Expert Details
Pharmaceutical Formulation
ID: 734127
New York, USA
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.
Education
| 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 |
|---|---|---|---|
| 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 | Employer | Title | Department |
| 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 | Employer | Title | Department |
| 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
manufacturing process development, melt rheology, polymer rheology, gel rheological measurement, dispersion rheology, topical drug, abbreviated new drug application, controlled-release drug delivery technology, transdermal drug delivery, claim (patent), intellectual property, medical device patent, patent infringement