Current Indian Science - Volume 2, Issue 1, 2024

The pharmaceutical industry is witnessing a growing demand for complex generic products, which are generic versions of drugs that possess complex formulations, delivery systems, or active ingredients. However, the approval process for these complex generic products poses unique challenges compared to traditional generics. There is no specific regulatory procedure available for the approval of complex generics, unlike small-molecule generics and biosimilars. This led to controversial arguments in the past about the scientific evidence needed for applications, which led to lengthy approval processes. The regulatory frameworks that are currently being used for complex generics are debatable and unclear. Complexity in the molecular structure, mechanism of action, route of delivery, and complex manufacturing process makes proving bioequivalence and pharmaceutical equivalence difficult. There is a need for harmonization of the regulatory framework by the agencies to help the generic manufacturers by providing scientific advice, defining the submission requirements for complex products, and fastening the approval process.

This review begins by discussing the regulatory landscape surrounding complex generic products in various regions, including the United States and Europe. It examines the specific guidelines and requirements set forth by regulatory authorities to ensure the safety, efficacy, and quality of these products. Additionally, the review explores the differences in terminology and definitions used to classify complex generics across different jurisdictions. Furthermore, it delves into the challenges faced by both regulatory agencies and pharmaceutical companies in evaluating and approving complex generic products. These challenges include establishing appropriate bioequivalence criteria, determining interchangeability with the reference product, addressing patent and exclusivity issues, and ensuring consistent quality throughout the product lifecycle. The impact of these challenges on market entry and competition is also discussed. The review highlights the need for harmonization and streamlining of regulations for complex generic products worldwide. It emphasizes the importance of clear and consistent guidelines to enable timely approvals, foster innovation, and facilitate patient access to affordable alternatives.

The nutritional and therapeutic potential of medicinal plants is constantly being investigated. This is especially relevant in today's world, where an increasing number of people are turning to complementary and alternative therapies to address their health-related concerns. Traditional knowledge, as a valuable resource, plays a crucial role in the development of new herbal medicines. Abroma augusta stands out as one such medicinal plant that has a rich history of use in traditional medicine. It has been employed to address a wide spectrum of health issues, including diabetes, menstrual irregularities, respiratory problems, musculoskeletal disorders, urinary ailments, and sexual dysfunctions, among others. While various parts of this plant species are believed to possess pharmacological properties, the active compounds and underlying mechanisms remain largely unexplored. To facilitate the development of innovative drugs for the benefit of individuals, this study places significant emphasis on delving into the phytochemical and ethnomedicinal attributes of A. augusta. Moreover, it seeks to bolster its findings with scientifically validated pharmacological investigations conducted through both in vivo and in vitro methodologies.

The cellular and biochemical stages of the wound-healing process are interrelated and work to repair the wound. The body heals wounds in stages, and each stage that is postponed raises the risk of microbial infection. The time needed for healing can be sped up, and unwanted events can be reduced to improve wound healing. To aid in the healing of the wounds, the medications are administered locally or systemically. In order to promote wound healing, antibiotics, antiseptics, desloughing agents, extracts, etc. have been employed. Due to their adverse effects, several synthetic medications are subject to restrictions. Investigation, identification, and formulation of plants or plant-derived combinations are required for the management and therapy of wound healing. Because they have fewer adverse effects and have been used to treat wounds for a longer period, medicinal plants are becoming more popular for use in wound healing. According to studies, medicinal herbs help diabetic, infected, and opened wounds heal more quickly. It has been claimed that medicinal herbs can speed up wound healing through a variety of processes. Many medicinal plants, including Allium sativum, Commiphora myrrha, Curcuma longa (L.), Rauwolfia serpentia, and Vateria indica, have demonstrated the ability to treat wounds.

