Name: Thakur Pharmaceutical Product Development For B. Pharm 8th Semester PTU
Brand: Amit Book Depot
Price: 160 INR
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Thakur Pharmaceutical Product Development for B. Pharm 8th Semester PTU is an indispensable and comprehensive academic resource, meticulously crafted to align with the prescribed PTU syllabus for the B. Pharm 8th Semester Elective course. Authored by the esteemed academicians Dr. Khanderao Rajaram Jadhav, Khemchand Rajendra Surana, Eknath Damu Ahire, and Vijayraj Narendra Sonawane, this book serves as a complete guide for students aspiring to master the scientific and industrial principles of bringing a drug from concept to market.

Structured across five detailed modules, the book begins with a foundational overview of pharmaceutical product development, covering critical stages from new-product development strategies and product life-cycle management to the core scientific processes. It provides an in-depth exploration of preformulation studies, including essential parameters like polymorphism, partition coefficient, and drug-excipient compatibility. The text further guides students through formulation development for various dosage forms—solid, semisolid, and liquid—and concludes with comprehensive quality control testing protocols for tablets, capsules, parenterals, transdermal patches, and other delivery systems.

A significant portion of the book is dedicated to a dual-module, advanced study of pharmaceutical excipients, a critical component of modern formulation science. Module II delves into solvents, solubilizers, cyclodextrins, non-ionic surfactants, and semisolid excipients. Module III expands into specialized areas, detailing tablet and capsule excipients, directly compressible vehicles like microcrystalline cellulose and spray-dried lactose, coat materials, and excipients for parenteral and aerosol products. It also introduces polymers and agents used in Novel Drug Delivery Systems (NDDS), such as chitosan, poloxamer, and alginates, linking theoretical knowledge to specific industrial applications.

The book places strong emphasis on modern optimization techniques and quality by design (QbD) principles, which are pivotal in today's regulatory environment. It explains various Design of Experiment (DoE) methodologies, including factorial designs, response surface designs, and Taguchi design, and demonstrates their application in developing robust, high-quality formulations efficiently. This focus on QbD and risk assessment equips students with the mindset required for contemporary pharmaceutical development and regulatory submissions.

Finally, the text addresses the crucial aspect of packaging materials, covering selection criteria, functions, and quality control testing for glass, plastics, metals, and closures from a regulatory perspective. Published by Thakur Publications, this book is characterized by clear explanations, a logical flow mirroring the PTU syllabus, and end-of-module exercises that aid in exam preparation and concept reinforcement. It is not merely a book but a vital reference for B.Pharm students seeking to build a strong career in pharmaceutical industry roles in R&D, formulation, production, and quality assurance.

Have Doubts Regarding This Product ? Ask Your Question

Q1

Is this book strictly aligned with the Punjab Technical University (PTU) B.Pharm 8th Semester syllabus?

A1

Yes, this textbook is meticulously structured to cover all units and topics specified in the latest PTU syllabus for the Elective course on Pharmaceutical Product Development (Semester VIII). The module index directly corresponds to the syllabus units.
Q2

Does the book cover the latest concepts like Quality by Design (QbD)?

A2

Absolutely. Module 4 is entirely dedicated to Optimization Techniques and QbD. It covers the principles, objectives, advantages, implementation steps, and tools like risk assessment and Design of Experiment (DoE) within the QbD framework.
Q3

How detailed is the coverage of pharmaceutical excipients?

A3

The book provides an extensive, two-module deep dive into excipients. It covers not just traditional categories but also advanced topics like directly compressible vehicles, excipients for NDDS (Novel Drug Delivery Systems), and specific industrial applications, going beyond basic definitions.
Q4

Are preformulation studies explained in a practical manner?

A4

Yes, Module 1 details the stages of product development and optimization, with a comprehensive section on Preformulation. It explains key parameters like polymorphism, hygroscopicity, partition coefficient (Log P), and drug-excipient compatibility studies that are crucial for practical formulation work.
Q5

Does it include quality control tests for modern dosage forms like transdermal patches?

