Search results for: drug safety

Authors: Indu Verma, Santanu Kumar Pal

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Interactions between DNA and adsorbed Poly (L-lysine) (PLL) on liquid crystal (LC) droplets were investigated using polarizing optical microcopy (POM) and epi-fluorescence microscopy. Earlier, we demonstrated that adsorption of PLL to the LC/aqueous interface resulted in homeotropic orientation of the LC and thus exhibited a radial configuration of the LC confined within the droplets. Subsequent adsorption of DNA (single stranded DNA/double stranded DNA) at PLL coated LC droplets was found to trigger a LC reorientation within the droplets leading to pre-radial/bipolar configuration of those droplets. To our surprise, subsequent exposure of complementary ssDNA (c-ssDNA) to ssDNA/ adsorbed PLL modified LC droplets did not cause the LC reorientation. This is likely due to the formation of polyplexes (DNA-PLL complex) as confirmed by fluorescence microscopy and atomic force microscopy. In addition, dsDNA adsorbed PLL droplets have been found to be effectively used to displace (controlled release) propidium iodide (a model drug) encapsulated within dsDNA over time. These observations suggest the potential for a label free droplet based LC detection system that can respond to DNA and may provide a simple method to develop DNA-based drug nano-carriers.

Keywords: DNA biosensor, drug delivery, interfaces, liquid crystal droplets

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Authors: Mahmoud Ahmed Farrag, Ali Zain Elabdeen Heikal, Mohamed Shawky Ahmed, Ahmed Osama Amer

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Crowd-sourced data refers to data that is collected and shared by a large number of individuals or organizations, often through the use of digital technologies such as mobile devices and social media. The shortage in crash data collection in developing countries makes it difficult to fully understand and address road safety issues in these regions. In developing countries, crowd-sourced data can be a valuable tool for improving road safety, particularly in urban areas where the majority of road crashes occur. This study is -to our best knowledge- the first to develop safety performance functions using crowd-sourced data by adopting a negative binomial structure model and the Full Bayes model to investigate traffic safety for urban road networks and provide insights into the impact of roadway characteristics. Furthermore, as a part of the safety management process, network screening has been undergone through applying two different methods to rank the most hazardous road segments: PCR method (adopted in the Highway Capacity Manual HCM) as well as a graphical method using GIS tools to compare and validate. Lastly, recommendations were suggested for policymakers to ensure safer roads.

Keywords: crowdsourced data, road crashes, safety performance functions, Full Bayes models, network screening

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Authors: Samson F. Agberotimi, Rachel B. Asagba, Choja Oduaran

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Disturbing rate of use of different substances such as cannabis, alcohol, as well as pharmaceutical drugs among Nigerian youth in recent times has been affirmed in the literature. There is, however, a paucity of literature addressing the pattern of usage of such drugs, especially for clinical relevance and intervention planning. The present study investigated the prevalence and pattern of drug usage among youth in Ogbomoso, Nigeria. A cross-sectional survey involving 92 purposively selected participants comprising of 82 males and 10 females aged between 15 and 24 years was conducted. A measure of drug involvement and demographic characteristics was administered to the participants. Descriptive analysis was done using the SPSS v.21. Cannabis (79.4%), alcohol (77.2%), codeine (70.7%), tobacco (65.2%) and tramadol (47.8%) are the five most frequently used substances. However, the majority of the users of tobacco (68.3%) and alcohol (62.0%) are casual users indicating a mild level of use of the substances among the participants. On the other hand, 49.2% of the codeine users, 27.3% of the tramadol users, and 21.9% of the cannabis users reported harmful/intensive levels of use. Furthermore, the results revealed individuals at the pathological level of use as 28.8% for cannabis, 25.0% for tramadol, and 21.6% for codeine, and thus require clinical/therapeutic intervention. In conclusion, cannabis remains the most frequently used substance among youths. However, there appears to be a shift from the use of conventional psychoactive substances to pharmaceutical/prescription drugs such as codeine and tramadol. The findings of this study raised the need for both preventive and therapeutic interventions addressing the problem of substance use disorder among youth in contemporary society.

Keywords: Ogbomoso, pattern of drug use, prevalence of drug use, youth

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Authors: Vipin Saini, Sunil Kamboj, Suman Bala, A. Pandurangan

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The present research is aimed at fabrication of multiple-unit controlled-release tablet formulation of aceclofenac by employing acrylic polymers as the release controlling excipients for drug multi-particulates to achieve the desired objectives of maintaining the same controlled release characteristics as that prior to their compression into tablet. Various manufacturers are successfully manufacturing and marketing aceclofenac controlled release tablet by applying directly coating materials on the tablet. The basic idea behind development of such formulations was to employ aqueous acrylics polymers dispersion as an alternative to the existing approaches, wherein the forces of compression may cause twist of drug pellets, but do not have adverse effects on the drug release properties. Thus, the study was undertaken to illustrate manufacturing of controlled release aceclofenac multiple-unit tablet formulation.

Keywords: aceclofenac, multiple-unit tablets, acrylic polymers, controlled-release

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Authors: Nizar Jawad Hadi, Sajad Abd Alabbas

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Because of their ability to encapsulate and release drugs in a controlled manner, microspheres fabricated from polymer emulsions using microfluidic devices have shown promise for drug delivery applications. In this study, the effects of velocity, density, viscosity, and surface tension, as well as channel diameter, on microsphere generation were investigated using Fluent Ansys software. The software was programmed with the physical properties of the polymer emulsion such as density, viscosity and surface tension. Simulation will then be performed to predict fluid flow and microsphere production and improve the design of drug delivery applications based on changes in these parameters. The effects of capillary and Weber numbers are also studied. The results of the study showed that the size of the microspheres can be controlled by adjusting the speed and diameter of the channel. Narrower microspheres resulted from narrower channel widths and higher flow rates, which could improve drug delivery efficiency, while smaller microspheres resulted from lower interfacial surface tension. The viscosity and density of the polymer emulsion significantly affected the size of the microspheres, ith higher viscosities and densities producing smaller microspheres. The loading and drug release properties of the microspheres created with the microfluidic technique were also predicted. The results showed that the microspheres can efficiently encapsulate drugs and release them in a controlled manner over a period of time. This is due to the high surface area to volume ratio of the microspheres, which allows for efficient drug diffusion. The ability to tune the manufacturing process using factors such as speed, density, viscosity, channel diameter, and surface tension offers a potential opportunity to design drug delivery systems with greater efficiency and fewer side effects.

