VISHVESH RAJE

PhD Candidate in Industrial Pharmacy - Pharmaceutical Sciences

Queens, US.

About

Highly accomplished PhD researcher with over 6 years of expertise in pharmaceutical formulation development, specializing in solid dosage forms, liquid/semi-solids, and advanced manufacturing technologies like hot melt extrusion and 3D printing. Proven ability to solve complex formulation challenges, evidenced by 5 peer-reviewed publications and a strong foundation in DoE, ICH stability studies, and in silico biopharmaceutics modeling. Adept at leveraging innovative approaches to enhance drug solubility and optimize drug delivery systems, driving significant advancements in pharmaceutical R&D.

Work

St. John's University

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Graduate Teaching Fellow

Jamaica, NY, US

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Summary

Led pharmaceutical manufacturing laboratories and co-developed curriculum, mentoring graduate students in formulation principles and quality by design.

Highlights

Instructed 100+ PharmD students in pharmaceutical manufacturing laboratories, covering tablet compression, capsule filling, suspension/emulsion preparation, and USP quality control testing.

Co-developed Biomedical Chemistry laboratory curriculum, integrating formulation principles to enhance practical learning experiences.

Mentored 15+ graduate students in replicating marketed formulations, emphasizing pharmaceutical development considerations and quality by design principles.

University of Mississippi

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Student Research Scientist, Neuropharmacology Core

Oxford, MS, US

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Summary

Optimized protein extraction protocols and executed radioligand binding assays, correlating receptor affinity with functional outcomes in neuropharmacology research.

Highlights

Optimized mammalian cell culture and protein extraction protocols, maximizing yield of opioid (KOR, MOR, DOR) and cannabinoid (CB1, CB2) receptors for radioligand binding assays.

Executed 100+ radioligand receptor binding assays and analyzed dose-response data to calculate IC50/EC50 values for novel compounds.

Performed in vivo behavioral studies (Morris water maze, hot plate) to correlate receptor affinity with functional outcomes, contributing to neuropharmacology insights.

Glenmark Pharmaceuticals Ltd.

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Formulation Development Intern

Mumbai, Maharashtra, India

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Summary

Contributed to Atropine HCl nebulizer development and nasal formulation projects, gaining exposure to ICH stability guidelines and cross-functional collaboration.

Highlights

Contributed to the development of Atropine HCl nebulizer and nasal formulation projects (DPI, single-dose).

Performed aerodynamic particle size analysis using Andersen Cascade Impactor (ACI) and Next Generation Impactor (NGI) to ensure product quality.

Gained exposure to ICH stability guideline compliance, packaging operations, and batch documentation, enhancing understanding of regulatory requirements.

Collaborated cross-functionally with formulation and analytical teams, streamlining development workflows.

Holden Laboratories Ltd.

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Pharmaceutical Manufacturing Intern

Mumbai, Maharashtra, India

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Summary

Gained hands-on experience in solid dosage form manufacturing and GMP workflows, assisting with batch record documentation and process reviews.

Highlights

Gained hands-on exposure to solid dosage form manufacturing processes and GMP workflows, including in-process controls and quality control testing.

Observed and learned manufacturing scale operations, contributing to an understanding of industrial production.

Assisted with batch record documentation and participated in manufacturing process reviews, ensuring compliance and operational efficiency.

Learned pharmaceutical manufacturing quality systems and regulatory compliance requirements, strengthening foundational knowledge.

Education

St. John's University

New York, NY, United States of America
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PhD Industrial Pharmacy - Pharmaceutical Sciences Grade:

Courses

Dissertation: "Acid-Base Supersolubilization: A Novel Approach for Enhancing Solubility of Poorly Water-Soluble Weakly Acidic and Basic Drugs"

University of Mississippi

Oxford, MS, United States of America
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Master of Science (M.S.) Pharmaceutical Sciences & Drug Delivery Grade:

Courses

Thesis: "Abuse Deterrent Formulation Using Hot Melt Extrusion Technology"

Institute of Chemical Technology (ICT)

Mumbai, Maharashtra, India
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Bachelor of Technology (B.Tech) Pharmaceutical Sciences & Technology Grade:

Awards

IPEC Award for Excellence in Pharmaceutical Excipients Research

IPEC

Award recognizing excellence in pharmaceutical excipients research, highlighting innovation and impact.

Best Abstract Award

AAPS PharmSci 360

Received for outstanding abstract presentation at AAPS PharmSci 360, demonstrating research quality and communication skills.

People's Choice Award

St. John's University Research Month

Recognized for popular and impactful research presented during St. John's University Research Month.

Skills

Formulation & Manufacturing

Suspensions, Solutions, Capsules, Tablets (compression, coating, granulation, roller compaction), Liquid/Semi-solid dosage forms, Hot Melt Extrusion (HME twin-screw), Spray Drying, 3D Printing (FDM), Nano-milling/Micronization, Bench-to-pilot scale.

