International Journal of Pharmacy and Pharmaceutical Sciences

ENHANCING OTC MONOGRAPH DRUG REGULATION THROUGH USER FEE PROGRAM

2023-08-18T19:42:26+0530

Food and Drug Administration (FDA) has introduced a distinctive regulatory program known as Over-the-Counter Monograph Drug User Fee Program (OMUFA) to improve the efficacy and security of over-the-counter (OTC) medications made available to consumers. The program, which represents a pivotal shift in the regulatory landscape, aims to address the challenges associated with the oversight of OTC monograph drugs. The OMUFA's primary objective is to expedite the review and approval process of OTC monograph drugs while maintaining stringent safety standards. By imposing user fees on manufacturers and sponsors seeking to bring new OTC products to market or seeking updates for existing ones, the program is designed to support the FDA's ability to allocate additional resources for timely reviews and assessments. This work delves into the key components and mechanics of the OMUFA, such as the user fee structure, types of submissions covered, and the corresponding performance goals established for the FDA. While acknowledging the benefits of the OMUFA, this work also discusses potential challenges and concerns raised by industry stakeholders and consumer advocacy groups. This critical regulatory initiative has the potential to facilitate further research and discussions on optimizing drug safety and access within the OTC market through required modifications and initiatives.

PHARMACEUTICAL AUDIT PROCESS, OUTCOMES, AND IMPLICATIONS–OVERVIEW

2023-09-02T18:33:00+0530

The audit process is a crucial component of regulatory compliance and quality assurance in both the United States of America (USA) and the European Union (EU). This review paper compares and analyses the audit processes, results, and ramifications in these two important markets.

The study investigates how pharmaceutical audits affect patients’ trust, market stability, and profitability of a company while highlighting the need for adherence to quality standards. Data integrity, supply chain complexity, and adherence to exacting quality standards are just a few of the notable difficulties faced by auditors in the USA and EU. There is a need to have a strong pharmacovigilance system as well to guarantee the security and effectiveness of pharmaceutical products for patients.

This study can be useful reference material for stakeholders, decision-makers, and companies looking to increase accountability, reduce risks, and uphold the integrity of a firm’s operations in the global market. A thorough analysis of audit procedures in the USA and EU will facilitate in promotion of effective and efficient manufacturing, control, and distribution of pharmaceutical products while boosting confidence among patients and in the healthcare system as a whole.

EXPLORING THE THERAPEUTIC POTENTIAL OF LOW-DOSE COLCHICINE IN CORONARY ARTERY DISEASE: AN IN-DEPTH ANALYSIS OF INFLAMMATION, SAFETY, AND CLINICAL EFFECTIVENESS

2024-02-08T21:29:18+0530

Coronary Artery Disease (CAD) is a prevalent cardiovascular illness that is a primary cause of morbidity and mortality globally. It is distinguished by the constriction or blockage of the coronary arteries, which limits blood circulation to the heart. Inflammation is a driving force in the pathophysiology of CAD. Colchicine is an anti-inflammatory medication that has lately been studied for its potential application in the treatment of CAD. Its multimodal method of action has sparked interest due to its ability to treat inflammation and lower the concentration of critical inflammatory biomarkers. Clinical evidence validates the safe and effective use of Colchicine in CAD. Several recommendations advocate the use of colchicine in the secondary prevention of CAD. This article discusses the use of low-dose colchicine in CAD, its function in inflammation, as well as its safety and therapeutic effectiveness.

A REVIEW ON TEMPLATE SYNTHESIS OF NANOPARTICLE

2024-02-15T19:31:09+0530

In recent years, there has been a rise in interest in the development of novel drug delivery systems that utilize nanoparticles. In terms of high stability, high specificity, high drug-carrying capacity, controlled release, the ability to use different routes of administration, and the ability to deliver both hydrophilic and hydrophobic drug molecules, nanoparticles can offer significant advantages over conventional drug delivery. We try to provide a detailed overview of template techniques designed for nanomaterial production. The pores and channels in the nanoporous “template” structures are used to generate the desired nanomaterials in template synthesis. Because this process has advantages over other methods, like allowing precise control over their size, shape, and structure, it is commonly used to generate nanoparticles. The first half of the review provides information on various template preparation processes. Templates are classified as “hard” or “soft” templates. Soft templates are often fluid-like, whereas hard templates are typically solid-state materials with distinct morphology and structure. This study discusses the effect of templates on morphologies and methodology and compares hard and soft templates.