Keywords: polymer emulsion, microspheres, numerical simulation, microfluidic device

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Authors: Heiko Jessen, Laura Tanus, Slobodan Ruzicic

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Objectives: The efficacy of Stribild®, an integrase strand transfer inhibitor (INSTI) -based STR, has been evaluated in randomized clinical trials and it has demonstrated durable capability in terms of achieving sustained suppression of HIV-1 RNA-levels. However, differences in monitoring frequency, existing selection bias and profile of patients enrolled in the trials, may all result in divergent efficacy of this regimen in routine clinical settings. The aim of this study was to assess the virologic outcomes, safety and tolerability profile of Stribild® in a routine clinical setting. Methods: This was a retrospective monocentric analysis on HIV-1-infected patients, who started with or were switched to Stribild®. Virological failure (VF) was defined as confirmed HIV-RNA>50 copies/ml. The minimum time of follow-up was 24 weeks. The percentage of patients remaining free of therapeutic failure was estimated using the time-to-loss-of-virologic-response (TLOVR) algorithm, by intent-to-treat analysis. Results: We analyzed the data of 197 patients (56 ART-naïve and 141 treatment-experienced patients), who fulfilled the inclusion criteria. Majority (95.9%) of patients were male. The median time of HIV-infection at baseline was 2 months in treatment-naïve and 70 months in treatment-experienced patients. Median time [IQR] under ART in treatment-experienced patients was 37 months. Among the treatment-experienced patients 27.0% had already been treated with a regimen consisting of two NRTIs and one INSTI, whereas 18.4% of them experienced a VF. The median time [IQR] of virological suppression prior to therapy with Stribild® in the treatment-experienced patients was 10 months [0-27]. At the end of follow-up (median 33 months), 87.3% (95% CI, 83.5-91.2) of treatment-naïve and 80.3% (95% CI, 75.8-84.8) of treatment-experienced patients remained free of therapeutic failure. Considering only treatment-experienced patients with baseline VL<50 copies/ml, 83.0% (95% CI, 78.5-87.5) remained free of therapeutic failure. A total of 17 patients stopped treatment with Stribild®, 5.4% (3/56) of them were treatment-naïve and 9.9% (14/141) were treatment-experienced patients. The Stribild® therapy was discontinued in 2 (1.0%) because of VF, loss to follow-up in 4 (2.0%), and drug-drug interactions in 2 (1.0%) patients. Adverse events were in 7 (3.6%) patients the reason to switch from therapy with Stribild® and further 2 (1.0%) patients decided personally to switch. The most frequently observed adverse events were gastrointestinal side effects (20.0%), headache (8%), rash events (7%) and dizziness (6%). In two patients we observed an emergence of novel resistances in integrase-gene. The N155H evolved in one patient and resulted in VF. In another patient S119R evolved either during or shortly upon switch from therapy with Stribild®. In one further patient with VF two novel mutations in the RT-gene were observed when compared to historical genotypic test result (V106I/M and M184V), whereby it is not clear whether they evolved during or already before the switch to Stribild®. Conclusions: Effectiveness of Stribild® for treatment-naïve patients was consistent with data obtained in clinical trials. The safety and tolerability profile as well as resistance development confirmed clinical efficacy of Stribild® in a daily practice setting.

Keywords: ART, HIV, integrase inhibitor, stribild

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Authors: Flavia Laffleur

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Summary: Biomaterials have gained immense interest in the pharmaceutical research in the last decades. Hyaluronic acid a carbohydrate and mucopolysaccharide was chemically modified in order to achieve and establish a promising platform for buccal drug delivery. Aim: Novel biomaterial was tested for its potential for buccal drug delivery. Background: Polysaccharide hyaluronic acid (HA) was chemically modified with cysteine ethyl ether (CYS). By immobilization of the thiol-bearing ligand on the polymeric backbone the thiolated bioconjugate HA-CYS was obtained. Methodology: Mucoadhesive, permeation enhancing and stability potential as well as mechanical, physicochemical properties further mucoadhesive strength, swelling index and residence time were investigated. The developed thiolated bioconjugate displayed enhanced mucoadhesiveness on buccal mucosa as well as permeation behavior and polymer stability. The near neutral pH and negative cytotoxicity studies indicated their non-irritability and biocompatible nature with biological tissues. Further, the model drug sulforhodamine 101 was incorporated to determine its drug release profiles. Results: The synthesized thiomer showed no toxicity. The mucoadhesion of thiolated hyaluronic acid on buccal mucosa was significantly improved in comparison to unmodified one. The biomaterial showed 2.5-fold higher stability in polymer structure. The release of sulforhodamine in the presence of thiolated hyaluronic acid was 2.3-fold increased compared to hyaluronic acid. Conclusion: Thus, the promising results encourage further investigations and exploitation of this versatile polysaccharide. So far, hyaluronic acid was not evaluated for buccal drug delivery.

Keywords: buccal delivery, hyaluronic acid, mucoadhesion, thiomers

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Authors: Polina Prokopovich

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Disease-modifying osteoarthritis drugs (DMOADs) are a new therapeutic class for OA, preventing or inhibiting OA development. Unfortunately, none of the DMOADs have been clinically approved due to their poor therapeutic effects in clinical trials. The joint environment has played a role in the poor clinical performance of these drugs by limiting the amount of drug effectively delivered as well as the time that the drug spends within the joint space. The current study aims to enhance the cartilage uptake and retention time of the DMOADs-model (licofelone), which showed a significant therapeutic effect against OA progression and is currently in phase III. Licofelone will be covalently conjugated to the hydrolysable, cytocompatible, and cationic poly beta-amino ester polymers (PBAE). The cationic polymers (A16 and A87) can be electrostatically attached to the negatively charged cartilage component (glycosaminoglycan), which will increase the drug penetration through the cartilage and extend the drug time within the cartilage. In the cartilage uptake and retention time studies, an increase of 18 to 37 times of the total conjugated licofelone to A87 and A16 was observed when compared to the free licofelone. Furthermore, the conjugated licofelone to A87 was detectable within the cartilage at 120 minutes, while the free licofelone was not detectable after 60 minutes. Additionally, the A87-licofelone conjugate showed no effect on the chondrocyte viability. In conclusion, the cationic A87 and A16 polymers increased the percentage of licofelone within the cartilage, which could potentially enhance the therapeutic effect and pharmacokinetic performance of licofelone or other DMOADs clinically.

