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  1. 1. QUALITY CONTROL AND QUALITY ASSURANCEOF VETERNERY DOSAGE FORMS 4-Quality control Tests For Vetenary Dosage Forms4.1-Quality control (Q. C.) tests for tablets:Quality of tablets should fulfill certain specifications:1. The tablet should include the correct dose of the drug (Weight uniformity and contentuniformity test).2. The drug should be released from the tablet in a controlled and reproducible way (Dissolutiontest).3. The tablet should show sufficient mechanical strength to withstand fracture and erosion duringmanufacturing and handling (Hardness and friability test).4. The appearance of the tablet should be elegant and its weight, size and appearance should beconsistent (Visual observation, weight variation, thickness and diameter of the tablet).5. The tablet should be packed in a safe manner.Quality control tests and specifications for someof these properties are given in pharmacopoeias. The most important for these are;- Weight uniformity,- Dose uniformity,- The drug release in terms of tablet disintegration and drug dissolution,- Resistance of tablets to fracture in terms of friability and hardness testing, and- The microbial quality of the product.These factors must be controlled during production (in-process control) and verified afterproduction. Some test methods are described in the pharmacopeias; others are not and thus arereferred to as "non-compendial" tests.N K B R COLLEGE OF PHARMACY AND RESEARCH CENTRE,MEERUT Page 37
  2. 2. QUALITY CONTROL AND QUALITY ASSURANCEOF VETERNERY DOSAGE FORMS4.2-Official Quality control tests for tablets (Compendial tests)British Pharmacopoeia (B.P.) & US Pharmacopoeia (USP)1- Uniformity of content of active ingredient (Uniformity of weight & Content uniformity)2- Disintegration test.3- Dissolution test.4- Friability test.USP mentions some Q.C. tests before the powder is compressed e.g. powder fineness, density,…Non-Compandial testsThere are many tests are frequently applied to tablets for which there are non-pharmacopoeialrequirements but will form a part of manufactures owner product specifications.1- Tablet thickness.2- Tablet hardnesNon-Compandial tests: 1. Tablet thicknessN K B R COLLEGE OF PHARMACY AND RESEARCH CENTRE,MEERUT Page 37
  3. 3. QUALITY CONTROL AND QUALITY ASSURANCEOF VETERNERY DOSAGE FORMSTablet thickness is important for tablet packaging; very thick tablets affect packaging either inblisters or plastic containers.The tablet thickness is determined by the diameter of the die, theamount of fill permitted to enter the die and the force or pressure applied during compression.The thickness of the tablet may be measured manually or by automatic equipment.A part of Good Manufacturing Practice (GMP), the production run is monitored under controlchart. At regular intervals (10-15 min.) during the course of manufacturing, the operator mustsample specified number of tablets for testing (in-process control)e.g.weight of tablet, tablet thickness, friability, disintegration time, …2. Hardness testIn general, tablets should be sufficiently hard to resist breaking during normal handling,packaging and shipping, and yet soft enough to disintegrate properly after swallowing.Hardnessof the tablet is controlled by (or is affected by) thedegree of the pressure applied during the compression stage.Micrometer (tablet thickness) (Tablet thickness & diameter)Tablet packaging in blisters Tablet packaging in plastic containersHardness is an important criterion, since it can affect disintegration and dissolution.N K B R COLLEGE OF PHARMACY AND RESEARCH CENTRE,MEERUT Page 37
  4. 4. QUALITY CONTROL AND QUALITY ASSURANCEOF VETERNERY DOSAGE FORMSSpecial hardness testers are used for this purpose (manually or motor driven testers).The testmeasures crushing strength property defined as the compressional force applied diametrically toa tablet which just fracture (break) it."Monsanto" Tablet hardness testerA force of about 4 Kg (may be measured in Kg) is considered the minimum requirement for asatisfactory tablet.Certain tablets such as lozenges and buccal tablets that are intended to dissolve slowlyintentionally are made hard; others such as immediate-release tablets are made soft. The Electronics Tablet HardnessII- Official standards (Q. C. tests) for tablets(Compendial tests):British Pharmacopoeia (B.P.) & US Pharmacopoeia (USP)1- Uniformity of content of active ingredient(Uniformity of weight & Content uniformity)2- Disintegration test.3- Dissolution test.4- Friability test.USP mentions some Q.C. tests before the powder is compressede.g. powder fineness, density, …1- Uniformity of active ingredient:N K B R COLLEGE OF PHARMACY AND RESEARCH CENTRE,MEERUT Page 37
