Quality Control Tests for Tablets PDF

Quality Control Tests for Tablets Course leader Dr. Sindhu Abraham 1 Intended Learning Objective At the end of this lecture, student will be able to: Classify types of tablets Enlist the methods for tablet prepa...

Quality Control Tests for Tablets Course leader Dr. Sindhu Abraham 1 Intended Learning Objective At the end of this lecture, student will be able to: Classify types of tablets Enlist the methods for tablet preparation Discuss direct comparison and compression granulation 2 What is Quality control? Quality control is a small part of QA and it is concerned with sampling, testing and documentation during manufacturing and also after completion of manufacturing It is the monitoring process through which manufacturer measures actual quality performance and compares it with standards and find out the causes of deviation from standard to ensure quality product not once but every time Quality control refers to a procedure or a set of steps taken during the manufacturing of a product to ensure that it meets requirements, and that the product is reproducible 3 Need to perform Quality control tests for tablets To ensure safety, potency, efficacy, stability, patient acceptability and patient compliance of tablet To check whether a pharmaceutical tablet satisfy certain standards to claim it to be a quality drug To check that the quality parameters are within the acceptance limits 4 Q. C. Tests for Tablets Unofficial Official tests tests Friability Tablet Weight appearance variation Organoleptic Disintegration parameters Drug content Thickness Dissolution Hardness Content uniformity 5  Organoleptic Characters Colour Many pharmaceutical tablets use color as a vital means of rapid identification and consumer acceptance The colour of a product must be uniform within a single tablet. Non uniformity is referred to as mottling' and hence it leads to poor quality of product Odour The presence of odor in a batch of tablets could indicate stability problems, such as the odor of acetic acid in degrading aspirin tablets However, the presence of an odor could be characteristic for the drug (vitamins), added ingredients (flavoring agents) or the dosage form (film-coated tablets) Taste Taste is important in consumer acceptance of, especially, chewable tablets 6  Weight Variation Test 20 tablets are individually weighed, calculating the average weights and comparing the individual tablet weights to the average The value of weight variation test is expressed in percentage The following formula is used Weight Variation = (IW - AW)/AW X 100% Where, IW: Individual weight AW: Average weight Factors responsible for weight variation: Flow properties and Degree of segregation 7  Weight Variation Test - standard Note: If we are using 20 tablets, then according to U.S.P., not more than 2 tablets should show % weight variation. If we are taking 10 tablets, then according to U.S.P., not more than 1 tablet show % weight variation 8  Thickness Tablet thickness is determined by the diameter of the tablet Micrometer and vernier caliper are used for checking tablet thickness Thickness should be controlled within ±5% variation of a standard value Thickness must be controlled for consumer acceptance of the product, and to facilitate packaging Factors affecting thickness Size and size distribution Compression force 9  Thickness Micrometer It is measured in micrometer(mm) Vernier caliper It is measured in centimeter(cm) Note: As per official standard, tablet thickness variation allotted up to (+ or -) 5% of standard value 10 Hardness Test This test is also known as "Crushing Strength Test“ Tablets require a certain amount of strength, or hardness to withstand mechanical shocks of handling in manufacture, packaging and shipping Factors affecting hardness: Concentration of binder Moisture content Compression force 11 Equipments used in this test a) Monsanto hardness tester b) Pfizer hardness tester c) Strong cobb hardness tester d) Erweka hardness tester Out of the above equipment's, Monsanto hardness tester and Pfizer are commonly used to determine hardness of tablet 12 Monsanto hardness tester Pfizer hardness tester Standards for Hardness 5-8 kg/cm2 for standard compressed tablet except Effervescent tablet, Dispersible tablet, Orodispersible tablet, Chewable tablet,etc. More than 8-12 kg/cm2 for Sustained release tablet and controlled release tablet 14 Friability Test Friability is the phenomenon where the surface of the tablet is damaged due to mechanical shock PURPOSE To evaluate the physical strength and durability of compressed and uncoated tablets upon exposure to mechanical shock and attrition -transportation and handling In simple words, friability test tells how much mechanical stress tablets are able to withstand during their manufacturing, distribution and handling by the customer 15  Friability Test Roche friabilator tester is used for determining % friability of tablet- The friability test measures how well tablets resist breaking or chipping due to friction, vibration, or pressure. 