Search results for: recalcitrant pharmaceutical

Authors: Niranjan Mukherjee, Burga Braun, Ulrich Szewzyk

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Recalcitrant pharmaceuticals are increasingly found in urban water systems forced by demographic changes. The groundwater-surface water interface, or the hyporheic zone, is known for its impressive self-purification capacity of water bodies. Redox gradients present in this zone provide a wide range of electron acceptors and harbour diverse microbial communities. Biotic transformations of pharmaceuticals in this zone have been demonstrated, but not much information is available on the kind of communities bringing about these transformations. Therefore, bioreactors using sediment from the hyporheic zone of a river in Berlin were set up and fed with iopromide, a recalcitrant iodinated X-ray contrast medium. Iopromide, who’s many oxic and anoxic transformation products have been characterized, was shown to be transformed in such a bioreactor as it passes along the gradient. Many deiodinated transformation products of iopromide could be identified at the outlet of the reactor. In our experiments, it was seen that at the same depths of the column, the transformation of iopromide increased over time. This could be an indication of the microbial communities in the sediment adapting to iopromide. The hyporheic zone, with its varying redox conditions, mainly due to the upwelling and downwelling of surface and groundwater levels, could potentially provide microorganisms with conditions for the complete transformation of recalcitrant pharmaceuticals.

Keywords: iopromide, hyporheic zone, recalcitrant pharmaceutical, redox gradients

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Authors: Saadan Man, Razidah Othmanjaludin, Madiha Baharuddin

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Nowadays, the pharmaceutical products are produced through the mixing of active and complex ingredient, naturally or synthetically; and involve extensive use of prohibited animal products. This article studies the challenges faced from fiqh perspective in the production of halal pharmaceutical products which frequently contain impure elements or prohibited animal derivatives according to Islamic law. This study is qualitative which adopts library research as well as field research by conducting series of interviews with the several related parties. The gathered data is analyzed from Sharia perspective by using some instruments especially the principle of Maqasid of Sharia. This study shows that the halal status of pharmaceutical products depends on the three basic elements: the sources of the basic ingredient; the processes involved in three phases of production, i.e., before, during and after; and the possible effects of the products. Various fiqh challenges need to be traversed in producing halal pharmaceutical products including the sources of the ingredients, the logistic process, the tools used, and the procedures of productions. Thus, the whole supply chain of production of pharmaceutical products must be well managed in accordance to the halal standard.

Keywords: fiqh, halal pharmaceutical, pharmaceutical products, Malaysia

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Authors: Sandip Sharma, Jayesh Ruparelia

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The present work focuses on the comparative study of ozone based advanced oxidation processes (AOPs): O3, O3/UV and O3/UV/Persulfate for mineralization of synthetic wastewater containing Reactive Black5 (RB5) dye. The effect of various parameters: pH, ozone flow rate, initial concentration of dye and intensity of UV light was analyzed to access performance efficiency of AOPs. The performance of all the three AOPs was evaluated on the basis of decolorization, % TOC removal and ozone consumption. The highest mineralization rate of 86.83% was achieved for O3/UV/Persulfate followed by 71.53% and 66.82 % for O3/UV and O3 respectively. This is attributed to the fact that Persulfate ions (S2O82-) upon activation produce sulfate radical (SO4-●) which is very strong oxidant capable of degrading a wide variety of recalcitrant organic compounds, moreover to enhance the performance of Persulfate it is activated using UV irradiation. On increasing the intensity of UV irradiation from 11W to 66W, TOC removal efficiency is increased by 59.04%. Ozone based AOPs gives better mineralization on basic conditions, at pH 12 it gives 68.81%, 60.01% and 40.32% TOC removal for O3/UV/Persulfate, O3/UV and O3 process respectively. The result also reveals that decolorization of 98.95%, 95.17% and 94.71% was achieved by O3/UV/Persulfate, O3/UV and O3 process respectively. In addition to above, ozone consumption was also considerably decreased by 17% in case of O3/UV/Persulfate, as efficiency of process is enhanced by means of activation of persulfate through UV irradiation. Thus study reveals that mineralization follows: O3/UV/Persulfate> O3/UV> O3.

