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E-grāmata: Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products

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Sarfaraz K. Niazi (Therapeutic Proteins International, LLC, USA)

Formāts: 456 pages
Izdošanas datums: 05-Dec-2019
Izdevniecība: CRC Press
Valoda: eng
ISBN-13: 9781351593502

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Formāts: 456 pages
Izdošanas datums: 05-Dec-2019
Izdevniecība: CRC Press
Valoda: eng
ISBN-13: 9781351593502

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The Handbook of Pharmaceutical Manufacturing Formulations, Third Edition: Volume Three, Liquid Products is an authoritative and practical guide to the art and science of formulating drugs for commercial manufacturing. With thoroughly revised and expanded content, this third volume of a six-volume set, compiles data from FDA and EMA new drug applications, patents and patent applications, and other sources of generic and proprietary formulations including author’s own experience, to cover the broad spectrum of cGMP formulations and issues in using these formulations in a commercial setting. A must-have collection for pharmaceutical manufacturers, educational institutions, and regulatory authorities, this is an excellent platform for drug companies to benchmark their products and for generic companies to formulate drugs coming off patent.

Features:

? Largest source of authoritative and practical formulations, cGMP compliance guidance and self-audit suggestions

? Differs from other publications on formulation science in that it focuses on readily scalable commercial formulations that can be adopted for cGMP manufacturing

? Tackles common difficulties in formulating drugs and presents details on stability testing, bioequivalence testing, and full compliance with drug product safety elements

? Written by a well-recognized authority on drug and dosage form development including biological drugs and alternative medicines

Preface to the Series-Third Edition

xxv

Preface to the Series-Second Edition

xxvii

Preface to the Series-First Edition

xxxi

Preface to the Volume-First Edition

xxxiii

Author

xxxv

Part I Regulatory and Manufacturing Guidance

Chapter 1 Manufacturing Considerations in Liquid Formulations

(6)

I Introduction

(1)

II Facilities

(1)

III Equipment

(1)

IV Raw Materials

(1)

V Compounding

(1)

VI Microbiological Quality

(1)

VII Oral Suspensions

(1)

VIII Product Specifications

(1)

IX Process Validation

(1)

X Stability

(1)

XI Packaging

(3)

Chapter 2 Oral Solutions and Suspensions

(4)

I Introduction

(1)

II Facilities

(1)

III Equipment

(1)

IV Raw Materials

(1)

V Compounding

(1)

VI Microbiological Quality

(1)

VII Oral Suspension Uniformity

(1)

VIII Product Specifications

(1)

IX Process Validation

(1)

X Stability

(1)

XI Packaging

(2)

Chapter 3 The FDA Drug Product Surveillance Program

(10)

I Background

(1)

II Implementation

(2)

A Objectives

(1)

B Strategy

(2)

1 Biennial Inspection of Manufacturing Sites

(1)

2 Inspection of Systems

(1)

3 A Scheme of Systems for the Manufacture of Drugs and Drug Products

(1)

III Program Management Instructions

(1)

A Definitions

(1)

1 Surveillance Inspections

(1)

2 Compliance Inspections

(1)

3 State of Control

(1)

4 Drug Process

(1)

5 Drug Manufacturing Inspection

(1)

B Inspection Planning

(1)

C Profiles

(1)

IV Inspectional Observations

(5)

A Investigational Operations

(5)

1 General

(1)

2 Inspection Approaches

(1)

3 System Inspection Coverage

(3)

4 Sampling

(1)

5 Inspection Teams

(1)

6 Reporting

(1)

V Analytical Observations

(1)

A Analyzing Laboratories

(1)

B Analysis

(1)

VI Regulatory/Administrative Strategy

(2)

Chapter 4 Changes to Approved NDAs and aNDAs

(12)

I Introduction

(1)

II Reporting Categories

(1)

III General Requirements

(1)

IV Assessing the Effect of Manufacturing Changes

(1)

