Pharm Ana 12 - Quality Control Procedures for Tablets

The 4 quality control procedures for tablets

• Tablet requires a certain amount of strength or hardness and resistance to friability to withstand mechanical shakes of handling in the manufacture, packaging, and shipping.
• Hardness generally measures the tablet crushing strength.
• The strength of a tablet was determined by following ways;
• By cracking the tablet between 2nd and 3rd fingers with the thumb acting as a fulcrum. If there is a sharp snap, the tablet is an acceptable strength.
• Tablet hardness can be defined as the force required breaking a tablet in a diametric compression.

T or F

Tablet requires a certain amount of strength or hardness and resistance to friability to withstand mechanical shakes of handling in the manufacture, packaging, and shipping

generally measures the tablet crushing strength.

T or F

The strength of a tablet was determined by following ways;

• By cracking the tablet between 2nd and 3rd fingers with the index acting as a fulcrum. If there is a sharp snap, the tablet is an acceptable strength.

T or F

Tablet hardness can be defined as the force required breaking a tablet in a diametric compression

In this test the tablet is placed between two anvils, force is applied to the anvils, and the crushing strength that just causes the tablet to break is recorded.

Generally used Hardness testers are:

Hardness for a compressed tablet is __ to __ kg.

The ____________________ was developed 50 years ago. The design consists of "a barrel containing a compressible spring held between 2 plungers". The tablet is placed on the lower plunger, and the upper plunger is lowered onto it.

- An ad hoc unit of force which is a legacy of one of the first tablet hardness testing machines. Although the SC is arbitrary, it was recognized as the international standard from the 1950s to the 1980s.

1 Strong-Cobb represented roughly __ kilogram of force or about __ newtons.

The ______________ compresses tablet between a holding anvil and a piston connected to a force-reading gauge when its plier-like handles are gripped.

The _____________ is the __________ basic device for testing tablet hardness (dual-mode: "constant speed" and "constant force"), offering accuracy, robust design as well as easy and quick handling. The unit is operated via a symbol keypad which allows effortless entering of the samples number required for testing.

he has been the professional leader in tablet testing solutions for more than 45 years

The Dr.Schleuniger range of physical test equipment includes tablet Hardness Testers , softgel Elasticity testers , tablet Disintegration testers, tablet Dissolution testers , tablet Friability testers and Tapped Density testers.

are known for their reliability, precision and ease of use and operation and tens of thousands of the products have been installed in different pharmaceutical companies in all the 5 continents.

Friability of a tablet can determine in the laboratory by

• This consist of a plastic chamber that revolves at 25 rpm, dropping the tablets through a Distance of six inches in the friabilator, which is then operated for 100 revolutions.

• The tablets are reweighed.

• The compressed tablet that loses less than 0.5 to 1.0 % of the Tablet weight are considered acceptable.

• Equipment used: Roche friabilator : Setting: 25 rpm, time: 4minutes = 100 revolutions

• No. of samples to use: less than 650mg -20 tablets

• 650mg or greater - 6-6.5g of dedusted sample

What types of tablets are used for Friability Tests?

How do you calculate Friability?

Measured using Vernier caliper += 5% of standard thickness. Note: Not used for coated tablets

This is provided to determine the compliance with the limits on Disintegration stated in the individual monographs except where the label states that the tablets or capsules are intended for use as troches, or are to be chewed, or are designed to liberate the drug content gradually over a period of time or to release the drug over two or more separate periods with a distinct time interval between such release periods .

Media Temperature for Tablet Disintegration Test

Procedure:

1. Load 1 tablet in each of the tube and exposed the product into the conditions specified.

2. Overlay with sinker or 10-mesh wired cloth

Oral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal analytical test used for detecting physical changes in an active pharmaceutical ingredient and formulated product.

is the process in which a substance forms a solution.

measures the extent and rate of solution formation from a dosage form, such as tablet, capsule, ointment, etc.

The _______________ of a drug is important for its bioavailability and therapeutic effectiveness.