Keywords: AOP, mineralization, TOC, recalcitrant organic compounds

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Authors: Adriana Sosa, Susana Rincon, Chérif Ben, Diana Cabañas, Juan E. Ruiz, Alejandro Zepeda

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The complex chemical composition (mixtures of ammonium and recalcitrant compounds) of the effluents from the chemical, pharmaceutical and petrochemical industries represents a challenge in their biological treatment. This treatment involves nitrification process that can suffer an inhibition due to the presence of aromatic compounds giving as a result the decrease of the process efficiency. The inhibitory effects on nitrification in the presence of aromatic compounds have already been studied; however a few studies have considered the presence of phenolic compounds in the form of mixtures, which is the form that they are present in real context. For this reason, we realized a kinetic study on the nitrifying process in the presence of different concentrations of a mixture of phenol, o-cresol, m-cresol and p-cresol (0 - 320 mg C/L) in a sequencing batch reactor (SBR). Firstly, the nitrifying process was evaluated in absence of the phenolic mixture (control 1) in a SBR with 2 L working volume and 176 mg/L of nitrogen of microbial protein. Total oxidation of initial ammonium (efficiency; ENH4+ of 100 %) to nitrate (nitrifying yield; YNO3- of 0.95) were obtained with specific rates of ammonium consumption (qN-NH4+) and nitrate production (qN-NO3-) (of 1.11 ± 0.04 h-1 and 0.67 h-1 ± 0.11 respectively. During the phase of acclimation with 40 mg C/L of the phenolic mixture, an inhibitory effect on the nitrifying process was observed, provoking a decrease in ENH4+ and YNO3- (11 and 54 % respectively) as well as in the specific rates (89 y 46 % respectively), being the ammonia oxidizing bacteria (BAO) the most affected. However, in the next cycles without the phenolic mixture (control 2), the nitrifying consortium was able to recover its nitrifying capacity (ENH4+ = 100% and YNO3-=0.98). Afterwards the SBR was fed with 10 mg C/L of the phenolic mixture, obtaining and ENH4+ of 100%, YNO3- and qN-NH4+ 0.62 ± 0.006 and 0.13 ± 0.004 respectively, while the qN-NO3- was 0.49 ± 0.007. Moreover, with the increase of the phenolic concentrations (10-160 mg C/L) and the number of cycles the nitrifying consortium was able to oxidize the ammonia with ENH4+ of 100 % and YNO3- close to 1. However a decrease in the values of the nitrification specific rates and increase in the oxidation in phenolic compounds (70 to 94%) were observed. Finally, in the presence of 320 mg C/L, the nitrifying consortium was able to simultaneously oxidize the ammonia (ENH4+= 100%) and the phenolic mixture (p-cresol>phenol>m-cresol>o-cresol) being the o-cresol the most recalcitrant compound. In all the experiments the use of a SBR allowed a respiratory adaptation of the consortium to oxidize the phenolic mixture achieving greater adaptation of the nitrite-oxidizing bacteria (NOB) than in the ammonia-oxidizing bacteria (AOB).

Keywords: cresol, inhibition, nitrification, phenol, sequencing batch reactor

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Authors: Ekta Pandey

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The Indian Pharmaceutical Industry is ranked third largest by volume and fourteenth by value. It thus accounts for 10% of world’s production by volume and 1.5% by value according to Department of Pharmaceuticals, Government of India. The industry has shown phenomenal growth over past few years, moving from US $ 1 billion turnover in 1990 to a turnover of around US $30 billion in 2015. The Indian pharmaceutical sector is ranked seventeenth in terms of export value of active pharmaceutical ingredients and dosage forms to more than 200 countries around the globe. It has shown tremendous changes especially after Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement. Recognizing the immense potential for growth and its direct impact on Indian economy, it is important to look up the industrial policies adopted since Indian independence which turnaround the Indian pharmaceutical industry. A systematic review of changes in market structure of Indian pharmaceutical industry due to shift in policy regimes is done from 1850 to 2015 using secondary peer reviewed published research work. The aim is to understand the impact of anti-trust laws, intellectual property rights, industry competition acts and regulations are quite crucial in determining effective economic policy and have overall lasting effects on international trade and ties. The proposed paper examines the position of Indian domestic firms relative to multinational pharmaceutical firms tries to throw some light on the growth curve of Indian pharmaceutical sector.

Keywords: active pharmaceutical ingredients, competition act, pharmaceutical industry, TRIPS

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Authors: Gamalath M. B. P. Abeysekara

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Primary objective of any organization is to enhance the bottom line profit. Strategic procurement is one of the prominent aspects in view of receiving this ultimate objective. Strategic procurement is an activity used in each and every organization in their operations. Pharmaceutical procurement is an especially significant task for any organizations, particularly state sector concerned. The whole pharmaceutical procurement requirement of the country is procured through the State Pharmaceutical Corporation (SPC) of Sri Lanka. They follow Pharmaceutical Procurement Guideline of 2006 as the procurement principle. The main objective of this project is to identify the importance of State Pharmaceutical Corporation supplier selection criteria and critical analysis of pharmaceutical procurement procedure. State Pharmaceutical Corporations applied net price, product quality, past performance, and delivery of suppliers’ as main criteria for the selection suppliers. Data collection for this study was taken place through a questionnaire, given to fifty doctors within the Colombo district attached to five main state hospitals. Data analysis is carried out with mean and standard deviation functions. The ultimate outcomes indicated product quality, net price, and delivery of suppliers’ are the most important criteria behind the selection of suppliers. Critical analysis proved State Pharmaceutical Corporation should focus on net price reduction, improving laboratory testing facilities and effective communication between up and down stream of supply chain.

