International Journal of Research in Pharmaceutical Sciences

review on vital role of regulatory affairs in pharmaceutical industry

Piyali Basak — 2024-10-18

The burgeoning field of Regulatory Affairs (RA) serves as the foundation for ensuring public health in today's globalized marketplace. In the pharmaceutical industry, regulatory affairs play a crucial role in assuring the safety, efficacy, and quality of drug products, which are essential for the approval of new products entering the market. Emerging from a collective international desire to protect individuals from potentially harmful medications, this profession bridges the gap between pharmaceutical companies and regulatory agencies, ensuring that products meet all necessary legal and scientific standards.Regulatory affairs professionals act as guardians, meticulously ensuring the accuracy and completeness of product information. They navigate the complex labyrinth of regulations, translating them into practical plans for companies to follow. Their expertise encompasses the entire life cycle of a drug, from initial application submission and oversight of clinical trials to ongoing adherence to evolving regulatory requirements. This comprehensive approach guarantees the development, manufacturing, and distribution of safe and effective medications across various fields, including traditional pharmaceuticals, veterinary medicine, medical devices, and complementary therapies.As the pharmaceutical landscape continues to evolve, the demand for highly skilled regulatory affairs professionals remains strong. In India, the Central Drug Standard Control Organization (CDSCO) regulates drug legislation, facilitating drug development from initial research to market approval and post-marketing surveillance.

Advances in Mass Spectrometry Fragmentation Techniques for Peptide and Protein Characterization: CID to ETD

Akhilesh Kumar Kuril — 2024-10-15

Mass spectrometry (MS) has transformed the field of proteomics by enabling the precise analysis of proteins and peptides at the molecular level. The heart of this analysis is the process of fragmentation, which plays a pivotal role in elucidating amino acid sequence, identifying post-translational modifications (PTMs), and characterizing structural features. Peptides and proteins are first ionized and then subjected to fragmentation techniques such as Collision-Induced Dissociation (CID), Electron-Transfer Dissociation (ETD), and Electron-Capture Dissociation (ECD). These techniques induce fragmentation along the peptide backbone, generating characteristic fragment ions (b and y ions, c and z ions) that reflect the sequence of amino acids. The mass-to-charge (m/z) ratios of these fragment ions provide crucial data for de novo sequencing and PTM identification. Furthermore, fragmentation patterns can reveal insights into protein folding, interactions, and dynamics. This article provides the detailed view of mass fragmentation techniques in peptides and proteins, highlighting its importance in advancing proteomic research and its applications in fields ranging from biomarker discovery to drug development.

Sleep Quality in School-Aged Children: The Role of Environmental Factors and Screen Time

Dr. Sowntharya Pasupathy — 2024-10-06

Sleep plays a vital role in the optimal functioning of our body and is crucial for overall well-being. However, many parents are unaware of the negative consequences of sleep deprivation in children. This study examines factors affecting sleep in children and their correlation with screen time. The aim is to evaluate the relationship between screen time and environmental factors impacting sleep quality among school-aged children.A cross-sectional observational study was conducted on children aged 6 to 12 years. Sleep quality was assessed using a 22-item, pre-validated, parent-administered Children’s Sleep Habits Questionnaire (CSHQ). Contributing factors, including a screen time questionnaire, were gathered from parents. Children with pre-existing sleep disorders, neurobehavioral disorders, and chronic illnesses were excluded. A CSHQ score above 41 was considered abnormal, indicating a sleep problem. Data were analyzed using the Chi-square test with SPSS version 20.0.In this study, 40.3% of children experienced sleep disturbances. The total mean sleep score was 39.56 ± 14.84, with private school children showing greater disruptions (41.78 ± 12.96) compared to public school children (37.14 ± 16.33; p = 0.001). Significant correlations were found between sleep quality, screen time exposure, and environmental factors such as lower socio-economic status, bed sharing, and room sharing.This study highlights that both excessive screen time and adverse environmental conditions negatively impact children's sleep quality. Efforts to increase awareness among parents, educators, and healthcare providers are needed to reduce sleep disturbances.