A5

Yes. Section 1.6 on Quality Control Testing includes evaluation methods for a wide range of dosage forms, including sustained-release systems, aerosols, nasal sprays, and transdermal patches, alongside conventional forms like tablets and capsules.
Q6

Is the topic of Design of Experiment (DoE) explained with different design types?

A6

Yes. Module 4 provides a dedicated study of Design of Experiment (DoE), explaining various types such as factorial designs, fractional factorial, Plackett-Burman, Central Composite, Box-Behnken, and Taguchi designs.
Q7

Does the book discuss the product development life cycle and strategy?

A7

Yes, the initial module covers Pharmaceutical Product Development fundamentals, including New-Product Development processes (from molecule identification to commercialization) and Product Life-Cycle Strategies.
Q8

Are solvents and solubilizers like cyclodextrins covered in detail?

A8

Yes, Module 2 has specific chapters on Solvents and Solubilizers (including water and alcohols) and a dedicated section on Cyclodextrins and Their Applications, which are important for enhancing drug solubility.
Q9

Does the book contain information on pilot batch manufacturing and scale-up?

A9

The New-Product Development section in Module 1 explicitly includes Pilot Batch Manufacturing as a key stage between sourcing raw materials and commercialization, addressing this important industrial step.
Q10

Is the content applicable to industry practices or purely academic?

A10

The book successfully bridges academic knowledge and industry practice. Chapters on excipient selection with industrial applications, QbD, optimization techniques, and packaging quality control are all framed with real-world pharmaceutical development processes in mind.

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Module 1: Pharmaceutical Product Development

