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Back to the forum  Query: 2018-05-22 04:34 UTC (UTC+2h)

2018-04-20 06:09

Posting: # 18704
Views: 648

 BCS III Classification [Dissolution / BCS / IVIVC]

Dear All,

I have a question concerning the criterion for classification of a pharmaceutical product as Class III. Some text would say there are two criteria namely: High Solubility and Low Permeability. However some other text would add a third criterion: Very Rapid Dissolution.

Which is correct? If the later is correct, then where do we classify a product with High Solubility, Low Permeability and Rapid Dissolution (ie 85% of the API does not go into solution within 15 minutes but will within 30 minutes or even beyond)?

Similarly, for BCS class I, must all products under this class be Rapidly Dissolving? If so, then how do we classify a product that's Highly Soluble, Highly Permeable and Moderately Dissolving (85% of API dissolves beyond 30 minutes across all physiologic pH.


Vienna, Austria,
2018-04-20 10:15

@ Obinoscopy
Posting: # 18707
Views: 543

 BCS-based biowaivers for Class III

Hi Scopy,

maybe you are mixing something up. BCS of the drug and applicability of BCS-based biowaivers of the drug product. Classes1 of the drug:
  1. high permeability, high solubility
      well absorbed, absorption rate higher than excretion
      BCS-based biowaiver generally possible
  2. high permeability, low solubility
      BA limited by solvation rate; IVIVC possible
  3. low permeability, high solubility
      BA limited by permeation rate
      BCS-biowaiver under certain conditions
  4. low permeability, low solubility
      low and highly variable BA
Whereas Class I drug products which are rapidly dissolving (≥85% dissolved in 30 minutes) may qualify for a biowaiver2 Class III drug products have to be very rapidly dissolving (≥85% dissolved in 15 minutes).
For details see the FDA’s Biowaiver Guidance and Appendix III of the EMA’s BE Guideline.

  1. Amidon GL, Lennernäs H, Shah VP, Crison JR. A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability. Pharm Res. 1995; 12(3): 413–20. doi:10.1023/A:1016212804288, [image] free resource.
  2. Yu LX, Amidon GL, Polli JE, Zhao H, Mehta MU, Conner DP, Shah VP, Lesko LJ, Chen ML, Lee VH, Hussain AS. Biopharmaceutics Classification System: The Scientific Basis for Biowaiver Extensions. Pharm Res. 2002; 19(7): 921-5. doi:10.1023/A:1016473601633, [image] free resource.

Helmut Schütz 

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2018-04-20 14:06

@ Helmut
Posting: # 18710
Views: 437

 BCS-based biowaivers for Class III

Dear Helmut,

Thanks for this clarification. I was actually leaning towards your explanation. Wanted to validate my thoughts.

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