16  Friability Test Procedure Take tablets weighing equal to or less than 6.5 g if the unit weight is 650 mg or less. If the tablets have a unit weight exceeding 650 mg, collect ten tablets as a whole sample. Check the calibration status before starting the operation. Before the test, dedust all tablets, record their weights (W1), and place in the drum. Set all parameters (revolution time) and start the test. The drum rotates for 4 min at a speed of 25 rpm- 100 rounds in 4 min Upon completion, dedust all the tablets and re-weigh them (W2) Calculate friability 17  Friability Test % Friability = W1-W2/W1 X 100 Where, W1= weight of tablets before testing, W2 weight of tablets after testing If the result exceeds the accepted limits, repeat the test three times and calculate the mean Standards for friability % Friability – NMT 1% for all standard compressed tablets For effervescent, chewable, orodispersible tablets % friability should be greater than 1 18  Disintegration Test Disintegration is a process in which tablets are break up into granules or smaller particles The test is a measure of the time required for a group of tablets to break up into particles under a given set of conditions This test is essential for tablets intended for administration by mouth, except those intended to be chewed before being swallowed or those that should dissolve slowly in the mouth, e.g, lozenges, glyceryl trinitrate, or effervescent tablets Also, disintegration does not apply to some types of sustained 19 release tablets  Disintegration time Disintegrating fluid may be either simulated gastric fluid or simulated intestinal fluid Apparatus construction Two batches of six tablets can be simultaneously tested with this instrument The USP device to test disintegration uses 6 open ended cylindrical glass tubes that are 3 inches long. They are open at the top and held against a 10-mesh screen at the bottom (plain square weave 2.0 ± 0.2 mm aperture)end of basket rack assembly. 20 Disintegration test apparatus  Disintegration test To test for disintegration time, one tablet is placed in each tube, and the basket rack is positioned in a 1-L beaker of water, simulated gastric fluid or simulated intestinal fluid, at 37°C+20C such that tablets remain 2.5 cm below the surface of liquid on their upward movement and descend not closer than 2.5 cm from the bottom of beaker A standard motor-driven is used to move the basket assembly containing the tablets up and down through a distance of 5-6 cm at frequency of 28-32 cycles per minute. Thus, note the time required to complete disappearance of tablet from glass tube 24  Disintegration time Disintegration is defined as that state in which no residue of the unit under test remains on the screen of the apparatus or, if a residue remains, it consists of fragments of disintegrated parts of tablets component parts 25  Disintegration time- Standards according to IP Type of Tablet Disintegration time Uncoated tablets ≤ 15 min (except chewable tablets) Coated tablets – sugar coated ≤ 60 min Coated tablets – film coated ≤ 30 min Enteric coated tablets - In 0.1N Hydrochloric Acid Should not disintegrate in 120 min (2 h) - In Phosphate buffer pH 6.8 ≤ 60 min (1 h) Dispersible/ soluble tablets ≤ 3 min Effervescent tablets ≤ 5 min Orodispersible / sublingual / ≤ 3 min soluble tablets Disintegration time Note Disintegration test does not apply for chewable tablets as they are chewed before swallowing 27  Dissolution Test The administration of drugs via oral dosage forms is one of the most common and effective means of delivering treatments to patients When a dosage form is swallowed, the rate at which it releases the active ingredient is critical to ensure that the drug is delivered properly The rate at which the drug is released is called the dissolution rate 28  Dissolution Test Types of dissolution apparatuses are: a) USP Dissolution Apparatus 1 - Basket b) USP Dissolution Apparatus 2 - Paddle c) USP Dissolution Apparatus 3- Reciprocating Cylinder d) USP Dissolution Apparatus 4 - Flow-Through Cell e) USP Dissolution Apparatus 5 - paddle over disk f) USP Dissolution Apparatus 6 -rotating cylinder g) USP Dissolution Apparatus 7-reciprocating disk 29  Dissolution Test Indian Pharmacopoeia (IP) typically recognizes the same dissolution apparatus types as USP and EP, namely: – Apparatus 1 (Basket) – Apparatus 2 (Paddle) – Apparatus 3 (Reciprocating Cylinder) 30  Dissolution Test Rotating basket apparatus Assembly consists of A covered vessel Metallic drive shaft Cylindrical basket Motor Sample port Water bath holding temperature 37°C 0.5°C Acidic media or alkaline media 31 Dissolution Test Rotating paddle apparatus Assembly consists of A covered vessel Metallic drive shaft Stainless steel paddle Motor Sinker to prevent floating of tablet Water bath holding temperature at 37°C ± 0.5°C Acidic media or alkaline media 32 Dissolution Test Note: 75% of drug should be dissolved within 45 mins as per U.S.P. 35 Content Uniformity Test Content uniformity test was developed to ensure content consistency of active drug substances Factors affecting drug content Tablet weight variation Uneven distribution of the drug in the powder or granules Segregation of the powder mixture or granulation during formulation processes By the USP method, 30 tablets are randomly selected, 10 of these tablets are assayed individually according to the method. described in the individual monograph Unless otherwise stated in the monograph, the requirements for content uniformity are met if the amount of active ingredient in nine (9) of the ten (10) tablets lies within the range of 85% to 115% of the label claim 36 Content Uniformity Test The tenth tablet may not contain less than 75% or more than 125% of the labelled drug content. If one or more dosage units do not meet these criteria, the remaining 20 tablets are assayed individually and none may fall outside of the 85% to 115% range for the batch to be accepted 37 Reference book ‘Theory and Practice of Industrial Pharmacy’-Leon Lachman, Herbert T Lieberman & Joseph L Kanig Indian Pharmacopoeia 38