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DEPARTMENT OF PHARMACEUTICS CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

QUALITY CONTROL TESTS OF TABLETS III/IV BPHARMACY (5 TH SEMESTER) Dosage form technology including cosmetics (503). DEPARTMENT OF PHARMACEUTICS CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES. QUALITY CONTROL TEST :

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DEPARTMENT OF PHARMACEUTICS CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

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  1. QUALITY CONTROL TESTS OF TABLETSIII/IV BPHARMACY (5TH SEMESTER)Dosage form technology including cosmetics (503) DEPARTMENT OF PHARMACEUTICS CHALAPATHI INSTITUTE OF PHARMACEUTICAL SCIENCES

  2. QUALITY CONTROL TEST : QC refers to produce (or) a set of steps taken during manufacturing of a product to ensure that it meets requirements QC is the monitoring process through which manufacturer measures actual quality performance compares it with standards & finds out the causes of deviation from standard to ensure quality product not once but every time .

  3. UNOFFICIAL TESTS : OFFICIAL TESTS Friability Weight variation test Content uniformity tests Dissolution test Disintegration test Appearance Size and shape Hardness

  4. INPROCESS QC TESTS FOR TABLETS For coated tablet : Appearance Dimensions Adhesion test Resistance to abrasion For uncoated tablet : Appearance Dimensions

  5. COATED TABLET : These are the tests conducted when the tableting is under process Appearance : The tablet should be free from cracks, depression ,pinholes etc. Dimensions : The dimensions of the tablets, thickness and diameter Measured by using digital vernier calipers or screw guage

  6. Adhesion test : This measured by using tensile strength testers The force required to peel the film from the tablet surface is measured Resistance to abrasion : The ability of the coating to remain stuck to the tablet surface is tested Any defects in the formulation of coating solution can be tested

  7. UNCOATED TABLETS : Appearance : It should be free from cracks ,depression, pinholes etc. Colour & polish of the tablet should be uniform on whole surface There should be no signs of coating Surface should be smooth

  8. Dimensions : The dimensions of the tablets, thickness & diameter are measured by using digital vernier calipers and screw guage play

  9. HARDNESS : It is defined as the crushing strength of the tablet or force required to break a tablet across the diameter Hardness of the tablet is the indication of strength Why do we do hardness test for tablets ? tablet should be stable to mechanical stress & transportation Degree of hardness varies with different manufacturers & different tablets

  10. It is a valuable test ,which influence the tablet dissolution & disintegration Depending upon the type & concentration of the binding agent the hardness varies Binding agents (eg) ; acacia mucilage ,starch paste , sugar syrup , methyl cellulose dispersion etc. The force is measured in kilograms & the hardness of about 4kg is considered to be satisfactory for uncoated tablet play

  11. Various types of hardness testers used are : Monsanto tester The tablet is placed across the spindle & anvil. Knob is adjusted to hold the tablet in position. The reading of the pointer is adjusted to zero. Pressure is slightly increased to break the tablet

  12. Pfizer tester It works on the mechanical principle as a pair of pliers Tablet is compressed between holding anvil & a piston connected to the direct force reading guage

  13. Erweka tester Tablet is placed on the lower anvil & the anvil is adjusted so that the tablet just touches the upper test anvil

  14. Schleuniger tester Operates in horizontal position An anvil is driven by an electric motor presses the tablet at a constant load rate against a stationary anvil until the tablet breaks These testers Does not produce same results for the same tablet

  15. Weight variation test for tablets USP – OFFICIAL LIMITS BP - OFFICIAL LIMITS IP – OFFICIAL LIMITS

  16. Test procedure : 30 tablets were randomly selected for the test .every tablet in each batch should have uniform weight . 20 tablets are weighed individually. Average weight is calculated from individual weight of all tablets Individual weight is compared with average weight. The percentage difference in the weight variation should be with in the permissible limits. The percentage deviation is calculated by using the formula: % weight variation = individual weight – average weight ---------------------------------------------×100 individual weight