Keywords: PBAE, cartilage., osteoarthritis, injectable biomaterials, drug delivery

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Authors: Mohsen Shirani, Micaela Demichela

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Food supply chain is one of the most complex supply chain networks due to its perishable nature and customer oriented products, and food safety is the major concern for this industry. IT system could help to minimize the production and consumption of unsafe food by controlling and monitoring the entire system. However, there have been many issues in adoption of IT system in this industry specifically within SMEs sector. With this regard, this study presents a novel approach to use IT and tractability systems in the food supply chain, using application of RFID and central database.

Keywords: food supply chain, IT system, safety, SME

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Authors: Salvana P. M. Costa, Tarcyla A. Gomes, Giovanna C. R. M. Schver, Leslie R. M. Ferraz, Cristovão R. Silva, Magaly A. M. Lyra, Danilo A. F. Fonte, Larissa A. Rolim, Amanda C. Q. M. Vieira, Miracy M. Albuquerque, Pedro J. Rolim-neto

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Efavirenz (EFV) is considered one of the most widely used anti-HIV drugs. However, it is classified as a drug class II (poorly soluble, highly permeable) according to the biopharmaceutical classification system, presenting problems of absorption in the gastrointestinal tract and thereby inadequate bioavailability for its therapeutic action. This study aimed to overcome these barriers by developing and obtaining solid dispersions (SD) in order to increase the EFZ bioavailability. For the development of SD with EFV, theoretical and practical studies were initially performed. Thus, there was a choice of a carrier to be used. For this, it was analyzed the various criteria such as glass transition temperature of the polymer, intra- and intermolecular interactions of hydrogen bonds between drug and polymer, the miscibility between the polymer and EFV. The choice of the obtainment method of the SD came from the analysis of which method is the most consolidated in both industry and literature. Subsequently, the choice of drug and carrier concentrations in the dispersions was carried out. In order to obtain DS to present the drug in its amorphous form, as the DS were obtained, they were analyzed by X-ray diffraction (XRD). SD are more stable the higher the amount of polymer present in the formulation. With this assumption, a SD containing 10% of drug was initially prepared and then this proportion was increased until the XRD showed the presence of EFV in its crystalline form. From this point, it was not produced SD with a higher concentration of drug. Thus, it was allowed to select PVP-K30, PVPVA 64 and the SOLUPLUS formulation as carriers, once it was possible the formation of hydrogen bond between EFV and polymers since these have hydrogen acceptor groups capable of interacting with the donor group of the drug hydrogen. It is worth mentioning also that the films obtained, independent of concentration used, were presented homogeneous and transparent. Thus, it can be said that the EFV is miscible in the three polymers used in the study. The SD and Physical Mixtures (PM) with these polymers were prepared by the solvent method. The EFV diffraction profile showed main peaks at around 2θ of 6,24°, in addition to other minor peaks at 14,34°, 17,08°, 20,3°, 21,36° and 25,06°, evidencing its crystalline character. Furthermore, the polymers showed amorphous nature, as evidenced by the absence of peaks in their XRD patterns. The XRD patterns showed the PM overlapping profile of the drug with the polymer, indicating the presence of EFV in its crystalline form. Regardless the proportion of drug used in SD, all the samples showed the same characteristics with no diffraction peaks EFV, demonstrating the behavior amorphous products. Thus, the polymers enabled, effectively, the formation of amorphous SD, probably due to the potential hydrogen bonds between them and the drug. Moreover, the XRD analysis showed that the polymers were able to maintain its amorphous form in a concentration of up to 80% drug.

Keywords: amorphous form, Efavirenz, solid dispersions, solubility

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Authors: Muhammad Imran Din

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The aim of this study was to understand the interaction between multi-walled carbon nano tubes (MCNTs) and anticancer agents and evaluate the drug-loading ability of MCNTs. Batch adsorption experiments were carried out for adsorption of 5-Fluorouracil (5-FL) using MCNTs. The effect of various operating variables, viz., adsorbent dosage, pH, contact time and temperature for adsorption of 5-Fluorouracil (5-FL) has been studied. The Freundlich adsorption model was successfully employed to describe the adsorption process. It was found that the pseudo-second-order mechanism is predominant and the overall rate of the 5-Fluorouracil (5-FL) adsorption process appears to be controlled by the more than one-step. Thermodynamic parameters such as free energy change (ΔG°), enthalpy change (ΔH°) and entropy change (ΔS°) have been calculated respectively, revealed the spontaneous, endothermic and feasible nature of adsorption process. The results showed that carbon nano tubes were able to form supra molecular complexes with 5-Fluorouracil (5-FL) by π-π stacking and possessed favorable loading properties as drug carriers.

Keywords: drug, adsorption, anticancer, 5-Fluorouracil (5-FL)

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Authors: Sz. Klátyik, B. Darvas, M. Mörtl, M. Ottucsák, E. Takács, H. Bánáti, L. Simon, G. Gyurcsó, A. Székács

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Environmental and health safety of condiments used for spicing food products in food processing or by culinary means receive relatively low attention, even though possible contamination of spices may affect food quality and safety. Contamination surveys mostly focus on microbial contaminants or their secondary metabolites, mycotoxins. Chemical contaminants, particularly pesticide residues, however, are clearly substantial factors in the case of given condiments in the Capsicum family including spice paprika and chilli. To assess food safety and support the quality of the Hungaricum product spice paprika, the pesticide residue status of spice paprika and chilli is assessed on the basis of reported pesticide contamination cases and non-compliances in the Rapid Alert System for Food and Feed of the European Union since 1998.

Keywords: spice paprika, Capsicum, pesticide residues, RASFF

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Authors: Ramadhan Febriansyah, Sarah Novianti, Santi Agustini

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Indonesia is a big country with Moslem population. The government must fulfill all needs of the people. However, we do not have a good policy yet especially on healthy, safety and halal food. We try to offer a new solution to overcome this with ASUH (Aman, Sehat, Utuh, Halal) or in English is SHIH (Safe, Healthy, Intact, Halal) as alternative Indonesian policy on food security. This policy is Indonesian Government’s commitment to support Sustainability Development Goals program for the zero hunger (end hunger, to achieve food security and improved nutrition for Indonesian people, of course, to promote sustainable agriculture). Hopefully, it not only can increasing quality on food especially on livestock goods (meat, egg, milk) but also to guarantee the halal food. However, this policy can be an example to others country especially Moslem countries to support SDG’s programs. This research conducted means of the descriptive method; the authors find compare the secondary data obtained from journals, textbook and scientific articles in order to determine the factors that influence food safety and food security. Relevant data used and contain a description of SDG’s as well as about the system food safety and food security that SHIH (Safe, Healthy, Intact and Halal) so these ideas can be implemented.