Preliminary phytochemical evaluation of methanol extracts of momordica dioica roxb

Pushpalatha Tanneeru — 2024-11-12

Momordica dioica, commonly known as spiny gourd, teasle gourd, or kakrol, is a perennial, dioecious climbing plant belonging to the Cucurbitaceae family. This versatile plant is not only used as a food source but also plays a role in preventing and treating various illnesses. The current study focuses on the phytochemical analysis of Momordica dioica, investigating its potential medicinal properties. The fruit is extracted in stages using methanol, after which the presence of key phytochemicals—such as flavonoids, phenolic compounds, tannins, saponins, phytosterols, triterpenoids, and quinones—is screened. The results indicate that this plant is a rich source of diverse phytochemicals. This experimental investigation has identified several biologically active secondary metabolites, which may contribute to the development of new drugs. Overall, Momordica dioica shows promise for future research in pharmacology and nutrition, highlighting its significance in both traditional and modern medicine.

Prevalence of GERD among adult asthmatics visiting a tertiary care hospital

Saravana Ethinder M — 2024-10-03

Asthma and its control is influenced by both external environmental factors and also on the presence of several comorbid conditions like allergic rhinitis, gastro esophageal reflux disease(GERD), obesity etc. We aim to study the prevalence of GERD in adult asthmatic patients visiting a tertiary care hospital. We conducted a period prevalence survey of adult asthmatics visiting the outpatient department. Gastro esophageal reflux disease was diagnosed clinically through GERD-Q questionnaire. The study was conducted at Sri Venkateswaraa Medical College and Hospital and Research Institute, Chennai. A total of 110 patients were taken for the study. GERD was prevalent among 50% of the study population. 86.2% of the smokers in the study were having GERD. Mean Body Mass Index(BMI) in the study population was 29.14 +/- 4.8 with 72.7% of the patients with gastro esophageal disease were overweight in their body mass index. Significant number of patients with asthma are known to suffer from GERD. GERD worsens the symptoms in asthma and makes it difficult to control with regular inhalational therapy. Being overweight in BMI, smoking are risk factors to the development of gastro esophageal disease and also influence lung function in asthma patients. Symptoms for GERD must be questioned to treat the disease and adequately control asthma.

Effectiveness of soya milk in the nutritional rehabilitation of malnourished children aged 1-5 years

Dr Srinivasan Ramamoorthy — 2024-11-06

Malnutrition is a presentation of poor nutritional use, an imbalance of essential nutrients, or a deficiency or excess of nutrients are all considered forms of malnutrition. Undernutrition, overweight a mentally and physically. Undernutrition, overweight and obesity, and noncommunicable illnesses linked to food are all consequences of malnutrition. During the early stages of life, the effects of malnutrition are more severe. Malnutrition in childhood causes growth retardation. Undernourished children do not develop to their full capacity, both mentally and physically. To assess the study strategy, a pre-experimental design (one group pre-test versus post-test) was used. A non-randomized purposive selection approach was used to choose the study's sample. Fifty preschoolers (ages 1–5) made up the study sample. The study's context refers to the location where it was conducted. The distribution of birth orders in the experimental and control groups in the current study showed that the second child had the highest percentage, and the fourth child had the lowest percentage. Malnutrition may be prevented, maintained, and recovered from with great effectiveness thanks to soy milk, which is the least expensive source of protein and other nutrients. Supplementing with soy milk has also been shown to improve children's overall development. Giving malnourished children soy milk caused them to gain weight, which decreased malnutrition and raised normal weights.

development and evaluation of an oral quinine sulphate sustained release formulation for the management of visceral leishmaniasis

