S 1 o PHARM we @ Delhi (South) @ Delhi (East) @Chandigarh — @ Nagpur p= SAPIENCE @ Raipur @indore — @PBhopal weneee) @ Bhopal i) @Bhopal jens @Sagar — @Gwalior @ Kanpur Tablets & their Evaluation Introduction > Tablets represents unit dosage forms in which one usual dose of the drug has been accurately placed > One of the major advantages of tablets over capsules is that the tablet is an essentially tamper proof dosage form > Any adulteration of a tablet after its manufacture is almost certain to be observed Types of Tablets S.No. Types/Classes Sub-Classes Compressed Tablets Or Standard Compressed Tablets (CT) Multiple compressed tablets (MCT) (Layered Tablets, Compression Coated Tablets) Chewable tablets Sugar And Chocolate Coated Tablets Oral Tablets For Ingestion Film Coated Tablets Repeat Action Tablets Delayed Action And Enteric Coated Tablets Controlled Release Tablets Buccal And Sublingual Tablets Tablets Used in The Oral aa Troches And Lozenges Dental Cones Tablets Administered By Implantation Tablet cea Vaginal Tablets Effervescent Tablets Tablets Used to Prepare Dispersible/Dispensing Tablets (OT) Solutions Hypodermic Tablet (HT) Tablet Triturates (TT) 2 i 7 P H A R M 7X Download Our App from DD Google Play E Like us on subserbeuson (EB YouTube For more queries visit us at: www.pharmasapience.com = SAPIENC NS KarineH A R M we @ Delhi (South) @ Delhi (East) @ Chandigarh @ Nagpur E @ Raipur @ indore — @Bhopal iweneesr) @ Bhopal we) @Bhopal jens @Sagar — @Gwalior @ Kanpur Tablet Evaluation 1. Size and Shape- The crown thickness of individual tablets may be measured with a micrometer or sliding caliper scale. Tablet thickness should be controlled within a + 5% variation of a standard value. Hardness- It is sometimes referred to as Tablet Crushing Strength. 5 testers are used. All give reading in common unit which is Kg/em? " Monsanto- Based on a compressible spring held between 2 plungers. * _ Strong-Cobb tester- It was developed to overcome the manual nature of Monsanto tester, Based on hydraulic pressure. * Pfizer tester- Based on the same mechanical principle as a pair of pliers. It was very popular. Download Our App from > Google Play Like us on subserbeuson (EB YouTube For more queries visit us at: www.pharmasapience.comH A R M we @ Delhi (South) @ Delhi (East) @ Chandigarh @ Nagpur NCE @ Raipur @indore — @PBhopal weneee) @ Bhopal i) jarma @Bhopal trarone) @PSagar @Gwalior @ Kanpur Erweka tester- It provides the breaking strength value in kg. * Schleuniger tester- It operates in the horizontal position. The instruments read in both kg and ‘Strong-Cobb units. It is most widely employed, Large tablets are harder than small tablets. A flat beveled tool produces a tablet harder than a deep cup tool. 3. Friability- Roche friabilator is used in the laboratory for friability testing. It revolves at 25 rpm and the tablets fall from a distance of 6 inches. For freshly made tablets the limit of friability is 0.8% and for tablets from old batches, 1.0% Download Our App from > Google Play Like us on subserbeuson (EB YouTube For more queries visit us at: www.pharmasapience.comS 1 o PHARM we @ Delhi (South) @ Delhi (East) @Chandigarh — @ Nagpur p= SAPIENCE @ Raipur @indore — @PBhopal weneee) @ Bhopal i) @Bhopal iereny) @Sagar —- @Gwalior @ Kanpur "When concave and deep concave punches are used, and especially when the punches are in poor condition, the tablets result in "whiskering" at the tablet edge. These have higher friability values. * Very dry granulations produce more friable tablets than do granulations having 2-4% of moisture. * Rough handling tests include a vibration test, a drop test, and an incline plane-impact test. 4, Weight Variation- "20 tablets are taken and weighed individually, calculating the average weight, and comparing the individual weights to the average. «= NMT2 