Keywords: food safety, food security, food sovereignty, halal SDG's

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Authors: Shraddha Acharya, Sharad Kumar Sharma, Ratna Bhattarai, Bhagwan Maharjan, Deepak Dahal, Serpahine Kaminsa

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Background: Drug-resistant (DR) tuberculosis (TB) continues to be a threat in Nepal, with an estimated 2800 new cases every year. The treatment of DR-TB with second line TB drugs is complex and takes longer time with comparatively lower treatment success rate than drug-susceptible TB. Delay in treatment initiation for DR-TB patients might further result in unfavorable treatment outcomes and increased transmission. This study thus aims to determine median time taken to initiate second-line treatment among Rifampicin Resistant (RR) diagnosed TB patients and to assess the proportion of treatment delays among various type of DR-TB cases. Method: A retrospective cohort study was done using national routine electronic data (DRTB and TB Laboratory Patient Tracking System-DHIS2) on drug resistant tuberculosis patients between January 2020 and December 2022. The time taken for treatment initiation was computed as– days from first diagnosis as RR TB through Xpert MTB/Rif test to enrollment on second-line treatment. The treatment delay (>7 days after diagnosis) was calculated. Results: Among total RR TB cases (N=954) diagnosed via Xpert nationwide, 61.4% were enrolled under shorter-treatment regimen (STR), 33.0% under longer treatment regimen (LTR), 5.1% for Pre-extensively drug resistant TB (Pre-XDR) and 0.4% for Extensively drug resistant TB (XDR) treatment. Among these cases, it was found that the median time from diagnosis to treatment initiation was 6 days (IQR:2-15.8). The median time was 5 days (IQR:2.0-13.3) among STR, 6 days (IQR:3.0-15.0) among LTR, 30 days (IQR:5.5-66.8) among Pre-XDR and 4 days (IQR:2.5-9.0) among XDR TB cases. The overall treatment delay (>7 days after diagnosis) was observed in 42.4% of the patients, among which, cases enrolled under Pre-XDR contributed substantially to treatment delay (72.0%), followed by LTR (43.6%), STR (39.1%) and XDR (33.3%). Conclusion: Timely diagnosis and prompt treatment initiation remain fundamental focus of the National TB program. The findings of the study, however suggest gaps in timeliness of treatment initiation for the drug-resistant TB patients, which could bring adverse treatment outcomes. Moreover, there is an alarming delay in second line treatment initiation for the Pre-XDR TB patients. Therefore, this study generates evidence to identify existing gaps in treatment initiation and highlights need for formulating specific policies and intervention in creating effective linkage between the RR TB diagnosis and enrollment on second line TB treatment with intensified efforts from health providers for follow-ups and expansion of more decentralized, adequate, and accessible diagnostic and treatment services for DR-TB, especially Pre-XDR TB cases, due to the observed long treatment delays.

Keywords: drug-resistant, tuberculosis, treatment initiation, Nepal, treatment delay

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Authors: M. R. Aher, R. B. Laware, G. S. Asane, B. S. Kuchekar

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Objective: Studies have shown that a new combination therapy with Artemisinin derivatives and curcumin is unique, with potential advantages over known ACTs. In present study an attempt was made to prepare microparticulate drug delivery system of Curcumin-Zn complex and evaluate it in combination with artemether for antimalarial activity. Material and method: Curcumin Zn complex was prepared and encapsulated using sodium alginate. Microparticles thus obtained are further coated with various enteric polymers at different coating thickness to control the release. Microparticles are evaluated for encapsulation efficiency, drug loading and in vitro drug release. Roentgenographic Studies was conducted in rabbits with BaSO 4 tagged formulation. Optimized formulation was screened for antimalarial activity using P. berghei-infected mice survival test and % paracetemia inhibition, alone (three oral dose of 5mg/day) and in combination with arthemether (i.p. 500, 1000 and 1500µg). Curcumin-Zn(II) was estimated in serum after oral administration to rats by using spectroflurometry. Result: Microparticles coated with Cellulose acetate phthalate showed most satisfactory and controlled release with 479 min time for 60% drug release. X-ray images taken at different time intervals confirmed the retention of formulation in GI tract. Estimation of curcumin in serum by spectroflurometry showed that drug concentration is maintained in the blood for longer time with tmax of 6 hours. The survival time (40 days post treatment) of mice infected with P. berghei was compared to survival after treatment with either Curcumin-Zn(II) microparticles artemether combination, curcumin-Zn complex and artemether. Oral administration of Curcumin-Zn(II)-artemether prolonged the survival of P.berghei-infected mice. All the mice treated with Curcumin-Zn(II) microparticles (5mg/day) artemether (1000µg) survived for more than 40 days and recovered with no detectable parasitemia. Administration of Curcumin-Zn(II) artemether combination reduced the parasitemia in mice by more than 90% compared to that in control mice for the first 3 days after treatment. Conclusion: Antimalarial activity of the curcumin Zn-artemether combination was more pronounced than mono therapy. A single dose of 1000µg of artemether in curcumin-Zn combination gives complete protection in P. berghei-infected mice. This may reduce the chances of drug resistance in malaria management.

