Iranian Journal of Pharmaceutical Sciences

Amikacin is commonly prescribed to pediatric patients as a bactericidal antibiotic. However, limited scientific data is available to determine safe and toxic levels in this population. This study aims to raise awareness among healthcare professionals about the adverse drug reactions associated with Amikacin therapy in pediatric patients and improve patient care and safety. The study involved a pharmacovigilance awareness program for healthcare professionals at the Pharmacovigilance unit of All India Institute of Medical Sciences (AIIMS), Bathinda. Patients reported adverse drug reactions (ADRs) through various means, such as phone or WhatsApp. The ADR reports were evaluated for demographic and ADR attributes such as date of onset, management description, causality, and overall event outcome. The causality of each ADR was determined using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) scale and Naranjo algorithm, and the severity was determined using the Modified Hartwig and Siegel Scale. Out of 60 pediatric patients given Amikacin, 5 reported adverse drug reactions. Most patients reporting ADRs were female, with a median age of 9 years and a median duration of one day. The adverse drug reactions were primarily skin-related and non-serious. The study highlights the need for a national-level control of preventable adverse drug reactions and a pediatric pharmacovigilance system in healthcare facilities. The data collected from this study will be used by the National Coordination Centre, Pharmacovigilance Programme of India, to create a drug alert and improve patient care and safety at the national level.

This investigation aimed to assess the influence of vitamin D3 and calcium on certain immunological and biochemical factors in rats. Forty-eight male rats were assigned to eight distinct groups. There were two main groups. The first group had standard Diet-Fed rats (Vit. D3, Ca+2, Vit. D3, and Ca+2, Sunlight, and Fasting). The second group had high-fat diet-fed rats (HFD and HFD with Vit. D3 and Ca+2), also compared to the control group. The administration of calcium and vitamin D supplements lasted for six weeks. The levels of vitamin K, IL-10, TNF-α, IgM, and Osteocalcin were determined by applying ELISA. The administration of Vitamin D and calcium has been observed to significantly increase Vitamin D, Vitamin K, and Osteocalcin levels in the rats fed on the typical diet. In contrast, sunlight exposure and fasting for the same duration did not substantially impact serum vitamin D and Osteocalcin in rats fed a normal diet. Additionally, a significant reduction in the concentration of Vitamin K in the serum was detected in the experimental rats fed on a normal diet and subjected to sunlight and fasting. The administration of HFD for six weeks was found to provoke hyperglycemia in experimental rats. However, it did not elicit any significant influence on the concentration of vitamin D, vitamin K, and osteocalcin. Furthermore, using calcium and vitamin D for six weeks negatively impacted immune disturbances in rats consuming a normal diet (ND) or HFD by regulating anti-inflammatory cytokine (IL-10) secretion.

Botulinum neurotoxin (BoNT), a lethal bacterial toxin causing neuroparalytic disease, necessitates robust detection methods to prevent and manage botulism outbreaks. The receptor-binding domain of the toxin's heavy chain (Hc) has been extensively explored as a potential BoNT vaccine candidate. This study's primary goal is the swift detection of Botulinum neurotoxin type A (BoNT/A) using a sandwich ELISA method employing polyclonal antibodies. The recombinant BoNT/A-285HcC was induced with one mM IPTG at 25°C for 18 hours to reduce inclusion bodies and purified using Ni-NTA under non-denaturing conditions. Immunization of animals followed a specific regimen using purified BoNT/A-285HcC recombinant antigen and Freund's adjuvant. IgG antibodies from immunized mice serum were isolated using protein G resin. The purified antibodies' reactivity with recombinant BoNT/A-285HcC protein was assessed through western blotting. Efficient protein expression was achieved, yielding 50 mg/L. The recombinant BoNT/A-285HcC, with a molecular weight of 46 kDa, was purified with a near 90% purity level. ELISA results demonstrated a significant rise in anti-BoNT/A antibody titers following three doses. Western blot analysis confirmed the specific binding capability of the purified anti-BoNT/A IgG. Ultimately, the sandwich ELISA developed in this study exhibited the ability to detect 100 pg/ml of BoNT/A, utilizing 1.25 µg/ml of mice antibody as the capture and 0.3 µg/ml of rabbit antibody as the detection antibody. Purified polyclonal antibodies against recombinant BoNT/A-285HcC can be effectively employed in diagnostic serological tests for BoNT/A detection, with a limit of detection (LOD) of 100 pg/ml, significantly enhancing our ability to combat BoNT-related threats and ensuring the safety of medical applications.

According to the increasing trend of antibiotic consumption all over the world, a rising concern is the emergence of resistant pathogens due to the inappropriate use of antibiotics, which increases the risk of treatment failure and mortality. Antibiotic Order Form (AOF) is an antimicrobial stewardship program protocol recommended to improve rational antibiotic use. We aimed to compare the antibiotic consumption rate, i.e., vancomycin and carbapenems, before and after preprinted AOFs were implemented. This study also evaluated physicians' compliance with AOFs as a secondary outcome. This prospective descriptive study was conducted from July to December 2015 in a 570-bed teaching hospital in Tehran, Iran. AOF includes demographics, microbiological, and clinical data on infection designed for vancomycin and carbapenems, including imipenem and meropenem. Prescribers were asked to fill out predesigned forms after prescribing the selected antibiotics and deliver them to the pharmacy on July 1, 2015. Collected data during this 6-month study period were compared with the same period times years 2011 to 2016 (4 years before and one year after implementation of AOF) to determine the effect of AOFs on the selected antibiotics consumption that had been calculated based on Daily Doses per 100-patients day (DDD/100-bed days). This study showed that although vancomycin had an increasing trend from 2011 to 2014, implementing the AOF program could stop this trend in 2015. vancomycin consumption significantly decreased compared to the previous year (P = 0.039). This effect of the program was not the same on the use rate of carbapenems, and their use was increased nonsignificantly in 2015 (P = 0.606). The acceptance of prescribers in filling out the forms for vancomycin increased from 5.12% in the first month to 57.75% in December. This increase was from 4.20% to 37.26% for carbapenems. According to the increasing trend of antibiotic consumption in hospitals, we recommend improving utilization surveillance of antibiotics by choosing an appropriate antibiotic, optimal dosing, and desired duration of treatment that are important in decreasing the risk of developing resistant microorganisms due to misuse. The forms are much more effective when accompanied by the acceptance of prescribers.