REGULATORY CHALLENGES AND LANDSCAPES OF MONOCLONAL ANTIBODY REGISTRATION: GLOBAL OUTLOOK

2024-02-23T21:47:05+0530

Objective: This review aims to illuminate the unprecedented growth and versatile therapeutic landscape of monoclonal antibody (mAb) products, highlighting their significant impact on diverse medical fields such as oncology, septicemia treatment, infection management, and substance abuse disorder interventions. This review outlines the challenges associated with the development, manufacturing, and regulatory approval of monoclonal antibodies, emphasizing the need for diligent attention to overcome these complexities. The review comprehensively examines the historical evolution and therapeutic applications of monoclonal antibodies, emphasizing their potent and versatile characteristics that have enabled successful interventions in challenging regulatory approvals. It delves into the critical considerations in manufacturing, regulatory navigation, and the strategic integration of expedited approval pathways, providing a holistic understanding of the intricate terrain of innovation, clinical translation, and impactful patient care in the realm of monoclonal antibody products. Monoclonal antibodies have significantly advanced medical treatment in various domains, revolutionizing cancer therapy, offering new avenues for septicemia management, augmenting the arsenal against infections, and opening novel pathways for addressing substance abuse disorders. Their development and regulatory approval are associated with challenges of scientific innovation, manufacturing, and regulatory compliance. Despite the challenges, monoclonal antibodies have demonstrated remarkable potential in addressing complex medical conditions. The review serves as a compass, guiding researchers, clinicians, and regulatory authorities through the intricate terrain of monoclonal antibody innovation and clinical translation. It emphasizes the need for diligent attention to overcome the complexities associated with their development and regulatory approval while highlighting their significant impact on advancing patient care.

ADVANCES IN BIOREMEDIATION AGENTS AND PROCESSES FOR REMOVAL OF PERSISTENT CONTAMINANTS FROM ENVIRONMENT

2024-02-24T09:40:06+0530

The development of bioremediation agents and processes-a sustainable solution to environmental pollution has advanced significantly. This is particularly valid when handling persistent pollutants such as Polycyclic Aromatic Hydrocarbons (PAHs). This study reviews the state-of-the-art in bioremediation technology, emphasizing the vital role that bacteria and their metabolic pathways play in the breakdown of pollutants. Microorganisms, which can be any type of fungus or bacteria, have been employed because of their unique capacity to break down a broad spectrum of contaminants. A thorough grasp of the metabolic subtleties of these bacteria is essential for optimizing bioremediation methods, especially with regard to PAH breakdown. The exploration of eco-friendly technologies, such bioaugmentation and biostimulation, emphasizes the commitment to eco-friendly approaches to environmental remediation. This review presents strong case studies and acknowledges ongoing issues to demonstrate the practical effectiveness of bioremediation. Future advancements in bioremediation-a crucial aspect of environmental management-may be possible through the combination of genetic engineering and artificial intelligence, which could assist overcome current obstacles.

A REVIEW ON MACROPHAGES AND THE IMPACT OF PROTEASOME INHIBITORS ON RHEUMATOID ARTHRITIS

2024-03-11T19:52:38+0530

Rheumatoid Arthritis (RA) is a common autoimmune disease that causes chronic inflammation of the tissues around the joints, which eventually results in systemic complications and bone destruction. Macrophages are critical cells in many tissues and organs essential to an innate and adaptive immune response. It is one of the most common cell types in the synovium of rheumatoid arthritis. Various conventional and experimental therapies for RA target proteins, cytokines or their synthetic pathways, T lymphocytes, and B lymphocytes. The Fibroblast-Like Synoviocytes (FLS) and macrophages are abundantly activated in RA, and the drugs targeting the monocytes and macrophages are explored significantly less. The drugs targeting monocytes and macrophages may provide a better therapeutic strategy for RA. Proteasome inhibitors act as a potential remedy for autoimmune and inflammatory diseases. Targeting the monocytes and macrophages with proteasome inhibitors may improve the therapeutic approaches to RA. This paper reviews the types and significance of macrophages in RA, various conventional and experimental therapy approaches targeting monocytes and macrophages, and the effect of proteasome inhibitors on macrophages in RA.

DESIGN AND DEVELOPMENT OF NANOEMULSION OF SMILAX CHINA FOR ANTI-PSORIASIS ACTIVITY

2024-01-08T16:11:50+0530

Objective: The present investigation aimed to prepare a smilax china loaded nanoemulsion using tween 80 as a surfactant and propylene glycol as a co-surfactant. Formulation of such drugs in nanoparticulate drug delivery will be advantageous for reducing dosing frequency, longer residence time, improved permeation, and patient compliance.

Methods: High-speed homogenization method. The smilax china oil was prepared by collecting the extract of smilax china leaves into the coconut oil and then used as a solvent. The authentication studies of smilax china and coconut oil were evaluated for their organoleptic and physicochemical characteristics. The quantitative estimation and pre-formulation study of quercetin was carried out which has major anti-psoriatic properties. Surfactant and co-surfactant were selected and the solubility studies of oil and Surfactants were done. The nanoemulsion was characterized by particle size, polydispersity index, zeta potential, and entrapment efficiency (%).

