameters for capsules and liquid form found that for free fatty acids 2.29±0.03, 3.92±0.11 % oleic acid, peroxide 23.11±1.18, 27.85±2.50 meqO2/kg, refractive index at 20 0C 1.4738±0.00, 1.4737±0.00, soap 0 ppm, moisture and volatility 0.32±0.01, 0.36±0.01 %, iodine value 123.00±0.00, 122.00±0.00 wijs, saponification value 196.25±0.46, 194.13±0.35 mg KOH/g and unsaponifiable matter 7.72±0.13, 6.88±0.36 g/kg respectively. The main fatty acids are found that linoleic acid 56.17%, oleic acid 24.64%, palmitic acid 11,94 %. As a result, it is found that cold pressed Nigella sativa oil soft gelatin capsules physicochemical properties are more stable than the Nigella sativa oil stored in glass bottles.

Keywords: black cumin seed (Nigella sativa) oil, cold press, nutritional supplements, soft gelatin capsule

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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 pharmaceutical industry, profits, TRIPS, performance

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Authors: Rebecca Pryce, Nijole Bernaitis, Andrew K. Davey, Shailendra Anoopkumar-Dukie

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Background: Warfarin is an oral anticoagulant widely used in the prevention of strokes in patients with atrial fibrillation (AF) and in the treatment and prevention of deep vein thrombosis (DVT). Regular monitoring of Internationalised Normalised Ratio (INR) is required to ensure therapeutic benefit with time in therapeutic range (TTR) used to measure warfarin control. A number of factors influence TTR including diet, concurrent illness, and drug interactions. Extensive literature exists regarding the effect of conventional medicines on warfarin control, but documented interactions relating to complementary medicines are limited. It has been postulated that fish oil and krill oil supplementation may affect warfarin due to their association with bleeding events. However, to date little is known as to whether fish and krill oil significantly alter the incidence of bleeding with warfarin or impact on warfarin control. Aim:To assess the influence of fish oil and krill oil supplementation on warfarin control in AF and DVT patients by determining the influence of these supplements on TTR and bleeding events. Methods:A retrospective cohort analysis was conducted utilising patient information from a large private pathology practice in Queensland. AF and DVT patients receiving warfarin management by the pathology practice were identified and their TTR calculated using the Rosendaal method. Concurrent medications were analysed and patients taking no other interacting medicines were identified and divided according to users of fish oil and krill oil supplements and those taking no supplements. Study variables included TTR and the incidence of bleeding with exclusion criteria being less than 30 days of treatment with warfarin. Subject characteristics were reported as the mean and standard deviation for continuous data and number and percentages for nominal or categorical data. Data was analysed using GraphPad InStat Version 3 with a p value of <0.05 considered to be statistically significant. Results:Of the 2081 patients assessed for inclusion into this study, a total of 573 warfarin users met the inclusion criteria. Of these, 416 (72.6%) patients were AF patients and 157 (27.4%) DVT patients and overall there were 316 (55.1%) male and 257 (44.9%) female patients. 145 patients were included in the fish oil/krill oil group (supplement) and 428 were included in the control group. The mean TTR of supplement users was 86.9% and for the control group 84.7% with no significant difference between these groups. Control patients experienced 1.6 times the number of minor bleeds per person compared to supplement patients and 1.2 times the number of major bleeds per person. However, this was not statistically significant nor was the comparison between thrombotic events. Conclusion: No significant difference was found between supplement and control patients in terms of mean TTR, the number of bleeds and thrombotic events. Fish oil and krill oil supplements when used concurrently with warfarin do not significantly affect warfarin control as measured by TTR and bleeding incidence.