1.1. Pharmaceutical Product Development

1.1.1. Introduction

1.1.2. Objectives

1.1.3. Qualities of Product Development

1.1.4. Consideration of Product Design

1.1.5. Product

1.1.5.1. Levels of Product

1.1.5.2. Quality Level

1.1.5.3. Features for Pharmaceutical Products

1.1.5.4. Dosage Form

1.1.5.5. Brand Name

1.1.5.6. Packaging

1.1.6. Product Classification

1.1.6.1. Prescription Products

1.1.6.2. OTC Products

1.1.7. Product Line Decisions

1.1.8. Product Mix Decisions

1.2. New-Product Development

1.2.1. Molecule Identification

1.2.2. Molecule Screening

1.2.3. Sourcing of Raw Material

1.2.4. Pilot Batch Manufacturing

1.2.5. Marketing Strategy Development

1.2.6. Test Marketing/Clinical Trial/User Trial

1.2.7. Commercialization

1.3. Product Life-Cycle Strategies

1.4. Stages of Product Development and Optimization

1.4.1. Preformulation

1.4.1.1. Organoleptic Properties

1.4.1.2. Purity of API and Excipients

1.4.1.3. Analytical Method

1.4.1.4. Solubility

1.4.1.5. Hygroscopicity

1.4.1.6. Dissociation/Ionization Constant

1.4.1.7. Partition Coefficient (LOG P)

1.4.1.8. Dissolution Behavior

1.4.1.9. Crystallinity and Polymorphism

1.4.1.10. Particle Size, Shape, and Surface Area

1.4.1.11. Bulk Density

1.4.1.12. Powder Flow Property

1.4.1.13. Stability

1.4.1.14. Drug-Excipient Compatibility Study

1.4.2. Formulation Development

1.4.2.1. Components of the Drug Product

1.4.2.2. Manufacturing Process Development

1.4.3. Stability Assessment

1.4.3.1. Importance of Stability Studies

1.4.3.2. Types of Stability Studies on Drug Substances

1.4.3.3. Stability Testing Methods

1.5. Manufacturing of Different Dosage Forms

1.5.1. Solid Dosage Forms

1.5.2. Semisolid Dosage Forms

1.5.3. Liquid Dosage Forms

1.5.3.1. Monophasic Liquid Dosage Forms

1.5.3.2. Biphasic Liquid Dosage Forms

1.6. Quality Control Testing of Pharmaceutical Dosage Forms

1.6.1. Evaluation of Tablets

1.6.1.1. Effervescent Tablets

1.6.1.2. Buccal Tablets

1.6.1.3. Orally Disintegrating Tablets

1.6.1.4. Sustained Controlled Release Dosage Forms

1.6.2. Evaluation of Capsules

1.6.3. Evaluation of Granules

1.6.4. Evaluation of Powders

1.6.5. Evaluation of Ointments

1.6.6. Evaluation of Creams

1.6.7. Evaluation of Suppositories

1.6.8. Evaluation of Syrups

1.6.9. Evaluation of Elixirs

1.6.10. Evaluation of Suspensions

1.6.11. Evaluation of Emulsions

1.6.12. Evaluation of Parenterals

1.6.13. Evaluation of Eye Drops

1.6.14. Evaluation of Aerosols

1.6.15. Evaluation of Nasal Sprays

1.6.16. Evaluation of Transdermal Patches

1.7. Summary

1.8. Exercise

Module 2: An Advanced Study of Pharmaceutical Excipients in Pharmaceutical Product Development—I

2.1. Pharmaceutical Excipients

2.1.1. Introduction

2.1.2. History of Use of Excipients in Pharmaceutical Formulations

2.1.3. Role of Excipients in Pharmaceutical Formulations

2.1.4. Criteria for Selection of Excipients

2.2. Solvents and Solubilizers

2.2.1. Water

2.2.2. Alcohols

2.3. Cyclodextrins and Their Applications

2.4. Non-ionic Surfactants and Their Applications

2.5. Polyethylene Glycols

2.6. Sorbitol

2.7. Suspending Agents

2.8. Emulsifying Agents

2.9. Semisolid Excipients

2.10. Other Excipients

2.10.1. Structure-Forming Excipients

2.10.2. Preservatives

2.10.3. Antioxidants

2.10.4. Gelling Agents

2.10.5. Emollients

2.10.6. Bases (Cream/Ointments/Suppositories)

2.10.6.1. Hydrocarbon Bases

2.10.6.2. Absorption Bases

2.10.6.3. Water-Removable Bases

2.10.6.4. Water-Soluble Bases

2.10.6.5. Miscellaneous Bases

2.11. Summary

2.12. Exercise

Module 3: An Advanced Study of Pharmaceutical Excipients in Pharmaceutical Product Development—II