Grace Lovia Allotey-Babington — 2024-10-17

Background: Visceral Leishmaniasis is a systemic disease caused by the invasion of reticuloendothelial cells in the liver, spleen, and bone marrow by Leishmania spp. parasites. Current medications have numerous adverse effects and some resistance has been reported. Most treatments are administered parenterally, leading to non-compliance and treatment failure. This study aimed to develop an oral formulation of quinine sulfate to address these challenges.Methods: Quinine sulfate was encapsulated in hydroxypropylmethylcellulose using the spray-drying method and evaluated for particle size, zeta potential, drug content, entrapment efficiency, and in vitro release properties. In the in vivo study, laboratory mice infected with L. donovani promastigotes were treated for two weeks.Results: The average size of the quinine sulfate microparticles ranged from 2.6 to 14.2 µm, with an entrapment efficiency of 93%. Oral formulations effectively cleared parasites from the organs.Conclusion: Orally administered quinine sulfate efficiently cleared parasites from the blood of infected mice and resolved infections in their organs.

Study on the occurrence and factors contributing to lower back pain in Taif region adolescents, KSA

Mohammad Yusuf — 2024-10-08

This study aimed to validate variables impacting the prevalence of low back pain (LBP) in adolescents, focusing on gender, age, exercise, sedentary activities, and dietary factors. A cross-sectional study with random sampling was conducted among adolescents aged 9 to 19 years, using a modified questionnaire based on the Oswestry and Roland-Morris LBP and Disability questionnaires. The response rate was 81.9%, with the highest LBP prevalence (87.5%) in 18-year-olds. Overall, 93.5% of participants reported experiencing back pain, particularly among those not actively involved in sports; notably, 63% led a sedentary lifestyle.Of the subjects, 23.5% reported sleeping 6-8 hours, 29.5% went to the gym 2-3 days a week, and 30.6% consumed over 3 liters of water daily. Additionally, 45.2% maintained a diet rich in fruits and vegetables, while 26.1% consumed high-protein foods. A good breakfast routine was linked to significantly reduced LBP. Males (59.2%) reported higher LBP frequency than females. For relief, 48.8% of males sought medical help or took medication, while 34.4% relied on self-healing methods. The study underscored the associations between various factors and LBP in adolescents and school-age children.

Convolution approach to estimate the in vivo behavior of ibuprofen soft gelatin capsules from in vitro release data of USP Apparatus 4

Medina-López J R — 2024-11-25

Hypothetical plasma concentration-time profiles of ibuprofen gelatin soft capsules were calculated using data from the USP apparatus IV (flow-through cell method). Four ibuprofen formulations (reference and generic products at 400 and 600 mg) were tested with laminar flow at 16 ml/min in pH 6.8 phosphate buffer. Samples were withdrawn at 10, 20, 30, 45, and 60 minutes, and dissolved drug levels were measured using UV derivative spectrophotometric analysis. Dissolution curves were compared by calculating model-dependent and model-independent parameters, employing Student’s t-test for statistical analysis (significance set at p < 0.05). The dissolution data were fitted to various mathematical models to explain ibuprofen's in vitro dissolution. Hypothetical plasma concentration-time profiles were also calculated using published pharmacokinetic data from in vivo studies combined with a convolution approach. Validation of results was assessed using prediction error (PE) data for two key pharmacokinetic parameters: peak plasma concentration (Cmax) and area under the curve from zero to infinity (AUC0-inf), with validity determined by a PE of ≤ 10%. Similar dissolution profiles were identified for the 400 mg formulations (f2 similarity factor), while dissimilarities were noted in other comparisons (f2 < 50, p < 0.05). The Weibull function best described the dissolution rate of the tested formulations. For the 400 mg reference product, PE values for Cmax and AUC0-inf were < 10%. A discriminatory dissolution method is essential for the 600 mg products, and further in vivo testing is necessary to corroborate the findings.