Keywords: atrial fibrillation, deep vein thormbosis, fish oil, krill oil, warfarin

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Authors: Jiraporn Rojtinnakorn, Mallika Supa-Aksorn, Sudaporn Tongsiri, Prachaub Chaibu

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Marble goby is one of high demand consuming in Southeast Asia. However, the product was from riparian fisheries because of low yield in aquaculture, especially in nursery stage. Therefore, we studied for herb supplement in pellet feed of marble goby fingering. Garlic, a common herb and illustrated novel pharmaceutical and medical effectiveness, was considered. Garlic extracts with water (DW), 50% EtOH (50E), 95% EtOH (95E) and diethyl ether (DE) were subjected for feed additive to induce immune response in marble goby fingering for 0 (control), 0.3, 0.5, 1.0, 3.0 and 5.0 % (w/w). After seven days of feeding, blood was collected for analysis of blood composition; i.e. haematocrit (HCT), red blood cells (RBC), white blood cells (WBC) and humoral immune responses; i.e. lysozyme activity (Lys). It was resulted that values of HCT, WBC and Lys in all garlic fed group were significantly different from control (p < 0.05). For HCT, the highest values belonged to 5% DW and 0.5% 95E. For WBC and Lys, the highest values were 5% DW. For RBC, there was not obviously significant (p < 0.05). There were only 3 groups; 0.5% 95E, 1% and 5% DW, showed distinct statistical significance from the other groups. It was concluded that garlic extracts showed satisfy bioactivity to enhancing innate immune response in marble goby fingering. This result will be valuable for specific feed formula of marble goby nursery.

Keywords: garlic extract, innate immune, marble goby, Oxyeleotris marmoratus

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Authors: Muhammad Danyal Khan

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The standards of patentability are drawing a great impact upon medicine industry of Pakistan which is indirectly troubling the right to health of ordinary citizen. Globalization of intellectual property laws is directly impacting access to medicine for population in Pakistan. Pakistan has enacted Patent Ordinance 2000 to develop the standards of Patent laws in consonance with international commitments. Moreover, Pakistan is signatory to UN Millennium Development Goals (2000-2015), and three of them directly put stress upon the health standards. This article will provide a critical brief about implications of TRIPS Agreement on standards of health in Pakistan and will also propose a futuristic approach for the pharmaceutical industry. This paper will define the paradox of globalization and national preparedness on pharmaceutical patents utilizing industry statistics and case laws from Pakistan. Moreover, this work will contribute towards debate on access to medicine at legislative and interpretative levels that will further help development of equilibrium between pharmaceutical patents and right to health.

Keywords: TRIPS (Trade Related Intellectual Property Rights), patents, compulsory licensing, patent, lifesaving drugs, WTO, infringement

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Authors: Stephan Koehler, Thomas Friedli

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Performance measurement has evolved over time from a unidimensional short-term efficiency focused approach into a balanced multidimensional approach. Today, integrated performance measurement frameworks are often used to avoid local optimization and to encourage continuous improvement of an organization. In literature, the multidimensional characteristic of performance measurement is often described by competitive priorities. At the same time, on the highest abstraction level an effectiveness and efficiency dimension of performance measurement can be distinguished. This paper aims at a better understanding of the composition of effectiveness and efficiency and their relation in pharmaceutical quality control labs. The research comprises a lab-specific operationalization of effectiveness and efficiency and examines how the two dimensions are interlinked. The basis for the analysis represents a database of the University of St. Gallen including a divers set of 40 different pharmaceutical quality control labs. The research provides empirical evidence that labs with a high effectiveness also accompany a high efficiency. Lab effectiveness explains 29.5 % of the variance in lab efficiency. In addition, labs with an above median operational excellence performance have a statistically significantly higher lab effectiveness and lab efficiency compared to the below median performing labs.

Keywords: empirical study, operational excellence, performance measurement, pharmaceutical quality control lab

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Authors: Bindya Jacob

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The aim of the present study was to assess the quality of catchup growth induced by Oral Nutrition Supplement (ONS), in animal model of growth restriction due to under nutrition. Quality of catch-up growth was assessed by proportion of lean body mass (LBM) and fat mass (FM). Young SD rats were food restricted at 70% of normal caloric intake for 4 weeks; and re-fed at 120% of normal caloric intake for 4 weeks. Refeeding diet had 50% calories from animal diet and 50% from ONS formulated for optimal growth. After refeeding, the quantity and quality of catch-up growth were measured including weight, length, LBM and FM. During nutrient restriction, body weight and length of animals was reduced compared to healthy controls. Both LBM and FM were significantly lower than healthy controls (p < 0.001). Refeeding with ONS resulted in increase of weight and length, with significant catch-up growth compared to baseline (p < 0.001). Detailed examination of body composition showed that the catch-up in body weight was due to proportionate increase of LBM and FM, resulting in a final body composition similar to healthy controls. This data supports the use of well-designed ONS for recovery from growth restriction due to under nutrition, and return to normal growth trajectory characterized by normal ratio of lean and fat mass.

