International Journal of Basic & Clinical Pharmacology
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An analysis of drug approvals in India over past 5 years
Get PDFBackground: Drug development is a tedious process and takes a long time for approval by regulatory authorities. With time, Indian authorities have revised rules and regulations for conducting clinical trials as well as for the marketing of drugs, impacting the number of drugs being approved.
Method: The information about drug approvals from 2019–2023 was obtained from the CDSCO website. The single drug products were classified into 14 main anatomical therapeutic chemical (ATC) groups, while Fixed Dose Combinations (FDCs) were classified based on the system they act upon. Descriptive statistical analysis was done. The findings of our observational study were expressed as absolute numbers and percentages.
Results: Total 362 drugs were approved. Out of these, 135 were single drug products, and the rest were FDCs. The highest & lowest number of drugs were approved in the year 2022 and 2019 respectively. Maximum single drug product approvals were seen in Category L-antineoplastic and immunomodulating agents, while maximum FDC approvals were for drugs acting on the endocrine system.
Conclusion: There is a rising trend of approval for FDCs. The pattern of single drug products approval flattened over the years, coinciding with the implementation of new rules and regulations
Evaluation of rationality of geriatric patients prescription based on STOPP/START criteria in a tertiary care hospital
Get PDFBackground: The geriatric population (65 years and above) is a challenge to treat for the medical fraternity, exposing them to the risk of potentially inappropriate prescription (PIP) and thus, increasing the risk of adverse drug reactions (ADR). The over-use of drugs and irrational choice lead to the prescription of a potentially inappropriate medication (PIM) and the underuse of appropriate drugs leading to potential prescribing omission (PPO). Screening Tool of Older Persons' Potentially Inappropriate Prescriptions (STOPP) and Screening Tool to Alert doctors to the Right Treatment (START) criteria is one of the most effective tools to check the rationality of the prescribed drugs.
Methods: The study was a six-month (March 2023 to August 2023) prospective observational design. A total of 193 patients were enrolled in the study. Case report forms were used to confirm the diagnosis and medications. Geriatric patients who fulfilled the study inclusion criteria were assessed using the STOPP/START toolkit version 2.
Results: The majority of the study participants belonged to age group 65 to 70 years. Out of these 40.4% of the study participants had Potentially Inappropriate Medications based on STOPP criteria and 31.1% had Potential Prescription Omissions based on START criteria.
Conclusions: Potentially Inappropriate Prescriptions were assessed using STOPP/START criteria in version 2. A high prevalence of PIM and PPO was found. Co-morbidity and polypharmacy were linked to a higher chance of PIM. Thus, this criterion can be used to generate rational prescriptions for the elderly population
New perspectives on markers implicated in signalling pathways that advance diabetic nephropathy and its therapeutic approaches
Get PDFDiabetic nephropathy is the chronic loss of kidney function occurring due to diabetes mellitus. Due to increased sugar levels, there is disfunctioning of glomeruli, loss of protein in urine, and decrease in the levels of serum albumin that mainly leads to edema. The progression of renal disfunctioning starts when glomerular filtration rate is greater than 90ml/min. A large body of evidence indicates that oxidative stress is the main attributor involved in the progression of macro-vascular complications of diabetes. (ROS), NAD(P)H oxidase, advanced glycation end products (AGE), polyol pathway, uncoupled nitric oxide synthase (NOS), mitochondrial respiratory chain via oxidative phosphorylation, protein kinase C, mitogen-activated protein kinases, cytokines and transcription factors eventually cause increased expression of extracellular matrix (EC) genes with progression to fibrosis and end stage renal disease. Apart from these well-established pathways, major markers in the kidney disease which could work as potential targets has been explored like MCP-1, BMP-7, p38 MAPK, MiR-130b, HSP-27, AKT which further needs more research as they have shown promising results in their early level of studies. The present review aims to investigate the molecular targets involved in diabetic nephropathy, and to comprehend the intricate signalling pathways, such as JAK/STAT, BMP-7–Smad1/5/8 pathway, RhoA/ROCK, caspases, to which the aforementioned markers have either an independent or dependent relationship. If these signalling pathways are properly studied, these markers may aid in the treatment of the disease and its associated secondary effects such as nephropathy
Evaluation of anti-anxiety activity of Garcinia indica using Vogel water lick conflict test in rats
Get PDFBackground: Anxiety is usually described as a psychological, physiological and behavioural state induced in animals and humans by a threat to well-being or survival, either actual or potential. In modern medicine, benzodiazepines are still commonly used anti-anxiety agents in spite of their unfavourable adverse effect profile. Traditional herbs like Garcinia indica (Kokum) known to have possible therapeutic relevance in treatment of anxiety as a potential anxiolytic herb. So, this study was conducted to evaluate anti-anxiety effect of Garcinia indica in both, low and high doses, using Vogel’s conflict test which is of broad significance to clinical anxiety.
