NANO-ENABLED THERAPEUTICS: EXPLORING BIOEQUIVALENCE AND BIOAVAILABILITY FRONTIERS ARAVINDA PAI, CHANDRASHEKAR K. S., BHAVANA BHAT B., VIDHI ANSUL SAXENA, VENKATESH KAMATH B. International Journal of Applied Pharmaceutics, 2025 The advancement of nanotechnology has significantly transformed pharmaceutical sciences, especially in enhancing the bioavailability and bioequivalence (BE) of drugs with poor solubility and permeability. Nanoparticulate drug delivery systems including nanoparticles, nanocrystals, nanoemulsions, and liposomes exhibit unique physicochemical properties such as increased surface area, improved dissolution rates, and enhanced permeability. These characteristics collectively contribute to superior therapeutic efficacy. For example, a 25-fold increase in the bioavailability of poorly soluble drugs such as retinoic acid has been reported by the use of solid lipid nanoparticles (SLNs), which act as protective lipid matrices, augmenting drug stability and allowing sustained release. This comprehensive review explores the fundamental concepts of bioavailability and BE as they pertain to nanoformulations, focusing on key factors that influence the absorption, distribution, metabolism, and excretion of nanosized drugs. It emphasizes the mechanistic pathways by which nanocarriers overcome biological barriers, including the gastrointestinal (GI) tract and first-pass metabolism, thereby improving pharmacokinetic (PK) profiles. Furthermore, the review discusses analytical methodologies and regulatory considerations critical to evaluating the BE of nanoformulated drugs. It highlights challenges in establishing equivalency arising from altered pharmacokinetic and pharmacodynamic (PD) behaviors unique to these formulations. A comparative analysis of conventional versus nanoformulated drugs illustrates the clinical implications of nanotechnology in drug delivery, such as dose reduction, improved patient compliance, and minimized adverse effects. Additionally, recent advancements in formulation strategies and characterization techniques are synthesized, showcasing how surface modifications, size optimization, and targeting moieties enhance oral bioavailability. By evaluating preclinical and clinical studies, this article provides valuable insights into the translational potential of nanoformulations. It also identifies existing gaps and future directions in regulatory frameworks and standardized BE testing. In summary, this review offers a holistic understanding of nanotechnology’s role in improving drug bioavailability and BE, serving as an essential resource for pharmaceutical scientists, clinicians, and regulatory authorities aiming to leverage nanoformulations for enhanced therapeutic outcomes. Despite notable progress, significant challenges remain especially in achieving scalable manufacturing, ensuring reproducibility of formulations and navigating complex regulatory landscapes. These challenges stress on the urgent need for internationally harmonized standards and robust quality control systems to support clinical translation.
Management of Vitamin D Deficiency Among the Under-Five Children Residing in Coastal Areas of Karnataka: A Study Protocol Mamatha Shivananda Pai, Reshma R Kotian, Suneel C Mundkur, Shobha U Kamath, Anjeline D'Souza, Bhavana B Bhat, Sangeetha M Acharya National Journal of Community Medicine, 2025 Introduction: Vitamin D deficiency has become the new normalcy due to rapid transition of lifestyles among the people globally. Vitamin D is synthesized in the body due to exposure of skin to sunlight. Correction of vitamin D deficiency poses a major demand due to its action on bone and muscle health. The objective of this study is to assess the effectiveness of sun exposure and Vitamin D supplement and Vitamin D supplements alone on serum vitamin D levels among the under-fives. Methods: This protocol is a randomized controlled study planned to be carried out among the under-five children with vitamin D deficiency. Children will be randomised into two groups (Group 1 -Vitamin D supplementation only) and (Group 2 - vitamin D supplementation +sun exposure). Both the group will receive intervention for 12 weeks and Serum Vitamin D levels will be tested after 12 weeks. Descriptive and inferential statistics will be used to present the findings of the study. Conclusion: Identification and treatment of Vitamin D deficiency is vital in children`s bone health. This protocol will provide direction and guidance to optimize utilization of treatments to improve vitamin D deficiency among under five children.
