It also includes entry fields for user name and product details. See the diagram below for a double drum tablet friability tester. Dual drum units can for example be fitted with one friability and one abrasion drum thus allowing comparisons to be made between the two parameters under identical test conditions. This chapter provides guidelines for the friability determination of compressed, uncoated tablets. If obviously cracked, cleaved, or broken tablets are present in the tablet sample after tumbling, the sample fails the test. Inform to quality control head in case of sample fails the test. The concentration of dissolved prednisone lot j at 30 min should be in the range 22% of the saturation value, i. Friability of uncoated tablets this chapter provides guidelines for the friability determination of compressed, uncoated tablets. Conventional compressed tablets that loss less than 0. The friability reducing agents include low molecular weight polyethylene glycol as well as similar agents exhibiting at least three percent 3% hydroxide moieties and a water solubility of at least eighty percent 80% ww % in room. Weight variation test is performed to check that the manufactured tablets have a uniform weight.
Most compounding pharmacy would not have the apparatus specified in section 1216. The instrument features an automated sample discharge at the end of a test and the possibility to connect an analytical balance. The tablets are tumbled at each turn of the drum by a curved projection with an inside radius between 75. Evaluation of tablets university of north carolina at. Manufacturing processes such as coating, packaging, and printing can involve considerable stresses, which the tablets must be able to withstand. The test over is indicated by an audible keep and the display would show end.
Friability test is used to determine the physical strength or tablet breaking force for compressed, uncoated tablets. Calculate the % friability as per formula given below. When the test is over, the drum rotates in the reverse direction, discharging the tablets into the tray. Friability tester tablet friability test apparatus. Friability testing is an accepted standard throughout the pharmaceutical industry for determining the resistance of uncoated tablets to the abrasion and shock experienced in manufacturing, packaging and shipping operations. Friability the condition of being friable testing is a method, which is employed to determine physical strength of uncoated tablets upon exposure to mechanical shock and attrition. Complete disintegration isertures and with a wire diameter of 0. Section of the usp 24nf19 outlines a standard tablet friability test applicable to manufactured tablets. Friability tester operators manual 3 contents figures 5 1safety7 electrical hazards 8 warning 9 caution 9 note 9 information symbols 10 general 11 weee directive 12 2 introduction available configurations 15 conventions used in this manual 16 usp suitability test 17 usp physical parameters 17 3 setting up the friability tester 19 initial. Dec 15, 2011 tablet friability,hardness and dissolution by don jacob. The rota tion speed can be set between 20 and 100 rpm and the test run duration can be set either in time or total number of revolutions. Friability describes the mass reduction of a solid dosage form such as compressed, uncoated tablets occurring when subjected to mechanical strain during handling such as tumbling, vibration, or rubbing in a blister packaging.
Then drum oscillates gently to make sure that all tablets are discharged into the tray. If obviously cracked, chipped or broken tablets are present in the sample after rotation, the sample fails the test. Friabilator operation cleaning friability test apparatus. If no tablet is cracked, split or broken, weigh the tablets againw f. Friability plot type i of a mcc and b dcpd used for validating the expedited friability test method by the conventional usp method. Since hardness is the opposite of friability, there are many differences between these two terms. Friability the laboratory friability tester is known as the roche friabilator. It automatically discharges the samples when testing is complete and then connects to an analytical balance. Usually, for conventional tablets, a friability value of 1% or less is desirable, while for chewable tablets due to the lower. Difference between hardness and friability definition. Pharmacopoeia jp and united states pharmacopeia usp.
Via a usb interface optional the test parameters time, actualnominal speed can be transferred to a pc or printed out on a connected printer. Quality control and evaluation parameters for chewable tablets. The u ni te d s ta te s p ha r m a c o pe i a i s the c o o r di na ti ng pha r m a c o pe i a f o r the i nte r na ti o na l ha r m o ni z a ti o n o f the. Dissolution is a test used by the pharmaceutical industry to characterize the dissolution properties of the active drug, the active drugs release, and the dissolution from a. Ptf 200 is a double drum tablet friability and abrasion test instrument. However, there are several hand operated tablet hardness testers that might be useful. Programming is easily performed by the symbol keypad. Friability tester vinsyst digital friability tester. Pdf tablet evaluation pharmaceutics pharmaceutical.
Dec 08, 2016 friabilator operation cleaning friability test apparatus procedure of tablets friabilator operation. Use a drum, with an internal diameter between 283 and 291 mm and a depth between 36 and 40 mm, of transparent synthetic polymer with polished internal surfaces, and not subject to static buildup see figure for a typical apparatus. The test procedure presented in this chapter is generally applicable to most compressed tablets. Friability is the tested for a tablet to see whether the tablet is stable to abrasion or not, it is tested by using roche friabilator and 1% maximum loss in the weight after friability test is allowed. Friability testing is used to test the durability of tablets during packing processes and transit. Tablet friability this method text provides guidance for the friability determination of compressed, uncoated tablets. Annex 9r1 tablet friability general chapter guidance for. The te s t pr o c e dur e pr e s e nte d i n thi s c ha pte r i s ge ne r a l l y a ppl i c a bl e to m o s t c o m pr e s s e d ta bl e ts. Tablet friability general information usp 35 hands of the end users patientsconsumers. Jul 28, 2015 tablets passes the friability test if the loss of weight is not more than 1 %. It is believed that no single test method completely covers all factors involving such forces for different kinds of materials, but this test method is intended to provide. Standard test method for tumbling friability of preformed. Dissolution is a test used by the pharmaceutical industry to characterize the dissolution properties of the active drug, the active drugs release, and the dissolution from a dosage formulation.
