FRIABILITY & HARDNESS

Question 1

• tablet property related to hardness
• ability to withstand abrasion in packaging, handling, and shipping
• tendency of a tablet to crumble, chip or break

Answer 1

FRIABILITY

Question 2

• drop test or abrasion test
• determines the percentage loss on tablet in packaging, handling, and shipping
• involves exposure to mechanical shock or attrition

Answer 2

FRIABILTIY TEST

Question 3

Friabiltiy test is also called as

Answer 3

DROP TEST or ABRASION TEST

Question 4

• involves repeatedly dropping a sample of tablets over a fixed time, using a rotating drum with a baffle
• the result is inspected for broken tablets, and the percentage of tablet mass lost through chipping

Answer 4

FRIABILITY TEST

Question 5

FRIABILITY

DETERMINE THE SAMPLE SIZE:
if the tablet weigh ≤ 650mg

Answer 5

use 20 tabs

Question 6

FRIABILITY

DETERMINE THE SAMPLE SIZE:
if the tablet weigh >650mg

Answer 6

use 10 tabs

Question 7

FRIABILITY test procedure

Answer 7

1. determine sample size
2. perform test
3. dedust
4. weigh tabs; initial
5. perform again
6. dedust
7. reweigh; final

if obvious cracks, cleaved, broken are present, auto fail

Question 8

FRIABILITY

formula %weight loss

Answer 8

initial wt - final wt / initial wt x 100

Question 9

FRIABILITY

USP criteria

Answer 9

%weight loss NMT 1.0%

Question 10

FRIABILITY

duration

Answer 10

25mins for 4 times
100 revolutions

Question 11

• induces self-abrasion of the tablets as the cylinder section rotates
• tablets undergo schock as they fall six inches on each turn
• loss due to abrasion or fracture the measure of tablet friability

Answer 11

Roche Friabilator

Question 12

• traditional drum
• a drum with single chamber design and a single arch

Answer 12

roche type

Question 13

a drum with two arched bridges which saves time by allowing for two test in one drum

Answer 13

Vankel-type

Question 14

• a drum with internal baffles to agitate hte product inside
• applied for products requiring high degree of mechanical stress

Answer 14

Abrasion drum

Question 15

COMMON FAILRUES IN TABLETS

• edges of the tablet break, either during handling or coating
• this results to granulation or incorrect equipment setting

Answer 15

chipping

Question 16

COMMON FAILRUES IN TABLETS

either the upper or lower part of the tablet separates horizontally

Answer 16

capping

Question 17

COMMON FAILRUES IN TABLETS

• separation of tablet into 2 or more horizontal layers
• air entrapment during compression, exaggerated by speedy ejection

Answer 17

lamination

Question 18

• the force required to cause tabelts to fail in a speicific plane
• tablets are generally placed between two platens, one of which moves to apply sufficient force to the tablet to cause fracture

Answer 18

HARDNESS

Question 19

tablet hardness is also called as

Answer 19

tablet breaking force or crushing force

Question 20

based on compressing tablets between two jaws via a spring gauge and screw

Answer 20

Monsanto-Stokes hardness tester

Question 21

PARTS OF MONSANTO HARDNESS TESTER

rotation causes the inner screw to press against the compressing spring

Answer 21

screw knob

Question 22

PARTS OF MONSANTO HARDNESS TESTER

screw knob is also known as

Answer 22

knurled screw

Question 23

PARTS OF MONSANTO HARDNESS TESTER

support at the far end of the device when tablet is compressed

Answer 23

fixed jaw

Question 24

PARTS OF MONSANTO HARDNESS TESTER

fixed jaw is also called as

Answer 24

stirrup

Question 25

# **PARTS OF MONSANTO HARDNESS TESTER** an **anvil** adapted to **engage** the tablet

Answer 25

moving jaw

Question 26

# **PARTS OF MONSANTO HARDNESS TESTER** **moving jaw** is also known as

Answer 26

plunger

Question 27

# **USP FOR HARDNESS** ordinary compressed tabs

Answer 27

4 - 10kg

Question 28

# **USP FOR HARDNESS** sublingual tabs

Answer 28

2kg

Question 29

# **USP FOR HARDNESS** chewable tabs

Answer 29

2kg

Question 30

# **USP FOR HARDNESS** buccal tabs

Answer 30

10kg

Question 31

to determine the **need for pressure adjustment** on the tableting machine

Answer 31

hardness test

Question 32

**hardness** can affect ____

Answer 32

disintegration

Question 33

if the tablet is **too hard**, it may ____ in the required period of time

Answer 33

not disintegrate

Question 34

if the tablet is **too soft**, it will ____ the handling during subsequent processing

Answer 34

not withstand

Question 35

Factors affecting **hardness**

Answer 35

1. compression force 2. amt of excipients 3. method of granulation

Question 36

**high compression force** ____ hardness

Answer 36

increases

Question 37

**more binders** ____ hardness

Answer 37

increases

Question 38

**more lubricants** ____ hardness

Answer 38

decreases

Question 39

**wet granulation** ____ hardness

Answer 39

increases

Question 40

instruemnt that measures the **force required to break** the tablet when the force generated by a **coil spring** is **applied diametrically** to the tablet

Answer 40

MONSANTO-STOKES tester

Question 41

* measures tablet **diametrical position** * applied force is produced by a **manually operated air pump** * the machine measures the force applied to the tablet and detects when it fractures * the **final breaking point** is **indicated** on a **dial** calibrated into 30 arbitrary units

Answer 41

STRONG-COBB tester

Question 42

* operates on the same mechanical principles as **ordinary pliers** * the force required to break the tablet is recorded on the dial and maybe expressed as either **kilograms** or **pounds** of force

Answer 42

PFIZER tester

Question 43

* it offers the choice of testing under "**constant speed**" as well as "**constant force**" measurement conditions

Answer 43

Erweka tester

Question 44

* **most widely used** apparatus to test hardness * **more acccurate results** are obtained with this instrument * **eliminates** operator variability

Answer 44

Schleuniger apparatus

Question 45

**Schleuniger** apparatus is also known as

Answer 45

Heberlein