  17. Result : Out of 20 tablets , if 2 tablets deviate the limit perform test for other 10 tablets Out of 30 tablets , if more than 2 tablets deviate the limit the batch passes the test play

  18. Friability test : It is used to measure the strength of the tablet It is used to measure tablet to withstand mechanical shock & abrasion without crumbling during the handling of manufacturing ,packaging, shipping , and consumer use. The friability of tablets is indicated by chipping , capping (or) breaking Friability is strictly adhered to coated tablets Friability problem is encountered with thin tablets ,large diameter tablets ,granules (excessively dried or excessive fine granules )

  19. The extent of friability is measured by using Roche Friabilator It rotates at a rate of 25 rpm .10 tablets are weighed collectively & placed in the chamber of friabilator.in the friabilator the tablets are exposed to rolling resulting from free fall of the tablets within the chamber of friabilator

  20. After 100 revolutions (4 min ) the tablets were taken out from the friabilator and intake tablets were again weighed collectively. % friability is calculated by using the formula : friability = W1 – W2 --------------- × 100 W1 W1 = Weight of the tablet before test W2 = Weight of the tablet after test

  21. Content uniformity test : This test is applied to assure uniform potency for tablets of low dose drugs The test is applicable to tablets that contain 10mg / < 10mg (or) < 10%w/w of active ingredients procedure : Select 30 tablets randomly from the batch Atleast 10 of them are assayed individually Out of 10 tablets 9 tablets must contain not less than 85% not more than 115% of labelled drug content 10 th tablet may not contain < 75% or > 125 % of labelled drug content.

  22. Result : Batch passes the test If there is any deviation then perform the assays individually for 20 tablets Out of 30 tablets 3 tablets can be within 75 – 125 % & the others should be within 85 – 115 %

  23. Disintegration test (D T) : Disintegration is the process of breakdown of tablet into smaller particles or granules . There is no correlation between dissolution & disintegration . Disintegration is a pre-requisite for the dissolution .

  24. DISINTEGRATION TEST APPARATUS

  25. It has a basket rack assembley . Basket has 6 cylinders (77.5 mm long,21.5 mm internal diameter , 2mm thick ) Tubes are held vertically by 2 super imposed plastic plates (90mm in diameter 6.75 mm thick ) and have perforations of size of cylinders. Lower plate has woven stainless steel (ss) wire atachment . Upper plate is covered by ss disc perforated by 6 holes . Plates are held rigidly in position & 77.5mm part by vertical metal rod at the periphery

  26. Metal rod is fixed at the centre (or) upper plate to enable the assembly to be attached to the device for raising & lowering it smoothly at constant frequency of between 28 – 32 cycles per minute through a distance of 50 – 60 mm DISCS : Discs are used to prevent the floating of tablet & to impart abrasive action to the tablet. Dimensions : 20.7mm in diameter ,9.5 mm thick. They are made up of transparent plastic & pierced with 5holes each 2mm in diameter 1 in centre &4 are equally spaced on the circle. play

  27. DISSOLUTION TEST : Dissolution is a process in which a solid substance solubilises in a given solvent ( mass transfer from the solid surface to the liquid phase. or It is a process by which drug released from solid dosage form & immediately goes into molecular solution . Rate of drug absorption for drugs is often determined by rate of drug dissolution from the tablet

  28. Based on sink (or) non sink conditions dissolution apparatus are classified as : Closed compartment apparatus Open compartment apparatus Types of dissolution apparatus (official) According to IP : TYPE I : PADDLE TYPE II : BASKET According to BP : TYPE I : BASKET TYPE II : PADDLE TYPE III : FLOW THROUGH CELL

  29. According to U S P : TYPE I : ROTATING BASKET TYPE II : PADDLE TYPE III : RECIPROCATING CYLINDER TYPE IV : FLOW THROUGH CELL TYPE V : PADDLE OVER DISC TYPE VI : ROTATING CYLINDER TYPE VII : RECIPROCATING DISC