3.1. Tablet and Capsule Excipients

3.1.1. Anti-adherents

3.1.2. Binders

3.1.3. Coatings

3.1.4. Disintegrants

3.1.5. Fillers

3.1.6. Flavors

3.1.7. Colors

3.1.8. Lubricants

3.1.9. Glidants

3.1.10. Sorbents

3.1.11. Preservatives

3.1.12. Sweeteners

3.2. Directly Compressible Vehicles

3.2.1. Lactose

3.2.2. α-Lactose Monohydrate

3.2.3. Anhydrous α-Lactose

3.2.4. Anhydrous β-Lactose

3.2.5. Spray-Dried Lactose

3.2.6. Agglomerated Lactose

3.2.7. Microcrystalline Cellulose

3.2.8. Hydroxypropylcellulose

3.2.9. Ethyl Cellulose

3.2.10. Sucrose

3.2.11. Di-Pac

3.2.12. Nu-Tab

3.2.13. Emdex and Maltrin

3.2.14. Mannitol

3.2.15. Starch

3.2.16. Starch 1500

3.2.17. Maltose

3.2.18. Dicalcium Phosphate Dihydrate

3.2.19. Emcompress

3.2.20. Fujicalin

3.2.21. Inulin

3.2.23. Cellactose

3.2.24. Pharmatose DCL 40

3.2.25. Prosolv

3.2.26. StarLac

3.3. Coat Materials

3.3.1. Plasticizers

3.3.2. Additives

3.3.3. Hydroxypropyl Methylcellulose

3.3.4. Methyl Hydroxyethyl Cellulose

3.3.5. Povidone

3.3.6. Hydroxypropylcellulose

3.3.7. Polyethylene Glycols

3.3.8. Solvents

3.3.9. Colorants

3.4. Excipients in Parenteral Products

3.4.1. Mannitol

3.4.2. Lactose

3.4.3. Sucrose

3.4.4. Polyethylene Glycol (PEG)

3.4.5. Polyvinyl Pyrrolidone (PVP)

3.4.6. Buffering Agents

3.4.7. Tonicity Adjusting Agents

3.4.8. Preservatives

3.4.9. Solubilizing Agents

3.5. Excipients in Aerosol Products

3.5.1. Propellants

3.5.2. Solvents/Co-Solvents

3.5.3. Buffering Agents

3.5.4. Preservatives

3.5.5. Antioxidants

3.5.6. Wetting Agents

3.5.7. Anti-Foaming Agents (Defoamers)

3.5.8. Humectants

3.6. Excipients for Formulation of NDDS

3.6.1. Pectins

3.6.2. Alginates

3.6.3. Starches

3.6.4. Gums

3.6.5. Guar Gum

3.6.6. Gum Acacia

3.6.7. Karaya Gum

3.6.8. Zein

3.6.9. Xanthan Gum

3.6.10. Tragacanth

3.6.11. Menthol

3.6.12. Caraway

3.6.13. Rosin

3.6.14. Chitin and Chitosan

3.6.15. Collagen

3.6.16. Polycaprolactone

3.6.17. Polyorthoesters

3.6.18. Thiolated Polymers

3.6.19. Poloxamer

3.7. Selection and Application of Excipients in Pharmaceutical Formulations with Specific Industrial Applications

3.8. Summary

3.9. Exercise

Module 4: Optimization Techniques in Pharmaceutical Product Development

4.1. Optimization Techniques in Pharmaceutical Product Development

4.1.1. Introduction

4.1.2. Important Terminologies

4.1.3. Optimization Benefits for Industry

4.1.4. Various Optimization Techniques

4.1.4.1. Continuous Optimization

4.1.4.2. Discrete Optimization

4.1.4.3. Unconstrained Optimization

4.1.4.4. Constrained Optimization

4.1.4.5. Deterministic Optimization

4.1.4.6. Stochastic Optimization

4.1.4.7. Graphical Optimization

4.1.4.8. Brute-force Search (Feasibility and Grid Search)

4.1.4.9. Numerical Optimization

4.2. Design of Experiment (DoE)

4.2.1. Introduction

4.2.2. Types of Experimental Design

4.2.2.1. Screening Designs

4.2.2.2. Response Surface Designs

4.2.2.3. Factorial Designs

4.2.2.4. Fractional Factorial Design (FFD)

4.2.2.5. Plackett-Burman Designs (Hadamard Designs)

4.2.2.6. Central Composite Design (Box-Wilson design)

4.2.2.7. Box-Behnken Designs

4.2.2.8. Taguchi Design

4.2.2.9. Mixture Design

4.3. Optimization by Factorial Designs

4.3.1. Introduction

4.3.2. Full Factorial Design

4.3.3. Fractional Factorial Design

