Industrial Pharmacy-I (Theory)

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.

10 Marks

1. Give an account of the Physico-chemical characteristics of drugs in preformulation studies and

explain its importance. (March 2020)

5 Marks

1. Physical factors of drug that affect stability of dosage form. (Sep 2020), (March 2021), (Mar 2024).
2. Chemical properties of preformulation studies. (Sep 2021)
3. BCS classification and its importance. (March 2020), (Mar 2024).
4. Application of preformulation considerations of solids. (Sep 2021)
5. Define a dosage form. Give the classification of dosage form. (Sep 2020)

2 Marks

1. Crystallinity and Polymorphs (Sep 2023).

2. Flow properties. (Sep 2021)
3. Importance of density in preformulation. (March 2022)
4. Polymorphism. (March 2021), (Mar 2024).
5. Stability of dosage forms. (March 2020)
6. Types of stability studies. (Sep 2020)
7. Razemisation. (March 2022)

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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.

10 Marks

1. Define tablet, classify them. Describe in detail about excipient used and evaluation tests for
tablets. (March 2021)
2. Discuss the different steps involved in multi tablet compression cycle. (Sep 2022).
3. Write in detail about the manufacturing defects of tablets and measures to overcome the defects. (Sep
2020), (March 2023), (Mar 2024).
4. Give an account of objectives of tablet coating and methods of coating of tablets (Sep 2023).
5. Explain the process of sugar coatingand its pharmaceutical applications. (Sep 2021).
6. Explain the types, formulation and evaluation of both suspensions and emulsions. (March 2020).

5 Marks

1. Organoleptic additives and their importance on formulation of tablets (Sep 2023).

2. Granulation methods for tablet dosage form. (March 2022)
3. Wet granulation Method and its limitations. (Sep 2020), (Mar 2024).
4. Coating of tablets and its application. (March 2021)
5. Coating materials. (March 2020)
6. Ideal properties of coating materials (Mach 2021).
7. Sugar coating process. (Sep 2020)
8. Film formers. (Sep 2021)
9. Pan coating. (March 2022)
10. Defects in tablets manufacturing. (Sep 2022), (Sep 2023).
11. Evaluation tests for tablets. (Sep 2021), (March 2022).

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12. Additives used in Liquid dosage forms (March 2021), (March 2023)
13. Composition and uses of syrup. (March 2020), (Sep 2020).
14. Differentiate flocculated and deflocculated suspension. (Sep 2022).
15. Evaluation of suspension. (Sep 2021)
16. Formulation of emulsions (Sep 2023).
17. Explain the identification tests for emulsion type. (Sep 2020), (Mar 2024).
18. Evaluation of emulsion. (March 2022)
19. Write about instability of emulsion (March 2023)

2 Marks

1. Crystallinity and Polymorphs (Sep 2023).

2. Organoleptic additives. (March 2020), (Sep 2020)
3. Binders. (Sep 2021)
4. Diluents. (Sep 2020), (March 2021).
5. List out additives used in syrups (March 2023).
6. Super disintegrants. (March 2022)
7. Slugging. (Sep 2020), (Mar 2024).
8. Crystallinity and Polymorphs (Sep 2023).
9. Components of a rotary punching machine (Sep 2020).
10. Importance of tablet coating. (Sep 2020)
11. . Ideal properties of coating materials (Mar 2024).
12. Methods of coating. (March 2020)
13. Enteric coating. (Sep 2021)
14. Name the enteric coated polymers. (Sep 2020),(Mar 2024).
15. Capping and Lamination. (Sep 2022)
16. Sticking and picking in coated tablets (Sep 2023).
17. Orange peel effect. (Sep 2022)
18. IPQC tests. (March 2021)
19. Weight variation limits for tablets as per I.P. (March 2022).
Weight variation limits of tablets. (Sep 2022)
20. Importance of hardness test on tablet. (Sep 2020)
21. Additives used in Liquid dosage forms. (March 2021)
22. List out additives used in syrups (March 2023), (Mar 2024).
23. Define Elixirs. (March 2021)
24. List out additives used in syrups (March 2023).
25. Define emulsion (March 2023)

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26. Types of suspensions (March 2021)
27. Desirable features of good suspension. (Sep 2022)
28. Packaging of semisolids (Sep 2023).
29. Mention the identification tests for emulsion type (March 2022)
Tests used for emulsion identification. (Sep 2022).
30. List out additives used in syrups (March 2023)

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

10 Marks

1. Explain about the production of hard gelatin capsule. (Sep 2020)

Explain the production of hard gelatin capsules and filing, finishing and quality control tests. (March
2021)
Explain the manufacturing, quality control tests, packing, storage and applications of hard gelatin
capsules. (Mar 2024).
2. Explain the manufacturing, quality control tests (March 2023) packing, storage and applications of
soft gelatin capsules. (Sep 2021)
3. Differentiate hard and soft gelatin capsules. Explain the method of manufacturing of soft gelatin
capsule by rotary die process. (March 2022)
With neat diagram explain the manufacturing of soft gelatin capsules by rotary die process. (Sep
2022)

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5 Marks

1. Manufacturing of empty hard gelatin capsule shell. (March 2022)

2. Quality control test for capsules. (March 2020), (Sep 2022), (Sep 2023).
Evaluation test for empty hard gelatin capsules (March 2023).
3. Pellets. (March 2020), (Sep 2022).
Formulation aids for pellets (Sep 2023).
Application of pellets (March 2023).

