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Definition: It refers to the establishment of rational
relationship between a biological response produced
by a dosage form and a physico chemical
characteristics.
1. Quality control procedures
2. Tablet or Capsule disintegration
3. Instrumental methods of analysis
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Important Purpose
1.Providing necessary process control
2.Determing stability of dosage form
3.Facilitatinmg certain regulatory determinations
Definition: In-vivo studies deals with the
evolution of bioavailability and bio
equivalence of pharmaceutical dosage forms
using parameters like AUC,Cmax etc..
PARAMETERS:
1.Drug concentration in plasma at each
sampling time
2.Apparent rate constant for elimination
3.Biological half life
4. Urinary excretion rate and amount
excreted in urine at infinity
Correlation:
Correlation is a measure of relationship between
two mathematical variables or measured data values,
which includes the Pearson correlation coefficient as
a special case
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1.This is the highest category of relation which act as a
meaningful quality control procedure predictive of
invivo performance of formulation
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In-Vitro
Dissolution testing of product to asses release rates
under various conditions.
Plasma Level Data:
It is established both for a batch of
material.
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Batch to Batch consistency.
Development of new dosage form.
Assisting validity.
Establishing a Relationship.
Data form previous bio-
availability.
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Advantages
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Drug or Product Requirements for an
IVIVC
• Linear pharmacokinetics
• Preferably BCS I or II
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Data Requirements
In vitro data
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Data Requirements
In vivo data
• cross-over design
• (biobatch)
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Mathematical Techniques
Assessment of in vivo drug release or absorption
from plasma profiles:
• Model-dependant
based on the mass balance among the pharmacokinetic
compartments
(e.g. Wagner-Nelson, Loo-Riegelman)
• Model-independant
based on Theory of Linear System Analysis
(Convolution / Deconvolution)
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Purpose of IVIVC and BCS
Reduction of regulatory burden: IVIVC in
lieu of additional in vivo experiments, leading
to
Time/Cost savings during product development
Scale-up, post approval changes
Biowaiver
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Rapid and similar dissolution
High Solubility
High permeability
Wide therapeutic window
Excipients
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Registration of Changes for Existing Products
where a Robust IVIVC can Substitute a
Bioequivalence Study
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Specification Setting for Modified Release
Products (EMEA)
In recent times much efforts has gone into establishing the invitro invivo
correlations for different types of control release formulations.
Physico chemical propeties of the invitro environment are simulated with those
invivo followed by comparision of the invitro release profiles with the invivo
absoprtion profile.
The development of control release dosage forms has been a major step
forward for therapy. However, the challenge of overcoming the vagaries
of the gastro intestinal tract exists.
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REFERENCES:
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Any Queries???
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THANK YOU
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