4.4. Quality by Design (QbD)

4.4.1. Introduction

4.4.2. Historical Background

4.4.3. Objectives

4.4.4. Advantages

4.4.5. Determination of Critical Quality Attributes (CQA)

4.4.6. Designing and Implementing Control Strategy

4.4.7. Elements of QbD

4.4.8. Steps for Pharmaceutical QbD Implementation

4.4.9. Tools of QbD

4.4.9.1. Risk Assessment

4.4.9.2. Design of Experiment

4.4.9.3. PAT

4.4.10. Applications of Quality by Design

4.4.10.1. Benefits to Industry

4.4.10.2. Pharmaceutical Development

4.4.10.3. Used in PAT

4.4.10.4. Quality Target Product Profile for the ANDA Product

4.4.10.5. Other Applications

4.4.11. Problems in Adoption of QbD

4.5. Summary

4.6. Exercise

Module 5: Packaging Materials

5.1. Packaging Materials

5.1.1. Introduction

5.1.2. Functions of Packaging

5.1.2.1. Containment

5.1.2.2. Protection

5.1.2.3. Presentation and Information

5.1.2.4. Labels

5.1.2.5. Repacking, Relabeling, and Dispensing

5.1.2.6. Package Inserts for Patients (Patient Information Leaflets)

5.1.2.7. Compliance

5.1.2.8. Protection of Patients

5.1.2.9. Detection of Packaging Materials

5.2. Selection of Packaging Materials

5.2.1. Glass

5.2.2. Plastics

5.2.3. Metal

5.2.4. Closures

5.2.5. Rubber Closures

5.2.6. Caps or Overseals

5.3. Quality Control Testing of Packaging Material

5.3.1. General Considerations

5.3.2. Quality Control

5.3.3. Sampling

5.3.4. Testing Program

5.3.5. Audit and Inspection

5.3.6. Quality Specifications

5.4. Summary

5.5. Exercise

Latest Syllabus of Pharmaceutical Product Development For B. Pharm 8th Semester PTU

Semester VIII – Elective course on Pharmaceutical Product Development

No. of Hours: 3, Tutorial: 1, Credit Points: 4

Unit-I (10 Hours)

- Introduction to pharmaceutical product development, objectives, and regulations related to preformulation, formulation development, stability assessment, manufacturing, and quality control testing of different types of dosage forms

Unit II: (10 Hours)

- An advanced study of pharmaceutical excipients in pharmaceutical product development with a special reference to the following categories:

i. Solvents and solubilizers

ii. Cyclodextrins and their applications

iii. Non-ionic surfactants and their applications

iv. Polyethylene glycols and sorbitols

v. Suspending and emulsifying agents

vi. Semisolid excipients

Unit-III (10 Hours)

- An advanced study of pharmaceutical excipients in pharmaceutical product development with a special reference to the following categories:

i. Tablet and capsule excipients

ii. Directly compressible vehicles

iii. Coat materials

iv. Excipients in parenteral and aerosol products

v. Excipients for formulation of NDDS

- Selection and application of excipients in pharmaceutical formulations with specific industrial applications

Unit IV: (08 Hours)

- Optimization techniques in pharmaceutical product development.

- A study of various optimization techniques for pharmaceutical product development with specific examples.

- Optimization by factorial designs and their applications.

- A study of QbD and its application in pharmaceutical product development.

Unit-V (07 Hours)

- Selection and quality control testing of packaging materials for pharmaceutical product development—regulatory considerations.

