Ramesh Chand Nagarwal Ph.D

Handling oncology injections, complex injections, platform technology based product development

Worked on Complex injections (Liposomes, suspension, Lyophilized, Nanoparticles, protein/peptides based injections)

Worked on Complex generics (Q1/Q2) and 505b2 projects such as Liposome injection (Lyophilized), nanotube injection (auto-gel), Intramuscular injectable oil based solution, Intramuscular suspension, Peptide injections, and polymer and albumin based Nanoparticles. Major Role: Project strategy and development planning, Literature search, Pre-formulation study, QbD document (QTPP, CQA, CMA, CPP, FMEA, Risk matrix, control strategy) preparations and review, formulation development, Expert role in Sameness and Characterization study by advanced analytical techniques (DLS, SEM, TEM, AFM, DSC, and powder XRD), manufacturing process optimization by DOE (Design Expert, Minitab), Filter validation, Terminal sterilization by Autoclave, stability study (as per ICH), Scale up batches at GMP sites, Pre-clinical study support (toxicity, acute toxicity, Pharmacokinetic study of screened formulations in animals), Pilot bio-equivalence study, Exhibit batches at GMP site. Product development Report (PDR) preparation, ANDA Filing support for US and EU market.

Largely worked on Ophthalmic/injectable Nano formulations, Thermo-reversible gel Developed PLGA based Nano/micro particles, In-situ gel formulations, Nano-gel hybrid formulation. Additional learnings: Drug uptake study on corneal cell lines, drug uptake study using radio-labeled drug in corneal cells.

Worked on 505b2/Para IV Ophthalmic product development (solution, suspension, and in-situ gel based solution). Major Role: Leading the complex generic ophthalmic projects, Project budgeting and development planning, Idea creation for platform technologies, Patent reading, Non-infringement composition finalization for ANDA Para IV projects. Pre-formulation study, compatibility study, formulation composition screening through DOE, formulation development, process optimization, scale up studies, Tech transfer support, Patent drafting support. Product development report, ANDA filing support.

Theory and practical classed of M.S (Pharmacy student), Lectures were taken on different topics such as Basics in drug delivery and formulation design. Pre-formulation study, formulation characterization, solid state pharmaceutics, pre-clinical and clinical studies. Pharmacokinetics. Project guidance to M.S students.

Worked on different polymer based nano-formulations, Literature search, patent reading, project writing, formulation trials based of Design of experiments (Design Expert), optimization study, analytical method development by HPLC, Nano formulation characterization, Particle size study, Nano imaging by SEM & TEM, Polymorphism by PXRD. Compatibility study by DSC and FT-IR, stability study. Pharmacokinetic study in Rabbit eye. Research work presented in different countries and recognized by several citations and awards. Worked as Teaching assistant, classes taken for B.Pharm/B.Tech Student for one and half year

Theory and practical classes taken of B. Pharmacy (B.S) students on Dosage form design and Pharmacokinetics.

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