Successfully reported this slideshow.
We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. You can change your ad preferences anytime.

pharmacopoeial standards for tablet

2,306 views

Published on

ip,bp,usp pharmacopoeial standards for tablet

Published in: Health & Medicine
  • Be the first to comment

pharmacopoeial standards for tablet

  1. 1. Pharmacopoeial Standards for tablet
  2. 2. Indian Pharmacopoeia Types of Tablet Uncoated Film Coated Enteric Coated Dispersible Tablet Modified Release Tablet Soluble Tablet Effervescent Tablet For use in mouth (Chewable, Lozenges, Sublingual) Orodispersible
  3. 3. Standards for Tablets • Content of Active Ingredient • Uniformity of weight • Uniformity of Content • Disintegration • Friability Test • Uniformity of dispersion • Dissolution
  4. 4. Content of Active Ingredient 1) Assay of Active 2) 20 tabs: - take avg. weight of tablet and follow procedure as per assay.
  5. 5. Uniformity of Content or Content Uniformity IP: - Active less than 10mg or 10%, BP:- Active less than 2 mg or 2%, USP:- Active less than 25mg or 25%. • 10 tabs limit NMT 1 tab deviate 85 – 115% & none outside 75 – 125% of the Avg value/IP/BP/USP (Relative Standard Deviation less than or equal to 6%), • If 2 or 3 individual values are outside the limits 85 – 115% of the Avg value, & none outside 75 – 125% repeat for 20 tabs. • Complies when 30 tabs NMT 3 of the individual values are outside the limit 85 – 115% of the Avg value, and none outside 75 – 125%.
  6. 6. Weight Variation Limits IP/BP Limit USP 80 mg or less 10% 130mg or less More than 80mg or Less than 250mg 7.5% 130mg to 324mg 250mg or more 5% More than 324mg Weigh individually 20 units selected at random or, for singledose preparations in individual containers, the contents of 20 units, and calculate the average weight. Not more than two of the individual weights deviate from the average weight by more than the percentage shown in the table and none deviates by more than twice that percentage.
  7. 7. Disintegration Uncoated Tablet NMT 15 min, in water with Disc 370C ± 20C Coated Tablet NMT 30 min, In water with Disc for Film Coated Tab, and NMT 60 min Other than Film coated tablet Enteric Coated Tab Intact for 1 hr in 0.1 N HCl & disintegrate within 2 hr in Mixed 6.8 Phosphate buffer. According to USP 1 hr in Simulated gastric fluid, then in Simulated Intestinal Fluid. Dispersible/Soluble Within 3 min in water at 250C ± 10C (IP) & 15 – 250C (BP) Orodispersible Within 1 min Effervescent Tab 5 min in 250 ml water at 20 – 300C (IP) & 5 min in 200 ml water at 15-250C (BP) Buccal & Sublingual Not Applicable but dissolve within 15 – 30 min. DT Apparatus:- Mesh Apperture:- 2mm (#10), Cycles:- 28 – 32 cycles/min, 50 – 60 mm distance from bottom & top, Temp of water 370C ± 20C. If 1 or 2 tablets or capsules fail to disintegrate, repeat the test on 12 additional tablets or capsules; not less than 16 of the total of 18 tablets or capsules tested disintegrate.
  8. 8. Friability Test • This test is additional to check crushing strength of tablet by this test one can check Capping &/or Lamination. USP limit is 0.5 to 1%. Rotation: - 25 rpm or 100 rotations in 4 min. • For tablets weight equal to or less than 650 mg, take tablets corresponding to 6.5 g. For tablets with a unit mass of more than 650 mg, take a sample of 10 tablets. The tablets should be carefully dedusted prior to testing. Accurately weigh the tablet , and place the tablets in the drum. Rotate the drum 100 times, and remove the tablets. Remove any loose dust from the tablets as before, and accurately weigh.
  9. 9. Uniformity of dispersion • Place 2 tablets in 100 ml of water and stir gently until completely dispersed. A smooth dispersion is obtained which passes through a sieve screen with a nominal mesh aperture of 710 mm (sieve number 22).
  10. 10. Dissolution • Conventional-release dosage forms LEVEL NUMBER TESTED ACCEPTANCE CRITERIA S1 6 Each unit is not less than D* + 5 per cent**. S2 6 Average of 12 units (S1 +S2) is equal to or greater than D, and no unit is less than D –15 per cent**. S3 12 Average of 24 units (S1+S2+S3)is equal to or greater than D, not, More than 2 units are less than D – 15 per cent** and no unit is less than D – 25 per cent**. Unless otherwise specified, the requirements are met if the quantities of active substance dissolved from the dosage units conform to above Table. If the results do not conform to the requirements at stage S1 given in the table, continue testing with additional dosage units through stages S2 and S3 unless the results conform at stage S2. *D is the amount of dissolved active ingredient specified in the individual monograph, expressed as a percentage of the labelled content. **Percentages of the labelled content.
  11. 11. Prolonged-release dosage forms • Unless otherwise specified, the requirements are met if the quantities of active substance dissolved from the dosage units conform to Table 2. If the results do not conform to the requirements at stage L1 given in the table, continue testing with additional dosage units through stages L2 and L3 unless the results conform at stage L2. The limits embrace each value of D, the amount dissolved at each specified dosing interval. Where more than one range is specified, the acceptance criteria apply to each range.
