Four Stage Drug Development Scale Up Studies and Commercialization.
pre-formulation ,prototype dev, biological aspect , scale up and commercialization.
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Four Stage Drug Development.
1. Four stage drug development: scaleup
studies And Commercialization.
PRESENTED BY:
GANESH PATIL
REG NO:PE/2022/301
M.S.PHARMACEUTICS
DEPARTMENT, NIPER HYDERABAD.
2. Contents
Introduction
overview of stages in the drug development process
Stage 1: Pre-formulation
Stage 2: Prototype Development
Stage 3: Biological Aspects
Stage 4: Scale Up Studies and Commercialization
3. Introduction
Drug development is a complex process that involves several stages, from initial
discovery of a potential drug target to approval and commercialization of a new
drug.
Here's an overview of the key stages in the drug development process:
Stage 1: Pre-formulation
Stage 2: Prototype Development
Stage 3: Biological Aspects
Stage 4: Scale Up Studies and Commercialization
Pre-formulation
Prototype
Development
Biological Aspects
Scale Up Studies
and
Commercialization
4. Pre-formulation
Prototype
Development
Biological Aspects Scale Up Studies Commercialization
Bulk
characterization
Solubility analysis
Stability analysis
Biopharmaceutical
factor
Preclinical study
Clinical
Development
Emerging Trend
Conceptualize a
product
Exp. Design and
Product
Optimization
Patent and
Evergreen strategy
Product Life Cycle
Commercialization
realities
Factor Affecting
Commercialization
Pilot study
Full Scale Plant
5. Stage 1: PRE-FORMULATION
Pre-formulation referred to as the development stage in which characterization, as well as
establishment of the physicochemical properties of the drug, are taking place.
Bulk Characterization
✓ Particle size
✓ Powder flow properties
✓ Crystallinity and polymorphism
Solubility Analysis
✓ Polarity of drug
✓ Solvents & co-solvent
✓ Hydrotropy
✓ Complexation
Stability Analysis
✓ Solution stability
✓ Solid state stability
✓ ICH Photostability
6. Stage 2:Prototype Development
IDEA CONCEPT
Prototype drug product development is the process of creating a preliminary
version of a new pharmaceutical product for testing and evaluation
Ideas are usually converted into a concept that in the case of pharmaceutical products
includes the product’s benefits and features.
7. Stage 2: Prototype Development
REVISING
&REDEFINING
TEST
PROTOTYPE
DESIGN
IDEATION
Prototype Development Process Involves following Steps:
Phase 1 Phase 2 Phase 3 Phase 4
8. Stage 2: Prototype Development
Conceptualize a product:
• Aspects regarding the active pharmaceutical ingredients (APIs) and their chemical nature are covered.
• Safety and efficacy concerns during the preclinical and the clinical stages of drug developments are
also discussed in addition to the issues of regulation and intellectual property.
• Pharmaceutical chemists and formulators typically tend to modify the drug’s chemical, physical,
economic, and biological characteristics by following the technique of salt conversion of drug
substances E.g.
Experimental Design and Product Optimization:
With cyclic aliphatic
amine DICLOFENAC With Sodium Salt
Solubility
Purpose of
experiment
Select factor
to be
investigated
Select proper
measurable
response
Exp.Design
Conduct The
Exp.
Analyze Data
Obtained
Conclusion
Based on
Analysis
9. The product optimization process is required in the development of pharmaceutical products in order to
ensure that the product fulfills the specified requirements of the regularity authorities and complies with
the quality standards.
The general outputs that should be attained from the optimization step are mainly a defined active
ingredient, excipients, pack and product specifications, in addition to a quantitatively defined formula of
the active ingredients and the excipients amounts used.
Parenteral Dosage Forms
Oral Solid Dosage Forms
Topical/Transdermal Dosage Forms
Inhalational Formulations
Parenteral
dosage form
Transdermal
dosage form
Ophthalmic
formulation
Inhalational
formulation
Nasal
solution
Oral solid
dosage form
10. Stage 3:Biological Aspect
A.Pre-clinical study
In Vitro Screening:
Cell based assay : MTT Assay
In silico Model:
Animal Model
Mouse
Rat
Rabbit
IN
SILICO
MODEL
Ligand
Similarity
& cross-
reactivity
Binding
Site
Detection
Data
analysis
&visualizatio
n
Docking
11. Stage 3:Biological Aspect
B.Clinical trials :
Clinical trial are the final stage of drug development before a new drug can be approved for
use in patients.
They are carefully designed and conducted studies that assess the safety and efficacy of a new
drug in human subjects.
Different Phases of Clinical Trials includes:
Phase 0 : Micro dosing
Phase 1 : Human pharmacology and safety
Phase 2 : Therapeutic Exploratory
Phase 3 : Therapeutic Confirmatory
Phase 4 : Post marketing surveillance
12. Phase Name Conducted on purpose
0 Micro dosing Studies Healthy volunteer
(Small Number)
To Know
Pharmacokinetics
I Human Pharmacology & Safety Healthy Volunteer
(20-100)
To know
maximumTolerable
dose ( safety)
II Therapeutic exploratory Homogeneous
population (100-
150)
To Establish
Therapeutic
Efficacy
III Therapeutic confirmatory Heterogeneous
population(3000)
To Confirm
Therapeutic
Efficacy
IV Post Marketing Surveillance Large number of
population
To Know Long
Term Adverse
Effect
14. Stage 4:Scale Up Studies
Scale up studies are a critical part of drug development that involve the transition
from laboratory-scale production to commercial-scale production.
scale up studies ensure the development of a manufacturing process that is reliable,
efficient, and cost-effective, while ensuring that the drug product maintains its
quality and safety profile.
Primary Goals of Scale up studies:
Manufacturing process development
Process validation
Cost Optimization
15. Stage 4:Commercialization
Large-scale manufacturing: The primary goal of commercial-scale studies is to
produce the drug product at a large scale that can meet the demands of the market.
This involves establishing a manufacturing process that is reliable, efficient, and cost-
effective, and that can produce a consistent product that meets regulatory
requirements.
Commercialization of drug Product Involve:
Large Scale Production
Quality Control
Regulatory compliance
16. References
Basant Amarji1 , Sara Nidal Abed2 et.al,2018.’ Four Stages of Pharmaceutical Product
Development: Pre formulation, Prototype Development and Scale-Up, Biological Aspects, and
Commercialization’ chapter 18,(638-650)
Gobind Rai Garg, Sparsh Gupta, Review of pharmacology.16th edition 2022 oct; page no.11-12
Deore AB, dhumane JR, wagh HV, Sonawane RB, The Stages of Drug Discovery and Development
Process. Asian Journal of Pharmaceutical Research and Development. 2019; 7(6):62-67