5. Which of the following should be considered during blending process in pilotPlant considerations for solids dosage form?

a. Mixing speeds b. Dry granulation

c. Characteristics of ingredient d. Binding agent amount

6. A liquid dosage form of two liquids that usually do not mix together but miscible

with the help of other substance is known as

a. Suspension b. Solution

c. Emulsion d. Tablet

7. Trial batches are:

a. Prepared after R&D b. 70% of size of exhibit batch

c. a and b both d. Also called NDA batch

8. The batches which have approximately 10% of production-scale batch are known

as

a. Pre-exhibit batch b. Exhibit batch

c. Scale-up batch d. None of the above

9. Arrange the following in order

1. Trial batch 2. Exhibit batch

3. Full-scale batch 4. Validation batch

5. Pre-exhibit batch

a. 1, 2, 3, 4, 5 b. 4, 2, 5, 3, 1

c. 1, 5, 2, 4, 3 d. None of the above

10. Match the following

Name of equipment Scale-up considerations

a. Hot air oven i. Capping

b. Dryer ii. Surface temperature

c. High speed tablet process iii. Depth of granulation on trays

d. Transfer pumps iv. Type of material

e. Fluidised bed coating column v. Viscosity of product

ANSWERS

1. d 2. d 3. c 4. c 5. a 6. c 7. c

8. b 9. c 10. a (ii), b (iii), c (i), d (v), e (iv)

SUPAC Guidelines and Platform Technology 25

SUPAC GUIDELINES