Design and development of
Novel drug delivery
systems: Oral, Topical etc.
Formulations for
Bioavailability
Enhancements
Development of Novel
herbal or polyherbal
Formulations,
Cosmetic and
cosmoceutical product
development.
Implementation of Quality
by Design Approach for
product developme
21
Scopus Publications
Scopus Publications
Deep eutectic solvents as emerging carriers for antihyperlipidemic drugs: current trends and future perspectives Sushant Gaikwad, Ambar Marne, Ashwini Gawade, Ashwin Kuchekar Pharmaceutical Development and Technology, 2026 The therapeutic effectiveness of the most antihyperlipidemic drugs, particularly Biopharmaceutics Classification system Class II drugs like statins, is severely limited by their low aqueous solubility and resulting low and variable oral bioavailability (e.g. ∼5% for simvastatin). Deep Eutectic solvents and Therapeutic Deep Eutectic System are explored in this review as an environmentally friendly and innovative next-generation platform designed to overcome these fundamental biopharmaceutical limitations. These systems function as good solubilizers, improving the dissolution rate and the thermodynamic stability of antihyperlipidemic drugs significantly. This directly enhances the drug absorption kinetics, resulting in more predictable and enhanced oral bioavailability. Commercialization of DESs still faces major challenges. Large-scale-up is difficult because their high viscosity reduces mixing and mass transfer efficiency. Also, a complete evaluation of their cytotoxicity, biodegradability, and long-term thermal stability is still needed to ensure their safe and sustainable use as effective pharmaceutical excipients.
Immune system involvement and neuropathology in Guillain-barré syndrome: Approaches to therapy Harshavardhan Karnik, Prajakta Wagh, Ashwini Gawade Indian Journal of Biochemistry and Biophysics, 2025 Guillain-Barré Syndrome (GBS) is increasing in incidence and is associated with significant morbidity, emphasizing the urgent need for improved therapeutic options beyond current treatments. While intravenous immunoglobulin (IVIG) and plasmapheresis are the primary therapies, their limited ability to prevent long-term neuromuscular impairments highlights the necessity for innovative approaches. GBS is an acute autoimmune disorder that often follows infections, leading to demyelination or damage to nerve axons and resulting in paralysis. This review discusses emerging immunomodulatory treatments, such as monoclonal antibodies aimed at B-cell depletion and complement system inhibition, which provide targeted mechanisms to modulate abnormal immune responses. Additionally, regenerative strategies, including mesenchymal stem cell therapy and neuroprotective agents, are explored for their potential to promote nerve repair and improve recovery. Advances in gene-editing technologies also offer promising possibilities for correcting immune dysregulation at the molecular level. Beyond pharmacological interventions, the review highlights the importance of addressing the complex physical, psychological, and socioeconomic burdens of GBS. Comprehensive rehabilitation comprising physiotherapy, occupational therapy, and psychological supportis vital for restoring independence and enhancing quality of life. Future research should focus on personalized treatment approaches, biomarker-guided monitoring, and large clinical trials to improve outcomes and lessen the global impact of GBS.
Synthesis and characterization of fenofibrate–atorvastatin calcium cocrystals with Para-Aminobenzoic Acid as a Coformer: Design, formulation, and evaluation Ashwin Kuchekar, Anirudha Chavan, Poonam Inamdar, Ashwini Ramkrishana Gawade Journal of Applied Pharmaceutical Science, 2025 This study aimed to improve the dissolution profile of two poorly soluble drugs, atorvastatin calcium and fenofibrate, through cocrystallization via carefully selected coformers. Five different coformers were screened via a molecular docking approach with the PyRx virtual screening tool. Binding energy and hydrogen bond formation data identified para-aminobenzoic acid (PABA) as the most suitable coformer for cocrystal formation. The cocrystallization process was carried out via the liquid-assisted grinding method. The resulting cocrystals were characterized via Fourier transform infrared (FT-IR), powder X-ray diffraction (PXRD), differential scanning calorimetry (DSC), and scanning electron microscope (SEM) techniques. A detailed evaluation of fenofibrate, atorvastatin calcium, and fenofibrate−atorvastatin calcium-PABA multidrug cocrystals revealed improved solubility compared with that of the pure drugs. Characterization through FT-IR confirmed interactions between the drugs and the coformer, whereas PXRD, DSC, and SEM analyses supported the formation of a distinct crystalline phase. An in vitro dissolution study demonstrated a significant increase in the dissolution rate of the cocrystals. The findings concluded that cocrystals prepared with PABA via the liquid-assisted grinding method successfully improved the solubility of atorvastatin calcium and fenofibrate, providing a promising approach to address the challenges associated with poorly soluble drugs. The novelty lies in the strategic combination of two lipid-lowering agents into a single multicomponent crystal system, offering improved solubility, dissolution rate, and potential bioavailability compared to their standalone forms. This work pioneers the application of pharmaceutical cocrystallization for dual-drug delivery in dyslipidemia management, offering a promising platform for fixed-dose combination therapies with enhanced patient compliance and therapeutic synergy.