Keywords: government procurement procedure, pharmaceutical procurement supplier selection criteria, importance of SPC supplier selection criteria

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Authors: Adegoke Yinka Adebayo

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An understanding of the critical product attributes that impact on in vivo performance is key to the production of safe and effective medicines. Thus, a key driver for our research is the development of new basic science and technology underpinning the development of new pharmaceutical products. Research includes the structure and properties of drugs and excipients, biopharmaceutical characterisation, pharmaceutical processing and technology and formulation and analysis.

Keywords: drug discovery, drug development, drug delivery

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Authors: Michael Leontiev, Danil Zhilikov, Dmitry Lobanov, Lenar Klimov, Vyacheslav Chertan, Daniel Bobrov, Vladislav Maslov, Vasilii Vologdin, Ksenia Balabaeva

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Pharmaceutical manufacturing is a complex process, where each stage requires a high level of safety and sterility. Personal Protective Equipment (PPE) is used for this purpose. Despite all the measures of control, the human factor (improper PPE wearing) causes numerous losses to human health and material property. This research proposes a solid computer vision system for ensuring safety in pharmaceutical laboratories. For this, we have tested a wide range of state-of-the-art object detection methods. Composing previously obtained results in this sphere with our own approach to this problem, we have reached a high accuracy ([email protected]) ranging from 0.77 up to 0.98 in detecting all the elements of a common set of PPE used in pharmaceutical laboratories. Our system is a step towards safe medicine production.

Keywords: sterility and safety in pharmaceutical development, personal protective equipment, computer vision, object detection, monitoring in pharmaceutical development, PPE

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Authors: J. Herrero, D. Puigserver, I. Nijenhuis, K. Kuntze, J. M. Carmona

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In the transition zone between aquifers and basal aquitards, the perchloroethene (PCE)-pools are more recalcitrant than those elsewhere in the aquifer. Although biodegradation of chloroethenes occur in this zone, it is a slow process and a remediation strategy is needed. The aim of this study is to demonstrate that combined strategy of biostimulation and in situ chemical reduction (ISCR) is more efficient than the two separated strategies. Four different microcosm experiments with sediment and groundwater of a selected field site where an aged pool exists at the bottom of a transition zone were designed under i) natural conditions, ii) biostimulation with lactic acid, iii) ISCR with zero-value iron (ZVI) and under iv) a combined strategy with lactic acid and ZVI. Biotic and abiotic dehalogenation, terminal electron acceptor processes and evolution of microbial communities were determined for each experiment. The main results were: i) reductive dehalogenation of PCE-pools occurs under sulfate-reducing conditions; ii) biostimulation with lactic acid supports more pronounced reductive dehalogenation of PCE and trichloroethene (TCE), but results in an accumulation of 1,2-cis-dichloroethene (cDCE); iii) ISCR with ZVI produces a sustained dehalogenation of PCE and its metabolites iv) combined strategy of biostimulation and ISCR results in a fast dehalogenation of PCE and TCE and a sustained dehalogenation of cisDCE. These findings suggest that biostimulation and ISCR with ZVI are the most suitable strategies for a complete reductive dehalogenation of PCE-pools in the transition zone and further to enable the dissolution of dense non-aqueous phase liquids.

Keywords: aged PCE-pool, anaerobic microcosm experiment, biostimulation, in situ chemical reduction, natural attenuation

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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: W. Jahouach-Rabai, J. Aribi, Z. Azzouz-Berriche, R. Lahsni, F. Hosni