Technologies

Amorphous solid dispersions, Solubility enhancement (acid-base supersolubilization), SNEDDS, Nanosuspensions, Controlled/Immediate-release systems, Abuse-deterrent formulations, Quality by Design (QbD), Design of Experiment (DoE), Oral drug delivery.

Characterization

DSC, TGA, XRD, FTIR, Raman Spectroscopy, SEM, Particle size analysis, Powder flow properties, Mechanical testing (hardness/friability, texture analysis), Rheology, Stability studies (ICH conditions).

Analytical

HPLC, UV-Vis Spectroscopy, USP dissolution testing (Apparatus I-IV), Content uniformity, Stability-indicating methods, Formulation-related impurities.

Software

Design Expert, JMP (DoE/statistical analysis), GastroPlus (PBPK modeling, IVIVC), WinNonlin, KNIME, SIMCA, GraphPad Prism, Python (pandas, scikit-learn, data analysis), TinkerCAD.

Regulatory Knowledge

ICH Q1-Q10 guidelines, FDA formulation requirements (immediate/controlled-release, abuse-deterrent), GLP, GMP principles, CMC documentation, DEA compliance.

Publications

Moisture sorption and desorption of different commercially available microcrystalline cellulose grades as a function of relative humidity

International Journal of Pharmaceutical Excipients

Microcrystalline cellulose (MCC) is extensively used in pharmaceutical formulations due to its exceptional functionality as a diluent, dry binder, disintegrant, and absorbent. Despite being marketed in numerous grades that vary in particle size, source, extraction techniques, and co-processing methods, its basic chemical structure remains consistent across grades, with differences primarily in physical properties. This study investigates moisture sorption and desorption behavior and its effects on solid-state properties of thirteen different MCC grades, including eleven regular and two co-processed varieties, as moisture content significantly influences compaction, tensile strength, and viscoelastic properties.

Development of Indomethacin Amorphous Solid Dispersion by Applying Acid-Base Supersolubilization (ABS) Principle to Enhance Solubility and Enable Low-Temperature Hot Melt Extrusion

Int J Pharm

Details the application of acid-base supersolubilization to enhance indomethacin solubility and enable low-temperature hot melt extrusion, published in Int J Pharm (2025).

Application of 3D Printing Technology for the Development of Dose-Adjustable Geriatric and Pediatric Formulation of Celecoxib

Int J Pharm

Discusses the use of 3D printing for developing dose-adjustable celecoxib formulations for geriatric and pediatric patients, published in Int J Pharm (2024).

Investigating Key Molecular Descriptors Affecting Particle Size: A Predictive Exemplary Approach for Self-Emulsifying System

Mol Pharm

Explores molecular descriptors influencing particle size in self-emulsifying systems, presenting a predictive approach, published in Mol Pharm (2023).

Tunable Drug Release from Fused Deposition Modelling (FDM) 3D-Printed Tablets Fabricated Using a Novel Extrudable Polymer

Pharmaceutics

Describes the fabrication of 3D-printed tablets with tunable drug release using FDM and a novel extrudable polymer, published in Pharmaceutics (2022).

Abuse Deterrent Formulation Using Hot Melt Extrusion Technology

University of Mississippi (M.S. Thesis)

Master's thesis detailing the development of abuse-deterrent formulations using hot melt extrusion technology (2021).

Projects

PhD Dissertation - Acid-Base Supersolubilization for Solubility Enhancement

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Summary

Applied acid-base supersolubilization (ABS) principle for solubility enhancement of BCS Class II/IV APIs, avoiding salt precipitation at pHmax, enabling continued solubility increase as well as superior dissolution performance, and a solvent-free spray drying process using aqueous ABS solutions.

Molecular Descriptors for Nanosuspension Particle Size Prediction using ML/AI

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Summary

Developed machine learning models to predict nanosuspension particle size from molecular descriptors, enabling rational drug candidate selection for nanosuspension formulations.

Tunable Drug Release from FDM 3D-Printed Tablets

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Summary

Designed 3D-printed tablets with tunable drug release profiles by manipulating outer shell numbers and infill patterns, using a novel extrudable polymer.

Abuse Deterrent Formulation using Hot Melt Extrusion Technology (MS Thesis)

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Summary

Pioneered the first extrusion of pectin and starch through HME to develop abuse-deterrent extended-release formulations with gel formation, extraction resistance, and alcohol-resistant release profiles.

Moisture Sorption-Desorption of Microcrystalline Cellulose

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Summary

Investigated moisture sorption-desorption behavior of 13 commercial microcrystalline cellulose grades using dynamic vapor sorption analysis at 25°C across 10-90% RH.

Self-Nanoemulsifying Drug Delivery Systems (SNEDDS)

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Summary

Identified key molecular descriptors affecting SNEDDS formulation success for 40+ drug molecules using computational analysis and developed predictive models.