Request Expert

Expert is a Pharmaceutical Formulations Development Scientist, with 6+ years of experience in the pharmaceutical field, 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