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Gamma irradiation applied in removing pharmaceutical contaminants from wastewater is an effective advanced oxidation process (AOP), considered as an alternative to conventional water treatment technologies. In this purpose, the degradation efficiency of several detected contaminants under gamma irradiation was evaluated. In fact, radiolysis of organic pollutants in aqueous solutions produces powerful reactive species, essentially hydroxyl radical ( ·OH), able to destroy recalcitrant pollutants in water. Pharmaceuticals considered in this study are aqueous solutions of paracetamol, ibuprofen, and diclofenac at different concentrations 0.1-1 mmol/L, which were treated with irradiation doses from 3 to 15 kGy. The catalytic oxidation of these compounds by gamma irradiation was investigated using hydrogen peroxide (H₂O₂) as a convenient oxidant. Optimization of the main parameters influencing irradiation process, namely irradiation doses, initial concentration and oxidant volume (H₂O₂) were investigated, in the aim to release high degradation efficiency of considered pharmaceuticals. Significant modifications attributed to these parameters appeared in the variation of degradation efficiency, chemical oxygen demand removal (COD) and concentration of radio-induced radicals, confirming them synergistic effect to attempt total mineralization. Pseudo-first-order reaction kinetics could be used to depict the degradation process of these compounds. A sophisticated analytical study was released to quantify the detected radio-induced radicals (electron paramagnetic resonance spectroscopy (EPR) and high performance liquid chromatography (HPLC)). All results showed that this process is effective for the degradation of many pharmaceutical products in aqueous solutions due to strong oxidative properties of generated radicals mainly hydroxyl radical. Furthermore, the addition of an optimal amount of H₂O₂ was efficient to improve the oxidative degradation and contribute to the high performance of this process at very low doses (0.5 and 1 kGy).

Keywords: AOP, COD, hydroxyl radical, EPR, gamma irradiation, HPLC, pharmaceuticals

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Authors: Abdel Qader Al Bawab, Mohannad Odeh, Rami Amer

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Recently, there has been an increasing interest in innovative business development. Nevertheless, in the pharmacy practice field, there seems to be a gap in perceptions, attitudes, and knowledge about innovation between practicing pharmacists and academia. This study explores this gap and aspects of pharmaceutical innovation in Jordan, comparing pharmacists and last-year pharmacy students. A validated (r2 = 0.74) and reliable (Pearson’s r = 0.88) online questionnaire was designed to assess and compare knowledge, attitude, and perceptions about pharmaceutical innovation. A total of 397 participants (215 pharmacy students and 182 pharmaceutical professionals) responded. Compared with 50% of the pharmacists, only 32.1% of the students claimed that they knew the differences between pharmaceutical innovation, discovery, invention, and entrepreneurship [x2 (2) = 14.238, p = 0.001; Cramer’s V = 0.189]. Pharmacists demonstrated a higher level of trust in the innovative website design for their institution compared with students (25.3% vs. 16.3%, p < 0.001, Cramer’s V = 0.327). However, 60% of the students did not know the innovative design standards for websites, while the corresponding percentage was 37% for the pharmacists (p < 0.001; Cramer’s V = 0.327). The majority of the students were interested in pharmaceutical innovation (81.9%). Unfortunately, 76.3% never studied innovation in their pharmacy curricula. Similarly, most pharmacists (76.4%) considered adopting innovation, but only 30% had a concrete plan. For the field where pharmacists aim to innovate in the next 5 years, new pharmaceutical services were the dominant field (34.6%). Despite a positive attitude and perception, pharmacists and pharmacy students expressed poor knowledge about innovation. Policies to enhance awareness about innovation and professional educational tools should be implemented.

Keywords: pharmacy, innovation, knowledge, attitude, practice

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Authors: R. Sharma, S. Kumar, C. Sharma

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A number of toxic chlorophenolic compounds are formed during pulp bleaching. The nature and concentration of these chlorophenolic compounds largely depends upon the amount and nature of bleaching chemicals used. These compounds are highly recalcitrant and difficult to remove but are partially removed by the biochemical treatment processes adopted by the paper industry. Identification and estimation of these chlorophenolic compounds has been carried out in the primary and secondary clarified effluents from the paper mill by GCMS. Twenty-six chorophenolic compounds have been identified and estimated in paper mill waste waters. Electrochemical treatment is an efficient method for oxidation of pollutants and has successfully been used to treat textile and oil waste water. Electrochemical treatment using less expensive anode material, stainless steel electrodes has been tried to study their removal. The electrochemical assembly comprised a DC power supply, a magnetic stirrer and stainless steel (316 L) electrode. The optimization of operating conditions has been carried out and treatment has been performed under optimized treatment conditions. Results indicate that 68.7% and 83.8% of cholorphenolic compounds are removed during 2 h of electrochemical treatment from primary and secondary clarified effluent respectively. Further, there is a reduction of 65.1, 60 and 92.6% of COD, AOX and color, respectively for primary clarified and 83.8%, 75.9% and 96.8% of COD, AOX and color, respectively for secondary clarified effluent. EC treatment has also been found to increase significantly the biodegradability index of wastewater because of conversion of non- biodegradable fraction into biodegradable fraction. Thus, electrochemical treatment is an efficient method for the degradation of cholorophenolic compounds, removal of color, AOX and other recalcitrant organic matter present in paper mill waste water.

