Industrial Pharmacy (Theory) - B. Pharma 5th Semester PDF Notes

BP 502 T. Industrial Pharmacy (Theory)

Scope: Course enables the student to understand and appreciate the influence of pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug product.

Objectives: Upon completion of the course the student shall be able to

1. Know the various pharmaceutical dosage forms and their manufacturing techniques.

2. Know various considerations in development of pharmaceutical dosage forms

3. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality

Course content:

UNIT-I

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, racemisation, polymerization

BCS classification of drugs & its significant

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

UNIT-II

Tablets:

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

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

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

Liquid orals: Formulation and manufacturing consideration of syrups and elixirs suspensions and emulsions; Filling and packaging; evaluation of liquid orals official in pharmacopoeia

UNIT-III

Capsules:

a. Hard gelatin capsules: Introduction, Production of hard gelatin capsule shells. Size of capsules, Filling, finishing and special techniques of formulation of hard gelatin capsules, manufacturing defects. 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 minim/gram factors, production, in process and final product quality control tests. Packing, storage and stability testing of soft gelatin capsules and their applications.

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

UNIT-IV

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, aseptic processing

c. Formulation of injections, sterile powders, large volume parenterals and lyophilized products.

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

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

UNIT-V

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

Formulation and evaluation of shampoo

Lipsticks

Ingredients in Cosmetics

Evaluation of Cream and Powder

Classification of Cosmetics

Cosmetics for face

Hair Dyes

Tooth Paste

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

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.

SOP for Analysis of Packaging Materials

BP 506 P. Industrial Pharmacy (Practical)

1. Preformulation studies on paracetamol/asparin/or any other drug

2. Preparation and evaluation of Paracetamol tablets

3. Preparation and evaluation of Aspirin tablets

4. Coating of tablets- film coating of tables/granules

5. Preparation and evaluation of Tetracycline capsules

6. Preparation of Calcium Gluconate injection

7. Preparation of Ascorbic Acid injection

8. Qulaity control test of (as per IP) marketed tablets and capsules

9. Preparation of Eye drops/ and Eye ointments

10. Preparation of Creams (cold / vanishing cream)