Irene_I
☆    

Indonesia,
2019-05-27 11:38

Posting: # 20301
Views: 1,080
 

 Bioequivalence Study of Sulfa­sa­la­zine [Regulatives / Guidelines]

Dear All,

Have anyone here ever conducted Bioequivalence study of Sulfasalazine? Since we lack of literature in bioequivalence study of Sulfasalazine, could you please share us any references of this study? :confused:
Thank you very much

Regards,


Irene I
cakhatri
★    

India,
2019-05-28 08:48

@ Irene_I
Posting: # 20302
Views: 906
 

 Bioequivalence Study of Sulfasalazine

Dear Irene,

Please check this link for Sulfasalazine.

https://www.accessdata.fda.gov/drugsatfda_docs/psg/Sulfasalazine_DRtab_07073_RC2-10.pdf

Regards
Chirag
Helmut
★★★
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Homepage
Vienna, Austria,
2019-05-28 12:04

@ Irene_I
Posting: # 20304
Views: 876
 

 Sulfasalazine: My study

Hi Irene,

» Have anyone here ever conducted Bioequivalence study of Sulfasalazine?

Yes. My results (T1: 1×4 500 mg IR, T2: 1×4 500 mg enteric coated, R: 2,000 mg suspension, six-sequence Williams’ design, sampling for 60 hours, washout two weeks, 24 eligible subjects, plasma and urine). This study was performed for the originator. Both test products showed lower bioavailabilities of sulfasalazine and 5-ASA, whereas sulfapyridine and N-acetylsulfapyridine were BE. CVs for plasma:
  • Sulfasalazine
    • Cmax: 44.9%
      AUC0–t: 44.6%
  • 5-Aminosalicylic Acid
    • Cmax: 46.8%
      AUC0–t: 45.8%
  • Sulfapyridine
    • Cmax: 12.7%
      AUC0–t: 12.6%
  • N-Acetylsulfapyridine
    • Cmax: 7.42%
      AUC0–t: 7.95%
Given the high variabilities of Sulfasalazine and 5-ASA I suggest reference-scaling.

Cheers,
Helmut Schütz
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