Keywords: formulation, microparticulate drug delivery, antimalarial, pharmaceutics

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Authors: Salma E. Ahmed

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Since the mid 50’s, enormous attention has been paid towards nanocarriers and their applications in drug and gene delivery. Among these vesicles, liposomes and micelles have been heavily investigated due to their many advantages over other types. Liposomes, for instance, are mostly distinguished by their ability to encapsulate hydrophobic, hydrophilic and amphiphilic drugs. Micelles, on the other hand, are self-assembled shells of lipids, amphiphilic or oppositely charged block copolymers that, once exposed to aqueous media, can entrap hydrophobic agents, and possess prolonged circulation in the bloodstream. Both carriers are considered compatible and biodegradable. Nevertheless, they have limited stabilities, chemical versatilities, and drug encapsulation efficiencies. In order to overcome these downsides, strategies for optimizing a novel drug delivery system that has the architecture of liposomes and polymeric characteristics of micelles have been evolved. Polymersomes are vehicles with fluidic cores and hydrophobic shells that are protected and isolated from the aqueous media by the hydrated hydrophilic brushes which give the carrier its distinctive polymeric bilayer shape. Similar to liposomes, this merit enables the carrier to encapsulate a wide range of agents, despite their affinities and solubilities in water. Adding to this, the high molecular weight of the amphiphiles that build the body of the polymersomes increases their colloidal and chemical stabilities and reduces the permeability of the polymeric membranes, which makes the vesicles more protective to the encapsulated drug. These carriers can also be modified in ways that make them responsive when targeted or triggered, by manipulating their composition and attaching moieties and conjugates to the body of the carriers. These appealing characteristics, in addition to the ease of synthesis, gave the polymersomes greater potentials in the area of drug delivery. Thus, their design and characterization, in comparison with liposomes and micelles, are briefly reviewed in this work.

Keywords: controlled release, liposomes, micelles, polymersomes, targeting

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Authors: Nick Woodier, Paul Sampson, Iain Moppett

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Background: For years, healthcare across the world has recognised that patients are coming to harm from the very processes meant to help them. In response, healthcare tells itself that it needs to ‘be more like aviation.’ Aviation safety is highly regarded by those in healthcare and is seen as an exemplar. Specifically, healthcare is keen to learn from how aviation uses near misses to make their industry safer. Healthcare is rife with near misses; however, there has been little progress addressing them, with most research having focused on reporting. Addressing the factors that contribute to near misses will potentially help reduce the number of significant, harm patientsafety incidents. While the healthcare literature states the need to learn from aviation’s use of near misses, there is nothing that describes how best to do this. The authors, as part of a larger study of near-miss management in healthcare, sought to learn from aviation to develop principles for how healthcare can identify, report, and learn from near misses to improve patient safety. Methods: A Grounded Theory (GT) methodology, augmented by a scoping review, was used. Data collection included interviews, field notes, and the literature. The review protocol is accessible online. The GT aimed to develop theories about how aviation, amongst other safety-critical industries, manages near misses. Results: Twelve aviation interviews contributed to the GT across passenger airlines, air traffic control, and bodies involved in policy, regulation, and investigation. The scoping review identified 83 articles across a range of safety-critical industries, but only seven focused on aviation. The GT identified that aviation interprets the term ‘near miss’ in different ways, commonly using it to specifically refer to near-miss air collisions, also known as Airproxes. Other types of near misses exist, such as health and safety, but the reporting of these and the safety climate associated with them is not as mature. Safety culture in aviation was regularly discussed, with evidence that culture varies depending on which part of the industry is being considered (e.g., civil vs. business aviation). Near misses are seen as just one part of an extensive safety management system, but processes to support their reporting and their analysis are not consistent. Their value alone is also questionable, with the challenge to long-held beliefs originating from the ‘common cause hypothesis.’ Conclusions: There is learning that healthcare can take from how parts of aviation manage and learn from near misses. For example, healthcare would benefit from a formal safety management system that currently does not exist. However, it may not be as simple as ‘healthcare should learn from aviation’ due to variation in safety maturity across the industry. Healthcare needs to clarify how to incorporate near misses into learning and whether allocating resources to them is of value; it was heard that catastrophes have led to greater improvements in safety in aviation.

Keywords: aviation safety, patient safety, near miss, safety management systems

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Authors: Burcu Doymus, Fatma N. Kok, Sakip Onder

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Titanium and titanium-based materials are commonly used to replace or regenerate the injured or lost tissues because of accidents or illnesses. Hospital infections and strong bond formation at the implant-tissue interface are directly affecting the success of the implantation as weak bonding with the native tissue and hospital infections lead to revision surgery. The purpose of the presented study is to modify the surface of the titanium substrates with nano/microspheres for local drug delivery and to prevent hospital infections. Firstly, titanium surfaces were silanized with APTES (3-Triethoxysilylpropylamine) following the negatively charged oxide layer formation. Then characterization studies using Scanning Electron Microscopy (SEM) and Fourier transform infrared spectroscopy (FTIR) were done on the modified surfaces. Secondly, microspheres/nanospheres were prepared with chitosan that is a natural polymer and having valuable properties such as non-toxicity, high biocompatibility, low allergen city and biodegradability for biomedical applications. Antibiotic (ciprofloxacin) loaded micro/nanospheres have been fabricated using emulsion cross-linking method and have been immobilized onto the titanium surfaces with different immobilization techniques such as covalent bond and entrapment. Optimization studies on size and drug loading capacities of micro/nanospheres were conducted before the immobilization process. Light microscopy and SEM were used to visualize and measure the size of the produced micro/nanospheres. Loaded and released drug amounts were determined by using UV- spectrophotometer at 278 nm. Finally, SEM analysis and drug release studies on the micro/nanospheres coated Ti surfaces were done. As a conclusion, it was shown that micro/nanospheres were immobilized onto the surfaces successfully and drug release from these surfaces was in a controlled manner. Moreover, the density of the micro/nanospheres after the drug release studies was higher on the surfaces where the entrapment technique was used for immobilization. Acknowledgement: This work is financially supported by The Scientific and Technological Research Council Of Turkey (Project # 217M220)

Keywords: chitosan, controlled drug release, nanosphere, nosocomial infections, titanium

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Authors: Behcet Al, Şener Cindoruk, Suat Zengin, Mehmet Murat Oktay, Mehmet Mustafa Sunar, Hatice Eroglu, Cuma Yildirim

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Objective: In present study we aimed to investigate the chronic drug use due to chronic diseases in patients admitted to emergency department. Materials-Methods: 144 patients who applied to emergency department (ED) of medicine school of Gaziantep University between June 2013 and September 2013 with chronic diseases and use chronic drugs were included. Information about drugs used by patients were recorded. Results: Of patients, half were male, half were female, and the mean age was 58 years. The first three common diseases were diabetes mellitus, hypertension and coronary artery diseases. Of patients, %79.2 knew their illness. Fifty patients began to use drug within three months, 36 patient began to use within the last one year. While 42 patients brought all of their drugs with themselves, 17 patients brought along a portion of drugs. While three patients stopped their medication completely, 125 patients received medication on a regular basis. Fifty-two patient described the drugs with names, 13 patients described with their colors, 3 patients described by grammes, 45 patients described with the size of the tablet and 13 patients could not describe the drugs. Ninety-two patients explained which kind of drugs were used for each diseases, 17 patient explained partly, and 35 patients had no idea. Hundred patients received medication by themselves, 44 patients medications were giving by their relatives and med carers. Of medications, 140 were written by doctors directly, three medication were given by pharmacist; and one patient bought the drug by himself. For 11 patients the drugs were not harmonious to their diseases. Fifty-one patients admitted to the ED two times within last week, and 73 admitted two times within last month. Conclusion: The majority of patients with chronic diseases and use chronic drugs know their diseases and use the drugs in order, but do not have enough information about their medication.