tablets should be outside the % limit set and none should be outside twice the % limit. As per USP- ‘Average weight of tablets (mg) Maximum % difference allowed 130 or less 130-324 More than 324 As per IP- Average weight of tablets (mg) ‘Maximum % difference allowed 80 or less More than 80 and less than 250 250 and more soe o) Download Our App ftom >> Google Play < SAPIENCE Like us on subscribe uson (EB YouTube ‘A brup of Best Phorma For more queries visit us at: www.pharmasapience.com(- PHARMA on one oman, Docs 7 SAPIENCE " ° = @Bhopal iereny) @Sagar —- @Gwalior @ Kanpur * Uniform Potency Test (Content Uniformity Test)- Generally for tablets with content of active ingredient, +£5% deviation from true content is allowed. For highly potent, low dose drugs such as digitoxin, this range is £10%, * Specifically, in the test, 30 tablets are taken and 10 are assayed individually. 9 of the 10 tablets must contain NLT 85% or more than 115% of the labeled drug content. ‘The 10th tablet may not contain less than 75% of more than 125% of the labeled amount. If fails then rest 20 tablets are assayed and, none may fall outside of the 85 to 115% range. fegration- ‘The device has 6 glass tubes that are 3 inches long, and held against a 10 mesh screen at the bottom, The assembly moves up and down through a distance of 5 to 6 cm below the surface of fluid of fiuid and not descend closer than 2.5 cm from the bottom of the beaker. The temperature is maintained at 37°C + 2°C umarts: Uncoated tablets should not take more than 30 minutes (as per USP) ‘Sugar coated-60 minutes Dispersible tablets-3 minutes at 25°C + 2°C For enteric coated tablets, they are first kept in simulated gastric fluid for 1 hour, during which they should not disintegrate, and then they are kept in simulated intestinal fluid for 2 hours where they should disintegrate completely, as per USP. For IP, the times are vice-versa, vie | Download Our App ftom >> Google Play z = SAPIENCE Like us on subserbeuson (EB YouTube 4.5. rena’ For more queries visit us at: www.pharmasapience.com@ Nagpur @- BHABM A aaa ore soe =¢:8 SAPIENCE ip Pal (MP Nagar} pal ) 4 @Gwalior @ Kanpur @Bhopal trarone) @PSagar 7. Dissolution- To show the release of drug is as close to 100% as possible and uniform from batch to batch. Different apparatuses are used for testing. There are 7 apparatus official in USP. For tablets apparatus 1 and 2 used. S.No. Basket Type Description Type! Paddle Type (In LP.) Type lt Basket Type (In 1.P.) Type ll Reciprocating Cylinder Type lV Flow Through Cell TypeV Paddle Over Disk Type VI Rotating Cylinder 7. Type Vil Reciprocating Cylinder + Temperature is maintained at 37°C + 0.5°C unless otherwise specified. + Dissolution testing is a multi-sampling plan- Download Our App from Google Play Like us on subserbeuson (EB YouTube For more queries visit us at: www.pharmasapience.coma. CHAR MA oe oe ome ons SAPIENCE " ° = s @Bhopal iereny) @Sagar —- @Gwalior @ Kanpur Dissolution testing and interpretation accor Quantity Number Of S.No. Stage/Levels Tablets Tested ‘Acceptance Criteria sa Each unit not less than Q* +5%** ‘Average of 12 units (S1 + $2) is equal to or greater than (>) Q and no unit is less than Q - 15%** ‘Average of 24 units (S1 + $2 +3) is equal to or greater than (>) Q, not more than 2 units are less than Q-15%** and no unit is less than Q- 25%** 82. * Qis the amount of dissolved active ingredient specified in the individual monograph expressed as a percentage of the labelled content ** percentages of the labelled content Validation of Dissolution apparatus is done by Salicylic Acid Tablets and Prednisolone Tablets made available for this purpose by USP only. i ® Download Our App from > Google Play -@- 2 eee Like us on subserbeuson (EB YouTube s Héreup of best Prova For more queries visit us at: www.pharmasapience.com