Study Set Content:
Property related to hardness. It is the ability to withstand abrasion in packing, handling and shipping.
Friability
a method, which is employed to determine physical strength of uncoated tablets upon exposure to mechanical shock and attrition.
Friability Testing β
Defined as the % of weight loss by tablets due to mechanical action during the test.
Friability Testing β
Friability also means (blank), by certain mechanical shock and lost of material from intact tablet
Surface erosion
To evaluate the ability of the tablet to withstand the breakage during the transportation and handling
Friability
If the weight is > 650mg per tablet use
10 samples
If the weight is
20 samples
Equipment: for friability
Measured by Roche Friabilator or Tumbler Test.
Requirement Β for OLD Formulation
NMT 1% loss
loss for NEW FORMULATION
NMT 0.8%
Formula:
%πππ π = ππππ‘πππ π€πππβπ‘ β πππππ π€πππβπ‘/ ππππ‘πππ π€πππβπ‘ π₯ 100
β’ Degree of uniformity of the amount of drug substance in a tablet
Uniformity of Dosage Units
Methods of Uniformity of Dosage Units
1. Content Uniformity
2. Weight Variation
Tablets, Uncoated >25 mg and >25% and
WV and CU
Tablets, coated film >25 mg and >25% and
WV and CU
Tablets, coated others >25 mg and >25% and
CU and CU
Capsules, Hard >25 mg and >25% and
WV and CU
Capsules Soft suspension emulsion or gel >25 mg and >25% and
CU and CU
Capsules Solutions >25 mg and >25% and
WV and WV
Solids in single-unit containers, Single component >25 mg and >25% and
WV and WV