Keywords: chlorophenolics, effluent, electrochemical treatment, wastewater

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Authors: Carolina Guatemala, Josefina Barrera

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A large number of soils highly polluted with recalcitrant hydrocarbons and the limitation of the current bioremediation methods continue being the drawback for an efficient recuperation of these under safe conditions. In this regard, soil washing by degradable surfactants is an alternative option knowing the capacity of surfactants to desorb oily organic compounds. The aim of this study was the establishment of the washing conditions of a soil polluted with diesel, using a nonionic surfactant. A soil polluted with diesel was used. This was collected near to a polluted railway station zone. The soil was dried at room temperature and sieved to a mesh size 10 for its physicochemical and biological characterization. Washing of the polluted soil was performed with surfactant solutions in a 1:5 ratio (5g of soil per 25 mL of the surfactant solution). This was carried out at 28±1 °C and 150 rpm for 72 hours. The factors tested were the Tween 80 surfactant concentration (1, 2, 5 and 10%) and the treatment time. Residual diesel concentration was determined every 24 h. The soil was of a sandy loam texture with a low concentration of organic matter (3.68%) and conductivity (0.016 dS.m- 1). The soil had a pH of 7.63 which was slightly alkaline and a Total Petroleum Hydrocarbon content (TPH) of 11,600 ± 1058.38 mg/kg. The high TPH content could explain the low microbial count of 1.1105 determined as UFC per gram of dried soil. Within the range of the surfactant concentration tested for washing the polluted soil under study, TPH removal increased proportionally with the surfactant concentration. 5080.8 ± 422.2 ppm (43.8 ± 3.64 %) was the maximal concentration of TPH removed after 72 h of contact with surfactant pollution at 10%. Despite the high percentage of hydrocarbons removed, it is assumed that a higher concentration of these could be removed if the washing process is extended or is carried out by stages. Soil washing through the use of surfactants as a desorbing agent was found to be a viable and effective technology for the rapid recovery of soils highly polluted with recalcitrant hydrocarbons.

Keywords: diesel, hydrocarbons, soil washing, tween 80

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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: Saira Tajdar, Sajad Ahmad

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The pharmaceutical market of Pakistan showed a mixed trend since 1947. In these six decades various local and foreign pharmaceutical companies entered the market with their highly researched based formulas and brands for various diseases. It also created a very competitive market between local and foreign companies and brands. But this intense competition does not clear the picture that whether the customers (Doctors) are preferring/prescribing foreign or local brands more frequently. Previous research has been done in various markets for different brands that whether the customers in that industry prefer foreign or local brands. However, the pharmaceutical industry in this regard has been ignored by the researchers. Generally people don't know that for prescription brands of medicines what the preferences of customers (Doctors) are. Therefore, this study is conducted in two departments of Pharmaceutical industry by selecting the top recommended formulas in those departments that for those formulas whether the customers (Doctors) are prescribing either foreign brands or local brands. Secondary data has been collected from previous studies on the country of origin (COO), ethnocentrism and factors influencing brands preferences from authentic sources. Primary data was also collected through 100 self administered questionnaires from top five hospitals of Peshawar. The results of the study were analyzed through SPSS which shows that in some categories of pharmaceutical products the COO is very important but not for all.

Keywords: customer prescription, country of origin, empirical study, foreign versus local brands, pharmaceutical industry, Pakistan

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Authors: Hayden R Schott, John M Felder III