Module 1: Pharmaceutical Product Development

1.1. Pharmaceutical Product Development

1.1.1. Introduction

1.1.2. Objectives

1.1.3. Qualities of Product Development

1.1.4. Consideration of Product Design

1.1.5. Product

1.1.5.1. Levels of Product

1.1.5.2. Quality Level

1.1.5.3. Features for Pharmaceutical Products

1.1.5.4. Dosage Form

1.1.5.5. Brand Name

1.1.5.6. Packaging

1.1.6. Product Classification

1.1.6.1. Prescription Products

1.1.6.2. OTC Products

1.1.7. Product Line Decisions

1.1.8. Product Mix Decisions

1.2. New-Product Development

1.2.1. Molecule Identification

1.2.2. Molecule Screening

1.2.3. Sourcing of Raw Material

1.2.4. Pilot Batch Manufacturing

1.2.5. Marketing Strategy Development

1.2.6. Test Marketing/Clinical Trial/User Trial

1.2.7. Commercialization

1.3. Product Life-Cycle Strategies

1.4. Stages of Product Development and Optimization

1.4.1. Preformulation

1.4.1.1. Organoleptic Properties

1.4.1.2. Purity of API and Excipients

1.4.1.3. Analytical Method

1.4.1.4. Solubility

1.4.1.5. Hygroscopicity

1.4.1.6. Dissociation/Ionization Constant

1.4.1.7. Partition Coefficient (LOG P)

1.4.1.8. Dissolution Behavior

1.4.1.9. Crystallinity and Polymorphism

1.4.1.10. Particle Size, Shape, and Surface Area

1.4.1.11. Bulk Density

1.4.1.12. Powder Flow Property

1.4.1.13. Stability

1.4.1.14. Drug-Excipient Compatibility Study

1.4.2. Formulation Development

1.4.2.1. Components of the Drug Product

1.4.2.2. Manufacturing Process Development

1.4.3. Stability Assessment

1.4.3.1. Importance of Stability Studies

1.4.3.2. Types of Stability Studies on Drug Substances

1.4.3.3. Stability Testing Methods

1.5. Manufacturing of Different Dosage Forms

1.5.1. Solid Dosage Forms

1.5.2. Semisolid Dosage Forms

1.5.3. Liquid Dosage Forms

1.5.3.1. Monophasic Liquid Dosage Forms

1.5.3.2. Biphasic Liquid Dosage Forms

1.6. Quality Control Testing of Pharmaceutical Dosage Forms

1.6.1. Evaluation of Tablets

1.6.1.1. Effervescent Tablets

1.6.1.2. Buccal Tablets

1.6.1.3. Orally Disintegrating Tablets

1.6.1.4. Sustained Controlled Release Dosage Forms

1.6.2. Evaluation of Capsules

1.6.3. Evaluation of Granules

1.6.4. Evaluation of Powders

1.6.5. Evaluation of Ointments

1.6.6. Evaluation of Creams

1.6.7. Evaluation of Suppositories

1.6.8. Evaluation of Syrups

1.6.9. Evaluation of Elixirs

1.6.10. Evaluation of Suspensions

1.6.11. Evaluation of Emulsions

1.6.12. Evaluation of Parenterals

1.6.13. Evaluation of Eye Drops

1.6.14. Evaluation of Aerosols

1.6.15. Evaluation of Nasal Sprays

1.6.16. Evaluation of Transdermal Patches

1.7. Summary

1.8. Exercise

Module 2: An Advanced Study of Pharmaceutical Excipients in Pharmaceutical Product Development—I

2.1. Pharmaceutical Excipients

2.1.1. Introduction

2.1.2. History of Use of Excipients in Pharmaceutical Formulations

2.1.3. Role of Excipients in Pharmaceutical Formulations

2.1.4. Criteria for Selection of Excipients

2.2. Solvents and Solubilizers

2.2.1. Water

2.2.2. Alcohols

2.3. Cyclodextrins and Their Applications

2.4. Non-ionic Surfactants and Their Applications

2.5. Polyethylene Glycols

2.6. Sorbitol

2.7. Suspending Agents

2.8. Emulsifying Agents

2.9. Semisolid Excipients

2.10. Other Excipients

2.10.1. Structure-Forming Excipients

2.10.2. Preservatives

2.10.3. Antioxidants

2.10.4. Gelling Agents

2.10.5. Emollients

2.10.6. Bases (Cream/Ointments/Suppositories)

2.10.6.1. Hydrocarbon Bases

2.10.6.2. Absorption Bases

2.10.6.3. Water-Removable Bases

2.10.6.4. Water-Soluble Bases

2.10.6.5. Miscellaneous Bases

2.11. Summary

2.12. Exercise

Module 3: An Advanced Study of Pharmaceutical Excipients in Pharmaceutical Product Development—II

