Questions asked in GTU examination in past.

1. Define Preformulation Studies. Discuss objectives and regulations related to

preformulation.
2. Describe Pharmaceutical Product development process with flow chart.
3. Discuss in brief about process of Pharmaceutical Product development.
4. Discuss stability testing parameters for dosage forms tablets, capsules, emulsions,
topical dosage form, metered dose inhalers and suppositories.
5. Explain in detail - quality control testing parameters of Tablets.
6. Explain the ICH guidelines related to stability assessment of a dosage form.
7. Give manufacturing and quality control testing of Liquid Dosage form.
8. Give manufacturing and quality control testing of Solid dosage form.
9. How many types of stability studies are there and what is the importance of
performing it during formulation development process?
10. Importance of pre-formulation study in pharmaceutical development process
11. What is IPQC? Explain its importance with suitable example of a dosage form.
12. What is pharmaceutical product development? Give the objectives of pharmaceutical
product development in details
13. What is the importance of solubility study in pharmaceutical product development
process and how equilibrium solubility study is done?
14. Which are the primary evaluation parameters needed to be studied as a part of a pre-
formulation study in a pharmaceutical product development process.
15. Which different parameters are evaluated of hard gelatin capsule shell during its
development?
16. Classify semi-solid excipients and write in brief about them with example.
17. Define Solvents. How solubilizers play important role in dosage form design?
18. Describe applications of polyethylene glycols and Sorbitol’s in pharmaceutical dosage
forms.
19. Describe properties, types and applications of Cyclodextrins.
20. Describe quality control tests of semi-solid dosage forms.
21. Describe role of various excipients in semi-solid dosage form development.
22. Describe the mechanism of action for different suspending and emulsifying agents
with suitable examples.
23. Discuss cyclodextrins and its application in product development.
24. Discuss in details various Semi solid excipients with examples.
25. Enumerate different types of disintegrant. Discuss in brief about Superdisintegrant.
26. Enumerate different types of solublizers with suitable examples.
27. Explain in brief about excipients used for cream and ointment.
28. Explain Non - ionic surfactants and their applications as emulsifier.
29. Pharmaceutical solublizers available in market.
30. What is Cyclodextrin? Give its applications in pharmaceutical product development
31. Classify types of excients used in tablet. Explain Diluents and Binder.
32. Classify types of solublizers. Discuss in detail about the different
33. Describe criteria for selection of excipients for parenteral dosage form.
34. Describe objectives of coating of dosage form. Explain enteric coating materials in
details.
35. Discuss ideal requirements of excipients used for Aerosol. Explain in brief about
Propellant.
36. Discuss in detail about various excipients used in the formulation of NDDS.
37. Discuss quality control test of capsule dosage form
38. Discuss selection and application of excipients for controlled drug delivery.
39. Discuss the role of various excipients used in parenteral Preparation
40. Enumerate excipients used for parenteral dosage form. Explain preservatives in detail.
41. Enumerate ideal requirements of excipients used for Aerosol. Discuss about
Propellant.
42. Explain different formulation ingredients needed for preparing tablet dosage form by
wet granulation method and discuss each category in detail with example.
43. Explain in details: Excipients use for formulation of NDDS.
44. Explain the role of various excipients used in aerosol preparation.
45. Give application of simplex lattice design with special reference to mouth dissolving
dosage form.
46. Give detail classification of directly compressible adjuvants with examples.
47. How selection of coating materials plays crucial role in release pattern of the dosage
form?
48. What are directly compressible vehicles? Give its applications.
49. What are the different selection criteria for glass- as packaging material for injectable
products?
50. Define Quality by Design concept and explain its importance. How QbD is different
from the conventional traditional approach?
51. Define: PAT, Design Space and QTTP.
52. Discuss applications factorial design in optimization of a pharmaceutical formulation.
53. Discuss applications of quality by design in detail.
54. Discuss experimental design with its use in detail.
55. Discuss the basic fundamentals of design of experimentation
56. Discuss use and applications of factorial design in product development.
57. Draw a flow chart describing formulation steps of any dosage form adopting the
concept of quality by design.
58. Enlist different screening and optimization designs used in formulation development.
Explain full factorial design giving a suitable example for 2 factor and 3 level.
59. Explain factorial design with example.
60. Explain plackett and burman screening design with suitable examples.
61. Explain role of factorial designs in optimization of a pharmaceutical formulation.
62. Explain various elements of QbD.
63. What is a mixture design? Explain with suitable example in detail.
64. What is CMA, CPP and CQA?
65. What is QbD? Describe advantages and challenges of QbD approach in product
development.
66. What is QbD? Give its application in pharmaceutical product development.
67. Write a note simplex lattice design.
68. Classify type of closures. Discuss quality control test of closures.
69. Describe criteria for selection of excipients for parenteral dosage form. Classify type
of closures.
70. Discuss quality control test of closures.
71. Describe different test of plastic containers in detail.
72. Describe Regulatory requirements for selection of packaging materials.
73. Describe various quality control testing of packaging materials for pharmaceutical
products.
74. Discuss selection criteria and quality control test of plastic as a packaging material.
75. Enumerate different types of packaging materials. Discuss glass as a packaging
material.
76. Explain function and features of packaging.
77. What are different test of closures?
78. Write a note on - excipients in parenteral and aerosols products.
79. Write a note on Coat materials used in Tablet Coating.
80. Write a note on container closure system for semi-solid dosage forms.
81. Write a note on control release polymers used in pharmaceutical development
process.
82. Write a note on Cyclodextrins and their applications in solid dispersion.
83. Write a note on directly compressible excipients.
84. Write a note on Emulsifying agent.
85. Write a note on Enteric and Non Enteric coating excipients.
86. Write a note on excipients use in capsule.
87. Write a note on excipients used in preparation of capsules.
88. Write a note on Non-ionic surfactant and their applications.
89. Write a note on placket-burman design.
90. Write a note on Polyethylene glycols and Sorbitol’s.
91. Write a note on risk assessment methodology with its tools.
92. Write a note on stability assessment of capsule dosage form.
93. Write a note on stability assessment of semisolid dosage form.
94. Write a note on stability assessment sterile Dosage form.
95. Write a note on super-disintegrants.
96. Write a note Polyethylene glycol as solubility enhancer for poorly soluble drugs.
97. Write a short note on plastics as a pharmaceutical packaging material.
98. Write in detail about the regulatory considerations for development of a
pharmaceutical pack.