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Introduction: Chronic lower extremity wounds in the diabetic and vasculopathic populations are associated with a high degree of morbidity.When wounds require more extensive treatment than can be offered by wound care centers, more aggressive solutions involve local tissue transfer and microsurgical free tissue transfer for achieving definitive soft tissue coverage. These procedures of autologous tissue transfer (ATT) offer resilient, soft tissue coverage of limb-threatening wounds and confer promising limb salvage rates. However, chronic osteomyelitis and recalcitrant soft tissue infections are common in severe diabetic foot wounds and serve to significantly complicate ATT procedures. Stimulan is a resorbable calcium sulfate antibiotic carrier. The use of stimulan antibiotic beads to treat chronic osteomyelitis is well established in the orthopedic and plastic surgery literature. In these procedures, the beads are placed beneath the skin flap to directly deliver antibiotics to the infection site. The purpose of this study was to quantify the success of Stimulan antibiotic beads in treating recalcitrant infections in patients with diabetic foot wounds receiving ATT. Methods: A retrospective review of clinical and demographic information was performed on patients who underwent ATT with the placement of Stimulan antibiotic beads for attempted limb salvage from 2018-21. Patients were analyzed for preoperative wound characteristics, demographics, infection recurrence, and adverse outcomes as a result of product use. The primary endpoint was 90 day infection recurrence, with secondary endpoints including 90 day complications. Outcomes were compared using basic statistics and Fisher’s exact tests. Results: In this time span, 14 patients were identified. At the time of surgery, all patients exhibited clinical signs of active infection, including positive cultures and erythema. 57% of patients (n=8) exhibited chronic osteomyelitis prior to surgery, and 71% (n=10) had exposed bone at the wound base. In 57% of patients (n=8), Stimulan beads were placed beneath a free tissue flap and beneath a pedicle tissue flap in 42% of patients (n=6). In all patients, Stimulan beads were only applied once. Recurrent infections were observed in 28% of patients (n=4) at 90 days post-op, and flap nonadherence was observed in 7% (n=1). These were the only Stimulan related complications observed. Ultimately, lower limb salvage was successful in 85% of patients (n=12). Notably, there was no significant association between the preoperative presence of osteomyelitis and recurrent infections. Conclusions: The use of Stimulanantiobiotic beads to treat recalcitrant infections in patients receiving definitive skin coverage of diabetic foot wounds does not appear to demonstrate unnecessary risk. Furthermore, the lack of significance between the preoperative presence of osteomyelitis and recurrent infections indicates the successful use of Stimulan to dampen infection in patients with osteomyelitis, as is consistent with the literature. Further research is needed to identify Stimulan as the significant contributor to infection treatment using future cohort and case control studies with more patients. Nonetheless, the use of Stimulan antibiotic beads in patients with diabetic foot wounds demonstrates successful infection suppression and maintenance of definitive soft tissue coverage.

Keywords: wound care, stimulan antibiotic beads, free tissue transfer, plastic surgery, wound, infection

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Authors: Chand Pasha, Yasser Turki Alharbi, Krasamira Stancheva

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A simple spectrophotometric method for the determination of folic acid in pharmaceutical dosage samples was developed. The method is based on the diazotization reaction of thiourea with sodium nitrite in acidic medium yields diazonium compounds, which is then coupled with folic acid in basic medium yields yellow coloured azo dyes. Beer’s Lamberts law is observed in the range 0.5 – 16.2 μgmL-1 at a maximum wavelength of 416nm. The molar absorbtivity, sandells sensitivity, linear regression equation and detection limit and quantitation limit were found to be 5.695×104 L mol-1cm-1, 7.752×10-3 g cm-2, y= 0.092x - 0.018, 0.687 g mL-1 and 2.083 g mL-1. This method successfully determined Folate in Pharmaceutical formulations.

Keywords: folic acid determination, spectrophotometry, diazotization, thiourea, pharmaceutical dosage samples

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Authors: Ben Main Piotr Ozieranski

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State government spending on pharmaceuticals stands at 1 trillion USD globally, promoting criticism of the pharmaceutical industry's monetization of drug efficacy, product cost overvaluation, and health injustice. This paper elucidates the mechanisms behind a state-institutional response to this problem through the sociological lens of the strategic relational approach to state power. To do so, 30 expert interviews, legal and policy documents are drawn on to explain how state elites in New Zealand have successfully contested a 30-year “pharmaceutical spending containment policy”. Proceeding from Jessop's notion of strategic “selectivity”, encompassing analyses of the enabling features of state actors' ability to harness state structures, a theoretical explanation is advanced. First, a strategic context is described that consists of dynamics around pharmaceutical dealmaking between the state bureaucracy, pharmaceutical pricing strategies (and their effects), and the industry. Centrally, the pricing strategy of "bundling" -deals for packages of drugs that combine older and newer patented products- reflect how state managers have instigated an “incentivization game” that is played by state and industry actors, including HTA professionals, over pharmaceutical products (both current and in development). Second, a protective context is described that is comprised of successive legislative-judicial responses to the strategic context and characterized by the regulation and the societalisation of commercial law. Third, within the policy, the achievement of increased pharmaceutical coverage (pharmaceutical “mix”) alongside contained spending is conceptualized as a state defence of a "social profit". As such, in contrast to scholarly expectations that political and economic cultures of neo-liberalism drive pharmaceutical policy-making processes, New Zealand's state elites' approach is shown to be antipathetic to neo-liberals within an overall capitalist economy. The paper contributes an analysis of state pricing strategies and how they are embedded in state regulatory structures. Additionally, through an analysis of the interconnections of state power and pharmaceutical value Abrahams's neo-liberal corporate bias model for pharmaceutical policy analysis is problematised.