A Assessment of the Effects of the Change

(1)

1 Conformance to Specifications

(1)

2 Additional Testing

(1)

B Equivalence

(1)

C Adverse Effect

(1)

V Components and Composition

(1)

VI Manufacturing Sites

(1)

A General Considerations

(1)

B Major Changes (Prior Approval Supplement)

(1)

C Moderate Changes (Supplement-Changes Being Effected)

(1)

D Minor Changes (Annual Report)

(1)

VII Manufacturing Process

(2)

A General Considerations

(1)

B Major Changes (Prior Approval Supplement)

(1)

C Moderate Changes (Supplement-Changes Being Effected)

(1)

D Minor Changes (Annual Report)

(1)

VIII Specifications

(2)

A General Considerations

(1)

B Major Changes (Prior Approval Supplement)

(1)

C Moderate Changes (Supplement-Changes Being Effected)

(1)

D Minor Changes (Annual Report)

(1)

IX Package

(1)

A General Considerations

(1)

B Major Changes (Prior Approval Supplement)

(1)

C Moderate Changes (Supplement-Changes Being Effected)

(1)

D Minor Changes (Annual Report)

(1)

X Labeling

(1)

A General Considerations

(1)

B Major Changes (Prior Approval Supplement)

(1)

C Moderate Changes (Supplement-Changes Being Effected)

(1)

D Minor Changes (Annual Report)

(1)

XI Miscellaneous Changes

(1)

A Major Changes (Prior Approval Supplement)

(1)

B Moderate Changes (Supplement-Changes Being Effected)

(1)

C Minor Changes (Annual Report)

(1)

XII Multiple Related Changes

(1)

Glossary

(1)

Chapter 5 Formulation Considerations of Liquid Products

(10)

I Solubility

(1)

II Chemical Modification

(1)

III Preservation

(1)

IV Sweetening Agents

(1)

V Flavors

(1)

VI Viscosity

(1)

VII Appearance

(1)

VIII Chemical Stability

(1)

IX Physical Stability

(1)

X Raw Material

(1)

XI Manufacturing Equipment

(1)

XII Manufacturing Directions

(1)

XIII Packaging

(1)

XIV Particle Size and Shape

(1)

XV Suspensions

(1)

XVI Emulsions

(2)

Emulsions

(2)

XVII Powder for Reconstitution

(1)

XVIII Nasal Spray Products

(3)

A Inhalation Solutions and Suspensions

(1)

B Inhalation Sprays

(1)

C Pump Delivery of Nasal Products

(1)

D Spray Content Uniformity for Nasal Products

(1)

E Spray Pattern and Plume Geometry of Nasal Products

(1)

F Droplet-Size Distribution in Nasal Products

(1)

G Particle-Size Distribution for Nasal Suspensions

(1)

XIX Emulsification and Solubilization

(1)

XX Complexing

(1)

XXI Hydrophilization

(1)

XXII Stabilizing Suspensions

(2)

Chapter 6 Container Closure Systems

(12)

I Introduction

(1)

A Definitions

(1)

B Current Good Manufacturing Practice, the Consumer Product Safety Commission, and Requirements on Containers and Closures

(1)

C Additional Considerations

(1)

II Qualification and Quality Control of Packaging Components

(7)

A Description

(1)

B Information about Suitability

(1)

C Stability Data (Packaging Concerns)

(1)

D Inhalation Drug Products

(1)

E Injection and Ophthalmic Drug Products

(1)

F Liquid-Based Oral and Topical Drug Products and Topical Delivery Systems

(1)

G Solid Oral Dosage Forms and Powders for Reconstitution

(11)

1 Polyethylene Containers (USP 661)

(1)

2 Single-Unit Containers and Unit-Dose Containers for Capsules and Tablets (USP 671)

(1)

3 Multiple-Unit Containers for Capsules and Tablets (USP 671)

(1)

