Syllabus | Industrial Pharmacy-I (Theory) | B. Pharmacy

Course: B. Pharmacy Vth  Semester/ 3rd  Year
Name of Subject: Industrial Pharmacy-I  (Theory)
Subject Code:  BP 502 T
Contents of the Topics             Domain Time(Hrs)  
Preformulation Studies: Introduction to Preformulation, goals and objectives, study of physicochemical characteristics of drug substances.

a.    Physical properties: Physical form (crystal & amorphous), particle size, shape, flow properties, solubility profile (pKa, pH, partition coefficient), polymorphism.

b.    Chemical Properties: Hydrolysis, oxidation, reduction, racemization, polymerization BCS classification of drugs

Application of Preformulation considerations in the development of solid, liquid oral and parenteral dosage forms and its impact on stability of dosage forms.

 

 

Must Know

 

Must Know

 

 

 

 

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Tablets:

Introduction, ideal characteristics of tablets, classification of tablets. Excipients, Formulation of tablets, granulation methods, compression and processing problems. Equipments and tablet tooling.

a. Tablet coating: Types of coating, coating materials, formulation of coating composition, methods of coating, equipment employed and defects in coating.

b. Quality control tests: In process and finished product tests

 

Must Know

 

 

 

Nice to know

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Liquid orals: Formulation and manufacturing consideration of solutions, suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia Must Know

 

04  
Capsules:

a.     Hard gelatin capsules: Introduction, Extraction of gelatin and production of hard gelatin capsule shells. size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules. In process and final product quality control tests for capsules.

b.     Soft gelatin capsules: Nature of shell and capsule content, size of capsules, importance of base adsorption and minimum/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules

Must Know

 

 

 

 

Must Know

 

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Pellets: Introduction, formulation requirements, pelletization process, equipments for manufacture of pellets Must Know

 

04  
Parenteral Products:

a.    Definition, types, advantages and limitations. Preformulation factors and essential requirements, vehicles, additives, importance of isotonicity

b.    Production procedure, production facilities and controls.

c.     Formulation of injections, sterile powders, emulsions, suspensions, large volume parenteral and lyophilized products, Sterilization.

d.    Containers and closures selection, filling and sealing of ampoules, vials and infusion fluids. Quality control tests.

Must Know

 

Nice to know

Must Know

 

Nice to know

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Ophthalmic Preparations: Introduction, formulation considerations; formulation of eye drops, eye ointments and eye lotions; methods of preparation; labeling, containers; evaluation of ophthalmic preparations Must Know

 

05  
Cosmetics: Formulation and preparation of the following cosmetic preparations: lipsticks, shampoos, cold cream and vanishing cream, tooth pastes, hair dyes and sunscreens. Must Know

 

04  
Pharmaceutical Aerosols: Definition, propellants, containers, valves, types of aerosol systems; formulation and manufacture of aerosols; Evaluation of aerosols; Quality control and stability studies. Must Know

 

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Packaging Materials Science: Materials used for packaging of pharmaceutical products, factors influencing choice of containers, legal and official requirements for containers, stability aspects of packaging materials, quality control tests. Must Know

 

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