Keywords: pharmaceutical governance, pharmaceutical bureaucracy, pricing strategies, state power, value theory

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Authors: Gifty Kumadey, Albert Tchey Agbenyegah

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This study explores the role of stakeholders in developing a sustainable supply chain policy framework in Ghana's pharmaceutical industry. It employs a qualitative research design to analyze policy documents, academic articles, and reports, shedding light on stakeholder involvement. The findings highlight the contributions of government agencies, regulatory bodies, pharmaceutical companies, suppliers, and civil society organizations. Key policies such as green procurement, waste management, and recycling initiatives are identified. However, challenges such as limited transparency, supplier engagement, and regulatory complexity impede implementation. The study recommends strengthening collaboration and promoting transparency to overcome these challenges. The findings provide valuable insights for policymakers, industry stakeholders, and researchers seeking to advance sustainable supply chain practices in Ghana's pharmaceutical industry.

Keywords: stakeholders, sustainable supply chain, policy framework, pharmaceutical industry

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Authors: Vikram Chowdhary, Marek Vins

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The profitability of the pharmaceutical drug business has attracted considerable interest, but it also faces significant challenges. Counterfeiters take advantage of the industry's vulnerabilities, which are further exacerbated by the globalization of the market, online trading, and complex supply chains. Governments and organizations worldwide are dedicated to creating a secure environment that ensures a consistent and genuine supply of pharmaceutical products. In 2019, the European authorities implemented regulation EU 2016/161 to strengthen traceability and transparency throughout the entire drug supply chain. This regulation requires the addition of enhanced security features, such as serializing items to the saleable unit level or individual packs. Despite these efforts, the incidents of pharmaceutical counterfeiting continue to rise globally, with regulated territories being particularly affected. This paper examines the effectiveness of the drug serialization system implemented by European authorities. By conducting a systematic literature review, we assess the implementation of drug serialization and explore the potential benefits of integrating emerging digital technologies, such as RFID and Blockchain, to improve traceability and management. The objective is to fortify pharmaceutical supply chains against counterfeiters and manipulators and ensure their security.

Keywords: blockchain, counterfeit drugs, EU drug serialization, pharmaceutical industry, RFID

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Authors: Clara T. Fatoye, April Betts, Abayomi Odeyemi, Francis A. Fatoye, Isaac O. Odeyemi

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Background: The post-launch stage is the last stage in the development of a pharmaceutical product. It is important to involve patients in the development of pharmaceutical products at the post-launch stage, as patients are the end-users of pharmaceutical products. It is expected that involving them might ensure an effective working relationship among the various stakeholders. However, involving patients in the development of pharmaceutical products comes with its problems. Hence, this study examined how to resolve problems experienced by involving patients in the developments of pharmaceutical products’ at post-launch consisting of Positioning of pharmaceutical products (POPP), detailing of pharmaceutical products (DOPP) and reimbursement and Formulary Submission (R&FS). Methods: A questionnaire was used for the present study. It was administered at the ISPOR Glasgow 2017 to 104 participants, all of which were professionals from Market access (MA) and health economics and outcomes research (HEOR) backgrounds. They were asked how the issues experienced by patients can be resolved. Participants responded under six domains as follows: communication, cost, effectiveness, external factors, Quality of life (QoL) and safety. Thematic analysis was carried out to identify strategies to resolve issues experienced by patients at the post-launch stage. Results: Three (3) factors cut across at POPP, DOPP, and R&FS that is (external factors, communication and QoL). The first resolution method was an external factor that is, the relationship with stakeholders and policymakers. Communication was also identified as a resolution method that can help to resolve problems experienced by patients at the post-launch stage. The third method was QoL as perceived by the patients based on professionals’ opinions. Other strategies that could be used to resolve problems experienced were the effectiveness of pharmaceutical products at the DOPP level and cost at R&FS. Conclusion: The study showed that focusing on external factors, communication, and patients’ QoL are methods for resolving issues experienced by involving patients at the post-launch stage of pharmaceutical product development. Hence, effective working relationships between patients, policymakers and stakeholders may help to resolve problems experienced at the post-launch stage. Healthcare policymakers are to be aware of these findings as they may help them to put appropriate strategies in place to enhance the involvement of patients in pharmaceutical product development at the post-launch stage, thereby improving the health outcomes of the patients.

