EXAM 3 L6

Question 1

Majority of tablets are made by

Answer 1

-Compression (Compaction)
-Very few made by molding

Question 2

Types of tablets:

Answer 2

-Immediate-release tablet
-Extended release tablet
-Rapidly disintegrating/dissolving tablets

Question 3

Immediate-Release tablets

Answer 3

Are designed to release their medication with no special rate-controlling features

Question 4

Extended release tablets:

Answer 4

Are designed to release their medication in a predetermined manner over an extended period

Question 5

Rapidly disintegrating or dissolving tablets:

Answer 5

Characterized by disintegrating or dissolving in the mouth within 1 minute, some within 10 seconds

Question 6

Tablet manufacturing processes (1):

Answer 6

-Wet granulation
-Dry granulation
-Direct Compression
Less processing steps and does not require granulation
The powders should have very good flowability, content uniformity and compressibility

Question 7

Tablet manufacturing processes (2):

Answer 7

1. Die Filling
2. Tablet compression
3. Tablet ejection

Question 8

Excipients for tablets: Diluents and Binders

Answer 8

-Diluents or fillers: add the necessary bulk to a formulation to prepare tablets of the desired size (lactose, mannitol, starch)
-Binders - promote adhesion of the particles of the formulation, allowing a granulation to be prepared and maintaining the integrity of the final tablet (water, alcohol, start paste, sucrose syrup, etc.)
More binder in the tablets may lead to HARDER tablet, SLOWER disintegration time, and SLOWER dissolution rate

Question 9

More binder in the tablets may lead to

Answer 9

HARDER tablets, SLOWER disintegration time, and SLOWER dissolution rate

Question 10

Excipients for tablets: Disintegrants and Glidants

Answer 10

-Disintegrants - promote breakup of tablets after admin to smaller particles for ready drug availability (Starch, cellulose derivatives)
-Glidants, enhance the flow of the material into the tablet dies (Colloidal silicone dioxide, talc)

Question 11

Excipients for tablets: Lubricants

Answer 11

-Prevent fill material from sticking to the punches and dies
-Decrease adhesion to punch/die
-Decrease friction to punch/die and facilitate tablet ejection
-Reduce punch/die wear
(Mg stearate, talc, sodium stearyl fumarate)

Question 12

Negative effects of over-lubriication with Mg stearate:

Answer 12

-Reduced tablet harness
-Retarded tablet dissolution due to hydrophobic nature of Mg stearate
-Some drugs are NOT compatible with Mg Stearate (sometimes caused by impurities such as magnesium oxide or MgO)

Question 13

Tablet coating main purpose

Answer 13

To provide special characteristics of drug release (enteric coatings employed when drug substance is destroyed by gastric acid or is particularly irritating to the gastric mucosa or when bypass of the stomach substantially enhances drug absorp

Question 14

Tablet coating other functions:

Answer 14

-To protect the medicinal agent against destructive exposure to air and/or humidity
-To mask the taste of the drug
-Improving the ease of swallowing
-Facilitating rapid identification of product

Question 15

Type of coating

Answer 15

-Sugar coating
-Film coating
-Compression coating

Question 16

Sugarcoating

Answer 16

-Tablets coated with a sugar layer (sucrose as the major coating material)
-The coating is water soluble and quickly dissolves after swallowing
-The sugarcoated tablets are usually round and smooth by polishing

Question 17

Disadvantages of sugar coating:

Answer 17

-Multi-steps - sealing, subcoating, smoothing, color coating and polishing
-Time consuming (8 hrs and more)
-Need expertise
-Increase tablets size and weight (up to 50%)

Question 18

Film coating

Answer 18

Thin, skin-tight film of polymeric materials

Question 19

Film coating types:

Answer 19

-Immediate-release film coating (“non functional”) - soluble in water
-Modified release film coating (“functional”(, including delayed release (enteric) - soluble in water only when pH > 5 or 6 - and extended -release coatings - not soluble in water

Question 20

Film coating properties:

Answer 20

-Deposition of a polymer formulation around each tablet core through spraying
-The coating formulation contains a polymer in a suitable liquid with other ingredients including pigments and plasticizers
-Drying of the liquid leaves a thin film of coating material around each tablet

Question 21

Film coating formation:

Answer 21

-Initial solvent evaporation is rapid because of the deposit and spreading of coating liquid droplets onto the surface of tablets: the initial, rapid drying leads to a non-sticky residue
-The coating polymers become more viscous and less mobile as the solvent starts to evaporate
-Complete drying occurs slowly

Question 22

Film Coating Requirement

Answer 22

• The coating liquid needs to be atomized into small droplets
  -Tablets need adequate mixing and agitating - each tablet surface needs to pass through the spraying zone for a uniform coating
  -Enough hot drying air to evaporate the solvent
  -Effective exhaust to remove dust - and evaporated solvent