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.