Solid Dosage Forms 1

Question 1

Unit Operations in Pharmacy Manufacturing

Answer 1

• Size Reduction
• Granulation
• Drying
• Compression
• Encapsulation
• Mixing and Blending
• Filtration and Clarification
• Sterilization

Question 2

Process of reducing larger size solid unit masses to
smaller size unit masses by mechanical means
Reasons to reduce particle size:

Answer 2

Size reduction

Question 3

Principle means of size reduction

Answer 3

• Cutting or shearing
• Compressing
• Impaction
• Attrition
• Combined impaction and attrition

Question 4

Factors in choosing a mill

Answer 4

1. Properties of feedstock
2. Specification of product

Question 5

Process by which poser particles are made to
adhere to form larger particles

Answer 5

Granulation

Question 6

reasons for granulation

Answer 6

• Prevent segregation of constituents in
  powder mix
• Improve the flow properties of the
  powder mix because particles are larger
  and more isodiametric
• Improve compression characteristics of
  mix

Question 7

Methods of granulation

Answer 7

wet granulation
dry granulation
hot melt granulation

Question 8

“Wet massing”
Massing of the powder mix using a solvent (alone
or within a granulating agent)

Answer 8

Wet granulation

Question 9

Solvents used in wet granulation

Answer 9

1. water
2. organic solvents

Question 10

It is nonflammable, nontoxic, undergoes hydrolysis, and has long drying time

Answer 10

water

Question 11

it is an alternative to dry granulation, used for water-sensitive drugs, and rapid drying

Answer 11

organic solvents

Question 12

examples of wet granulation equipment

Answer 12

• Shear granulator
• Fluid bed granulator
• Spray dryer
• Spheronizer/pelletizer

Question 13

Particles are aggregated using high pressure
For drugs which do not compress well after wet
granulation and are sensitive to moisture

Answer 13

Dry granulation

Question 14

2 processes for dry granulation

Answer 14

slugging
roller compaction

Question 15

Process of putting together in one mass with more or less thorough diffusion blending

Answer 15

Mixing

Question 16

Classification of Mixing Equipment

Answer 16

1. batch type
2. continuous type

Question 17

Process of removing water (or other liquid) from a
solid or semisolid mass by evaporative process

Answer 17

Drying

Question 18

factors in choosing a drying equipment

Answer 18

nature of product
cost

Question 19

examples of drying equipment

Answer 19

1. Tray dryer
2. Vacuum dryer
3. Infrared dryer
4. Radiofrequency dryer
5. Fluid bed dryer

Question 20

Solid Dosage Form Excipients

Answer 20

1. Diluents
2. Binders
3. Lubricants
4. Glidants and Antiadherents
5. Disintegrants
6. Superdisintegrants
7. Added Functionality Ingredients
8. Colorants

Question 21

Should be chemically inert, nonhygroscopic, and hydrophilic. An inert substance is frequently added to increase the bulk of a tablet for processing and handling.

Answer 21

1. Lactose
2. Starch
3. Sucrose
4. Mannitol
5. Sorbitol
6. Microcrystalline cellulose
7. Hydrolyzed starch

Question 22

Promote cohesiveness within powders, thereby ensuring that the tablet remains intact after compression as well as improving the flow by forming granules impart adequate cohesion without retarding disintegration or dissolution

Answer 22

Binder

Question 23

Binder examples

Answer 23

1. Water
2. Alcohol
3. Starch Paste
4. Acacia Mucilage
5. Gelatin Solution
6. Tragacanth Mucilage
7. Sucrose Solution
8. Methylcellulose Solution
9. Sodium CMC Solution
10. PVP Solution
11. Sorbitol

Question 24

reduce friction between the tablet and the die wall during compression and ejection

Answer 24

Lubricant

Question 25

Fine powders and may be required for tablet compression at high production speeds to improve the flow properties of the material into the die or during initial compression stages They are added in the dry state immediately prior to compression and, by virtue of their low adhesive potential, reduce the friction between particles

Answer 25

Glidants and antiadherents

Question 26

added to a formulation to overcome the cohesive strength imparted during compression, thus facilitating break up of the formulation in the body and increasing the surface area for dissolution. They can be either intragranular, extragranular, or both

Answer 26

Disintegrant

Question 27

Mechanism of Action of Disintegrant:

Answer 27

* Swelling * Porosity and Capillary Action (Wicking) * Deformation

Question 28

example of disintegrants

Answer 28

1. Starch 2. Starch derivatives 3. Gums 4. Cellulose derivatives 5. MCC (Avicel) 6. Alginates 7. Clays 8. Effervescent mixtures 9. Enzymes

Question 29

so called because of the relatively low levels required (2 – 4% w/ w)

Answer 29

Superdisintegrant

Question 30

Three superdisintegrants

Answer 30

- Sodium starch glycollate (primojel, explotab) - Crospovidone - Croscarmellose sodium

Question 31

- modified starch - made by cross-linking potato starch - can swell up to 12 - fold in less than 30 s

Answer 31

Sodium starch glycollate

Question 32

- cross-linked povidone - completely insoluble in water - rapidly disperses and swells in water, but does not gel even after prolonged exposure - It rapidly exhibits high capillary activity and pronounced hydration capacity

Answer 32

Crospovidone

Question 33

- modified cellulose - a cross - linked polymer of carboxymethyl cellulose sodium - insoluble in water - rapidly swells to 4 – 8 times its original volume on contact with water

Answer 33

croscarmellose sodium