A deep dive into the development of complex generics: A comprehensive review Amatha Sreedevi, Prashant B. Musmade, Krishnamurthy Bhat, Sreedhar Dharmagadda, Manthan D. Janodia, Bhavana B. Bhat, Virendra S. Ligade Journal of Applied Pharmaceutical Science, 2024 In recent years, complex generics a special class has excel the scope of Generic Drug User Fee Act (GDUFA) in contrast to traditional small molecular drugs. The recent trends reveal a growing demand that has incentivized pharmaceutical companies to focus more on producing generic versions of complex drugs, such as biosimilars, drug-device combination products, nanotechnological products and controlled-release formulations, topical preparations containing complex drugs, long-acting injectables, and inhalation products. Despite the growth and benefits, the pharmaceutical companies engaged in the production of these products are facing many challenges mainly, advanced analytical techniques to demonstrate bioequivalence and safety, novel complex manufacturing processes to reduce losses, quality issues, regulatory approval, patent litigation, and market competition to bring low-cost products to market. The regulatory status of complex generics varies across different countries. Although the United States Food and Drug Administration (US FDA) has established clear pathways for complex generics by issuing case-by-case product-specific guidelines, other regulatory agencies mainly the European Medical Agency, Health Canada, and (Agencia Nacional de Vigilancia Sanitaria) Brazil are highlighting the challenges associated with the current product-specific guidelines. The regulatory aspect of complex generic is in the nascent stage for countries like India. Harmonization and convergence of regulatory standards are essential for streamlining global access to complex generics. The present review highlights the evolving frontier of complex generics, their classification, trends, regulatory status, and challenges to ensure patient access to safe, effective, and affordable alternative treatments.
Bioinspired nanofibers: advancing drug delivery for enhanced therapeutic applications Amisha S. Raikar, Bhavana B. Bhat, Sandesh N. Somnache Journal of Applied Pharmaceutical Science, 2024 Nanomedicine is advancing with bioinspired nanofiber-based drug delivery systems (DDSs). This field explores the use of collagen and spider silk-like nanofibers to transport therapeutic agents to anatomical locations in the system. Nanofibers have a larger surface-area-to-volume ratio, mechanical strength, and ECM-mimicking properties. They are made with organic and artificial polymers, but natural polymers are better for biocompatibility and ECM resemblance. Synthetic polymers are versatile and can be customized to meet specific needs. Various techniques such as electrospinning, self-assembly, and templating are used to make bioinspired nanofibers. Electrospinning creates versatile and robust nanofibers that can be functionalized to boost therapeutic benefits. Control/extended DDSs using nanofibers are attainable by adjusting their physical and chemical properties (e.g., diameter, surface chemistry, and porosity). The nanofiber DDSs inspired by biology have shown promising use in wound healing, cancer therapy, and regenerative medicine. Creating these systems requires achieving biocompatibility, reducing toxicity, maintaining stability, long drug release, scalability, and cost-effectiveness.
Developing a module on the care of LGBTQIA+ individuals for health professionals: Research protocol. Mamatha Shivananda Pai, Renjulal Yesodharan, Vikram Palimar, Latha Thimmappa, Bhavana B. Bhat, Nirmal Krishnan M., Deeksha Shetty, Bontha V. Babu F1000research, 2024 Lesbian, Gay, Bisexual, Transgender, Queer, Intersex and Asexual (LGBTQIA+) people struggle to identify a healthcare service that understands their problems and needs. Additionally, healthcare professionals also find it difficult to care for LGBTQIA+ as very little is studied or heard about management. The article presents a protocol for a pilot study aimed at the development of an LGBTQIA+ care curriculum for health science professionals. The study includes Phase I: The development of a curriculum based on a literature review and focus group discussion among LGBTQIA+ individuals, and Phase II: Pilot testing of LGBTQIA+ care curriculum. The study outcome will reflect the improvement in the knowledge of healthcare professionals on LGBTQIA+ care.
