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Application of SUPAC-MR in Processing Postapproval Changes to Modified Release Sold Oral Dosage Forms

경구용 서방성/지연성 성형제품의 허가 후 변경사항 관리를 위한 SUPAC-MR 응용

  • 사홍기 (대구가톨릭대학교 약학대학) ;
  • 조미현 (대구가톨릭대학교 약학대학) ;
  • 박상애 (식품의약품안전청 의약품평가부) ;
  • 윤미옥 (식품의약품안전청 의약품평가부) ;
  • 강신정 (식품의약품안전청 의약품평가부)
  • Published : 2004.06.20

Abstract

The objective of this study was to scrutinize the rationale of SUPAC-MR and its application in processing postapproval changes to modified release solid oral dosage forms. The types of postapproval changes that were primarily covered with SUPAC-MR included variations in the components and composition, the site of manufacturing, batch size, manufacturing equipment, and manufacturing process. SUPAC-MR defined levels of postapproval changes that the industry might make. Classification of such categories was based on the likelihood of risk occurrence and potential impact of changes upon the safety and efficacy of approved drug products. In most cases, the changes could be classified into 3 levels. It described what chemistry, manufacturing, and control tests should be conducted for each change level. The important tests specified in SUPAC-MR were batch release, stability, in vitro dissolution, and in vivo bioequivalence tests. It then suggested what type of a filing report should be submitted to the FDA for each change level. In general, level 1 changes could be reported in an annual report, whereas level 2 and/or 3 changes could be submitted in changes-being-effected or prior approval supplements. It could be understood that the purpose of SUPAC-MR was to maintain the safety and quality of approved modified release solid oral dosage forms undergoing certain changes. At the same time, it contributed to providing a less burdensome regulatory process with the manufacturers when they wanted to make postapproval changes. European regulatory agencies also implemented SUPAC-like regulations in handling such changes to drug products. Therefore, in this study a recommendation was made for KFDA and the Korean industry to evaluate thoroughly the usefulness of these guidances and regulations in dealing with postapproval changes to modified release solid oral dosage forms.

Keywords

References

  1. FDA, Center for Drug Evaluation and Research, Guidance for Industry - SUPAC-MR: Modified release solid oral dosage forms; Scale-up and postapproval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing and in vivo bioequivalence documentation, September 1997
  2. FDA, Center for Drug Evaluation and Research, Guidance for Industry - Immediate release solid oral dosage forms; Scale-up and postapproval changes: Chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation, November 1995
  3. H. Sah, S.A. Park, M.O. Yun and S.J. Kang, Scrutiny made to SUPAC-IR dealing with postapproval changes in immediate release solid oral dosage forms, J. Kor. Pharm. Sci., 34, 57-71 (2004)
  4. M.J. Rathbone, J. Hadgraft and M.S. Roberts (Eds.), Modifled-Release Drug Delivery Technology, Marcel Dekker Inc, New York, NY, USA, pp. 1-996 (2003)
  5. FDA, Center for Drug Evaluation and Research, Guidance for Industry - Q1A(R2): Stability testing of new drug substances and products, November 2003
  6. ICH Guideline, Q1C: Stability testing for new dosage forms, November 1996
  7. ICH Guideline, Q1D: Bracketing and matrixing designs for stability testing of drug substances and drug products, Febmary 2002
  8. ICH Guideline, Q1E: Evaluation of stability data, February 2003
  9. FDA, Guidance for Industry - Extended release oral dosage forms: Development, evaluation and application of in vitrol in vivo correlations, September 1997
  10. FDA, Center for Drug Evaluation and Research, Guidance for dissolution testing of immediate release solid oral products, August 1997
  11. FDA, Center for Drug Evaluation and Research, Oral extended (controlled) release dosage forms: In vivo bioequivalence and in vitro dissolution testing, September 1993
  12. FDA, Center for Drug Evaluadon and Research, Guidance for Industry: SUPAC-IR/MR: Immediate release and modified release solid oral dosage forms; Manufacturing equipment addendum, January 1999
  13. FDA, Center for Drug Evaluadon and Research, Guidance for Industry: Changes to an approved NDA or ANDA, November 1999
  14. FDA, Center for Drug Evaluadon and Research, Guidance for Industry: Changes to an approved NDA or ANDA(revision 1), April 2004
  15. 식품의약품안전청 고시 제 2002-62호 '생물학적동등성시험기준' 제 3조 제 4항
  16. 일본국립의약품식품위생연구소(National Institute of Health Sciences), Division of Drugs, Guideline for bioequivalence studies for formulation changes of oral solid forms, February 2000
  17. European Commission, Note to Applicants: Guideline on dossier requirements for type IA and type IB notifications, July 2003
  18. European Commission, Note to Applicants: Procedures for marketing authorisation - Chapter 5. Variations, February 2004