Methods: Wistar albino rats of either sex (150-250 g) were divided into four groups with eight rats in each group. Different groups were given distilled water (0.5 ml p.o.), Diazepam (1 mg/kg p.o.), Garcinia indica (1.75 gm/kg p.o.) and Garcinia indica (3.5 gm/kg p.o.) respectively. Effect of test drugs on anxiety was evaluated using Vogel’s water lick conflict test. Parameters such as number of water licks, total number of shocks tolerated were assessed. Results expressed in mean and standard deviation were analysed using one-way analysis of variance (ANOVA) test followed by Tukey’s test.
Results: Diazepam and high dose Garcinia indica (3.5 gm/kg) showed statistically significant increase in number of water licks and number of shocks tolerated but low dose Garcinia indica (1.75 gm/kg) did not show any significant increase in these parameters.
Conclusions: This study shows that high dose Garcinia indica possess significant anti-anxiety effect comparable to that of diazepam
Truth in a pill
Get PDFIn 1937, the elixir sulphanilamide disaster was one of the mass poisonings. It occurs due to the presence of the diluent diethylene glycol in the elixir preparation of sulphanilamide. Because of its therapeutic use, around 100 patients died. In response to the calamity, Federal Food, Drug and Cosmetic Act was passed in the year 1938 by U.S congress and this ensured the proof of safety before the drug comes to market. The similar incident occurred for thalidomide in late 1950s and early 1960s when the drug was used for the treatment of nausea in pregnant women and resulted in children with birth defects. The development of drugs is a complex and costly process and it takes around 10-15 years for the drug to develop. Because of these reasons, the development of generic drugs is essential and this review will deal about the use of generic drugs and also its advantages with limitations
A study of cutaneous adverse drug reactions in the dermatology department of a tertiary care teaching hospital in Gujarat
Get PDFBackground: Various drugs are responsible for different cutaneous adverse drug reactions (CADRs). Considering variation in drug responses and the day-to-day increasing burden of ADRs, this study was done with emphasis on the need for effective evaluation and the reporting of the ADR reporting programme.
Methods: This was an observational cross-sectional study conducted for the duration of six months in the dermatology department to evaluate various clinical patterns of CADRs.
Results: A total of 60 CADRs were reported. Among them, 51.67% were present in males and 48.33% were present in females. The most common CADR was FDE (35%), followed by macula-papular rash (25%). Antimicrobials were most commonly responsible for CADRs, followed by NSAIDs, antiepileptic, anti-gout, and anti-hypertensive medications.
Conclusions: For better patient care, drug safety, and rational use of medicines, knowledge of various drugs responsible for CADRs can be useful for health care professionals to reduce mortality and morbidity by monitoring, reporting, and assessment of CADRs whenever detected
A review on potential adverse effects associated with Janus-kinase inhibitors
Get PDFRheumatoid arthritis (RA) is a chronic, symmetrical, inflammatory autoimmune disease that affects small joints. RA has a population prevalence of 0.5% to 1% in the U.S. The annual cost of care for chronic treatment of RA in the United States is estimated at $12,509. Pharmaceutical companies have developed drugs to treat RA using Janus kinase (JAK) inhibitors. These drugs can have potential adverse effects. Forecasting a better output to JAK inhibitors (JAKI’s). Therapy duration of JAKI’s and Problems regarding to strategies of dose reduction or if the discontinuation of therapy takes place in case of low disease activity. The accurate pharmacological profile and interactions of other drugs with JAKI’s have to establish. Proper safety, efficacy profile of JAKI’s and when administered in combination with DMARD’s. The safety, efficacy data of JAKI’s when compared to non-anti-TNF biologics. Obtaining of experience on JAKI’s that were already existed in the market and further experimental findings on newer compounds and which may clarify many of the aspects which are to be solved in nearer future as these JAKI will have greater application in treatment of RA. Regardless of significant developments in latest years in the pharmacotherapy of RA in the use of JAK inhibitors, yet the adverse effects of JAK inhibitors are unanswered. Therefore, one of the main concerns associated with JAK inhibitor is the potential adverse effects. The challenges can be addressed by clinical pharmacist mediated interventions related to dosing of JAK inhibitors and proper management of adverse drug reactions (ADRs)