3.1. Tablet and Capsule Excipients

3.1.1. Anti-adherents

3.1.2. Binders

3.1.3. Coatings

3.1.4. Disintegrants

3.1.5. Fillers

3.1.6. Flavors

3.1.7. Colors

3.1.8. Lubricants

3.1.9. Glidants

3.1.10. Sorbents

3.1.11. Preservatives

3.1.12. Sweeteners

3.2. Directly Compressible Vehicles

3.2.1. Lactose

3.2.2. α-Lactose Monohydrate

3.2.3. Anhydrous α-Lactose

3.2.4. Anhydrous β-Lactose

3.2.5. Spray-Dried Lactose

3.2.6. Agglomerated Lactose

3.2.7. Microcrystalline Cellulose

3.2.8. Hydroxypropylcellulose

3.2.9. Ethyl Cellulose

3.2.10. Sucrose

3.2.11. Di-Pac

3.2.12. Nu-Tab

3.2.13. Emdex and Maltrin

3.2.14. Mannitol

3.2.15. Starch

3.2.16. Starch 1500

3.2.17. Maltose

3.2.18. Dicalcium Phosphate Dihydrate

3.2.19. Emcompress

3.2.20. Fujicalin

3.2.21. Inulin

3.2.23. Cellactose

3.2.24. Pharmatose DCL 40

3.2.25. Prosolv

3.2.26. StarLac

3.3. Coat Materials

3.3.1. Plasticizers

3.3.2. Additives

3.3.3. Hydroxypropyl Methylcellulose

3.3.4. Methyl Hydroxyethyl Cellulose

3.3.5. Povidone

3.3.6. Hydroxypropylcellulose

3.3.7. Polyethylene Glycols

3.3.8. Solvents

3.3.9. Colorants

3.4. Excipients in Parenteral Products

3.4.1. Mannitol

3.4.2. Lactose

3.4.3. Sucrose

3.4.4. Polyethylene Glycol (PEG)

3.4.5. Polyvinyl Pyrrolidone (PVP)

3.4.6. Buffering Agents

3.4.7. Tonicity Adjusting Agents

3.4.8. Preservatives

3.4.9. Solubilizing Agents

3.5. Excipients in Aerosol Products

3.5.1. Propellants

3.5.2. Solvents/Co-Solvents

3.5.3. Buffering Agents

3.5.4. Preservatives

3.5.5. Antioxidants

3.5.6. Wetting Agents

3.5.7. Anti-Foaming Agents (Defoamers)

3.5.8. Humectants

3.6. Excipients for Formulation of NDDS

3.6.1. Pectins

3.6.2. Alginates

3.6.3. Starches

3.6.4. Gums

3.6.5. Guar Gum

3.6.6. Gum Acacia

3.6.7. Karaya Gum

3.6.8. Zein

3.6.9. Xanthan Gum

3.6.10. Tragacanth

3.6.11. Menthol

3.6.12. Caraway

3.6.13. Rosin

3.6.14. Chitin and Chitosan

3.6.15. Collagen

3.6.16. Polycaprolactone

3.6.17. Polyorthoesters

3.6.18. Thiolated Polymers

3.6.19. Poloxamer

3.7. Selection and Application of Excipients in Pharmaceutical Formulations with Specific Industrial Applications

3.8. Summary

3.9. Exercise

Module 4: Optimization Techniques in Pharmaceutical Product Development

4.1. Optimization Techniques in Pharmaceutical Product Development

4.1.1. Introduction

4.1.2. Important Terminologies

4.1.3. Optimization Benefits for Industry

4.1.4. Various Optimization Techniques

4.1.4.1. Continuous Optimization

4.1.4.2. Discrete Optimization

4.1.4.3. Unconstrained Optimization

4.1.4.4. Constrained Optimization

4.1.4.5. Deterministic Optimization

4.1.4.6. Stochastic Optimization

4.1.4.7. Graphical Optimization

4.1.4.8. Brute-force Search (Feasibility and Grid Search)

4.1.4.9. Numerical Optimization

4.2. Design of Experiment (DoE)

4.2.1. Introduction

4.2.2. Types of Experimental Design

4.2.2.1. Screening Designs

4.2.2.2. Response Surface Designs

4.2.2.3. Factorial Designs

4.2.2.4. Fractional Factorial Design (FFD)

4.2.2.5. Plackett-Burman Designs (Hadamard Designs)

4.2.2.6. Central Composite Design (Box-Wilson design)

4.2.2.7. Box-Behnken Designs

4.2.2.8. Taguchi Design

4.2.2.9. Mixture Design

4.3. Optimization by Factorial Designs

4.3.1. Introduction

4.3.2. Full Factorial Design

4.3.3. Fractional Factorial Design

4.4. Quality by Design (QbD)

4.4.1. Introduction

4.4.2. Historical Background

4.4.3. Objectives

4.4.4. Advantages

4.4.5. Determination of Critical Quality Attributes (CQA)

4.4.6. Designing and Implementing Control Strategy

4.4.7. Elements of QbD

4.4.8. Steps for Pharmaceutical QbD Implementation

4.4.9. Tools of QbD

4.4.9.1. Risk Assessment

4.4.9.2. Design of Experiment

4.4.9.3. PAT

4.4.10. Applications of Quality by Design

4.4.10.1. Benefits to Industry

4.4.10.2. Pharmaceutical Development

4.4.10.3. Used in PAT

4.4.10.4. Quality Target Product Profile for the ANDA Product

4.4.10.5. Other Applications

4.4.11. Problems in Adoption of QbD

4.5. Summary

4.6. Exercise

Module 5: Packaging Materials

5.1. Packaging Materials

5.1.1. Introduction

