Coating Defects***

Question 1

*Local DETACHMENT of film from the substrate forming blister
*Cause: too high temp

Answer 1

Blistering

Question 2

*Appearance of VOLCANIC-like craters exposing the tablet surface
*Cause: inefficient drying, high rate of coating solution application
*Remedy: optimum drying conditions, increase viscosity of the coating solution

Answer 2

Cratering

Question 3

*Isolated areas of film are PULLED AWAY from the surface when the tablet STICKS together and then PART
*small amount of material from a tablet is sticking to and being removed off from the tablet surface by a punch face
*Occurs when the granules STICK to the DESIGN embedded in the PUNCH TIP such as in the lettering or logo
*Causes: similar to cratering
*Sticking: Problem in die

Answer 3

Picking

Keyword: Punch

Question 4

*PITS in the surface of the TABLET CORE without any visible disruption of the film coating
* Cause: inappropriate drying temperature

Answer 4

Pitting

Question 5

*Coating becomes DULL immediately or prolong storage at high temp
*Cause: Plasticizer problem (high conc or low MW)

Answer 5

Blooming

Question 6

*Whitish/White specks or haziness in the film
*Reason: precipitate polymer exacerbated using high temp

Answer 6

Blushing

Question 7

• Filling of INTAGLIATIONS (engrave) (logo, monogram) → indistinct and illegible
• Same end effect as bridging
• Cause: accumulation of bubbles or foam within the intagliations rather than dispersion over the whole tablet
• Remedy: add alcohol to the polymer solution to improve dispersion

Answer 7

Infilling

Question 8

*Coating solution fills in the lettering or logo on the tablet.
*Cause: poor design of tablet embosses, high viscosity/solid particles

Answer 8

Bridging

Question 9

*Tablet surface becomes ROUGH and NON-SHINY (non-glossy)
* Causes: High solution viscosity resulting in inadequate spreading of the coating solution; rapid drying

Answer 9

Orange-peel

Question 10

*Films CRACKS across the CROWN of the tablet, or SPLITS around the EDGE of the tablet
* Reason: internal stress in the film

Answer 10

Cracking/Splitting

Question 11

Variation in colors in the film

Answer 11

Color variation

Question 12

*Partial or complete separation of the TOP or BOTTOM of tablet

*FRACTURE at the TOP of the tablet and separating itself from the tablet body.

Answer 12

Capping

Question 13

*Separation of tablets in LAyers
*Occur as a SPLIT in the tablet anywhere except the top; it often happens due to over compression of the tablet

Answer 13

LAmination

Question 14

BREAKING of tablet edges

Answer 14

Chipping

Question 15

UNEQUAL distribution of COLOR in the tablet

Answer 15

Mottling

Question 16

Due to free ROTATION of the PUNCHES during ejection

Answer 16

Double impression

Question 17

Upper and lower central SURFACE CRACK

Answer 17

Cracking

Question 18

*Tablet material ADHERING to the die wall
*Occurs when the granules of a formulation become STUCK to the face of the PRESS PUNCH

Answer 18

Sticking

Question 19

Process Related

'’prAcess’’

Answer 19

cApping
lAmination
crAcking

Question 20

Excipient Related

'’excIpient’’ - unang I

Answer 20

chIpping
stIcking
pIcking
bInding

Question 21

Machine Related

'’MacDo’’

Answer 21

DOuble impression

Question 22

MOre than 1 factor

Answer 22

MOttling

Question 23

Partial spray drying or OVERWETTING causing soft coating to rub

Answer 23

Rough coating

Question 24

Coating cracks due to thermal expansion of tablet cores caused by OVER-DRYING

1nit

Answer 24

Film-cracking (Type I)

Question 25

Coating cracks due to core swelling caused by excessive MOISTURE

2big

Answer 25

Film-cracking (Type II)

Question 26

Exposure of tablet cores to tablet process
conditions

Answer 26

Delayed dissolution for intermediate release product

Question 27

The key to controlling this defect is maintaining the WEIGHT of the tablet

Answer 27

Hardness

Question 28

This refers to the tendency for a TABLET to CHIP, CRUMBLE or BREAK following COMPRESSION

Answer 28

Friability