Keywords: chronic disease, drug use, emergency department, medication

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Authors: Ibrahim M. Labouta, Marwa H. El-Wakil, Hayam M. Ashour, Ahmed M. Hassan, Manal N. Saudi

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The receptor tyrosine kinase c-Met is an attractive target for therapeutic treatment of cancers nowadays. Among the wide variety of heterocycles that have been explored for developing c-Met kinase inhibitors, the 1,2,4-triazines have been rarely investigated, although they are well known in the literature to possess antitumor activities. Herein we describe the design and synthesis of a novel series of 1,2,4-triazine derivatives possessing N-acylarylhydrazone moiety and another series combining the 1,2,4-triazine scaffold to the well-known anticancer drug 6-MP in order to explore their “double-drug” effect. The synthesized compounds were evaluated for their in vitro antitumor activity against three c-Met addicted cancer cell lines (A549, HT-29 and MKN-45). Most compounds showed moderate to excellent antiproliferative activity and four compounds showed potent inhibitory activity more than the reference drug Foretinib against one or more cancer cell lines. The obtained results revealed that the potent compounds are highly selective to A549 (lung adenocarcinoma) cancer cell line. The c-Met kinase inhibitory activity of the potent derivatives is still under investigation. The present study clearly demonstrates that the 1,2,4-triazine core ring exhibits promising antitumor activity with potential c-Met kinase inhibitory activity.

Keywords: 1, 2, 4-triazine, antitumor, c-Met inhibitor, double-drug

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Authors: Mirad Böhm, Diede De Kok

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It goes without saying that for many NGOs a high level of safety and security are crucial issues, which often necessitates the support of military personnel to varying degrees. The relationship between military and NGO personnel is usually a difficult one and while there has been progress, clashes naturally still occur owing to different interpretations of mission objectives amongst many other challenges. NGOs tend to view safety and security as necessary steps towards their goal instead of fundamental pillars of their core ‘business’. The military perspective, however, considers them primary objectives; thus, frequently creating a different vision of how joint operations should be conducted. This paper will argue that internalizing safety and security into the NGO organizational culture is compelling in order to ensure a more effective cooperation with military partners and, ultimately, to achieve their goals. This can be accomplished through a change in perception of safety and security concepts as a fixed and major point on the everyday agenda. Nowadays, there are several training programmes on offer addressing such issues but they primarily focus on the individual level. True internalization of these concepts should reach further by encompassing a wide range of NGO activities, beginning with daily proceedings in office facilities far from conflict zones including logistical and administrative tasks such as budgeting, and leading all the way to actual and potentially hazardous missions in the field. In order to effectuate this change, a tool is required to help NGOs realize, firstly, how they perceive and define safety and security, and secondly, how they can adjust this perception to their benefit. The ‘safety culture ladder’ is a concept that suggests what organizations can and should do to advance their safety. While usually applied to private industrial scenarios, this work will present the concept as a useful instrument to visualize and facilitate the internalization process NGOs ought to go through. The ‘ladder’ allows them to become more aware of the level of their safety and security measures, and moreover, cautions them to take these measures proactively rather than reactively. This in turn will contribute to a rapprochement between military and NGO priority setting in regard to what constitutes a safe working environment.

Keywords: NGO-military cooperation, organisational culture, safety and security awareness, safety culture ladder

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Authors: Harish K. Chandrawanshi, Mithun S. Rajput, Neelima Choure, Purnima Dey Sarkar, Shailesh Jain

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The present research study aimed to fabricate and evaluate biodegradable nanoparticles of aromatase inhibitor letrozole, intended for breast cancer therapy. Letrozole loaded poly(D,L-lactide-co-glycolide acid) nanoparticles were prepared by solvent evaporation method using dichlorometane as solvent (oil phase) and polyvinyl alcohol (PVA) as aqueous phase. Prepared nanoparticles were characterized by particle size, infrared spectra, drug loading efficiency, drug entrapment efficiency and in vitro release and also evaluated for in vivo anticancer activity. The high speed homogenizer was used to produce stable nanoparticles of mean size range 198.35 ± 0.04 nm with high entrapment efficiency (69.86 ± 2.78%). Percentage of drug and homogenization speed significantly influenced the particle size, entrapment efficiency and release (p<0.05). The nanoparticles show significant in vivo anticancer activity against Ehrlich ascites carcinoma in mice. The significant system sustained the release of letrozole drug effectively and further investigation could exhibit its potential usefulness in breast cancer therapy.

Keywords: breast cancer/therapy, letrozole, nanoparticles, PLGA

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Authors: Moustafa Ali Elwan, Ibrahim Salem Abdelrafa, Ashraf Moharm

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Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most commonly prescribed oral and topical drugs worldwide. Moreover, NSAIDs are responsible for most of all adverse drug reactions. For several decades, there are numerous attempts to use the cutaneous layers as a gate into the body for the local delivery of the therapeutic agent. Transdermal drug delivery is a validated technology contributing significantly to global pharmaceutical care. Transdermal Drug Delivery systems can be improved by using therapeutic agents. Moreover, Transdermal Drug Delivery systems can be improved by using chemical enhancers like ultrasound or iontophoresis. Iontophoresis provides a mechanism to enhance the penetration of hydrophilic and charged molecules across the skin. Objective: to compare the drug administration by ‘iontophoresis’ versus the oral rule. Methods: This study was conducted at the Faculty of Physical Therapy, Modern University for technology and information, Cairo, Egypt, on 20 participants (8 female & 12 male) who complained of tennis elbow. Their mean age was (25.45 ± 3.98) years, and all participants were assessed in many aspects: Pain threshold was assessed by algometer. Range of motion was assessed by electro goniometer, and isometric strength was assessed by a portable hand-held dynamometer. Then Participants were randomly assigned into two groups: group A was treated with oral NSAID (diclofenac) while group B was treated via administration of NSAIDs (diclofenac) via an iontophoresis device. All the participants were subjected to blood samples analysis in both pre-administration of the drug and post-administration of the drug for 24 hours (sample/every 6 hours). Results: The results demonstrated that there was a significant improvement in group b, “iontophoresis NSAIDs group,” more than in group B,” oral NSAIDs group,” in all measurements ‘ pain threshold, strength, and range of motion. Also, the iontophoresis method shows higher maximum plasma concentrations (Cmax) and concentration-time curves than the oral method.

