This document provides an overview of pharmaceutical product development, focusing on achieving predictable therapeutic responses and ensuring consistent product quality. It details the preformulation phase, highlighting its importance in characterizing new drug compounds, and outlines regulatory requirements for stability and quality testing. The guidelines mentioned pertain to both small molecules and herbal products, emphasizing the necessity of thorough testing to support safe and effective drug formulation.

1. Unit 1
PHRAMACEUTICAL PRODUCT
DEVELOPMENT
ELECTIVE COURSE
IV/IV B.PHARM II SEM
Dr.K.L.DEEPTHI, M.PHARM PH.D
ASSOCIATE PROFESSOR
DEPARTMENT OF PHARMACEUTICS

2. Overview of Pharmaceutical Product
Development
• Objective:
To achieve a predictable
therapeutic response to a drug
included in a formulation which is
capable of large scale
manufacture with reproducible
product quality.
PROCESS OF PPD:
NEED
IDEAS
CONCEPT
IMPLEMENT
PRODUCT
MARKETING
CUSTOMERS

3. Steps In PPD

4. TYPES OF PRODUCTS
BREAK THROUGH PRODUCTS:
NEW TO WORLD PRODUCTS
• AIDS VACCINE
• COVID VACCINE

5. INCREMENTAL PRODUCTS

6. Process of PPD

8. REGULATORY REQUIREMENTS FOR
PREFORMULATION STUDIES
INTRODUCTION:
• Prior to nomination into full development, a candidate drug
should undergo a phase traditionally called
preformulation.Preformulation is the physiochemical
characterization of the solid and solution properties of
compounds.
• Preformulation encompasses all studies enacted on a new
drug compound in order to produce useful information for
subsequent formulation of a stable and
biopharmaceutically suitable drug dosage form.These
should focus on those physiochemical properties of new
compound that could effect drug performance and
development of an efficacious dosage form.

9. • DEFINITION:“
• A phase of a research and development process where the
preformulation scientist characterizes the physical , chemical
and mechanical properties of a new drug substance in order
to develop stable , safe and effective dosage forms”
• GOAL:
To establish the physico-chemical properties of a new drugTo
establish the data on drug-excipient compatibilityTo establish
API ‘s kinetic rate profile

10. REGULATORY REQUIREMENTS SMALL
MOLECULES/General:
1. Q1A(R2) Stability Testing of New Drug Substances and Products (Issued 11/2003,
Posted 11/20/2003);
2. Q1B Photo stability Testing of New Drug Substances and Products (Issued 11/1996,
Reposted 7/7/1998);
3. Q1C Stability Testing for New Dosage Forms (Issued 5/9/1997, Posted 3/19/1998);
4. Q1D Bracketing and Matrixing Designs for Stability Testing of New Drug Substances
and Products (Issued 1/2003, Posted 1/15/2003);
5. Q3A Impurities in New Drug Substances (Issued 2/10/2003, Posted2/10/2003
6. Q3B(R) Impurities in New Drug Products (Issued 11/2003, Posted 11/13/2003);
7. Q3C Impurities: Residual Solvents (Issued 12/24/1997, Posted 12/30/1997);
8. Q3C Tables and Lists (Posted 11/12/2003);
9. Q6A International Conference on Harmonization; Guidance on Q6A Specifications:
Test Procedures and Acceptance Criteria for New Drug Substances and New Drug
Products: Chemical Substances (12/29/2000);
10. Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
(Issued 8/2001, Posted 9/24/2001).

11. The general method of preparation is
provided under Sec312
•
The general method of preparation is provided under Sec
(a)(7)(iv)(a).
• The EMEA provides the following guidelines for herbal (botanical as
listed in United States) products:
• COMMITTEE FOR PROPRIETARY MEDICINE PRODUCTS
(CPMP)/QUALITY WORKING PARTY (QWP)/2819/00 [EUROPEAN
MEDICINES EVALUATION AGENCY (EMEA)/COMMITTEE ON
VETERINARY MEDICINAL PRODUCTS (CVMP)/814/00] Note for
Guidance on Quality of Herbal Medicinal Products (CPMP/CVMP
adopted July 01).CPMP/QWP/2820/00 (EMEA/CVMP/815/00)
• Note for Guidance on Specifications: Test procedures and
Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and
Herbal Medicinal Products (CPMP/CVMP adopted July 01).

12. REFERENCES
N.K.JAIN PHARMACEUTICAL PRODUCT
DEVELOPMENT