Advancing technologies in Drug

Discovery and Formulation development

: A Regulatory Perspective

Supervised by: Presented by:

Dr. Sanju Nanda Kanika Chawla
M. Pharmacy
III SEM

Department of Pharmaceutical Sciences (MDU, Rohtak)

1
CONTENTS

• INTRODUCTION TO TITLE
• LITERATURE REVIEWS
• AIM AND OBJECTIVES
• PLAN OF WORK

DEPARTMENT OF PHARMACEUTICAL SCIENCES (MDU, ROHTAK) 2

INTRODUCTION

• Pharmaceutical Drug development is an expensive, time consuming and

uncertain process that takes years to complete.
• Developing a commercially successful drug involves a series of compromises,
each of which may result in costly bottlenecks, inefficiencies and unacceptably
high failure rates.
• BENEFITS OF DRUG DEVELOPMENT
• Extending life expectancy
• Reducing health care cost
DEPARTMENT OF PHARMACEUTICAL SCIENCES (MDU, ROHTAK) 3
EXAMPLES OF SOME NEW TECHNOLOGIES AND
FORMULATIONS
• Microneedle array
• Aquatech
• Mucogrip
• Parenteral Nano Emulsion
• Matrix
• 3D Printed Body Parts
• Bionic eye
DEPARTMENT OF PHARMACEUTICAL SCIENCES (MDU, ROHTAK) 4
AIM & OBJECTIVES

• AIM
The aim of present work is to study the role of various advancing technologies in drug discovery and
formulation development and their current regulatory scenario.
• OBJECTIVES :- After literature search it was inferred that the major technologies, which have influenced
drug discovery and formulation development are:-
• Nanotechnology
• Biotechnology
• Herbal Technology
• Information Technology
• Packaging Technologyy
DEPARTMENT OF PHARMACEUTICAL SCIENCES (MDU, ROHTAK) 5
CONTDD….

I. Collect from literature suitable evidences of technologies being used in

drug discovery and formulation development.
II. A study of patents filled and commercial products out of these technologies
III. Regulatory status of these technologies.

DEPARTMENT OF PHARMACEUTICAL SCIENCES (MDU, ROHTAK) 6

 LITERATURE REVIEW
▪ Costas Kaparissides, 2006 To minimize drug degradation and loss, to prevent harmful side-effects
and to increase drug bioavailability and the fraction of the drug accumulated in desired zone,
various drug delivery and drug targeting systems are currently under development. Nanoparticles
and nanoformulations have already been applied as drug delivery systems with great success and
nanoparticulate drug delivery systems have still greater potential for many applications, including
anti tumour therapy, gene therapy, AIDS radiotherapy, antibiotics etc.
▪ Manthan D. Janodia, 2007 Drug development is a risky and costly affair and involves a lot of
money and time. Many compounds that are screened initially fail to make it to next stage of
development. If FDA decides, after applications filed at each stage of drug development, that
the benefit of drug overweighs the risks associated with it, a drug is given marketing approval.
But the road to success is painstaking and the companies have to take the risk associated with
drug development.

7
• Bobby George, 2011 the use of stem cells as medicine is a promising and upcoming area of research as they may be
able to help the body to regenerate damaged or lost tissue in a host of diseases like Parkinson’s, multiple sclerosis,
heart disease, liver disease, spinal cord damage, cancer and many more. In US and Europe we have guidelines for
stem cells in place while in India we do not have well defined regulatory framework for “STEM CELL BASED
PRODUCTS”. In Europe Directive 2003/63/EC , Directive 2001/20/EC and Directive 2004/23/EC deals with stem
cells regulations. In the US, use of cell therapy products is codified within the Code of Federal Regulations in the
following sections: IND regulations (21 CFR 312), biologics regulations (21 CFR 600) and cGMP (21 CFR 211).
• Pratibha Muntha, 2016 Targeting the drug to specific organ and tissue has become one of the critical goals as the
use of conventional dosage forms do not help in achieving the desired concentration at target site during a proper
time period. The recently drug discovered new drug delivery system lipid , protein and polymer technologies with
better lipid distribution in body, prevention from drug degradation and reducing clearance time.

DEPARTMENT OF PHARMACEUTICAL SCIENCES (MDU, ROHTAK) 8

PLAN OF WORK

• Identification of some advancing technologies and their role in DD and

formulation.
• Detailed study of nanotechnology and its regulatory status in India, USA and Europe.
• Detailed study of biotechnology and its regulatory status in India, USA and Europe.
• Detailed study of information technology and its regulatory status in India, USA and Europe.
• Detailed study of packaging technology and its regulatory status in India, USA and Europe.
• Detailed study of herbal technology and its regulatory status in India, USA and Europe.
• Summary and conclusion

DEPARTMENT OF PHARMACEUTICAL SCIENCES (MDU, ROHTAK) 9

REFERENCES

• Costas Kaparissides, Sofia Alexandridou, Katerina Kotti and Sotira

Chaitidou ;“ Recent Advances in Novel Drug Delivery Systems”; Pg 8-9
;2006
• Bobby George;“Regulations and guidelines governing stem cell based
products: Clinical considerations; 2011
• Manthan janodia, D. Shreedhar, Pise Ajay; Drug Development Process : A
review; 2007
DEPARTMENT OF PHARMACEUTICAL SCIENCES (MDU, ROHTAK) 10
DEPARTMENT OF PHARMACEUTICAL SCIENCES (MDU, ROHTAK) 11