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Defects Flashcards

1
Q

Tablet Defects

A

Capping
Lamination
Sticking
Picking
Cracking
Chipping
Double Impression
Mottling
Hardness variations

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2
Q

The partial or complete separation of the top or bottom of a tablet from the main body

A

Capping

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3
Q

Separation into 2 or more distinct horizontal layers

A

Lamination

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4
Q

Cause of Capping and Lamination

A

Entrapped Air

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5
Q

Remedy for Capping & Lamination

A

Change granulation procedure

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6
Q

Adhesion to die

A

Sticking

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7
Q

Cause of Sticking

A

Granules are not properly dried

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8
Q

Remedy for Sticking

A

Reduce moisture content of granules

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9
Q

Adhesion to punches

A

Picking

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10
Q

Fine cracks on the surface

A

Cracking

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11
Q

Cause of Cracking

A

Rapid expansion of table

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12
Q

Remedy for Cracking

A

Change granulation procedure

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13
Q

Breaking of tablet edges

A

Chipping

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14
Q

Cause of Chipping

A

Granules are too dried

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15
Q

Remedy for Chipping

A

Moisten the granules

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16
Q

Defect on tablet during ejection

A

Double impression

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17
Q

Cause of Double Impression

A

Free rotation of punches

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18
Q

Remedy for Double Impression

A

Install anti-turning device

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19
Q

Uneven color distribution

A

Mottling

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20
Q

Cause of Mottling

A

Migration of colors during drying

Improper mixing of granular materials

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21
Q

Remedy for Mottling

A

Reduce drying temperature
Mix properly and reduce size to prevent segragation

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22
Q

Remedy for Hardness variation

A

Maintain weight of tablets

23
Q

Process related defects

A

Capping
Lamination
Cracking

24
Q

Excipient related defects

A

Sticking
Picking
Chipping

25
Machine related defects
Double impression
26
Caused by >1 factors
Mottling
27
Film Coating Defects
Film Cracking (Type I, II) Rough coating/Orange-peel effect Bridging and Filling Blistering Cratering Blooming Sweating
28
Coating **cracks** in the **crown area** or **split** around the **edges**.
Film Cracking Type I, II
29
Cause of Film Cracking Type I
**Thermal expansion** of tablet cores and **lack of film flexibility** caused by **overdrying**
29
Cause of Film Cracking Type I
**Thermal expansion** of tablet cores and **lack of film flexibility** caused by **overdrying**
29
Cause of Film Cracking Type I
**Thermal expansion** of tablet cores and **lack of film flexibility** caused by **overdrying**
29
Cause of Film Cracking Type I
**Thermal expansion** of tablet cores and **lack of film flexibility** caused by **overdrying**
30
Cause of Film Cracking Type II
Excessive moisture uptake into tablet cores
31
Remedy for Film Cracking Type I
Reduce processing temperatures and drying conditions
32
Remedy for Film Cracking Type II
Improve drying
33
Coating deposited on the tablet surface is excessively due to failure of spray droplet to coalesce
Rough Coating / Orange Peel Effect
34
Cause of Orange Peel Effect
Partial Spray Drying
34
Remedy for Orange Peel Effect
Reduce & Improve Drying condition
35
Masking of the monogram or bisection, filling-in of the score line or indented logo on the tablet by the film
Bridging & Filling
36
Cause of Bridging & Filling
Application of too much solution
37
Remedy for Bridging
Increase or change plasticizer
38
Reduced adhesion of the film or detachment of film forming blisters
Blistering
39
Cause of Blistering
Too rapid evaporation of the solvent from the core
40
Remedy for Blistering
Apply milder drying condition
41
Appearance of volcanic-like craters
Cratering
42
Cause of Cratering
Insufficient drying
43
Remedy for Cratering
Use efficient and optimum drying conditions
44
Coating becomes dull immediately or after prolonged storage at high temperature
Blooming
45
Cause of Blooming
High concentration and low molecular weight of plasticizer
46
Remedy for Blooming
Decrease concentration and increase molecular weight of plasticizer
47
The presence of an oily film or droplets of liquid on the surface
Sweating
48
Cause of Sweating
Too much moisture
49
Remedy for sweating
Optimum drying condition

Manufacturing (13 decks)

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