DRUG DEVELOPMENT

From Research to Market

Bambang Widjaja
Dept. Farmasetika - Prodi Farmasi
FK UHT Surabaya

This presentation is for educational purpose only 1

 OUTLINE

INTRODUCTION

DRUG DISCOVERY & DEVELOPMENT

PRODUCT DEVELOPMENT

PROCESS DEVELOPMENT

CONCLUSION

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INTRODUCTION

DRUG DISCOVERY & DEVELOPMENT

PRODUCT DEVELOPMENT

PROCESS DEVELOPMENT

CONCLUSION

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PHARMA INDUSTRY

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INTRODUCTION

DRUG DISCOVERY & DEVELOPMENT

PRODUCT DEVELOPMENT

PROCESS DEVELOPMENT

CONCLUSION

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The stages from drug discovery to marketing approval (Rick Ng, 2015)

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Drug development costs (Schnatz, R.G., 2013)
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Aylin Sertkaya ,Anna Birkenbach ,Ayesha Berlind,John Eyraud
Eastern Research Group, Inc.

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FDA Drug Approval Process 11
FDA Drug Approval Process 12
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I. Introduction
II. Quality Management
III. Personnel
IV. Buildings and Facilities
V. Process Equipment
VI. Documentation and Records
VII. Materials Management
VIII. Production and In-process Control
IX. Packaging and Identification Labeling of APIs and Intermediates
X. Storage and Distribution
XI. Laboratory Controls
XII. Validation
XIII. Change Control
XIV. Rejection and Re-use of Materials
XV. Complaints and Recalls
XVI. Contract Manufacturers (including laboratories)
XVII. Agents, Brokers, Traders, Distributors, Repackers, and Relabellers
XVIII. Specific Guidance for APIs manufactured by Cell Cultures /Fermentation
XIX. APIs for Use in Clinical Trials 14
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 Substance Drug Manufacturer

cimetidine Tagamet SK&F

ranitidine Zantac Glaxo

famotidine Pepcid Yamanouchi

olanzapine Zyprexa Ely Lily

esomeprazole Nexium AztraZeneca

atorvastatin Lipitor Pfizer

clopidogrel Plavix Bristol-Myers

Squib/Sanofi

perindopril Bioprexum

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INTRODUCTION

DRUG DISCOVERY & DEVELOPMENT

PRODUCT DEVELOPMENT

PROCESS DEVELOPMENT

CONCLUSION

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Immel, B.K., Pharmaceutical Technology, July, 2001

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 API

Highly
Regulated

Manufact. Delivery
Quality-Safety-Efficacy
Process Forms

Excipients

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Quality
by
Design

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(Moheb Nasr, FDAs view on QbD, 2006)
Product Design & Development

Process Design & Development

Manufacturing Development

Continuous Improvement

Candidate Product
Selection Approval

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Selection of the API

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Biopharmaceutics Classification System (BCS)
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Examples of Chiral Drugs from Various Therapeutic Classes

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Selection of Manufacturing Process

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Selection of Excipients and Compatibility Study

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drug-excipient interactions :
- change of color
- drug degradation
- change of solubility
- change of dissolution
- decrease of potency

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DSC thermogram of glipizide, MCC and physical mixture of glipizide-
MCC showing NO INTERACTION

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DSC thermogram of glipizide, lactose and physical mixture of glipizide-
lactose showing an INTERACTION

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 Selection of Packaging Material

Permeability to Vapor of Various Packaging Materials

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(Method ASTM F 1249, 38C /90% RH)
Development of Analytical Methods

(USP 36)
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STABILITY STUDY

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 Climatic Zone ICH Q1A (R2)

Climatic Zone Definition Storage Condition

I temperate 21C/45% r.h

II subtropical & 25C/60% r.h

mediterranean
III hot, dry 30C/35% r.h

IV hot, humid 30C/70% r.h

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Asean Guideline on Stability Study of Drug Product ( Februari 2005)

Storage conditions Sampling intervals (month)

Accelerated 0, 1, 3, 6
40C 2C / 75% RH 5% RH
Real time 0, 3, 6, 9, 12, 18, 24, 36, 48, 60
30C 2C / 75% RH 5% RH

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INTRODUCTION

DRUG DISCOVERY & DEVELOPMENT

PRODUCT DEVELOPMENT

PROCESS DEVELOPMENT

CONCLUSION

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INTRODUCTION

DRUGDISCOVERY & DEVELOPMENT

PRODUCT DEVELOPMENT

PROCESS DEVELOPMENT

CONCLUSION

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 PUSTAKA
Badan Pengawas Obat dan Makanan Republik Indonesia: Peraturan Kepala
Badan POM RI
Cato, A., Sutton, L., 2002, Clinical Drug Trials and Tribulations, 2nd Ed., Marcel
Dekker Inc., NY
Gibson M., 2004, Pharmaceutical Preformulation and Formulation A Practical
Guide from Candidate Drug Selection to Commercial Dosage Forms, CRC, Fl
Rick Ng, 2015, Drugs From Discovery to Approval, 3rd Ed., John Wiley & Sons,
C anada
Schnatz, R.G., Modern-Day Drug Discovery and Development, in Felton, L.
(Ed.), 2012, Remington Essentials of Pharmaceutics, Pharmaceutical Press,
London, UK
The CDER Handbook
U.S FOOD & DRUG Administration : The Drug Development Process,
http://www.fda.gov/ForPatients/Approvals/Drugs/ucm405382.htm
USP 36

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Email : bambang_widjaja1@yahoo.com

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