Extended Spectrum Beta Lactamase (ESBL)-Producing Acinetobacter baumannii has threatened patients’ optimal healthcare in various tertiary care hospitals globally. The paucity of information regarding this life-threatening organism in Nigeria necessitated this research. Hence, this study aimed to molecularly characterize ESBL-producing A. baumannii among debilitated patients in a tertiary care hospital in Ebonyi State, Nigeria. Debilitated patients admitted in the intensive care unit (ICU), medical, surgical, and orthopedic wards were sampled, and 385 clinical samples were obtained from them over a six-month study period. Standard microbiological methods were used to identify A. baumannii isolates, while 16S rRNA PCR was used to confirm the isolates molecularly. The Kirby-Bauer disc diffusion techniques were used to ascertain the antibiotic sensitivity profiles of A. baumannii isolates. The double disc synergy test (DDST) method was employed to determine ESBLs production among the isolates, while to determine A. baumannii isolates harboring bla_TEM, bla_SHV, and bla_OXA genes, PCR techniques were used. A total of 23 (6%) A. baumannii isolates were recovered from 385 clinical samples. The isolated A. baumannii exhibited multidrug resistance (MDR) traits, while 43.5% of the isolates were ESBL-producing A. baumannii. Also, 9 (90%) and 3 (30%) of the isolated A. baumannii harbored bla_TEM and bla_OXA genes, respectively, while no isolate harbored the bla_SHV gene. The isolated A. baumannii were observed to harbor ESBL genes. Importantly, this is the first report of ESBL-producing A. baumannii in Ebonyi State, Nigeria.

Since the prevalence of pressure ulcers has been increasing in recent years, they need a new and efficient treatment. The pleiotropic effects of statins can be used for this purpose. This study aimed to evaluate the appropriate formulation of 3% simvastatin (SIM) topical cream and its effect on the healing of bedsores. At first, the appropriate formulation of SIM topical cream was investigated. In a randomized, double-blind trial, 42 patients were divided into two groups: placebo and SIM cream, and used these creams for three weeks, once every 12 hours on a clean bedsore. Bedsore dimensions were measured at the beginning and end of the study. Seventy-seven percent of patients in the SIM group and 35% in the placebo group had more than 20% healing of bedsores. Age (P=0.03), gender (P=0.01), statin use (P=0.04), and diabetes (P=0.04) had statistically significant impacts on bedsore healing. Also, better wound healing in the non-diabetic patients was observed. It seems that the topical cream of SIM significantly affects the healing of bedsores and can also be used in bedsores of diabetic patients. In diabetic patients with bedsores, blood sugar control through nutritional counseling and consumption of regular diabetic medication seems to be very effective and efficient.

Pantoprazole (PPZ) is one of the proton pump inhibitors which is used to prevent the secretion of excess gastric acid in both adults and children. However, it is difficult to use in patients under 5 years of age or elderly patients due to the lack of appropriate liquid formulation. In this study, a liquid liposomal formulation of pantoprazole with improved physicochemical stability has been introduced to facilitate the drug administration in above mentioned patients. Lecithin and cholesterol in different ratios were used to prepare liposomes by the thin-layer hydration method. Optimization studies were performed to find the best formulation. Liposomes were examined for particle size, entrapment efficiency, and stability at ambient temperature. The morphology of liposomes was also investigated by scanning electron microscopy and light microscopy. The release rate of the drug from the liposomal formulation in the aqueous phase was monitored for 24 hours. The results showed more than 60% loading of pantoprazole into the liposomes. The particle size of liposomes decreased with increasing levels of lecithin. Analysis of variance showed a significant difference in drug release within 24 hours. The effects of time, temperature, and light on the apparent instability of the drug were restrained by liposomal formulation and the entrapped drug was more stable compared to the pantoprazole solution. The results of the present study demonstrated that the formulation of pantoprazole in liposomes could provide a new perspective for the treatment of gastric reflux.

Remdesivir (RDV) is one of the drugs that showed beneficial effects in treating Coronavirus disease in 2019 (COVID-19). We performed the present study to evaluate the safety of Remdesivir administration in the outpatient setting. In this study, 512 patients with COVID-19 participated. When selected patients came to the hospital for the drug injection on the appointed day, the vital signs and the percentage of oxygen saturation were measured before Remdesivir administration. During and after the injection, if any drug side effects occurred, it was recorded. Laboratory tests, including Complete blood count differential, C-reactive protein, Liver function tests, Blood urea nitrogen, and creatinine, were checked before and between the treatment courses. The mean age of participants was 46.19±14.20 years, and 46.9% were men. 97.4 percent of patients did not experience any side effects following Remdesivir administration. The amounts of laboratory components like White blood cells, Platelet, Alanine aminotransferase, and Blood urea nitrogen were significantly increased. In contrast, Hemoglobin, C-reactive protein, Aspartate aminotransferase, Alkaline phosphatase, and Creatinine levels were significantly decreased following the administration of Remdesivir compared to baseline values.