Prospective potential of enzymes from Novel Bacillus sonorensis: Insights into the Structural aspects, Industrial and Therapeutic significance Vidi Mehra, Aravinda Pai, Bhavana B Bhat, Aswatha Ram H N, Venkatesh Kamath B Research Journal of Pharmacy and Technology, 2023 Different studies on a novel strain Bacillus sonorensis revealed potential enzyme production and their use in different sectors like food industries, waste management and medical sector. As industrially important microorganism, B. licheniformis shows close relation to B. sonorensis, about which little information is established. It is thus expected that, the information gained about enzymes from the novel Bacillus sonorensis will prove beneficial towards investigating the biotechnological significance of the microorganism, and the genomics and phylogenetic importance in relation to members belonging to Bacillus subtilis group. The summarization about significant enzymes obtained from the organism including hyper thermostable alkaline lipase, L-asparaginase, keratinase, complex cellulase and pectinase shows medical significance, environment friendly waste management and essential ecological process.
Job skill assessment of pharmacy students in South Karnataka: A cross-sectional study Shanthi Lysetty, Anup Naha, Usha Yogendra Nayak, Virendra S. Ligade, Bhavana B. Bhat, Usha Ran Journal of Applied Pharmaceutical Science, 2023 Leadership Attitudes and Beliefs of Pharmacy Students: A cross-sectional Study from a Malaysian UniversityMohamed Azmi Hassali, Fahad Saleem, Alian A. Alrasheedy, Zeehan Shanaz Ibrahim, Tahir Mehmood Khan, Hisham Aljadhey
Controlled Release Technologies for Chronotherapy: Current Status and Future Perspectives Usha Y. Nayak, Bhavana B. Bhat, Chetan H. Mehta, Akhil Suresh, Varalakshmi Velagacherla Current Pharmaceutical Design, 2023 The expression “as sure as night follows a day” emulates those certain cycles in the environment that are always stable. Circadian rhythms are a group of processes that occur within the body in synchronisation with the external factors in a 24 h cycle. Changes in lifestyle and work shifts have disrupted these stable rhythms, which is a leading cause of lifestyle diseases. Associations between these biological clocks and diseases are abundant. However, it is also known that certain drugs work more efficiently and have minimum toxicity when given during a particular phase of the circadian cycle. Chronotherapeutics focuses on treating diseases according to the endogenous processes which mediate xenobiotic metabolism and drug response at a cellular level. Therefore, treatment of those diseases that show aggravation of symptoms according to the circadian rhythms at a particular time is highly beneficial by chronotherapy. In this article, we have emphasised how the changes in rhythms caused diseases and how chronotherapeutic approaches such as controlled drug release technologies can be a better option for these circadian manipulations that seem to influence all types of disease conditions.
Development, implementation, and testing of LGBTQIA+ care curriculum for health science professionals: Research protocol Mamatha Shivananda Pai, Renjulal Yesodharan, Vikram Palimar, Latha Thimmappa, Bhavana B. Bhat, Nirmal Krishnan M., Deeksha Shetty, Bontha V. Babu F1000research, 2023 Lesbian, Gay, Bisexual, Transgender, Queer, Intersex and Asexual (LGBTQIA+) people struggle to identify a healthcare service that understands their problems and needs. Additionally, healthcare professionals also find it difficult to care for LGBTQIA+ as very little is studied or heard about management. The article presents a protocol for a pilot study aimed at the development of an LGBTQIA+ care curriculum for health science professionals. The study includes Phase I: The development of a curriculum based on a literature review and focus group discussion among LGBTQIA+ individuals, and Phase II: Pilot testing of LGBTQIA+ care curriculum. The study outcome will reflect the improvement in the knowledge of healthcare professionals on LGBTQIA+ care.
Medical device industry in india: Past to present Bhavana B Bhat, Pavithra Pradeep Prabhu, Manisha Joshel Lobo, Anusha, Prathvi, B Venkatesh Kamath Research Journal of Pharmacy and Technology, 2019
