International Journal of Pharmacy and Pharmaceutical Sciences

ACETAMINOPHEN-INDUCED TOXIC EPIDERMAL NECROLYSIS IN PEDIATRIC PATIENTS-A CASE SERIES

DHARMESH MEVADA — 2024-07-01

Acetaminophen is the most widely used over-the-counter medication for treating fever and pain. While adverse reactions to this drug are infrequent, they can occasionally result in severe and potentially fatal events, such as Toxic Epidermal Necrolysis (TEN). Due to the rarity of such reactions, there is a limited amount of information available about toxic epidermal necrolysis caused by acetaminophen. This case series will contribute to the existing knowledge in this area. In our cases, acetaminophen is the most suspected drug for the development of toxic epidermal necrolysis in patients. Causality assessment in all of these adverse drug reaction in context with World Health Organization (WHO) causality assessment scale suggests “Possible.” This case series concludes that severe hypersensitivity reactions like TEN caused by acetaminophen use and which can be potentially life-threatening which needs additional treatment.

EXPLORING THE CLINICAL SPECTRUM AND INDIVIDUALIZED DRUG THERAPY IN PEMPHIGUS VULGAR IS: A CASE SERIES

EVANGELINE GLADWIN — 2024-07-01

Pemphigus Vulgaris (PV) is a rare, chronic, life-threatening immunopathogenic disease that is characterized by flaccid, easily ruptured intraepithelial bullae, mostly found on the skin and mucous membranes. Attempting to keep the treatment plan of this potentially deadly disorder in primary focus, we have observed five patients with Pemphigus vulgaris. All patients have been presented with oral lesions or ulcers resulting in difficulty in swallowing. Patient one had a family history of the disease, while the other patients did not present any family history. All five patients had diverse ways of dealing with the disease before getting hospitalized. Microcytic anaemia and hypoalbuminemia have been found in all of them. Patients 1 and 3 had leucocytosis, while patient three had platelets in clumps with Hypercobalaminemia and the presence of ketone bodies in urine analysis. The Desmoglein I and Desmoglein III Antibody along with Punch biopsy results, confirmed the diagnosis. All patients were given systemic corticosteroids on hospitalization, but the case series observed variations in the dosages emphasizing individualized drug therapy. Some developed psychological impairment, some had generalized headaches or cardiac impairment, while ophthalmic involvement was seen in the other patients. Healthcare providers should do close monitoring while providing individualized drug therapy to prevent any systemic involvement and further complications.

GENERIC DRUG REGISTRATION AND COUNTRY-SPECIFIC REQUIREMENTS IN SAUDI ARABIA, QATAR, BAHRAIN, AND OMAN

GUNASEELAN J. — 2024-07-01

Objective: This research aims to examine the regulatory framework and prerequisites for generic drug registration in the Middle East and North Africa (MENA) region, with a specific focus on the countries that make up the Gulf Cooperation Council (GCC). This will enable a deeper understanding of the procedures, records, schedules, and discrepancies related to registration.

Methods: The study makes use of an extensive examination of the rules, regulations, and practices about the registration of generic drugs in the MENA. Official government sites, regulatory agencies, and respectable trade journals for the pharmaceutical sector were used as sources of information. The main procedures for registering generic drugs were explained and inspected, encompassing the submission of documents, dossier preparation, bioavailability/bioequivalence tests, and application filing.

Results: There are substantial growth prospects for generics. Research highlights the sequential registration process for generic drugs, submitting documents electronically using the Common Technical Document (eCTD) method. For registration to be successful, specific records and data such as bioavailability/bioequivalence research data must be provided.

Conclusion: The effective registration of generic medications in the MENA region, especially in the GCC nations, depends on understanding and abiding by nation-specific regulatory standards. The research offers a tactical guide that outlines the essential procedures, paperwork needs, and regional variances in the generic medicine registration process. The goal is to offer affordable healthcare solutions by navigating the regulatory landscape meticulously and streamlining the approval and market entry process for generic pharmaceuticals in the MENA region.

KNOWLEDGE, ATTITUDE AND APPLICATION OF HEMOVIGILANCE BY POSTGRADUATES AND INTERNS IN A TERTIARY CARE HOSPITAL

SWETHA K. — 2024-07-01

Objective: This study was conducted to assess the knowledge, attitude and application of hemovigilance by postgraduates and interns in a tertiary care hospital.