Enhancing hemophilia A management: emicizumab as a cost-effective adjunct to standard therapy for inhibitor patients
Get PDFThis case report discusses the cost-effectiveness of emicizumab + low dose recombinant factor VIIa (rFVIIa) therapy in management of mild hemophilia A with inhibitors. Initial treatment with recombinant factor VIII was complicated by inhibitor development, leading to recurrent bleeding and hematoma formation. After administering full dose rFVIIa to patient for controlling bleeding episodes initially, patient was transitioned to emicizumab alongside low-dose recombinant factor VIIa, which proved efficacious and cost-effective. This case highlights the potential of emicizumab to alleviate the financial burden on patients and healthcare systems, improving treatment access and outcomes for a broader hemophilia patient population
Formulation and effectiveness test of Tekelan leaf ethanol extract nanogel preparations against Propionibacterium acnes
Get PDFBackground: Ethanol extract of Tekelan leaves can inhibit the growth of Propionibacterium acnes bacteria. The nanogel preparation can penetrate the deepest layer of the stratum corneum. Utilization of Tekelan leaves in the form of nanogels that have better absorption capabilities with minimal side effects due to the use of natural ingredients is essential to be carried out as an alternative to anti-acne drugs.
Methods: This study was conducted experimentally, including the preparation of ethanol extract of Tekelan leaves and formulation in nanogel preparations, which were then tested for antibacterial activity. The concentration of ethanol extract of Tekelan leaves in nanogel preparations were 2.5%, 5%, and 7.5%.
Results: The organoleptic of nanogel containing ethanol extract of Tekelan leaves showed that the color was brown and had a distinctive odor, the preparation was homogen, viscosity was still in the required range, pH was still in the required range, 4.5-6.5. The size was below 200 nm, and the cycling test showed that they were stable during storage for six cycles. The nanogel preparations with concentrations of 2.5%, 5%, and 7.5% had diameter inhibitions of 7.93 mm, 9.10 mm, and 10.23 mm, respectively.
Conclusions: Based on the study's results, it can be concluded that the nanogel preparation of ethanol extract of tekelan leaves is stable during 12 weeks of storage and has a particle size below 200 nm. The antibacterial test results of nanogel preparations of ethanol extract of tekelan leaves at a concentration of 7.5% have the maximum activity
Therapeutic potential of Garcinia cambogia and Emblica officinalis in the management of obesity and lipid profiles in a rat model of diet induced obesity
Get PDFBackground: Obesity has emerged as one of the significant public health burdens across the globe, which predisposes the risk of cardiovascular diseases and metabolic dysfunctions. Medicinal plants can be possible therapeutic measures for managing obesity. Garcinia cambogia and E. officinalis have been used for their anti-obesity and hypolipidemic properties. The objective of this study was to evaluate and compare the anti-obesity and hypolipidemic effects of Garcinia cambogia and E. officinalis in a high energy diet-induced obese rat model.
Methods: A total 36 albino rats were included in the study. The animals were randomly divided into 6 groups of 6 rats each. Group 1 (control) received distilled water orally, Group 2 received Garcinia cambogia extract orally in dose of 200 mg/kg/day, Group 3 received Garcinia cambogia extract orally in dose of 400 mg/kg/day, Group 4 received E. officinalis extract orally in dose of 20 mg/kg/day, Group 5 received E. officinalis extract orally in dose of 40 mg/kg/day and Group 6 (standard) received Orlistat in dose 20 mg/kg/day. Parameters assessed included body weight and lipid profile (total cholesterol, triglycerides, LDL cholesterol, and HDL cholesterol).
Results: Both Garcinia cambogia and Emblica officinalis interventions demonstrated significant reductions in body weight gain and improvements in lipid profile compared to the HED group. The intervention groups exhibited notable decreases in total cholesterol, triglycerides, and LDL cholesterol levels, along with an increase in HDL cholesterol levels.
Conclusions: Our findings suggest that Garcinia cambogia and Emblica officinalis possess anti-obesity and hypolipidemic effects in a high energy diet-induced obese rat model. These naturals show promise as potential therapeutic agents for combating obesity and associated dyslipidemia. Further research is needed to understand and validate their efficacy in human populations