Keywords: catch up growth, body composition, nutrient restriction, healthy growth

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Authors: Alireza Barari

Abstract:

Physical activity and diet are factors that influence the body's structure. The purpose of this study was to compare the effects of four weeks of resistance training, and glutamine supplement consumption on growth hormone (GH), and Insulin-like growth factor 1 (IGF-1) Axis. 40 amateur male bodybuilders, participated in this study. They were randomly divided into four equal groups, Resistance (R), Glutamine (G), Resistance with Glutamine (RG), and Control (C). The R group was assigned to a four week resistance training program, three times/week, three sets of 10 exercises with 6-10 repetitions, at the 80-95% 1RM (One Repetition Maximum), with 120 seconds rest between sets), G group is consuming l-glutamine (0.1 g/kg^-1/day^-1), RG group resistance training with consuming L-glutamine, and C group continued their normal lifestyle without exercise training. GH, IGF1, IGFBP-III plasma levels were measured before and after the protocol. One-way ANOVA indicated significant change in GH, IGF, and IGFBP-III between the four groups, and the Tukey test demonstrated significant increase in GH, IGF1, IGFBP-III plasma levels in R, and RG group. Based upon these findings, we concluded that resistance training at 80-95% 1RM intensity, and resistance training along with oral glutamine shows significantly increase secretion of GH, IGF-1, and IGFBP-III in amateur males, but the addition of oral glutamine to the exercise program did not show significant difference in GH, IGF-1, and IGFBP-III.

Keywords: strength, glutamine, growth hormone, insulin-like growth factor 1

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Authors: Ilham Benali, Nasser Hajji, Nawfal Acha

Abstract:

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: Jing (Claire) LI

Abstract:

The topic of corporate social responsibility (CSR) is significant for pharmaceutical companies in China at this current stage. This is because, as a rapid growth industry in China in recent years, the pharmaceutical industry in China has been undergone continuous and terrible incidents relating to CSR. However, there is limited research and practice of CSR in Chinese pharmaceutical companies. Also, there is an urgent call for more research in an international context to understand the implications of corporate life cycle on CSR performance. To respond to the research need and research call, this study examines the relationship between corporate life cycle and CSR performance of Chinese listed companies in pharmaceutical industry. This research studies Chinese listed companies in pharmaceutical industry for the period of 2010-2017, where the data is available in database. Following the literature, this study divides CSR performance with regards to CSR dimensions, including shareholders, creditors, employees, customers, suppliers, the government, and the society. This study uses CSR scores of HEXUN database and financial measures of these CSR dimensions to measure the CSR performance. This study performed regression analysis to examine the relationship between corporate life cycle stages and CSR performance with regards to CSR dimensions for pharmaceutical listed companies in China. Using cash flow pattern as proxy of corporate life cycle to classify corporate life cycle stages, this study found that most (least) pharmaceutical companies in China are in maturity (decline) stage. This study found that CSR performance for most dimensions are highest (lowest) in maturity (decline) stage as well. Among these CSR dimensions, performing responsibilities for shareholder is the most important among all CSR responsibilities for pharmaceutical companies. This study is the first to provide important empirical evidence from Chinese pharmaceutical industry on the association between life cycle and CSR performance, supporting that corporate life cycle is a key factor in CSR performance. The study expands corporate life cycle and CSR literatures and has both empirical and theoretical contributions to the literature. From perspective of empirical contributions, the findings contribute to the argument that whether there is a relationship between CSR performance and various corporate life cycle stages in the literature. This study also provides empirical evidence that companies in different corporate life cycles have difference in CSR performance. From perspective of theoretical contributions, this study relates CSR and stakeholders to corporate life cycle stages and complements the corporate life cycle and CSR literature. This study has important implications for managers and policy makers. First, the results will be helpful for managers to have an understanding in the essence of CSR, and their company’s current and future CSR focus over corporate life cycle. This study provides a reference for their actions and may help them make more wise resources allocation decisions of CSR investment. Second, policy makers (in the government, stock exchanges, and securities commission) may consider corporate life cycle as an important factor in formulating future regulations for companies. Future research can explore the "process-based" differences in CSR performance and more industries.

