Pharm-618-Biopharmaceutics and
Pharmacokinetics
By: Dr. Shabnam Nazir
Asst. Professor, Department of Pharmacy
KUST
Lecture 16
“ Introduction to IVIVC
and its various levels
“In-Vivo-In-Vitro Correlation IVIVC”
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invitro invivo correlation, Assignments of Biopharmaceutics and Pharmacokinetics
in vitro in vivo correlation in bioparmaceutics
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Pharm-618-Biopharmaceutics and
Pharmacokinetics
By: Dr. Shabnam Nazir
Asst. Professor, Department of Pharmacy KUST
Lecture 16
“ Introduction to IVIVC
and its various levels
“In-Vivo-In-Vitro Correlation IVIVC”
Outline
Topic: Introduction to IVIVC and its various levels Various levels of IVIVC correlation Introduction to IVIVC FDA and USP definitions of IVIVC
Topic: Introduction to IVIVC and its various levels
Definition
The establishment of a rational relationship between a biological property, or a parameter derived from a biological property produced by a dosage form, and a physicochemical property or characteristic of the same dosage form. It is popularly known as USP definition.
What is IVIVC
Topic: Introduction to IVIVC and its various levels
Definition by FDA
What is IVIVC
IVIVC is a predictive mathematical model describing the relationship between an in vitro property of a dosage form and a relevant in vivo response. Generally, the in vitro property is the rate or extent of drug dissolution or release while the in vivo response is the plasma drug concentration or amount of drug absorbed.
Cont….
Topic: Introduction to IVIVC and its various levels Identified levels are: Correlation level A Correlation level C Multiple Correlation level C Correlation level D Correlation level B
Level A Correlation Topic: Introduction to IVIVC and its various levels This level of correlation is the highest category of correlation and represents a point-to-point relationship between in vitro dissolution rate and in vivo input rate of the drug from the dosage form.
Level B correlation
Topic: Introduction to IVIVC and its various levels A level B IVIVC utilizes the principles of statistical moment analysis. In this level of correlation, the mean in vitro dissolution time (MDT vitro) of the product is compared to either mean in vivo residence time (MRT) or the mean in vivo dissolution time (MDT vivo).
Level C Correlation
Topic: Introduction to IVIVC and its various levels In this level of correlation, one dissolution time point (t50%, t90%, etc.) is compared to one mean pharmacokinetic parameter such as AUC, tmax or Cmax This is the weakest level of correlation as partial relationship between absorption and dissolution is established. Level C correlations can be useful in the early stages of formulation development when pilot formulations are being selected.
Level D Correlation Topic: Introduction to IVIVC and its various levels Level D correlation is a rank order and qualitative analysis and is not considered useful for regulatory purposes. It is not a formal correlation but serves as an aid in the development of a formulation or processing procedure
Outline
Topic: Factors to consider for IVIVIC studies Internal predictibility Factors to be considered for IVIVC BCS External predictibility
Cont…..
Topic: Factors to consider for IVIVIC studies It is also used as a tool for developing the in-vitro dissolution specification BCS becomes a basic tool in determining the conditions under which IVIVCs are anticipated.
Bioavailability studies for determination of IVIVC
Topic: Factors to consider for IVIVIC studies A bioavailability study should be conducted to determine the plasma concentration -time profile for each of the formulation. Sufficient number of subjects is important to conduct such studies in order to determine the performance of the formulations.
Cont…..
Topic: Factors to consider for IVIVIC studies Depending on the intended application of an IVIVC and the therapeutic index of the drug, evaluation of prediction error internally and/or externally may be appropriate.
Cont….
Topic: Factors to consider for IVIVIC studies External predictability evaluation is not necessary unless the drug is a narrow therapeutic index, or, if the internal predictability criteria are not met i.e. prediction error internally is inconclusive