Pharmaceutical Process Chemistry(Pharmaceutical Chemistry) M.Pharm Second Semester

Syllabus

 

 

 

MPC 204T

 

 

Pharmaceutical Process Chemistry

 

 

 

Theory                                                                                          (60 Hours)

 

 

 

Unit 1: Process Chemistry                                                                                             (12 hours)

 

 

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

 

 

 

Unit 2: Unit Operations                                                                                                 (12 hours)

 

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.

 

 

 

Unit 3: Unit Processes - I                                                                                               (12 hours)

 

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.

 

 

 

Unit 4: Unit Processes - II                                                                                              (12 hours)

 

 

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

 

 

1. Streamlining reaction steps, route selection,

    

2. Characteristics of expedient routes, characteristics of cost-effective routes, reagent selection, families of reagents useful for scale-up.

    

 

 

Unit 5: Industrial Safety                                                                                                (12 hours)

 

 

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