  12. 12. Level Number tested Acceptance criteria L1 6 No individual value lies outside each of the stated ranges and no individual value is less than the stated amount at the final test time. L2 6 The average value of the 12 units (L1 + L2) lies within each of the stated ranges and is not less than the stated amount at the final test time; none is more than 10 per cent of labelled content outside each of the stated ranges; and none is more than 10 per cent of labelled amount below the stated amount at the final test time. L3 12 The average value of the 24 units (L1 + L2 + L3) lies within each of the stated ranges, and is not less than the stated amount at the final test time; not more than 2 of the 24 units are more than 10 per cent of labelled content outside each of the stated ranges; not more than 2 of the 24 units are more than 10 per cent of labelled content below the stated amount at the final test time; and none of the units is more than 20 per cent of labelled content outside each of the stated ranges or more than 20 per cent of labelled content below the stated amount at the final test time
  13. 13. USP
  14. 14. Modified-release dosage forms Method A • Acid stage- Place 750 ml of 0.1M HCL in the vessel, and assemble the apparatus. Warm the dissolution medium to 36.5º to 37.5º. Place one dosage unit in the apparatus, cover the vessel and operate the apparatus at the specified rate. After 2 hours of operation in the acid medium, withdraw an aliquot of the liquid and proceed immediately as directed under Buffer stage. Perform the analysis of the aliquot using a suitable assay method. • Buffer stage- Complete the operations of adding the buffer and adjusting the pH within 5 minutes. With the apparatus operating at the rate specified, add to the medium in the vessel 250 ml of a 0.2 M solution of trisodium phosphate dodecahydrate that has been warmed to 36.5º to 37.5º. Adjust, if necessary, with 2M HCL or 2M NAOH to a pH of 6.8 ± 0.05. 2M HCL or 2M NAOH to a pH of 6.8 ± 0.05.
  15. 15. Method B • Acid stage- Place 1000 ml of 0.1M HCL in the vessel and assemble the apparatus. Set temp. 36.5º to 37.5º. Place one dosage unit in the apparatus. After 2 hours of operation in the acid medium, withdraw an aliquot of the liquid and proceed immediately as directed under Buffer stage. Perform the analysis of the aliquot using a suitable assay method. • Buffer stage- Use buffer that has previously been warmed to 36.5º to 37.5º. 1000 ml of pH 6.8 phosphate buffer, prepared by mixing 3 volumes of 0.1M HCL with 1 volume of 0.2 M solution of trisodium phosphate dodecahydrate and adjusting, if necessary, with 2M HCL or 2M NAOH to a pH of 6.8 ± 0.05. This may also be done by removing from the apparatus the vessel containing the acid and replacing it with another vessel containing the buffer and transferring the dosage unit to the vessel containing the buffer. Continue to operate the apparatus for 45 minutes, or for the specified time. At the end of this period, withdraw an aliquot of the liquid and perform the analysis using a suitable assay method.
  16. 16. Acid stage Level Number tested Acceptance criteria A1 6 No individual value exceeds 10 per cent dissolved. A2 6 The average value of the 12 units (A1 + A2) is not more than 10 per cent dissolved, and no individual unit is greater than 25 per cent dissolved. A3 12 The average value of the 24 units (A1 + A2 + A3) is not more than 10 per cent dissolved, and no individual unit is greater than 25 per cent dissolved. Acid stage- Unless otherwise specified, the requirements of this part of the test are met if the quantities, based on the percentage of the labelled content of active substance dissolved from the units tested conform to Table . Continue the testing through the 3 levels unless the results of both acid and buffer stages conform at an earlier level.
  17. 17. BUFFER STAGE LEVEL Number tested Acceptance criteria B1 6 No unit is less than D + 5 per cent* B2 6 The average value of the 12 units (B1 + B2) is equal to or greater than D,and no unit is less than D – 15 per cent*. B3 12 The average value of 24 units (B1 + B2 + B3) is equal to or greater than D, not more than 2 units are less than D – 15 per cent*, and no unit is less than D – 25 per cent*. •percentages of the labelled content. Buffer stage. Unless otherwise specified, the requirements of this part of the test are met if the quantities, based on the percentage of the labelled content of active substance dissolved from the units tested conform to Table 4. Continue the testing through the 3 levels unless the results of both acid and buffer stages conform at an earlier level. The value of D in Table is 75 per cent dissolved unless otherwise specified. The quantity, D, is the specified total amount of active substance dissolved in both the acid and buffer stages, expressed as a percentage of the labelled content.

×