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The role of dissolution in the demonstration of bioequivalence

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PharmaCon2007 Congress, Dubrovnik, Croatia "New Technologies and Trends in Pharmacy, Pharmaceutical Industry and Education" http://www.pharmacon2007.com Abstract is available at http://www.pharmaconnectme.com

TechnologieBusiness
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THE ROLE OF DISSOLUTION IN THE DEMONSTRATION OF BIOEQUIVALENCE Prof.Dr.Nevin ÇELEBİ Gazi University Faculty of Pharmacy Department of Pharmaceutical Technology PharmaCon 2007-Dubrovnik
OUTLINE ,[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution ,[object Object]
Dissolution rate ,[object Object]
 
[object Object]
Effects of factors on dissolution rate of solid dosage forms ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Effects of factors on dissolution rate of solid dosage forms ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Effects of factors on dissolution rate of solid dosage forms ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution test ,[object Object],[object Object]
Dissolution test ,[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution Test Equipment ,[object Object],[object Object],[object Object],[object Object],[object Object]
Official dissolution apparatus ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 1 - Basket ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Klein S., Hands-on-Dissollution workshop,İstanbul,2005
USP apparatus 1 - Basket ,[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 2 - Paddle ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 3 – Reciprocating cylinder ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 4 – Flow-Through Cell ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
USP apparatus 5 – Paddle over disk ,[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
[object Object],[object Object],[object Object]
Dissolution/In vitro Release Testing-Important Tool ,[object Object],[object Object],[object Object],[object Object],[object Object]
Role of Dissolution Testing in Regulating Pharmaceuticals ,[object Object],[object Object],[object Object]
Policy Related Dissolution BA/BE Guidances ,[object Object],[object Object],[object Object],[object Object],http://www.fda.gov/cder/guidance/index.htm
Setting Dissolution Specification (FDA) ,[object Object],[object Object],[object Object]
Setting Dissolution Specification(FDA) ,[object Object],[object Object],[object Object]
Guidance of BY/BE (EMEA2001) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Guidance of BY/BE (EMEA2001) ,[object Object],[object Object],[object Object],[object Object]
Dissolution-Based Biowavers ,[object Object]
Dissolution-Based Biowavers ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution-Based Biowavers ,[object Object],[object Object],[object Object],[object Object],[object Object]
Dissolution Specifications (FDA) ,[object Object],[object Object],[object Object],[object Object]
Dissolution Specifications (FDA) ,[object Object],[object Object],[object Object],[object Object]
 
The comparison of dissolution profiles ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
The comparison of dissolution profiles ,[object Object],[object Object]
Difference factor (f 1 ) n is the number of time points R t is the dissolution value of the reference batch at time t, and T t is the dissolution value of the test batch at time t.
Similarity factor (f 2 ) n is the number of time points Rt is the mean percent drug dissolved of e.g a reference product, Tt is the mean percent drug dissolved of e.g a test product
Similarity factor (f 2 ) ,[object Object],[object Object],[object Object],[object Object],[object Object]
Similarity factor (f 2 ) ,[object Object]
[object Object]
Biopharmaceutics Classification System(BCS) ,[object Object],[object Object]
According to BCS,drug substances are classified as follows: ,[object Object],BCS for Immediate Release (IR) products Case by case Low Low IV Permeability Low High III Dissolution High Low II Gastric Emptying High High I Absorption rate control Permeability Solubility Class
BCS (Cont’d) ,[object Object],[object Object]
BCS (Cont’d) ,[object Object],[object Object],[object Object]
BCS (Cont’d) ,[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
Reference product-EU origin ,[object Object]
Reference product-EU origin ,[object Object]
Graffner C., Eur.Pharm.Sci.,29,288-298 (2006)
Summary ,[object Object]
[object Object],[object Object]
Dissolution ,[object Object]
Dissolution ,[object Object],[object Object]
Dissolution ,[object Object]
Dissolution ,[object Object]
Dissolution test ,[object Object],[object Object]
Dissolution Guidance ,[object Object],[object Object]
Dissolution-Based Biowavers ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object]
Regulation aspects of drug dissolution from a European perspective ,[object Object],[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object],[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
Regulation aspects of drug dissolution from a European perspective (Con’t) ,[object Object]
[object Object]
Graffner C., Eur.Pharm.Sci.,29,288-298 (2006)

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The role of dissolution in the demonstration of bioequivalence

  • 1. THE ROLE OF DISSOLUTION IN THE DEMONSTRATION OF BIOEQUIVALENCE Prof.Dr.Nevin ÇELEBİ Gazi University Faculty of Pharmacy Department of Pharmaceutical Technology PharmaCon 2007-Dubrovnik
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  • 37. Difference factor (f 1 ) n is the number of time points R t is the dissolution value of the reference batch at time t, and T t is the dissolution value of the test batch at time t.
  • 38. Similarity factor (f 2 ) n is the number of time points Rt is the mean percent drug dissolved of e.g a reference product, Tt is the mean percent drug dissolved of e.g a test product
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