Results: This nanoemulsion provides the particle size and entrapment efficiency range between 80.52 to 89.78 nm and 68.66 to 70.16 % respectively. Batch SC1 showed the lowest particle size, PDI, and optimized drug entrapment effectiveness (%), indicating good particle size consistency within the remaining formulation batches. The optimized formulation SC 1 was found to be stable for 90 d.

Conclusion: The formulated nanoemulsion showed significant antipsoriasis activity due to the presence of quercetin which has a rhetorical yield of 1.066 mg per 5 gm powder of smilax china leaves. Formulated smilax china-loaded nanoemulsion, has the potential as an effective antipsoriasis agent with a good spreading property with faster absorption which is beneficial for reducing drug concentration with maximum therapeutic effect.

PREVALENCE OF DEPRESSION AND ANXIETY IN POLYCYSTIC OVARIAN SYNDROME WOMEN

2024-01-22T15:34:31+0530

Objective: The objective of the study was to determine the prevalence of depression and anxiety ranges in women having Polycystic Ovarian Syndrome (PCOS).

Methods: An epidemiological observational study on 80 PCOS patients confirmed through ultrasound scanning over a study period of 6 mo at Government General Hospital, RIMS, KADAPA. HAM-D and HAM-A assessment scales were used to analyze the severity of depression and anxiety in PCOS women.

Results: Among 80 patients, the prevalence of depression is 86.25% (n=69) and anxiety is 93.75% (n=75). Among 69 depressed patients 38 mild, 28 moderate, and 3 severe ranges were noted. Among 75 patients with anxiety, 52 mild, 18 moderate, and 5 severe ranges were noted. The age of the patient does not show a major difference in the development of depression and anxiety. PCOS women who married and have children (n=45) were mostly affected with depression (n=39) and anxiety (n=43). Menstrual irregularity in PCOS patients with depression and anxiety is majorly seen among those who have last menstrual between 30–60 d. Middle-income patients were affected by depression and anxiety greatly, according to this study.

Conclusion: We conclude that the prevalence rate of depression and anxiety is greater in PCOS patients.

EVALUATION OF PRESCRIBING PATTERN IN ORTHOPEDICS DEPARTMENT IN A TERTIARY CARE HOSPITAL: A PROSPECTIVE OBSERVATIONAL STUDY

2024-02-10T22:55:35+0530

Objective: To study the demographic profile and prescription pattern in Orthopedics department in a tertiary care hospital.

Methods: A prospective, observational and cross-sectional study design was adopted for this study. A total of 144 patients were enrolled and their prescriptions were analyzed for three months. The data was analyzed by using a Microsoft Excel Worksheet. The Anatomical Therapeutic Chemical classification system and defined daily dose were used to classify the prescribed drugs.

Results: Out of 144 patients enrolled, 105 (72.92%) were male and 39 (27.08%) were female. Maximum patients were between 21-40 y of age. The mean age of the patients was 35.04±18.53. The average number of drugs per prescription was 4.84. Fracture of limbs (58.33%) was the most common diagnosis. Analgesics were the most commonly prescribed drugs. Diabetes was the most common comorbidity. The percentage of drugs prescribed by generic names was 48.06, and that from the essential drug list was 47.78. The percentage of fixed-dose combinations used was 28.55.

Conclusion: Although we found that a good percentage of drugs were prescribed from essential drug list but, this practice has to be increased in future. It is also seen that average number of drugs per prescription was high and percentage of drugs prescribed by generic names was less than that by brand names. So, there is immense scope of improvement for prescribing in the hospital.

A COST VARIATION COMPARISON AMONG ORAL ANTI-MIGRAINE DRUGS AVAILABLE IN THE INDIAN MARKET

2024-03-07T10:46:52+0530

Objective: Our study aimed to evaluate the cost percent variation and cost ratio of different brands of oral anti-migraine drugs available in Indian market.

Methods: The cost of various commonly used oral anti-migraine drugs were taken from the latest issue of Current Index of Medical Specialities January 2022, Drug Today January-April 2022 and 1 mg online site. Cost percent variation and Cost ratio were calculated.

Results: A total of 7 single anti-migraine drugs and 9 Fixed-Dose Combinations (FDCs) showed a wide range of cost variation. The highest cost percent variation of 433% was seen in Sumatriptan 50 mg with a cost ratio of 5.33, whereas Amitriptyline 10 mg showed the lowest cost percent variation of 47.9% with a cost ratio of 1.47. Among FDCs Naproxen 500 mg+Sumatriptan 85 mg showed the highest cost per cent variation of 400% with a cost ratio of 5.25 and Propranolol 40 mg+Flunarizine 10 mg showed the lowest cost per cent variation of 46.56% with a cost ratio of 1.46.

Conclusion: Our study showed a wide variation in the cost of oral anti-migraine drugs available in the Indian market, which provides insight to the healthcare professional and gives Drug Price Control Order (DPCO) authorities to minimize the financial burden and improve patient compliance.