Keywords: China, corporate life cycle, corporate social responsibility, pharmaceutical industry

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Authors: Farzad Khajavi

Abstract:

Recognition of the interaction between active pharmaceutical ingredients (API) and excipients is a pivotal factor in the development of all pharmaceutical dosage forms. By predicting the interaction between API and excipients, we will be able to prevent the advent of impurities or at least lessen their amount. In this study, we used principle component analysis (PCA) to predict the interaction between Gliclazide as a secondary amine with Lactose in pharmaceutical solid dosage forms. The infrared spectra of binary mixtures of Gliclazide with Lactose at different mole ratios were recorded, and the obtained matrix was analyzed with PCA. By plotting score columns of the analyzed matrix, the incompatibility between Gliclazide and Lactose was observed. This incompatibility was seen experimentally. We observed the appearance of the impurity originated from the Maillard reaction between Gliclazide and Lactose at the chromatogram of the manufactured tablets in room temperature and under accelerated stability conditions. This impurity increases at the stability months. By changing Lactose to Mannitol and using Calcium Dibasic Phosphate in the tablet formulation, the amount of the impurity decreased and was in the acceptance range defined by British pharmacopeia for Gliclazide Tablets. This method is a fast and simple way to predict the existence of incompatibility between excipients and active pharmaceutical ingredients.

Keywords: PCA, gliclazide, impurity, infrared spectroscopy, interaction

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Authors: Yulistiani Yulistiani, Zamrotul Izzah, Lintang Bismantara, Wenny Putri Nilamsari, Arif Bachtiar, Budi Suprapti

Abstract:

Interferon-gamma (IFN-γ) and interleukin-6 (IL-6) are pro-inflammatory cytokines, which have the protective immune response against Tuberculosis (TB). Indeed, pro-inflammatory cytokines Mycobacterium tuberculosis antigen-specific CD4+ and CD8+ T cells and NK cells increase the level of production of IFN-γ, a cytokine critical for augmenting the microbicidal activity of phagocytes. On the other hand, M. tuberculosis reduces the effects of IFN-γ by inhibiting the transcription of IFN-γ- responsive genes and by inducing the secretion of IL-6, which inhibits IFN-γ signaling. Probiotics Lactobacillus sp. and Bifidobacterium sp. were known to increase IFN-γ production in vivo, while vitamin B1, B6, and B12 worked on macrophages and releasing cytokines. Therefore, the present study was to evaluate the effect of probiotics and vitamin B supplement on changes of plasma cytokine levels in active pulmonary TB. From October to November 2016, twelve M. tuberculosis-infected patients starting anti-TB drugs were recruited, then divided into two groups. Seven patients were given a combination of probiotics and vitamin B, while five patients were in the control group. Plasma IFN-γ and IL-6 levels were measured by the ELISA kit before and a month after treatment. IFN-γ levels raised in four patients receiving the supplement (P = 0.743), while IL-6 increased in three patients in this group until day 30 of treatment (P = 0.298). Taken together, these results show the promising effect of probiotics and vitamin B on stimulation of IFN-γ and IL-6 production during intensive therapy of TB.

Keywords: interferon-gamma, interleukin-6, probiotic, tuberculosis

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Authors: J. Satya Eswari, Ch. Venkateswarlu

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The formulation of a commercial pharmaceutical product involves several composition factors and response characteristics. When the formulation requires to satisfy multiple response characteristics which are conflicting, an optimal solution requires the need for an efficient multiobjective optimization technique. In this work, a regression is combined with a non-dominated sorting differential evolution (NSDE) involving Naïve & Slow and ε constraint techniques to derive different multiobjective optimization strategies, which are then evaluated by means of a trapidil pharmaceutical formulation. The analysis of the results show the effectiveness of the strategy that combines the regression model and NSDE with the integration of both Naïve & Slow and ε constraint techniques for Pareto optimization of trapidil formulation. With this strategy, the optimal formulation at pH=6.8 is obtained with the decision variables of micro crystalline cellulose, hydroxypropyl methylcellulose and compression pressure. The corresponding response characteristics of rate constant and release order are also noted down. The comparison of these results with the experimental data and with those of other multiple regression model based multiobjective evolutionary optimization strategies signify the better performance for optimal trapidil formulation.

