Intellex Acquires Expert by Big Village

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Expert Details

Pharmaceuticals, Formulation R&D & Oral Solid Dosage Forms

ID: 739694 India

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Expert is a Pharmaceutical Formulations Development Scientist, with 6+ years of experience in the pharmaceutical field, specifically with tablet capsules, and solid oral dosage forms. He is familiar with the process analytical technology (PAT) tools, design of experiments, and stability studies ICH guidelines.

In his current role as a Senior Research Associate in Formulation R&D, he has successfully developed two prototypes of extended release (ER) pellets (capsules) of an anti-anginal molecule for the US market - ANDA filling. He also developed and submitted anti-hypertensive instant release (IR) tablet for a bioequivalence study. In this role, some additional accomplishments include supporting IR tablets combo formulation development, formulating minitablets (capsule) of anti-inflammatory drug for the US market (NCE formulation), developing and scaling up pellets (capsules) of an anti-inflammatory drug by extrusion-spheronization technique (NDA Filling), formulating instant release capsule of antiviral drug for phase 1a and phase 1b clinical development, formulating an IR tablet by top spray granulation for anti-retroviral drug (ANDA filling), and formulating dispersible granules for antimalarial drug by roller compaction technique.

Equipment Handled:
 Fluid Bed Processor (Umang, Milinium, Rowland, ACG GPCG 1.1 & 2.0)
 Extruder-Spheronizer (Umang, Caleva)
 Tablet compression machine (Cadmach CMD4, Parle elizabeth EP 200 and Eco III AFR, Korsch XL 100)
 Tablet coating Machine (Ganson Ltd.)
 Pellet Coating Pan (Milinium)
 Rapid Mixer Granulator (Saral, Gansons)
 Fluidized Bed Drier (Retsch TG 200)
 Co-mill (QUADRO COMIL Canada) and Multimilll.
 Octagonal Blender (SAAN Engineers)
 Automatic Capsule filling Machine (Pam AFT Lab)
 USP Friability test apparatus (Electrolab)
 5 Parameter Tester (Electrolab EHT-5PR)
 USP Tap density tester (Electrolab ETD-1020)
 Water activity tester
 High speed Homogeniser and Lyophilizer (Labconco).
 USP Dissolution apparatus (Electrolab)
 USP Disintegration Tester (Electrolab ED-2L)
 UV Spectrophotometer (Shimadzu 1800)
 Gas pycnometer (AccuPyc II 1345)
 Envelope density analyser (GeoPyc 1360)
 Roller compactor (Alxenderwerk)
 Hot melt Extruder (Pharma 11 Thermo Scientific).
 Automatic weight sorter

Technical skills:
 Knowledge of USFDA, SUPAC, ICH guidelines and requirements for IND, NDA, ANDA development.
 Knowledge of MAA and various regulatory market requirements.
 QbD Approch, Design Expert 13, GraphPad Prism etc softweres.
 MS-Office


Year Degree Subject Institution
Year: 2019 Degree: Master of Pharmacy Subject: Pharmaceutics Institution: SRTM University Nanded, India
Year: 2017 Degree: B. Pharmacy Subject: Pharmaceutical sciences Institution: Pune University

Work History

Years Employer Title Department
Years: 2021 to Present Employer: Undisclosed Title: Senior Research Associate Department: Formulation R&D
 Successfully developed 2 prototype of ER Pellet (capsule) of Anti anginal molecule for US market- ANDA filling.
 Successfully developed and submitted antihypertensive IR tablet for Bioequivalence study.
 Supported in IR Tablets combo formulation development.
 Formulated minitablets (Capsule) of anti-inflammatory drug for US market (NCE formulation)
 Successfully developed and scale up Pellets (Capsule) of anti-inflammatory drug by extrusion-spheronization technique (NDA Filling).
 Formulation development of IR Capsule of antiviral drug for phase 1a and phase 1b clinical development.
 Formulated IR tablet by top spray granulation for Anti-retroviral drug (ANDA filling).
 Formulated Dispersible granules for antimalarial drug by roller compaction technique.
 Drug-Excipients compatibility, stability study.
 Pilot Scale clinical batch documentation, BMR preparation and review
Years Employer Title Department
Years: 2019 to 2021 Employer: Murli Krishna Pharma Pvt. Ltd. Pune. Title: Research Scientist Department: Formulation R&D
 Formulated chewable tablet with antiviral combination for Investigational drug product development for Covid 19 ( clinical Trials).
 Formulated IR, DR, DDR, ER release capsule (Pellets) of PPI's, antidepressant, antifungal, alpha blocker, anti-ulcerative, antihypertensive, Immunosuppressants, antispasmodic, aminosalicylate class drug by Extrusion-spheronization, FBP, coating pan drug layering process.
 Formulated taste mask micro pellets and MUPS tablets.
 Conducted literature search, innovator characterization, pre-formulation studies, drug excipients compatibility, stability study, small molecule
 Planned lab batches, technology transfer (scale up and validation batch activity)
 MFR, BMR, PDR, CMC documentation, solved regulatory query (formulation)
 Preparation of documents for test license and import license
Years Employer Title Department
Years: 2018 to 2018 Employer: Aurobindo Pharma Pvt. Ltd. Title: Project Trainee Department: Formulation R&D
 Formulation developed for extended release osmotic tablet, IR tablets for US markets
 Applied DOE and QbD tools for R&D Projects

Career Accomplishments

Licenses / Certifications
Registered Pharmacist
Maharashtra State Certificate In Information Technology- 2011
Awards / Recognition
- Qualified GPAT (AIR 1864) & got stipend during PG
- Achieved Shining Star Award for development of two release profile (24 hr and 18 hr) with aggressive timelines for Medicinova (Piramal Pharma Ltd).
- Super-Achiever Award for development of two prototypes for Biostudy (US market)
Publications and Patents Summary
6 publications.

Fields of Expertise

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