Methods: A pre-validated questionnaire is used in this cross-sectional investigation. Postgraduates’ and interns’ Knowledge, Attitude and Practice (KAP) about hemovigilance, potential reasons for under-reporting, and strategies for enhancing transfusion reaction reporting were all intended to be evaluated in this study. The study was carried out over a period of 2 mo and included all the clinical PGs and interns who willingly gave consent.

Results: The questionnaire was completed by 243 individuals in total. A mean of 94% of postgraduate students and 92% of interns were familiar with transfusion reactions. Merely 68% of the respondents possessed knowledge of India's Hemovigilance initiative. A total of 90% of participants concurred that it is essential to report adverse transfusion reactions. The idea of hemovigilance should be taught in UG curricula, according to 92% of participants overall. The majority of participants exhibited a favourable attitude towards the idea of hemovigilance. All the participants were willing to report unfavourable transfusion reactions.

Conclusion: Although most participants have a good attitude towards reporting transfusion reactions, there is a lack of information about the hemovigilance program and the reporting process. For this reason, our research recommends that reporting procedures be included in undergraduate curricula and that seminars like training programs be held for postgraduates and practitioners.

A SIMULATION APPROACH FOR NOVEL 1,3,4 THIADIAZOLE ACETAMIDE MOIETIES AS POTENT ANTIMYCOBACTERIAL AGENTS

SAIRA SUSAN VARGHESE — 2024-07-01

Objective: To design novel series of 1,3,4 thiadiazoles and to evaluate their anti-mycobacterial potency via In silico modeling.

Methods: In silico modeling comprising of Lipinski rule evaluation, ADMET prediction, Molecular docking and Simulation studies aimed to identify potent 1,3,4 thiadiazoles.

Results: The various physiochemical parameters and molecular descriptors of the proposed 1,3,4 thiadiazoles were predicted. And they exhibited good binding score compared with standard drug INH. The simulation studies showed minimal fluctuation of the ligand receptor complexes.

Conclusion: The MD simulation and binding affinity of designed 1,3,4 thiadiazoles proved their efficiency as InhA inhibitors. The potency of the selected derivatives can be confirmed by further in vitro and in vivo experiments.

A REVIEW ON THE CHEMICAL-INDUCED EXPERIMENTAL MODEL OF CARDIOTOXICITY

MONISHAA RAI — 2024-07-01

Drug-induced cardiotoxicity is a major concern during drug development, prompting the need for reliable experimental models to thoroughly assess potential cardioprotective drugs. The review delves into the intricacies of various models for drug-induced cardiotoxicity in experimental animals, with a specific focus on streptozotocin, isoprenaline, and antineoplastic drugs like cisplatin, doxorubicin, and 5-fluorouracil in rats and mice. Streptozotocin-induced cardiotoxicity is characterized by oxidative stress, inflammation, and mitochondrial dysfunction, resulting in myocardial damage and impaired cardiac function. Preclinical studies employing streptozotocin-induced cardiotoxicity models have revealed crucial pathways related to diabetic cardiomyopathy, aiding the evaluation of potential cardioprotective interventions. Isoprenaline, a beta-adrenergic agonist, is known for inducing acute myocardial injury resembling cardiac ischemia and heart failure in animals. Its mechanism involves overstimulation of beta-adrenergic receptors, calcium overload, oxidative stress, and apoptosis. Isoprenaline-induced models have offered insights into acute myocardial injury pathophysiology and facilitated the screening of cardioprotective agents against Myocardial Infarction (MI) and injury. Antineoplastic drugs, such as cisplatin, doxorubicin, and 5-fluorouracil, are linked to significant cardiotoxic effects, including cardiomyopathy and heart failure. Animal models have revealed dose-dependent cardiomyopathy, shedding light on underlying mechanisms like oxidative stress, Deoxyribonucleic Acid (DNA) damage, and mitochondrial dysfunction. The article aims to consolidate the current understanding of the pathophysiology and mechanisms behind drug-induced cardiac damage. Additionally, it underscores the importance of using animal models in preclinical evaluations to assess drug safety and efficacy and to develop potential cardioprotective therapies.