Prevalence of systemic hypertension in COPD patients with GOLD stage 1 disease

Saravana Ethinder M — 2024-10-04

Morbidity and death in COPD patients is greatly influenced by co morbidities. We aim to study the prevalence of systemic hypertension in the initial stages of COPD, i.e. in patients with GOLD stage 1 disease having a FEV1 greater than 80% of predicted value in PFT. We conducted a period prevalence study on patients with early stages of COPD. Patients were evaluated for systemic hypertension after being diagnosed with COPD by pulmonary function test. The study was conducted at Sri Venkateswaraa Medical College Hospital and Research Institute, Chennai. A total of 205 patients were identified with COPD meeting the necessary inclusion and exclusion criteria. 150 patients were male and 55 were female. Among them 53.6% patients were diagnosed with systemic hypertension. 20.9% of the hypertensive patients were having obesity. 95.4% of the patients with hypertension were tobacco smokers. 4.6% of the patients with hypertension were having a history of biomass fuel smoke exposure. Tobacco smoking, biomass fuel smoke exposure and obesity are important factors which influence lung function and many cardiovascular/cerebrovascular diseases. Patients in the early stages of COPD have a higher prevalence of systemic hypertension. Systemic hypertension must be identified and treated early to prevent long term cardiovascular/cerebrovascular complications in COPD patients.

A study on nutritional benefits of soya milk in malnourished children aged 1- 5 years

Dr Srinivasan Ramamoorthy — 2024-11-10

Poor nutritional usage, an imbalance of vital nutrients, or an excess or shortage of nutrients are all manifestations of malnutrition. emotionally and physically undernourished and overweight. Malnutrition leads to undernutrition, overweight and obesity, and food-related noncommunicable diseases. The consequences of malnutrition are particularly severe in the early years of life. Growth retardation is the result of childhood malnutrition. Children who are undernourished do not reach their full potential in terms of their mental and physical development. This study used a quasi-experimental research approach. Although it manipulates an independent variable to see how it affects a dependent variable, it is devoid of at least one of the two elements of a real experimental design: a control group or randomisation. The data collected were summarised with differences between pre and post scores of the degree of malnutrition was statistically analysed. It has also been demonstrated that soy milk supplements enhance children's general growth. Malnourished youngsters gained weight when given soy milk, which reduced malnutrition and increased normal weights.

Correlates of Sexual Dysfunction in Male Patients with Alcohol Dependence Syndrome: A Cross-Sectional Study

Dr. Saritha Dhuruvasan — 2024-10-01

Introduction: Sexual dysfunction and alcohol dependence syndrome are complex issues that significantly impact the overall well-being and quality of life of affected individuals. Sexual dysfunction, encompassing various issues such as erectile dysfunction, reduced libido, and orgasmic disorders, is a prevalent concern affecting a substantial proportion of the male population worldwide. Aim: To estimate prevalence of sexual dysfunction in patients admitted for Alcohol dependence and to identify various Clinical and Socio demographic correlates for sexual dysfunction in this population. Materials and Methods: The study involved fifty-eight male participants who had sought deaddiction treatment at the Psychiatry Outpatient Department of Tertiary Care Centre, Maduranthakam for alcohol dependence syndrome, diagnosed according to the ICD‑10. Information on sociodemographic, alcohol-related, and sexual dysfunction-related variables was gathered. Sexual dysfunction was assessed for the past year, ignoring temporary and situational complaints. The relationship between sexual dysfunction and various study variables was explored using relevant statistical tools. Results: Out of the total sample size evaluated using SAD-Q score, 71% are moderately dependent and 29 % are severely dependent. Sexual Dysfunction was present for 64% of patients in the study. For the 58 patients in the study, the most common sexual dysfunction reported was an absence of sexual desire in 19 patients, followed by erectile dysfunction which was present in 18 patients. The ability to reach orgasm was difficult for 6 patients. Satisfaction from orgasm was absent for 4 patients. Conclusion: This research seeks to advance our understanding of sexual dysfunction in male patients with alcohol dependence syndrome by unravelling the intricate web of factors influencing their sexual health.