Digitalis purpurea L. belongs to the Scrophulariaceae family. The most significant is digitoxin, a very toxic substance that builds up in the body and is impenetrable in water. For millennia, people have utilized the medication Digitalis to treat cardiac problems induced by obesity. External triggers like strenuous exercise, emotional stress, eating, exposure to extreme weather, sexual activity, coffee and alcohol consumption, and use of cocaine or marijuana temporarily increase the risk of having a myocardial infarction. A person's genetic makeup influences disease progression, the presence of chronic risk factors, and lifestyle choices. Despite various educational programs, the fight against obesity does not appear to be successful. According to WHO (World Health Organisation) statistics, 13 percent of adults over the age of 18 are obese, and 39 percent are overweight. Being overweight or obese significantly raises the chance of developing disorders, including coronary heart disease. Digitalis is primarily used to treat heart conditions. It encourages and stimulates the action of all muscle tissues in cases of clogged heart failure. The herb improves heart nutrient absorption by forcing more blood into the coronaries. Digitalis aids in the repair and regulation of the heart's function when blood circulation is hampered.

A chronic skin condition called psoriasis can manifest as plaque, flexural, guttate, pustular, and erythrodermic lesions, among other clinical symptoms. Sixty million people are believed to be affected by psoriasis worldwide. In India, the frequency ranges from 0.44 to 2.8%, with males affected two times more frequently than females in their third or fourth decade of life. An immune-mediated inflammation condition with a sizable genetic component is psoriasis. Due to its connection to psoriatic arthritis and the increased prevalence of cardiometabolic, hepatic, and psychiatric problems, a thorough and interdisciplinary strategy for treatment is required. Corticosteroids and analogs of vitamin D are examples of topical treatments for psoriasis. Phototherapy includes NB-UVB, psoralen, and ultraviolet radiation (PUVA). Standard systemic treatments include methotrexate, acitretin, and ciclosporin. This disease is useful for physicians and scientists since it might be used as a model for research into the underlying causes of chronic inflammation. It is also crucial for clinical trial scientists as a first-choice disease indication for preliminary research of new pathogenesis-based treatment approaches. This review covers both the therapeutic choices that have resulted from the analysis of the aggressive psoriatic pathways and the processes involved in the onset and progression of the disease. We start by writing regarding the important cell kinds and inflammatory mechanisms that initiate and maintain psoriatic inflammation. Next, we discuss how skin flora interacts with heredity, related epigenetic processes, and the pathogenesis of psoriasis. Finally, we provide a thorough analysis of recently targeted medications as well as well-known, extensively used treatments.

Introduction: Nanoencapsulation has gained popularity in recent decades due to its numerous benefits, such as improved stability, oxidation resistance, retention of volatile ingredients, controlled release, delivery of multiple active ingredients in a row, improvement in organoleptic properties, reduction of toxic side effects, and water solubility.

Methods: The present study was aimed to prepare eugenol nanoemulsions (EuNEs) using non-ionic surfactant (Tween 80) by ultrasound-assisted techniques and to evaluate the effects of surfactant concentration on their droplets size, polydispersity index (PDI), zeta potential, storage stability, antioxidant, and antibacterial activities. Antimicrobial activity of the prepared nanoemulsions was tested against Gram-positive; Staphylococcus aureus, Bacillus subtilis and Gram-negative; Escherichia coli, and Alcaligenes faecalis bacteria using well diffusion method.

Results: The results showed that the droplet size decreased after a threshold Tween 80 concentration (10%), while PDI value increased with the increase in surfactant concentration (Tween 80).

Conclusion: The prepared EuNEs exhibited good antibacterial activity against all the four bacterial strains: E. coli, A. faecalis, S. aureus, and B. subtilis.

API analysis plays an important role in nourishing the quality, safety, efficacy, and potency of bulk drugs and pharmaceutical formulations. Increased drug products in the market lead to increased demand for new analytical techniques for Active Pharmaceutical Ingredient (API) analysis. During the past decades, method developments were necessitated for drug impurities, excipient profiling, and testing for biopharmaceuticals like dissolution and bioavailability. Moreover, advancements in the pharmaceutical industries necessitate upgrading newer technologies like analytical Quality by Design (QbD) and artificial intelligence. This review focused on analytical method development and its official guidelines provided by various regulatory bodies including ICH, US-FDA, AOAC, and USP. Moreover, this present art also states various validation and system parameters along with their applicability and recommended range. The critical appraisal of analytical technologies for performing various API analyses was also written in a scientific manner. Moreover, applications in recent trends in pharmaceutical industries as well as research were also documented. Hence, this review provides sufficient information for the readers for in-depth information starting from scratch to higher technologies for developing analytical methods and recent trends in the pharmaceutical industry.