Keywords: patients, pharmaceutical products, post-launch stage, quality of life, QoL

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Authors: Milad Keshvardoost, Amir Khanlari, Nader Khalesi

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Background: Any firm in the pharmaceutical industry requires efficient and effective management information systems (MIS) to support managerial functions. Purpose: The aim of this study is to investigate the impact of Task-Technology Fit on user effectiveness, efficiency, and creativity in Iranian pharmaceutical companies. Methodology: 345 reliable and validate questionnaires were distributed among selected samples, through the cluster method, to Information system users of eight leading Iranian pharmaceutical companies, based on the likert scale. The proposed model of the article is based on a model with Task technology fit, on user performance with the definition of efficiency, effectiveness, and creativity through mediation effects of perceived usefulness and ease of use. Results: This study confirmed that TTF with definitions of adequacy and compatibility has positive impacts on user performance Conclusion: We concluded that pharmaceutical users of IS, utilizing a system with a precise and intense observation of users' demands, may make facilitation for them to design an exclusive IS framework.

Keywords: information systems, user performance, pharmaceuticals, task technology fit

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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: Abdul Rahim Al Umairi, Mohamed Gamal El-Din

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The removal of the selected contaminants of emerging concerns (CECs) presented under related environmental conditions by Peracetic Acid (PAA) and PAA-UV photolysis processes was examined in this study. A mixture of (CECs) (pesticides and pharmaceutical compounds) was prepared inclean water and treated with different doses of PAA (3.2, 6.4, and 9.6 mg/L) under different pH values (5.2, 7.2, and 9.2). The results revealed that the reactivity of the selected CECs with PAA was classified into three groups: Group 1 poorly reactive (removal <25%), Group2 moderately reactive (removal 25% to 50%), and Group 3 highly reactive (> 50%). Group1 includes atrazine (ATZ) and fluconazole (FCL), Group2 includes carbamazepine (CBZ), sulfamethoxazole (SMX), trimethoprim (TMP), mecoprop (MCPP), diazinon (DZN) and Group 3 includes perfluorooctanoic acid (PFOA) and clindamycin (CLN). The pH was found to affect the CECs' degradation differently, for Group 1 and Group 3, better removal was achieved in the acidand alkaline medium. In contrast, for Group 2 pH effects were not well pronounced. PAA-UV photolysis processes were explored to degrade the recalcitrant indicators compounds: ATZ (Group1) and SMX(Group2). PAA-UV process showed no improvement in the removal of ATZ. In contrast, PAA-UV removed SMX drastically with a pseudo decay rate constant of 0.014 cm2/mJ compared to 0.002 cm2/mJ by UV alone. The contribution of hydroxyl radical to the degradation process using the PAA-UV process was found to be negligible. This study illustratedPAA's capability on the degradation of the CECs presented in relative environmental conditions and unveiled the potential of using PAA-UV processes as advanced oxidation processes.

Keywords: advanced oxidation process, contaminants of emerging concerns, peracetic acid, hydroxyl radical

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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: Lata Kumari Dhanesh Tiwary, Pradeep Kumar Mishra

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The effluent coming from various industries such as textile, carpet, food, pharmaceutical and many other industries is big challenge due to its recalcitrant and xenobiotiocs in nature. Recently, biodegradation of dye wastewater through biological means was widely used due to eco-friendly and cost effective with the higher percentage of removal of dye from wastewater. The present study deals with the biodegradation and decolourization of Direct Red 23 dye using indigenously isolated bacterial consortium. The bacterial consortium was isolated from soil sample from dye contaminated site near a cluster of Carpet industries of Bhadohi, Uttar Pradesh, India. The bacterial strain formed consortia were identified and characterized by morphological, biochemical and 16S rRNA gene sequence analysis. The bacterial strain mainly Staphylococcus saprophyticus strain BHUSS X3 (KJ439576), Microbacterium sp. BHUMSp X4 (KJ740222) and Staphylococcus saprophyticus strain BHUSS X5 (KJ439576) were used as consortia for further studies of dye decolorization. Experimental investigations were made in a Sequencing Air- lift bioreactor using the synthetic solution of Direct Red 23 dye by optimizing various parameters for efficient degradation of dye. The effect of several operating parameters such as flow rate, pH, temperature, initial dye concentration and inoculums size on removal of dye was investigated. The efficiency of isolated bacterial consortia from dye contaminated area in Sequencing Air- lift Bioreactor with different concentration of dye between 100-1200 mg/l at different hydraulic rate (HRTs) 26h and 10h. The maximum percentage of dye decolourization 98% was achieved when operated at HRT of 26h. The percentage of decolourization of dye was confirmed by using UV-Vis spectrophotometer and HPLC.

Keywords: carpet industry, bacterial consortia, sequencing air-lift bioreactor

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