The quality control test for tablets involves different evaluation tests that are used to determine whether product quality standards (official or unofficial) are met, these tests should be carried out during production and verified after each batch is produced.
The dosage forms are pharmaceutical products are meant to deliver the drug/medication to the diagnosis, prevention, and treatment of disease at the specific site of the body. They are formulated in different types based on the physical form and route of the drug administration. Based on the physical form they are solid, semisolid, liquid, and gaseous, and based on the route they are oral, parenteral (injection), ocular, topical, nasal, inhalation, sublingual, and buccal, etc. Some examples of dosage forms are tablets, capsules, caplets, granules, powders, cream, gel, liniment, moisturizer, paste, colloid, lotion, suspension, emulsion, elixir, linctus, drop, tonic, and syrup, etc.
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Tablets are solid unit dosage forms of pharmaceuticals intended for oral administration that contains active ingredients (API) as well as excipients. It is usually in powder form and is pressed or compressed into a solid dosage using a compression machine. They vary in size, shape, weight, hardness, thickness, dissolution, dissolution, and other release characteristics depending on the amount of medicinal substance and the intended method of administration. Tablets can be made in different types depending on the rate of release in the stomach or intestines, for example, compressed tablets, multiple-compressed tablets, sustained action tablets, gelatin-coated tablets, film-coated tablets, sugar-coated tablets, chewable tablets, and enteric-coated tablets, etc.
Tablets are the most popular dosage forms among physicians, patients, and manufacturers when compared to other types of dosage forms, as it has a broad range of advantages and applications, good physical and chemical stability, and ease of swallowing. However, a significant disadvantage in its formulation is that if a minor defect occurs during production, the entire batch of the unit may be discarded. Therefore, the evaluation of tablets is very important to avoid any errors during the production process, and before the final batch is dispatched or delivered.
Evaluation test for tablets:
Tablet evaluation includes assessment of the physical, chemical, and biological aspects of the tablet. To ensure the quality of tablets, capsules, and different types of dosage forms, almost all pharmacopeias (USP, BP, and IP) incorporate suitable standards and tests. These tests are divided into two categories: pharmacopoeial (official) tests and non-pharmacopoeial (unofficial) testing. Pharmacopoeial or official tests are standardized testing procedures that clearly state the limits within which tablets can be accepted.
Appearance test for tablets:
Consumer acceptance, managing lot-to-lot consistency, and tablet-to-tablet uniformity all depend on the overall design, identity, and elegance. The general appearance of the tablet can be controlled by assessing several characteristics such as size, color, shape, readability of any identification marks, presence or absence of taste, and odor, etc.
Size and shape test for tablets:
The thickness of a tablet determines its size and shape and it can be described and controlled dimensionally. The size and shape of the tablet dosage form have a significant impact on patient compliance. As tablet size increases, administration (swallow) becomes more difficult, particularly for child and elderly patients. To determine the thickness of a tablet a micrometer apparatus is used. The thickness of the tablet should be controlled within a ± 5% variation of the standard value.
Unique identification marking test for tablets:
For rapid identification of their product, in addition to providing color, the pharmaceutical manufacturers use printing, embossing, or engraving as a type of distinctive marking. These markings include the name of the manufacturer, the name, and code of the product, the strength of the drug, etc.
Organoleptic properties test for tablets:
As an important means of quick identification and consumer acceptance several pharmaceutical tablets use color, and the color of the product should be uniform within one tablet. Mottling is the term for non-uniformity, resulting in poor product quality. For comparison, the color of the tablet should be compared with the standard color. Organoleptic compounds such as coloring additives, flavoring agents, and sweeteners may be found in some tablets. A reflectance spectrophotometer is used to be evaluated the color uniformity of the tablet.
Hardness test for tablets:
Tablet hardness refers to the amount of force required to completely crush a tablet. To withstand the mechanical shocks of handling in production, packaging, and shipping, tablets require a particular amount of hardness or strength and resistance. Hardness is performed by tablet hardness tester they can be Monsanto hardness tester or Pfizer hardness tester, nowadays automated testers are also used. It is a significant quality control test since it can impact tablet disintegration, dissolution, and friability. It is also used adjustment pressure on the tablet compression machine and adjusts the disintegration of the tablet.
Weight variation test for tablets:
If the statistical distribution of tablet weight is considered normal then all tablets must fall within the specified range of predefined tablet weights. Many tablets are weighed separately, and the average weight and variation of individual tablet weight from the average are calculated and controlled throughout the manufacturing process to confirm that the tablets contain the preferred quantity of active ingredients and that there is no more than acceptable variation among tablets within a batch.
As per the USP, the weight variation test is performed by individually weighing 20 tablets, calculating the average weight, and comparing the individual tablet weight to the average. Tablet passes the USP test if not more than 2 tablets do not exceed the percentage limit and if no tablets differ by more than 2 times the percentage limit.
The formula of weight Variation = (IW - AW)/AW X 100% Where, IW is individual weight, and AW is average weight.
Friability test for tablets:
The friability test is official in USP but not in BP and IP. It is designed to measure how much weight loss occurs during transportation and handling, as well as the physical strength of tablets when exposed to mechanical shock and attrition.
The friability of a tablet can be determined in a laboratory using friability test apparatus. It consists of a plastic chamber that rotates at 25 rpm, 10 tablets are weighed and placed in the chamber of the friabilator, dropping the tablets into the friabilator over a 6-inch distance, and then operating for 100 revolutions. As per the USP, IP, and BP, it should be no more than 1.0%.
The % friability is calculated using the below formula.
Friability = W1–W2/W1x100, where W1=Weight of the tablet before the test, and W2=Weight of the tablet after the test.
Content uniformity test for tablets:
Content uniformity test is to ensure that each dosage form contains an equal amount of the active pharmaceutical ingredient or pharmaceutical substance. In which randomly 10 tables are taken, if 9 out of 10 tablets should not contain less than 85% and more than 115% of the labeled drug content and the 10th tablet may not contain less than 75% and more than 125% of the labeled drug content, the tablet passes the test. It is usually tested using analytical methods such as high-performance liquid chromatography (HPLC), or UV-spectrophotometer for drug potency in several individual tablets.
Disintegration test for tablets:
This test is used to observe whether tablets disintegrate in the specified amount of time when placed in a liquid medium under the specified conditions. It is evaluated to make sure that the tablet dissolves or breaks up into granules or smaller particles upon contact with water under agitation. This allows it to be dissolved from its primary particles, fully available for dissolution and absorption from the gastrointestinal tract (GI).
Tablet disintegration test is perfumed using the USP disintegration test apparatus. This consists of 6 glass tubes that are 3” long that open at the top and 10 mesh screens at the bottom end. For testing disintegration time, a tablet sample is placed in each tube and the basket rack is placed in a beaker (1liter) of water or simulated gastric or intestinal fluid at 370C
Dissolution test for tablets:
Dissolution is the process in which a substance forms a solution. The dissolution test measures the extent and rate of formation of a solution from dosage form (solid/semisolid). It is utilized as a quality control method to assure tablet-to-tablet and batch-to-batch uniformity in drug-release characteristics of tablets, as well as an in vitro–in vivo correlation tool for drug release (in vitro) and drug absorption (in vivo) (in vivo).
Dissolution includes seven USP standardized apparatus, of which baskets and paddles (Apparatus-1 and 2 ) are more commonly used. It consists of a specially coated paddle or basket, the rotating shaft is attached vertically at the end. The vessels are usually either partially immersed in a water bath solution. A motor to rotate a shaft immersed in the vessel, and a temperature controller that maintains the bath at 370C.
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