2 Marks

1. Types of gelatin with their iso electric point. (Sep 2022)

2. Bloom strength. (March 2021), (Mar 2024).
3. Sizes of hard gelatin capsules. (March 2020), (Mar 2024).
Sizes and volumes of hard gelatin capsules. (Sep 2021)
4. Evaluation test for empty hard gelatin capsules (March 2023).
5. Advantages of soft gelatin capsules. (March 2021).
6. Composition and uses of syrup (March 2020)
7. Types of suspensions. (March 2021).

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 andlyophilized 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

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10 Marks

1. Explain the production procedures and production facilities of aseptic processing in the formulation
of Injectables. (March 2021)
Write in detail about the production facilities for parenteral formulation. (Sep 2022)

2. Write in detail about the formulation and evaluation of ophthalmic products (Sep 2023).

3. Define parenteral products with examples. Write the formulation considerations, method of
preparation, labeling procedures and evaluation of eye drops. (March 2020)

5 Marks

1. Explain the different additives used in parenteral formulations. (Sep 2020), (Mar 2024).
2. Formulation of lyophilized sterile products. (March 2020)
3. Sterile powders. (Sep 2021)
4. Small volume parenterals. (Sep 2021)
5. Sterilization procedures of large volume parenterals (LVP). (March 2021)
6. Evaluation of parenteral products (Sep 2023).
7. Sterility testing of parenteral products. (March 2022)
8. Define pyrogens. Describe pyrogen test. (Sep 2020)
9. Sham test in parentrals (March 2023).
10. Glass containers used in parenterals. (Sep 2022)
11. Formulation of eye drops. (March 2021), (March 2022), (Sep 2022), (Mar 2024).
12. Eye ointment. (Sep 2021), (March 2023).
13. Containers for ophthalmic products (Sep 2023).

2 Marks

1. Advantages of parenteral formulations. (Sep 2022)

2. Non aqueous vehicle in parenterals. (Sep 2021)
3. Preservatives used in sterile preparations. (March 2020), (March 2023).
4. Isotonisity. (Sep 2021)
Importance of Isotonicity (Mar 2024).
5. Aseptic conditions. (March 2021)
6. LVP (March 2023)
7. LAL Test. (Sep 2021), (March 2022), (Mar 2024).
8. Why thickening agents are added to ophthalmic preparations? (Sep 2022)
9. Eye drops. (Sep 2021)
10. Labeling method of eye preparations. (Sep 2020)

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UNIT V

Cosmetics

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

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.

10 Marks

1. Briefly explain the formulation methods and evaluation tests for shampoo. (March 2022)
2. Define pharmaceutical aerosols. Discuss in detail about types, propellants used, formulation and
evaluation of aerosols. (Sep 2021), (Mar 2024).
Describe the quality control test to be carried out for pharmaceutical aerosols. (Sep 2020)
Define aerosols and discuss about formulation and evaluation of aerosols (March 2023), (Sep 2023).
3. Explain the different types of glasses and plastics used in Pharma industry for storage of
Pharmaceutical preparation. (March 2022)

5 Marks

1. Composition (March 2020), (Sep 2021) and formulation of lipsticks (Mar 2024).
2. Shampoo. (Sep 2020), (Sep 2022),(Sep 2023), (Mar 2024).
Ideal properties of shampoo. (March 2020)
3. Preparation of cold cream. (March 2020), (March 2022), (Sep 2022).
4. Formulation aspect of tooth paste. (March 2021), (March 2023).
5. Propellants used in pharmaceutical aerosols. (March 2021)
6. Numbering system used for propellants used in aerosols. (March 2022)
7. Importance of valve in the aerosol package. (Sep 2022)
8. Types of aerosol systems. (March 2020)
9. Aerosol containers (Sep 2023).
10. Packaging materials used in pharmaceutical preparations. (March 2020), (March 2023), (Sep 2023)
Types of packaging material and its importance. (March 2021), (Mar 2024).

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2 Marks

1. Composition of lipsticks. (March 2020)

2. Shampoo (March 2023).
3. Application of creams. (Sep 2021), (Mar 2024).
4. Name the ingredients required to prepare tooth paste. (Sep 2022)
5. Dentifrices (Sep 2023).
6. Sunscreens. (Sep 2021)
7. Packaging of semisolids (Sep 2023).
8. Define aerosols. (March 2020)
9. Types of glasses (Sep 2023).
10. Inert gases. (March 2020)
11. Valve assembly in aerosols. (March 2021).
12. Various types of actuators. (March 2022), (March 2023).
13. Metered dose aerosols. (March 2022)
14. Types of aerosol systems. (Sep 2020)
15. Applications of aerosol. (March 2022)
16. Types of packaging. (Sep 2022)
17. Alu-Alu pack. (March 2020)
18. Blister pack. (March 2021)
19. Tamper resistant packaging. (March 2022)