  30. TYPE I : BASKET TYPE : Design : Vessel Made up of borosilicate glass Hemispherical bottom Inner diameter 98 to 106 mm Capacity 1000 ml Height 160 to 210 mm shaft Stainless steel 316 Rotates smoothly without significane . Wooble positioned in such a way that its axis is not more than 2mm from vertical axis of the vessel

  31. BASKET TYPE

  32. Basket stainless steel 316 made of # 22mesh gold coatings upto 0.0001 inch placed at a distance of 2cm from bottom Water bath maintained at 37 ± 0.5 ˚c Agitation 100RPM Use capsules ,tablets , delayed release , suppositories , floating dosage forms.

  33. TYPE II : PADDLE TYPE DESIGN : Shaft The blade passes through shaft so that bottom of the blade fuses with bottom of the shaft Stirring elements made up of tefflon for laboratory purposes stainless steel 316 Water bath maintain at 37± 0.5 ˚c Sinkers platinum wire is used to prevent capsule / tablet from floating Agitation 50 to 75 RPM Basket mesh size ranges from 10 to 80 can be used

  34. TYPE II PADDLE APPARATUS

  35. TYPE III : RECIPROCATING CYLINDER : DESIGN : Vessel cylindrical flat bottom glass vessel. Agitation type reciprocating generally 5 to 35 RPM Volume of dissolution fluids 200 – 250 ml water bath maintained at 37± 0.5 ˚c Use extended release eg : chloramphenicol chewable tablets eg : carbamazepine

  36. RECIPROCATING CYLINDER

  37. Type IV : FLOW THROUGH CELL : DESIGN : Reservoir For dissolution medium Pump forces dissolution medium through cell holds the sample flow rate 10 – 100 ml / min laminar flow is maintained peristalic / centrifugal pumps are not recommended Water bath 37± 0.5 ˚c

  38. TYPE V : PADDLE OVER DISC : DESIGN : Sample holder disc assembly that hold the product in such a way that release surface is parallel with paddle Paddle is directly attached over disc assembly Samples are drawn away between the surface of medium & top of the paddle blade Volume 900ml Water bath 32 ˚c

  39. TYPE VI : ROTATING CYLINDER : DESIGN : Vessel In place of basket ,cylinder is used Cylinder stainless steel 316 Sample mounted to cuprophan ( inner porous cellulosic material ) an entire system is adhere to cylinder Dosage unit is placed in cylinder & released from outside water bath maintained at 37± 0.5 ˚c Use transdermal patches

  40. TYPE VII :RECIPROCATING DISC : Vessel flat bottom cylindrical vessel volume of dissolution medium 50 – 200ml Sample is placed on disc shaped holders Agitation reciprocation reciprocating frequency 30 cycles / min Water bath maintained at 37± 0.5 ˚c Use transdermal patches

  41. Limits : Dissolution testing & interpretation can be done by 3 stages (S1,S2,S3) In stage 1 : 6 tablets were tested & are acceptable if all of the tablets are not less than Q + 5% In stage 2 : additional 6 tablets were tested .if all average of 12 tablets is greater than or equal to Q & no unit is less than Q – 15% If the tablets fails the test In stage 3 : all the average of 24 tablets is greater than or equal to Q & if not more than tablets are less than Q - 15 % play

  42. Conclusion : quality control tests are used for evaluating the quality of tablets Inorder to maintain quality very batch of formulation should be tested according to compendial standards

  43. REFERENCES : http://www.accessdata.fda.gov/scripts/cder/dissolution/dsp_SearchResults_Dissolutions.cfm?PrintAll=1 http://apps.who.int/phint/en/p/docf/ United states pharmacopeia – 2007 page no 2154 (701),2155 – 2164 (711)(721)(724). Indian pharmacopeia – 2007 volume 1 page no 177-185 British pharmacopeia - 2009 Leon lachman , Herbert A.Liberman,theory &practice of industrial pharmacy .pg no 296 - 303

  44. Thank you

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