REVIEW ON CHEMICAL CONSTITUENTS AND BIOLOGICAL ACTIVITIES OF GENUS JUNIPER

GHINA ABDUL MAJID — 2024-07-01

Juniper species belonging to the family Cupressaceae are evergreen shrubs or trees that thrive in dry, rocky, or sandy soils. There are roughly 67 species in the genus, all indigenous to the northern hemisphere. Several species of this genus have been reported to have a variety of pharmacological activities, including diuretic, anti-inflammatory, anti-fungal, hepatoprotective, antidiabetic, and anti-hyperlipidemic properties. Additionally, some species have been shown to have antioxidant, antimicrobial, and neuroprotective properties in Parkinson's disease patients. The majority of these activities are caused by the phytochemical constituents found in these species. This article covers most of the constituents of plants of the genus juniper reported from 2010 to 2023. Furthermore, the biological activities of plants of the genus juniper are presented.

GASTRORETENTIVE EFFERVESCENT FLOATING TABLETS (GREFT) OF DRUGS ACTING ON CARDIOVASCULAR DISEASES

SUTAPA BISWAS MAJEE — 2024-07-01

Incidences of Cardio Vascular Diseases (CVDs) are increasing in an alarming proportion in India. Conventional oral dosage forms cannot be retained in the stomach for long owing to gastric emptying. Moreover, drugs which are commonly employed in management of chronic CVDs either have reduced solubility at alkaline pH, undergo colonic degradation, exhibit site-specific absorption or varying bioavailability with combination therapy. Gastro-retentive drug delivery systems (GRDDS) are designed to overcome these challenges. Since 2006, Food and Drug Administration has approved only few GRDDS for treating CVDs. The aim of the present review is to summarize the outcomes of research carried on GRRDS with drugs for CVDs since last 15 y and comprehensive analysis of limitations of such studies due to which no product has been approved or commercialized in over last 18 y. Literature survey includes single unit, multi-particulate, monolayer and bilayer dosage forms with or without effervescence-inducing agents and made of natural and/or synthetic polymers like hydroxypropylmethyl cellulose, natural gums etc. Efforts have been made to compile in vitro buoyancy data such as floating lag time, total floating time, swelling index, release profile and release kinetics. Among various studies reported on monolayer and bilayer Gastro-Retentive Effervescent Floating Tablets, only 3 involved bioavailability studies in human volunteers. Toxicity studies in animals or stability studies are totally lacking. Observation with floating-type multi-particulate GRDDS is more disappointing. lack of safety, efficacy data, stability data, in vivo imaging studies and in vitro-in vivo correlation data might be actually responsible for lack of commercialization of any GRDDS for drugs acting on CVDs in 21^st century.

ETHNIC STUDY OF ADUWA KO JAANR, A LESSER-KNOWN FERMENTED GINGER MILD ALCOHOLIC BEVERAGE OF EASTERN HIMALAYAS

AAWAJ KULOONG RAI — 2024-07-01

Consumption of fermented foods and beverages is a part of the dietary cultures of the Himalayan community and is prevalent amongst various ethnic groups in this region. Native of the Himalayan range ferment food and beverages using 'ethno-microbiological' knowledge acquired and practiced since ages, which lacks documentation. This knowledge is transmitted through practice and verbally to new generations. Women folk are engaged in this traditional fermentation culture with cultural and ethnic significance. In addition to its distinctive tastes, fermented foods and beverages provide health advantages to indigenous people. It becomes essential to highlight their scientific value due to their health benefits and ethnic relevance. The diverse nature of fermented foods and beverages, the fermentation process, and the traditional knowledge behind fermentation are a heritage of the eastern Himalayas. Traditional fermentation, in which raw materials are organic and natural starter culture is used, is part of the people's socio-economic lifestyle. Their preservation highlights organic and conventional practices as an excellent alternative to a healthy lifestyle. The present study documents a lesser-known mild-alcoholic fermented beverage, 'Aduwa ko Jaanr,' from the Eastern Himalayan region. A steady decline in traditional fermentation practices has recently been observed due to changes in food habits and culinary practices.