Expert Details

Expert in Pharmaceutical Formulation

Expert ID: 734127 New York, USA

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Expert received his M.S. and doctorate in Pharmaceutical science from Long Island University, Brooklyn campus in 2017. During his doctoral dissertation, he worked on the rheological characterization of transdermal formulation and application of rheological models in product development and scale-up process. He has 10 years of experience in controlled release product development with a strong emphasis on multiple day transdermal drug delivery system. He supports Research and Development activities in the formulation and product development. Currently, he serves as a director of R&D Department. He lead and supported multiple 505(b)2 and NDA projects for TRPL. Prior to joining TRPL, he volunteered at HTS (High Throughput Screening) core-facility of Memorial Sloan Kettering cancer center to determine the solubility of HTS library compounds using novel Nephelometry technique. He acquired solid dosage formulation development experience by doing an internship.

Expertise: Techniques/ Instruments
• In vitro studies: Permeability, dissolution, and disintegration
• Solid state characterization: PXRD, DSC, TGA, FTIR, microscopy (polarized/hot stage)
• Semi Solid Processing: Rheological Characterization, Franz diffusion
• Powder processing: tablet press, texture analyzer, spray drying, high-shear wet granulation
• Particle engineering and characterization for size, surface area, porosity, density
• Analytical Techniques: HPLC, UV-Visible Spectrophotometry

Research Experience
• Formulation development of transdermal drug delivery using various excipients (permeability
enhancers) and in-vitro studies using human cadaver skin and cellulose membrane
• Development and validation of HPLC methods
• Solid-state characterization of pharmaceutical materials (drugs and excipients) using DSC
• Evaluation of rheological properties for different polymers using Bohline Gemini II Rheometer.

Expert can provide consultation for Formulation development and optimization, Formulation characterization method and FDA related guidance. More information available upon request.

Expert may consult nationally and internationally, and is also local to the following cities: New York, New York - Yonkers, New York - Newark, New Jersey - Jersey City, New Jersey - Paterson, New Jersey - Elizabeth, New Jersey - Bridgeport, Connecticut - New Haven, Connecticut - Hartford, Connecticut - Philadelphia, Pennsylvania

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Year Degree Subject Institution
Year: 2017 Degree: Ph.D. Subject: Pharmaceutical Science Institution: Long Island University, Brooklyn Campus
Year: 2012 Degree: M.S. Subject: Industrial Pharmacy Institution: Long Island University, Brooklyn Campus
Year: 2008 Degree: B.Pharm Subject: Pharmacy Institution: Sardar Patel University, Anand, India

Work History

Years Employer Title Department Responsibilities
Years: 2013 to Present Employer: Undisclosed Title: Director Department: Research & Development Responsibilities: • Successfully transfer product to CMO. Two products are currently in clinical trial.
• Write and applied for two patent related to transdermal drug delivery of drug molecule for 7 days. Also submitted couple of provisional patents.
• Developed Technology Transfer documents for CMO site.
• Development and Validation of stability indicating HPLC methods for drug molecules by applying analytical Quality based Design (QbD) approach
• Carrying out In-Vitro study for semi-solid Dosage forms by using different mathematical models and predicted steady state concentration in-vivo for different formulations
• Performing various pre-formulation studies such as solubility study, pH dependent solubility study, Rheological studies.
• Optimizing formulation by applying Design of Experiment (DOE) and QbD approach.
• Conducting different in process and finish product tests for semi-solid dosage forms such as stability, viscosity, elasticity of formulation and In-vitro study.
Years: 2012 to 2012 Employer: Memorial Sloan - Kettering Cancer Center Title: Volunteer (HTS Core Facility) Department: High Throughput Screening Core Facility Responsibilities: • Solubility and stability studies for new chemical entity
• Evaluation of pharmaceutical suspension using laser Nephelometry
• Data analysis, report writing and presentation
HIPA trained
Years: 2011 to 2011 Employer: Apex Pharmaceuticals, Inc. Title: Intern - Research Trainee Department: Formulation Development Responsibilities: • Critical analysis of literature on latest research
• Developed different formulations for ODT, and OROS types of tablets
• Performed dissolution, assay and purity testing using HPLC
• Executed IPQC tests for finished products such as disintegration, weight variation, hardness, friability
• Documentation, data analysis, report writing and presentation.

International Experience

Years Country / Region Summary
Years: 2009 to 2009 Country / Region: India Summary: •Conducted IPQC for specific products according to regulatory requirements • Performed formulation and pre-formulation studies for drug products • Carried out the stability studies of finished product using specific requirements • Prepared and reviewed the production documents such as Batch Manufacturing Record, Master Formula Card, Process Validation Protocol, and Validation Summary Report as per US FDA guidelines • Analyzed and fixed the critical parameters for the large scale production using validation batches.
Years: 2009 to 2009 Country / Region: India Summary: Production Chemist (Formulation Development) • Recorded the in-process production parameters in Batch Manufacturing Record • Conducted the prospective process validation as per FDA regulation and guidelines • In vitro evaluation of pharmaceutical products for various tests like disintegration, hardness, friability and dissolution.

Career Accomplishments

Associations / Societies
AAPS: American Association of Pharmaceutical scientists
AAiPS: American Association of Indian Pharmaceutical Scientists
AAPS-Oral Absorption Group (Student representative)
AAPS-Excipient Focus Group (Programming Committee)
Awards / Recognition
Recipient of Rho-Chi award from Long Island University, Brooklyn Campus.
Travel Grant award by Long Island University, Brooklyn campus
Anticipated Colony Graduate Award by Long Island University, Brooklyn campus
India Association of Physics Teacher award by Indian Association of Physics Teachers

Language Skills

Language Proficiency
English Expert
Hindi Skillful
Gujarati Expert

Fields of Expertise

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