The major difference between hardness and friability of tablet is that the tablet hardness testing determines its breaking point and structural integrity, as well as find out how it changes throughout packing, handling shipping, and storage before use, whereas the friability testing is a laboratory technique used by the pharmaceutical industry to test the durability of tablets during transit.
The pharmaceutical dosage forms are meant to deliver the active pharmaceutical ingredients (API) to the specific site of the body for diagnosis, prevention, and treatment of disease. As per the physical form dosage forms are solid, semisolid, liquid, and gaseous, and as per the route of drug administration dosage forms are oral, parenteral (injection), topical, inhalation, ocular, otic, nasal, sublingual, and buccal, etc. Tablets, caplets, capsules, powders, granules, syrup, suspension, tonic, drop, elixir, linctus, emulsion, suspension, liniment, lotion, paste, gel, cream, moisturizer, and colloid are some of the examples of dosage forms.
Pharmaceutical tablets:
The pharmaceutical tablets kind of oral solid dosage form is one of the most popular among patients, physicians, and manufacturers since it has a wide range of advantages, applications, good physical and chemical stability, and may contribute to patient compliance given their ease of swallow.
It consists of a mixture of drugs and excipients, usually in powder form, pressed or compacted from a powder to a solid dosage. Based on the amount of medicinal compounds, intended use, and preparation technique, they can vary in shape, weight, size, thickness, hardness, disintegration and dissolution characteristics, and other release characteristics.
Tablets can be formulated in different types according to the rate of release in the stomach or intestines such as compressed tablets, multiple-compressed tablets, sugar-coated tablets, film-coated tablets, gelatine-coated tablets, chewable tablets, sustained action tablets, enteric-coated tablets, and uncoated tablets.
Overview:
Hardness and friability both are quality control tests for tablet dosage forms. The quality control test is the process by which a manufacturer determines actual quality performance, compares it to official pharmacopeia standards such as USP, IP, or BP, and determines the causes of deviation from the standard to ensure a high-quality product. Types of quality control tests are thickness and diameter, hardness test, weight variation test, friability test, drug content, disintegration time test, and in-vitro dissolution test, etc.
Tablet hardness test:
Tablet hardness testing is a quality control test used to check breaking point and structural integrity of tablet dosage form, as well as to determine how it changes "during storage, transit, packing, and handling conditions before use." The units of measurement for tablet hardness are largely based on materials testing standards.
- It is used to determine the need for pressure adjustment on the tablet compression machine.
- It is used in manufacturing, packaging, and shipping to withstand mechanical shocks.
- It is used to ensure consumer acceptance.
- It is used to adjust the disintegration of the tablet since hardness can affect the disintegration.
- Monsanto and Pfizer hardness tester is commonly used to determine tablet hardness however nowadays digital hardness tester is also used.
- This measures the degree of force Kilogram (kg), Newton (N), Kilopond (KP), and Strong-Cobb (SC), etc. needed to fracture a tablet.
- This involves placing the tablet directly into the sample compartment and pressure can be applied manually or automatically.
Tablet friability test:
Friability is the percentage of weight loss of powder from the surface of the tablets caused by mechanical action, and the test is used to determine how much weight loss occurs during transportation and handling or determine the physical strength of uncoated tablets upon exposure to mechanical shock and attrition.
- It is used to determine the ability of tablets to withstand breakage during manufacturing, distribution transportation, and handling.
- This is a supplementary test for uncoated/compressed tablets other than hardness.
- Friability tester is commonly used to determine to evaluate the ability of the tablet which is operated automatically by the control panel.
- The friability tester determines friability by allowing the tablet to roll and fall up to 6 inches within the rotating tumbling equipment.
- Friability strictly adheres to coated tablets and is indicated by chipping, breaking, (or) capping.
- To operate, the tablets (previously weighed) must be placed in a drum that is rotated.
Commonly asked questions on hardness and friability are as follows.
What are the factors that affect the friability of tablets?
moisture content, the addition of a large amount of fine powder to the formula, hardness variations, amount and type of binder and lubricants used in formulation, etc.
What are the factors that affect the Hardness of tablets?
Amount of binder, compression of the tablet and compressive force, Method of granulation, types of binders used, the nature, press speed, granulation flow, and composition of the active pharmaceutical ingredients, etc.
What is the limit for friability of tablets?
A maximum mean weight loss USP limit is 0.5% to 1.0% is considered acceptable for most products.
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