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Response Surface Methodology in Pharma

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Vraj Soni
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0% found this document useful (0 votes)
47 views19 pages

Response Surface Methodology in Pharma

Uploaded by

Vraj Soni
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

RESPONSE SURFACE

METHODOLOGY
NAME OF PRESENTER

VRAJ SONI
D E VA N S H PAT E L
HIMANI GOHIL
P R I T PAT E L
DANISHA GREY
CONTENT OF PRESENTATION
Introduction to Response Surface Methodology

Components of RSM

Independent and Dependent Variables

Steepest Ascent and Descent Gradient

Practical Steps to Implement RSM

Overview of Types of RSM Designs

Central Composite Design (CCD)

Features of CCD

Observations and Conclusions


INTRODUCTION TO RESPONSE SURFACE
METHODOLOGY (RSM)

• Definition: A statistical tool to model and optimize processes,


exploring relationships between independent (input) and
dependent (output) variables.

• Key Applications in Pharmaceuticals:


1.Optimization of drug formulation (e.g., release profiles,
stability).
2.Process parameter tuning (e.g., granulation, drying).
3.Analytical method development.

• Purpose of RSM:To achieve the best possible outcomes with


COMPONENTS
OF RSM
• Independent Variables (Factors): Variables you manipulate (e.g., drug
concentration, pH).
• Dependent Variables (Responses): Outcomes you measure (e.g., drug
dissolution rate, stability).
• Interactions and Quadratic Effects: Study how variables interact or
affect responses non-linearly.

• Mathematical Model:
PHARMACEUTICAL EXAMPLE -
INDEPENDENT AND DEPENDENT

VARIABLES
Independent Variables
(Factors):
• Controllable parameters.
• Example:
• Polymer concentration (X1): 10%-
30%.
• Stirring speed (X2): 50-150 rpm.

• Dependent Variables
(Responses):
• Output measurements of
interest.
• Example:
• Drug release at 12 hours (Y).
GRAPHICAL REPRESENTATION OF RSM

• Optimizing Tablet
Disintegration Time
• Objective: Minimize disintegration
time for a tablet.

• Factors (Independent Variables):


• Binder concentration (X1): 1%-5%.
• Compression force (X2): 100-200N.

• Response (Dependent Variable):


• Disintegration time (Y) in seconds.
STEEPEST ASCENT AND DESCENT GRADIENT
• Steepest Ascent: Moves toward optimal conditions by incrementally
increasing input factors.
• Steepest Descent: Adjusts variables downward when conditions are
suboptimal.
PRACTICAL STEPS TO IMPLEMENT RSM IN
PHARMACEUTICALS

Optimize
Define Design Analyze Pinpoint
the Conduct Data Visualize the
the
Experime Trials Results combinatio
Problem Build
Identify nt Collect
regression Generate n of
models and response
critical factors Use factorial, experimental
examine surface and variables
data.
and desired axial, and interaction contour plots. yielding
responses. center points. terms. optimal
results.
OVERVIEW OF TYPES OF RSM
DESIGNS
Types of Designs:Central Composite Design
(CCD): Most widely used, suitable for quadratic models.
Box-Behnken Design (BBD): Fewer runs, avoids
extreme points.

Doehlert Design: Uniform coverage, fewer experiments.

Mixture Design: Proportion-focused for formulations.

Importance: Selection depends on the


number of actors,
desired resolution, and resource constraints.
CENTRAL COMPOSITE DESIGN (CCD)
• What is CCD?
A type of experimental design used to build quadratic
models.
• Purpose: Optimizes processes with curvature effects,
enabling a better understanding of variable interactions.
• Efficient for predicting the outcome of responses.

• Advantages
• Economical: Requires fewer runs than a full factorial
design.
• Robust: Detects interactions and quadratic effects
effectively.
FEATURES OF CCD
• Three Types of Points:
• Factorial Points: Corners of the
design space (e.g., 2^k runs
for kk factors).
• Axial Points: Extend the design
space along each axis to capture
curvature.
• Center Points: Ensure reproducibility
and assess variability.

• Design Structure:
• Consists of factorial design + axial
points + center points.
• Allows for accurate modeling of
quadratic relationships.
CENTRAL COMPOSITE
DESIGN
VALUE OF INDEPENDENT VARIABLE
MATHEMATICAL
MODEL:
RESULT AND OBSERVATION
Aspect Summary
Significant Surfactant concentration, homogenization time, and
Factors oil content.
Key Findings - Emulsifying conditions and ingredients significantly
impact nanoemulsion properties.
- Quadratic model accurately predicts responses like
droplet size, p-Anisidine value, and β-carotene
retention.
Optimization Achieved through numerical optimization using
Results desirability function.
Optimized - Surfactant concentration: 5.82%
Conditions - Homogenization time: 4 minutes
- Oil content: 6.50%

Outcome Enhanced protection of β-carotene under harsh


environmental conditions for food fortification.
THANK
YOU

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