Novel Isocratic HPLC Method for Simultaneous Estimation of Sacubitril and Valsartan in Bulk and Formulation Harshavardhan Rajendra Karnik, Ambar Bhikasaheb Marne, Ashwin Bhanudas Kuchekar, Ashwini Ramkrishna Gawade Brazilian Archives of Biology and Technology, 2025 In compliance with ICH requirements, a new selective, precise, and accurate reverse-phase High-Performance Liquid Chromatographic method for valsartan and sacubitril quantification was developed and validated. Eluents were detected at 284 nm. The HPLC method was designed utilizing a C18, (150mm × 4.6mm, 3.5μm) column with 1% Acetic acid in water: Methanol (45:55 v/v) as a mobile phase at a flow rate of 0.8 mL/min. For valsartan and sacubitril, the calibration curves were linear over the concentration range of 10 to 100 ng/mL (R2 = 1) and 20 to 140 ng/mL (R2 = 1), respectively. Valsartan and sacubitril were shown to have average retention times of 5.79 and 7.019 minutes, respectively. Valsartan and sacubitril had average percentage recoveries of 99.83± 0.14 and 100.06± 0.19 percent, respectively. Valsartan and sacubitril had respective LOD values of 0.0958 and 0.1059 ng/mL. The suggested method's intraand inter-day precision values (% RSD) were under 2%. For the simultaneous measurement of valsartan and sacubitril, a straightforward, exact, accurate, linear, and quick RP-HPLC technique was created and verified by ICH recommendations. The findings imply that the devised approach can be used for pharmaceutical formulation and routine bulk measurement of valsartan and sacubitril. The method’s applicability was confirmed through successful analysis of pharmaceutical formulations, indicating its potential utility for routine quality control and stability testing of Sacubitril and Valsartan in combined dosage forms. The choice of gradient elution, despite its complexity, was justified by the need for improved separation and resolution, which are critical for the accurate determination of these therapeutic agents.
3D Printing of Solid Dosage Forms Ashwin Kuchekar, Prajakta Wagh, Harshavardhan Karnik, Ashwini Gawade Precision 3D Printing in Pharmaceutical Sciences A Transformative Shift in Drug Manufacturing and Delivery Systems, 2025 Three-dimensional (3D) printing is transforming the pharmaceutical landscape, particularly in the design of solid dosage forms (SODFs) as advanced drug delivery. This technology offers significant advantages over traditional manufacturing methods, allowing for the development of patient-specific dosage forms with complex geometries and controlled drug release characteristics. The FDA's approval of Spritam ® , the first 3D-printed tablet, marked a significant milestone and increased research and development in this area. Traditional platforms lack the flexibility needed for personalized medicine, but 3D printing can rapidly prototype various dosage forms without expensive equipment. This adaptability is very important for tailoring individualized drug doses and release profiles to meet specific patient needs. 3D printing technology offers a promising approach to creating solid dosage forms in nanomedicine that feature improved functionality and tailored characteristics for individual patients. Current research in this area has significant potential to transform drug delivery systems and enhance treatment outcomes across various medical conditions. As scientists delve deeper into the applications of 3D printing in pharmaceuticals, the prospects for personalized medicine and precise drug delivery are becoming more attainable.
Recent technologies for TNBC management Poonam R. Inamdar, Ashwini R. Gawade, Parixit J. Bhandurge, Prajakta V. Adsule, Padmaja S. Kore, Sachin N. Kothawade Artificial Intelligence Driven Precision Medicine for Triple Negative Breast Cancer Innovations and Insights in Tnbc Management, 2025
Multi-pulse chronotherapeutic approaches for circadian rhythm disease management Sanika Kole, Rutuja Vinchurkar, Rutuja Desai, Prajakta Wagh, Ambar Marne, Harshavardhan Karnik, Ashwini Gawade, Ashwin Kuchekar Chronobiology International, 2025 This review explores the field of multipulse drug delivery systems, emphasizing their potential to transform drug administration and improve therapeutic outcomes. Multipulse systems provide controlled and sustained medication release by emulating the body's natural rhythms and utilizing advanced technologies such as stimuli-responsive systems, artificial intelligence, and nanotechnology. The review examines the classification, mechanisms, and benefits of multipulse systems, highlighting their significance in chronic disease management and personalized medicine. Integrating artificial intelligence with personalized medicine enables the development of customized drug delivery systems that improve efficacy, reduce side effects, and enhance patient compliance. As we advance toward the era of precision medicine, the combination of technological and pharmaceutical innovations shows great promise for optimizing patient care and treatment outcomes.
Synthesis of mesoporous silica nanoparticles Rajashri B. Sumbe, Kunal G. Raut, Ashwini R. Gawade, Amruta A. Bankar, Kalyani A. Autade, Sachin N. Kothawade Mesoporous Silica Nanoparticles Drug Delivery Catalysis and Sensing Applications, 2024
Polymeric Biomaterials Ramdas B. Pandhare, Kalyani A. Autade, Rajashri B. Sumbe, Sachin N. Kothawade, Ashwini Gawade Polymers in Modern Medicine Part 1, 2024
!.5 years if Industrial experience in the department of technology transfer at sai life sciences, Pune, Maharashtra India.
7 months industrial experience in the depaertment Developmental Quality Assurance at Lupin research park, Pune, Maharashtra India.