  5. 5. QUALITY CONTROL AND QUALITY ASSURANCEOF VETERNERY DOSAGE FORMS(WHY?) To ensure a constant dose of drug between individualtablets.Traditionally, dose variation between tablets is tested in twoseparate tests;1- Weight uniformity2- Content uniformityIf the drug forms greater part of the tablet, any variation in thetablet weight obviously indicates a variation in the activeingredient.(Weight uniformity test)If the drug is potent (USP specifies 50 mg of the active ingredient or less), the excipients formthe greater part of the tablet weight and the correlation between the tablet weight and amount ofthe active ingredient can be poor, in this case another test (Content uniformity) must beperformed.A. Weight uniformityB.P. design:- Weigh 20 tablets individually (i.e. determine the weight of each tablet alone; X1, X2, X3…X20)- Calculate the average weight of tablets ( = Total weight of tablets )Number of tabletsAverage weight of tablets (X) = (X1+X2 +X3+…+ X20)/20Not more than two of the individual weights (for example, X1 and X7) deviate from the averageweight (X) by more than the % deviation shown in the table below and none deviates by morethan twice that %:N K B R COLLEGE OF PHARMACY AND RESEARCH CENTRE,MEERUT Page 37
  6. 6. QUALITY CONTROL AND QUALITY ASSURANCEOF VETERNERY DOSAGE FORMSPharmaceutical Average tabletweight Percentageform (X) deviationTablets 80 mg or less 10Tablets > 80- < 250 mg 7.5(IMPORTANT) Example for Weight uniformity test (B.P. design): - Weigh 20 tablets individually • (X1, X2, X3… X20) • For example; (200, 202, 190, 205, 201, 200, 198, 190, 199, 203, 210, 220, 210, 201, 202, • 199, 190, 195, 200, 200 mg) - Calculate the average weight of tablets • X = Total weight of tablets • Number of tablets • Average weight of tablets (X) = (200+202+190+ • 205+201+200+198+190+199+ 203+210+220+210+ 201+202+ 199+ • 190+195+200+200)/20 = • 201.75 mg • 7.% Error for a tablet= • Difference between Actual tablet weight & Average tablet weight x 100 • Average tablet weight • % error for tablet 1= 201.75 - 200/201.75 x 100= 0.86% • % error for tablet 2= 202 - 201.75/201.75 x 100= 0.12%N K B R COLLEGE OF PHARMACY AND RESEARCH CENTRE,MEERUT Page 37
  7. 7. QUALITY CONTROL AND QUALITY ASSURANCEOF VETERNERY DOSAGE FORMS • % error for tablet 3= 201.75 - 190/201.75 x 100= 5.82% • % error for tablet 4= 205 - 201.75/201.75 x 100= 1.61% • % error for tablet 5= ……………Calculate % error for each tablet:Tablet no 1 2 3 4 5 6 7 8 9% error 0.86 12 5 5.82 1.61 0.37 0.86 1.85 5.82 1.36Pharmacopoeial requirement:Not more than two of the individual tablet weights deviate from the average weight (X) by morethan 7.5% according to the following table and none deviate by double this %:Test result: Only one tablet (tablet number 12) deviated >7.5%,and this deviation (%error 9.04%) is less than 15 %, i.e. tablets passed this test successfullyB. Content uniformityUSP defines content uniformity test for tablets containing 50 mgor less of drug substance in caseof uncoated tablets and for all sugar coated tablets regardless to the drug content.USP design:Ten tablets are individually assayed for their content (according to the method described in theindividual monograph)The requirements for content uniformity are met if the amount of theactive ingredient in each tablet lies within the range of 85-115 % of the label claim.(If one or more tablet does not meet these criteria, additional tests asprescribed in the USP are required)1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20Tablet no:0.86 0.12 5.82 1.61 0.37 0.86 1.85 5.82 1.36 0.6 4.08 9.04 4.08 0.37 0.12 1.36 5.823.34 0.86 0.86% errorN K B R COLLEGE OF PHARMACY AND RESEARCH CENTRE,MEERUT Page 37
  8. 8. QUALITY CONTROL AND QUALITY ASSURANCEOF VETERNERY DOSAGE FORMS1- Tablet thickness and hardness test are non-compendial quality control tests2- Tablet thickness is important for tablet packaging3- Hardness does not affect disintegration or dissolution of the tablet4- If content uniformity test is required, the weight uniformity test is not required5- 1 Kg is a suitable hardness value for a satisfactory buccal tablet6- Disintegration test is a Pharmacopoeial Requirement for chewable tablets7- Content uniformity test is essential for all sugar coated tablets regardless to their drug content8- In weight uniformity test, tablets are individually assayed for their contentIII- What is the only suitable Quality Control Test forDexamethasone tablet (0.5 mg/Tab), to ensure a constant dose ofdrug between individual tablets- Friability test- Dissolution test- Hardness test- Weight uniformity- Content uniformity1- USP quality control test performed for tablets containing 20mg drug to ensure that eachinclude the correct dose2- Quality control test performed for tablets to ensure that each shows sufficient mechanicalstrength3- Quality control test performed for tablets to ensure that the drug is released in a controlled andreproducible way4- During the in-process quality control testing of tablet hardness, many tablet samples werefound to be very hard (10N K B R COLLEGE OF PHARMACY AND RESEARCH CENTRE,MEERUT Page 37

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