Keywords: pharmaceutical formulation, multiple regression model, response surface method, radial basis function network, differential evolution, multiobjective optimization

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Authors: Gule Teri

Abstract:

The effective validation of analytical methods forms a crucial component of pharmaceutical manufacturing. However, traditional validation techniques can occasionally fail to fully account for inherent variations within datasets, which may result in inconsistent outcomes. This deficiency in validation accuracy is particularly noticeable when quantifying low concentrations of active pharmaceutical ingredients (APIs), excipients, or impurities, introducing a risk to the reliability of the results and, subsequently, the safety and effectiveness of the pharmaceutical products. In response to this challenge, we introduce an enhanced, tolerance-based Design of Experiments (DoE) approach for the validation of analytical methods. This approach distinctly measures variability with reference to tolerance or design margins, enhancing the precision and trustworthiness of the results. This method provides a systematic, statistically grounded validation technique that improves the truthfulness of results. It offers an essential tool for industry professionals aiming to guarantee the accuracy of their measurements, particularly for low-concentration components. By incorporating this innovative method, pharmaceutical manufacturers can substantially advance their validation processes, subsequently improving the overall quality and safety of their products. This paper delves deeper into the development, application, and advantages of this tolerance-based DoE approach and demonstrates its effectiveness using High-Performance Liquid Chromatography (HPLC) data for verification. This paper also discusses the potential implications and future applications of this method in enhancing pharmaceutical manufacturing practices and outcomes.

Keywords: tolerance-based design, design of experiments, analytical method validation, quality control, biopharmaceutical manufacturing

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Authors: Gayathri.G, Hemamalini.A.J, Chandrasekaran.A

Abstract:

Problem statement: Nutritional deficiency, especially calcium, may lead to poor bone formation and mineralization. Although there are plenty of synthetic supplements available, it is essential to make a calcium rich food supplement accessible to combat calcium deficiency that could be readily prepared at the household level. Thus the current study aimed to formulate and standardize an indigenous low-cost calcium-rich food supplement and to study the impact of supplementation on the bone resorption and formation markers. Methods: A Randomized controlled trial was conducted with 60 subjects distributed equally in control and experimental groups, including perimenopausal and postmenopausal women. A plant-based calcium-rich product was developed and supplemented in form of balls as a midmorning and evening snack by addition of optimized proportions of leaves of Sesbania Grandiflora, seeds of Sesamum indicum, Eleusine coracana, Glycine max, Vigna mungo for a period of 6 months. Postmenopausal and perimenopausal women received 1200mg and 800mg of calcium per day from the supplemented, respectively. Outcome measures like serum calcium; betacrosslaps (bone resorption marker) and total P1NP (bone absorption marker) were assessed after 3 months and after 6 months. Results: There were no significant changes seen in the serum calcium and total P1NP levels (bone formation marker) among the subjects during the supplementation period. The bone resorption marker (betacrosslaps) reduced in all the groups and the reduction (0.32 ± 0.130 ng/ml to 0.25 ± 0.130 ng/ml) was found to be statistically highly significant (p < 0.01) in experimental group of perimenopausal subjects and significant (p < 0.05) in experimental group of postmenopausal subjects (1.11 ± 0.290 ng/ml to 0.42 ± 0.263 ng/ml). Conclusion: With the current severe calcium deficiency in the Indian population, integrating low-cost, calcium-rich native foods that could be readily prepared at household level would be useful in raising the nutritional consumption of calcium, which would, in turn, decrease bone turnover.

Keywords: calcium, sesbania grandiflora, sesamum indicum, eleusine coracana, glycine max, vigna mungo, postmenopause, perimenopause, bone resorption, bone absorption, betacrosslaps, total P1NP

Procedia PDF Downloads 110