PHARMACEUTICAL PROCESS CHEMISTRY (MPC 204T)
Scope
Process chemistry is often described as scale up reactions, taking them fromsmall quantities created in the research lab to the larger quantities that are needed for further testing and then to even larger quantities required for commercial production. The goal of a process chemist is to develop synthetic routes that are safe, cost-effective, environmentally friendly, and efficient. The subject is designed to impart knowledge on the development and optimization of a synthetic route/s and the pilot plant procedure for the manufacture of Active Pharmaceutical Ingredients (APIs) and new chemical entities (NCEs) for the drug development phase.
Objectives
At completion of this course it is expected that students will be able to understand
- The strategies of scale up process of apis and intermediates
- The various unit operations and various reactions in process chemistry
Process chemistry Introduction, Synthetic strategy Stages of scale up process: Bench, pilot and large scale process. In-process control and validation of large scale process. Case studies of some scale up process of APIs. Impurities in API, types and their sources including genotoxic impurities
2 Unit operations 12 Hrs
a) Extraction: Liquid equilibria, extraction with reflux, extraction with agitation, counter current extraction. b) Filtration: Theory of filtration, pressure and vacuum filtration, centrifugal filtration, c) Distillation: azeotropic and steam distillation d) Evaporation: Types of evaporators, factors affecting evaporation. e) Crystallization: Crystallization from aqueous, nonaqueous solutions factors affecting crystallization, nucleation. Principle and general methods of Preparation of polymorphs, hydrates, solvates and amorphous APIs.
3 Unit Processes-I 12 Hrs
a) Nitration: Nitrating agents, Aromatic nitration, kinetics and mechanism of aromatic nitration, process equipment for technical nitration, mixed acid for nitration, b) Halogenation: Kinetics of halogenations, types of halogenations, catalytic halogenations. Case study on industrial halogenation process. c) Oxidation: Introduction, types of oxidative reactions, Liquid phase oxidation with oxidizing agents. Nonmetallic Oxidizing agents such as H2O2, sodium hypochlorite, Oxygen gas, ozonolysis.
4 Unit Processes - II 12 Hrs
a) Reduction: Catalytic hydrogenation, Heterogeneous and homogeneous catalyst; Hydrogen transfer reactions, Metal hydrides. Case study on industrial reduction process. b) Fermentation: Aerobic and anaerobic fermentation. Production of i. Antibiotics; Penicillin and Streptomycin, ii. Vitamins: B2 and B12 iii. Statins: Lovastatin, Simvastatin c) Reaction progress kinetic analysis i. Streamlining reaction steps, route selection, ii. Characteristics of expedient routes, characteristics of cost-effective routes, reagent selection, families of reagents useful for scale-up.
5 Unit 12 Hrs
Industrial Safety a) MSDS (Material Safety Data Sheet), hazard labels of chemicals and Personal Protection Equipment (PPE) b) Fire hazards, types of fire & fire extinguishers c) Occupational Health & Safety Assessment Series 1800 (OHSAS-1800) and ISO-14001(Environmental Management System), Effluents and its management.
- Teacher: Harsh Bhardwaj
MOLECULAR PHARMACEUTICS (NANO TECHNOLOGY & TARGETED DDS) (NTDS)
(MPH 201T)
Scope
This course is designed to impart knowledge on the area of advances in novel drug delivery systems.
Objectives
Upon completion of the course student shall be able to understand
The various approaches for development of novel drug delivery systems.
The criteria for selection of drugs and polymers for the development of NTDS
The formulation and evaluation of novel drug delivery systems.
THEORY 60 Hrs
1. Targeted Drug Delivery Systems: Concepts, Events and biological process involved in drug targeting. Tumor targeting and Brain specific delivery.
2 Targeting Methods: introduction preparation and evaluation.
Nano Particles & Liposomes: Types, preparation and evaluation.
3 Micro Capsules / Micro Spheres: Types, preparation and evaluation , Monoclonal Antibodies ; preparation and application, preparation and application of Niosomes, Aquasomes, Phytosomes, Electrosomes.
4 Pulmonary Drug Delivery Systems : Aerosols, propellents,
ContainersTypes, preparation and evaluation, Intra Nasal Route Delivery systems; Types, preparation and evaluation.
5 Nucleic acid based therapeutic delivery system : Gene therapy, introduction (ex-vivo & in-vivo gene therapy). Potential target diseases for gene therapy (inherited disorder and cancer). Gene expression systems (viral and nonviral gene transfer). Liposomal gene delivery systems.
Biodistribution and Pharmacokinetics. knowledge of therapeutic antisense molecules and aptamers as drugs of future.
- Teacher: Kaminee Sahu