Keywords: diclofenac, iontophoresis, NSAIDs, oral, tennis elbow

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Authors: Mohammad Raihan Mukhlis, M. Abdur Rahman Bhuiyan

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Bangladesh is a developing country in which a lot of multi-span simply/continuous supported flyovers are being constructed in its major cities. Being situated in a seismically active region, seismic safety evaluation of flyovers is essential for seismic risk reduction. Effects of site amplification on seismic safety evaluation of flyover piers are the main concern of this study. In this regard, failure mode, lateral strength and displacement ductility of piers of a typical multi-span simply supported flyover have been evaluated by Japan Road Association (JRA) recommended guidelines, with and without considering site amplification. Ultimate flexural strengths of piers have been computed using the pushover analysis results. Shear capacity of piers has been calculated using the guidelines of JRA. Lateral strengths have been determined depending on the failure modes of the piers. Displacement ductility of piers has been computed using yield and ultimate displacements of the piers obtained from the pushover analysis results. Selected earthquake time history is used in seismic safety evaluation of the flyover piers. Finally, the ductility design method is used to conduct the seismic safety evaluation of the piers with and without considering site amplification. From the numerical results, it has been revealed that the effects of site amplification on seismic safety evaluation of bridge structures should be carefully taken into account.

Keywords: displacement ductility, flyover pier, lateral strength, safety evaluation, site amplification

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Authors: Siphesihle Hlongwane

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Background: Globally, alcohol consumption, smoking, and the use of illicit drugs kill more than 11.8 million people each year. In sub-Saharan Africa, substance abuse is responsible for more than 6.4% of all deaths recorded and about 4.7% of all Disability Adjusted Life Years (DALYs), with numbers still expected to grow if no drastic measures are taken to curb and address drug use. In a setting where substance use is rife, understanding contextual factors that influence an individual’s perceived eligibility to seek rehabilitation is paramount. Using the candidacy framework, we unpack how situational factors influence an individual’s perceived eligibility for healthcare uptake in adolescents and youth with substance use disorder (SUD). Methods: The candidacy framework is concerned with how people consider their eligibility for accessing a health service. The study collected and analyzed primary qualitative data to answer the research question. Data were collected between January and July 2022 on participants aged between 18 and 35 for drug users and 18 to 60 for family members. Participants include 20 previous and current drug users and 20 family members that experience the effects of addiction. A pre-drafted semi-structured interview guide was administered to a conveniently sampled population supplemented with a referral sampling method. Data were thematically analyzed using the NVivo 12pro software to manage the data. Findings: Our findings show that people with substance use disorders are aware of their drug use habits and acknowledge their candidacy for health services. Candidacy for health services is also acknowledged by those around them, such as family members and peers, and as such, information on the navigation of health services for drug users is shared by those who have attended health services, those affected by drug use, and this includes health service research by family members to identify accessible health services. While participants reported willingness to quit drug use if assistance is provided, the permeability of health care services is hindered by both individual determinations to quit drug use from long-time use and the availability of health services for drug users, such as rehabilitation centers. Our findings also show that drug users are conscious and can articulate their ailments; however, the hunt for the next dose of drugs and long waiting cues for health service acquisition overshadows their claim to health services. Participants reported a mixture of treatments prescribed, with some more gruesome than others prescribed, thus serving as both a facilitator and barrier for health service uptake. Despite some unorthodox forms of treatments prescribed in health care, the majority of those who enter treatment complete the process of treatment, although some are met with setbacks and sometimes relapse after treatment has finished. Conclusion: Drug users are able to ascertain their candidacy for health services; however, individual and environmental characteristics relating to drug use hinder the use of health services. Drug use interventions need to entice health service uptake as a way to improve candidacy for health use.

Keywords: substance use disorder, rehabilitation, drug use, relapse, South Africa, candidacy framework

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Authors: Wanwimon Mekwimon

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Drug addiction is a serious problem in Thailand which has occurred continuously and repeatedly and enormously impacting health and economy of drug users. The indigenous wisdom and folk medicine is an attractive alternative choice, especially in detoxification and rehabilitation period. There are two objectives: First is to study about rehabilitation process and the curing for drug eaters and 2nd is to investigate the effectiveness of the curing and rehabilitation process by indigenous wisdom at Tamkrabok monastery, Pra-Puttabat district, Saraburi province. The main informants are 10 curers, 15 patients and 17 after-1-year rehabilitators. In the process, the semi-structured questionnaire is administered, the data are analyzed and proved by triangulation. The curing and rehabilitation process which use herbal remedies has a period of 15 days (5 days for detoxification and 10 days for recovery period) and the occupational training and self-consciousness awakening were delivered. The follow-up process includes twice-a-month recall for 6 months, follow-up letters and in depth interview with their families. The outcome of 1 year post-treatment was 94% (16 from 17). There are many reasons for not relapsing: the recovering patients have drawn on their inner strength, self-awareness and coping skill as well as their family and social support while rehabilitation process which includes difficulties in contacting with family members. They can void themselves from high risk situations to relapse. Recommendations: The follow-up system should be improved for continuous quality improvement, there should be the qualification standard for herbal remedies and the comparison among rehabilitation process of Tamkrabok and another methods are to be guideline for the further development.