5.1.2. Functions of Packaging

5.1.2.1. Containment

5.1.2.2. Protection

5.1.2.3. Presentation and Information

5.1.2.4. Labels

5.1.2.5. Repacking, Relabeling, and Dispensing

5.1.2.6. Package Inserts for Patients (Patient Information Leaflets)

5.1.2.7. Compliance

5.1.2.8. Protection of Patients

5.1.2.9. Detection of Packaging Materials

5.2. Selection of Packaging Materials

5.2.1. Glass

5.2.2. Plastics

5.2.3. Metal

5.2.4. Closures

5.2.5. Rubber Closures

5.2.6. Caps or Overseals

5.3. Quality Control Testing of Packaging Material

5.3.1. General Considerations

5.3.2. Quality Control

5.3.3. Sampling

5.3.4. Testing Program

5.3.5. Audit and Inspection

5.3.6. Quality Specifications

5.4. Summary

5.5. Exercise

Have Doubts Regarding This Product ? Ask Your Question

Q1

Is this book strictly aligned with the Punjab Technical University (PTU) B.Pharm 8th Semester syllabus?

A1

Yes, this textbook is meticulously structured to cover all units and topics specified in the latest PTU syllabus for the Elective course on Pharmaceutical Product Development (Semester VIII). The module index directly corresponds to the syllabus units.
Q2

Does the book cover the latest concepts like Quality by Design (QbD)?

A2

Absolutely. Module 4 is entirely dedicated to Optimization Techniques and QbD. It covers the principles, objectives, advantages, implementation steps, and tools like risk assessment and Design of Experiment (DoE) within the QbD framework.
Q3

How detailed is the coverage of pharmaceutical excipients?

A3

The book provides an extensive, two-module deep dive into excipients. It covers not just traditional categories but also advanced topics like directly compressible vehicles, excipients for NDDS (Novel Drug Delivery Systems), and specific industrial applications, going beyond basic definitions.
Q4

Are preformulation studies explained in a practical manner?

A4

Yes, Module 1 details the stages of product development and optimization, with a comprehensive section on Preformulation. It explains key parameters like polymorphism, hygroscopicity, partition coefficient (Log P), and drug-excipient compatibility studies that are crucial for practical formulation work.
Q5

Does it include quality control tests for modern dosage forms like transdermal patches?

A5

Yes. Section 1.6 on Quality Control Testing includes evaluation methods for a wide range of dosage forms, including sustained-release systems, aerosols, nasal sprays, and transdermal patches, alongside conventional forms like tablets and capsules.
Q6

Is the topic of Design of Experiment (DoE) explained with different design types?

A6

Yes. Module 4 provides a dedicated study of Design of Experiment (DoE), explaining various types such as factorial designs, fractional factorial, Plackett-Burman, Central Composite, Box-Behnken, and Taguchi designs.
Q7

Does the book discuss the product development life cycle and strategy?

A7

Yes, the initial module covers Pharmaceutical Product Development fundamentals, including New-Product Development processes (from molecule identification to commercialization) and Product Life-Cycle Strategies.
Q8

Are solvents and solubilizers like cyclodextrins covered in detail?

A8

Yes, Module 2 has specific chapters on Solvents and Solubilizers (including water and alcohols) and a dedicated section on Cyclodextrins and Their Applications, which are important for enhancing drug solubility.
Q9

Does the book contain information on pilot batch manufacturing and scale-up?

A9

The New-Product Development section in Module 1 explicitly includes Pilot Batch Manufacturing as a key stage between sourcing raw materials and commercialization, addressing this important industrial step.
Q10

Is the content applicable to industry practices or purely academic?

A10

The book successfully bridges academic knowledge and industry practice. Chapters on excipient selection with industrial applications, QbD, optimization techniques, and packaging quality control are all framed with real-world pharmaceutical development processes in mind.