Remove any loose dust from the tablets and accurately weigh 10 tablets. Shipped bottled products across the country and back again to estimate the strength of the new tablet product in shipment. Test, and usp tablet friability, can be used as interchangeable in the ich regions. Friability is defined as a reduction in the mass of the granules or spheroids or. All testers can be equipped with a choice of either usp friability drums andor abrasion test drums. Friability test quality control management for tablets. This test is crucial for tablets having a drug content of less than 2 mg or when the active ingredient comprises less than 2% of the total tablet weight. Q4b annex 9 step 5 tablet friability general chapter.
Measurement of tablet friability supplements other physical strength measurements, such as tablet breaking force. Section 1216 of the usp 24nf19 outlines a standard tablet friability test applicable to manufactured tablets. Validation and applications of an expedited tablet friability. For the purposes of this test, disintegration doesplate is a woven stainless steel wire cloth, which not imply complete solution of the unit or even ofhas a plain square weave with 1. Friability tester supports 2 types of drumstandard drum and abrasion. Before sharing sensitive information, make sure youre on a federal government site. Acceptance criteria for interchangeability, the loss of mass for a single determination should be not more than 1.
Providing highly reproducible, costefficient friability testing for all tablet types, the frvi series and friabimat testers from copley allow analysts to easily characterise the critical tendency of tablets to chip, crumble or break. The main difference between hardness and friability is that hardness is the resistance to scratch or deformation whereas friability is the tendency to crumble. Sop on operating procedure for friability test appratus. If the tablets are chipped or broken during friability test, then the tablets fail the friability test. Fr and frv models are easy to operate and are in full accordance with the specifications set by the ep chapter 2. The drums are filled and emptied through a special orifice. Start v connect power cord to an appropriate electrical outlet v unscrew locking nut to release drum v brush any loose dust from tablets v accurately weigh tablets v load tablets into drum v place plastic cover over drum v.
How to determine friability of pharmaceutical tablets youtube. Ptf e and ptf er, single or doubledrum tablet friability test instruments, are manufactured in compliance to the usp, european and other pharmacopoeias. Friabilityabrasion tester tar features tar friability abrasion the tar series is a uspepjp compliant erweka unit for testing friability and abrasion. Tablet friability testing pharmaceuticalnetworking. Measurement of tablet friability supplements other physical strength measurements, such as tablet crushing strength. Validation and applications of an expedited tablet. The fr has one test drum and the frv 2000 has two test drums. This test is intended to determine, under defined conditions, the friability of granules and spheroids. Sop for operation and calibration of friability test apparatus.
It is intended to be included in the supplementary information section of the ph. Tablet friability test, and usp tablet friability, can be used as interchangeable in the ich regions. Content uniformity test was developed to ensure content consistency of active drug substances within a narrow range around the label claim in dosage units. The usp provided an apparatus suitability test to ensure that a dissolution apparatus operates satisfactorily and is free from significant extraneous vibration. It is recognised, however, that many methods with equal suitability may be used. Ptf 200 double drum tablet friability test instrument ptf 200 is a double drum tablet friability and abrasion test instrument. Most compounding pharmacy would not have the apparatus specified in section. It is manufactured in compliance to the usp, ep and jp pharmacopoeias. This test necessary to ensure that they possess suitable mechanical strength to avoid crumbling or breaking on handling or subsequent processing.
These tests can be performed to give indication of how well a. Friability is the condition of being easily crumbled or pulverized. Results of the statistical analyses suggest a strong correlation between tablet compaction pressure and tablet friability for both mcc and dcpd using either friability methods with r 2. The test over is indicated by an audible beep and the display would show end. On units equipped with the repor t center printer, you can enter the starting and ending weights of the tablets and the percentage loss is calculated per usp. The ptf instruments are manufactured with either one or two drums, both friability and optionally abrasion drums are available. They are placed in the drum which rotates at 251 rpm. The standard fr model employed for tablet friability testing operates at a constant speed of 25 rpm. Tablets passes the friability test if the loss of weight is not more than 1 %. In simple words, friability test tells how much mechanical stress tablets are able to withstand during their manufacturing, distribution and handling by the customer.
Friabilator operation cleaning friability test apparatus procedure of tablets friabilator operation. Tablets are prepared with friability reducing agents to yield tablets that are more resistant to breakage or crumbling, but with satisfactory hardness. How to determine friability of pharmaceutical tablets. It is made in compliance with usp, ep and jp pharmacopoeias. Chewable tablets and most effervescent tablets undergo high friability weight losses special stack packaging. Warning the friability tester contains electrical circuits, devices, and.
Pdf calibrationthe usp dissolution apparatus suitability test. All pharma test friability testers are fully compliant to the current usp, ep and jp pharmacopeia and come ready to use with friability roche drums included in the standard scope of supply. Friability of uncoated tablets, jp general information 26. Acceptance criteria for friability of uncoated tablet are not more than 1. After a test run the samples are automatically fed into a container located below the friability drums. Abrasion drums as well as friability drums with antistatic coating are available as options. If the results are difficult to interpret or if the weight loss is greater than the targeted value, the test should be repeated twice and the mean of the three tests determined. It is believed that no single test method completely covers all factors involving such forces for different kinds of materials, but this test method is intended to provide a procedure that gives reproducible results.
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