Keywords: rehabilitation, drug addiction, Thai indigenous knowledge, herbal remedies

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Authors: Eija Raatikainen

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The aim of the study is to examine psychological safety in the context of change in working life and continuous learning in social- and educational organizations. The participants in the study are social workers and vocational teachers working as employees and supervisors in the capital region of Finland (public and private sectors). Research data has been collected during 2022-2023 using the qualitative method called empathy-based stories (MEBS). Research participants were asked to write short stories about situations related to their work and work community. As researchers, we created and varied the framework narratives (MEBS) in line with the aim of the study and theoretical background. The data were analyzed with content analysis. According to the results, the barriers and prerequisites for psychological safety at work could be located in four different working culture dimensions. The work culture dimensions were named as follows: 1) a work culture focusing on interaction and emotional culture between colleagues, 2) communal work culture, 3) a work culture that enables learning, and 4) a work culture focused on structures and operating models. All these have detailed elements of barriers and prerequisites of psychological safety at work. The results derived from the enlivening methods can be utilized when working with the work community and have discussed psychological safety at work. Also, the method itself (MEBS) can prevent open discussion and reflection on psychological safety at work because of the sensitivity of the topic. Method aloud to imagine, not just talk and share your experiences directly. Additionally, the results of the study can offer one tool or framework while developing phycological safety at work.

Keywords: psychological safety, empathy, empathy-based stories, working life

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Authors: Susmita Roy, Madhavan Nallani

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In recent years' polymersomes, self-assembled polymeric vesicles emerge from block copolymers, have been widely investigated due to their enhance stability and unique advantageous properties compared to their phospholipid counterpart, liposomes, dendrimers, and micelles. It provides a distinctive platform for advanced therapeutics and the creation of complex (bio) catalytically active systems for research in Nanomedicine and synthetic biology. Inspired by nature, where compartmentalization of biological components is all ubiquitous, we are interested in developing a platform technology of self-assembled multifunctional compartments with applications in areas from targeted drug/gene delivery, biosensing, pharmaceutical to cosmetics. Polymersome surfaces can be a proper choice of derivatization with a controlled amount of functional groups. To achieve site-specific targeting of polymersomes, biological recognition motives can be attached to the polymersomes surface by standard bioconjugation techniques, (like esterification, amidation, thiol-maleimide coupling, click-chemistry routes or other coupling methods). Herein, we are developing easy going, one-step bioconjugation strategies for site-specific surface functionalized biodegradable polymeric and/or polymer-lipid hybrid vesicles for targeted drug delivery. Biodegradable polymer, polycaprolactone-b-polyethylene glycol (PCL-PEG), polylactic acid-b-polyethylene glycol (PLA-PEG) and phospholipid, 1-palmitoyl-2- oleoyl-sn-glycero-3-phosphocholine (POPC) has been widely used for numerous vesicle formulations. Some of these drug-loaded formulations are being tested on mice for controlled release. These surface functionalized polymersomes are also appropriate for membrane protein reconstitution/insertion, antibodies conjugation and various bioconjugation with diverse targeted molecules for controlled drug delivery.

Keywords: drug delivery, membrane protein, polymersome, surface modification

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Authors: Andrew Kizito Seruma, Dickson Okello, George Owuor

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Low adoption of food safety practices has serious consequences for smallholder dairy farmers’ productivity, profitability, and market access. Farmers’ low levels of knowledge concerning FSMs coupled with a negative perception of it have greatly influenced compliance with food safety standards. Therefore, it is imperative to understand the drivers that influence dairy farmers’ behaviors to perform safety and hygiene control practices at the farm level. Using data obtained from structured questionnaires completed by 757 smallholder farmers in Central Uganda, we construct a theoretical framework based on the theory of planned behavior and structural equation model to capture the mechanisms behind smallholder dairy farmers’ adoption of SHCP. The findings indicate that there was a positive relationship between perceived behavioral control (β = 0.121, p=0.06) and attitude (β = 0.883, p=0.01) with the adoption of safety and hygiene control practices. However, the relationship between subjective norms and the adoption of safety and hygiene control practices was negative (β = -0.533, p=0.02). It is noteworthy that perceived behavioral control and attitudes play a crucial role in increasing farmers’ adoption of SHCP. The result of this study shows that by fully understanding the merits and demerits of performing safety and hygiene control practices at the farm, smallholder farmers can make better decisions on adopting the SHCP at their farms linked to their cognitive behavior. Based on these findings, future policy interventions to promote SHCP should focus on improving farmers’ perception and attitude toward implementing safety and hygiene control practices through capacity building and providing incentives such as better milk prices through a quality-based buying system.

Keywords: food-safety, hygiene, behavioral, norms, attitude, smallholder, dairy

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Authors: Naima Bouslah, Leila Bounabi, Farid Ouazib, Nabila Haddadine

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Conventional release dosage forms are known to provide an immediate release of the drug. Controlling the rate of drug release from polymeric matrices is very important for a number of applications, particularly in the pharmaceutical area. Hydrogels are polymers in three-dimensional network arrangement, which can absorb and retain large amounts of water without dissolution. They have been frequently used to develop controlled released formulations for oral administration because they can extend the duration of drug release and thus reduce dose to be administrated improving patient compliance. Tramadol is an opioid pain medication used to treat moderate to moderately severe pain. When taken as an immediate-release oral formulation, the onset of pain relief usually occurs within about an hour. In the present work, we synthesized pH-responsive hydrogels of (hydroxyl ethyl methacrylate-co-acrylic acid), (HEMA-AA) for control drug delivery of tramadol in the gastro-intestinal tractus. The hydrogels with different acrylic acid content, were synthesized by free radical polymerization and characterized by FTIR spectroscopy, X ray diffraction analysis (XRD), differential scanning calorimetry (DSC) and thermo gravimetric analysis (TGA). FTIR spectroscopy has shown specific hydrogen bonding interactions between the carbonyl groups of the hydrogels and hydroxyl groups of tramadol. Both the XRD and DSC studies revealed that the introduction of tramadol in the hydrogel network induced the amorphization of the drug. The swelling behaviour, absorptive kinetics and the release kinetics of tramadol in simulated gastric fluid (pH 1.2) and in simulated intestinal fluid (pH 7.4) were also investigated. The hydrogels exhibited pH-responsive behavior in the swelling study. The (HEMA-AA) hydrogel swelling was much higher in pH =7.4 medium. The tramadol release was significantly increased when pH of the medium was changed from simulated gastric fluid (pH 1.2) to simulated intestinal fluid (pH 7.4). Using suitable mathematical models, the apparent diffusional coefficients and the corresponding kinetic parameters have been calculated.

Keywords: biopolymres, drug delivery, hydrogels, tramadol

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