III Other Dosage Forms

(1)

III Postapproval Packaging Changes

(1)

IV Type III Drug Master Files

(1)

V Bulk Containers

(1)

Bibliography

(2)

Chapter 7 Material for Containers

(6)

I Glass Containers

(1)

II Nonplasticized Poly(Vinyl Chloride) for Containers for Noninjectable Aqueous Solutions

(1)

III Polyethylene Terephthalate for Containers for Preparations Not for Parenteral Use

(1)

IV Nonplasticized Poly(Vinyl Chloride) for Containers for Dry Dosage Forms for Oral Administration

(1)

V Plasticized Poly(Vinyl Chloride) for Containers for Aqueous Solutions for Intravenous Infusion

(1)

VI Polyethylene Terephthalate for Containers for Preparations Not for Parenteral Use

(1)

VII Polyolefins

(1)

VIII Polyethylene with Additives for Containers for Parenteral Preparations and for Ophthalmic Preparations

(1)

IX Polypropylene for Containers and Closures for Parenteral Preparations and Ophthalmic Preparations

(1)

X Poly(EthyleneNinyl Acetate) for Containers and Tubing for Total Parenteral Nutrition Preparations

(1)

XI Plastic Containers for Aqueous Solutions for Infusion

(1)

XII Sterile Single-Use Plastic Syringes

(1)

XIII Rubber Closures for Containers for Aqueous Parenteral Preparations, for Powders, and for Freeze-Dried Powders

(1)

XIV Silicone Oil Used as a Lubricant

(1)

XV Silicone Elastomer for Closures and Tubing

(1)

Chapter 8 Stability Testing of New Drug Substances and Products

(10)

I Introduction

(1)

A Objectives of the Guideline

(1)

B Scope of the Guideline

(1)

C General Principles

(1)

II Guidelines

(10)

A Drug Substance

(3)

1 General

(1)

2 Stress Testing

(1)

3 Selection of Batches

(1)

4 Container Closure System

(1)

5 Specification

(1)

6 Testing Frequency

(1)

7 Storage Conditions

(1)

8 Stability Commitment

(1)

9 Evaluation

(1)

10 Statements/Labeling

(1)

B Drug Product

(3)

1 General

(1)

2 Photostability Testing

(1)

3 Selection of Batches

(1)

4 Container Closure System

(1)

5 Specification

(1)

6 Testing Frequency

(1)

7 Storage Conditions

(2)

8 Stability Commitment

(1)

9 Evaluation

(1)

10 Statements/Labeling

(1)

Glossary

(2)

Bibliography

(2)

Chapter 9 Stability Testing: Photostability Testing of New Drug Substances and Products

(4)

I General

(1)

A Preamble

(1)

B Light Sources

(1)

C Procedure

(1)

II Drug Substance

(1)

A Presentation of Samples

(1)

B Analysis of Samples

(1)

C Judgement of Results

(1)

III Drug Product

(1)

A Presentation of Samples

(1)

B Analysis of Samples

(1)

C Judgement of Results

(1)

IV Annex

(1)

A Quinine Chemical Actinometry

(1)

Chapter 10 Bracketing and Matrixing Designs for Stability Testing of New Drug Substances and Products

(4)

I Introduction

(1)

A Objectives of the Guideline

(1)

B Background

(1)

C Scope of the Guideline

(1)

II Guidelines

(4)

A General

(1)

B Applicability of Reduced Designs

(1)

C Bracketing

(1)

1 Design Factors

(1)

2 Design Considerations and Potential Risks

(1)

3 Design Example

(1)

D Matrixing

(2)

1 Design Factors

(1)

2 Design Considerations

(1)

3 Design Examples

(1)

4 Applicability and Degree of Reduction

(1)

5 Potential Risk

(1)

E Data Evaluation

(1)

Chapter 11 Evaluation of Stability Data

(10)

I Introduction

(1)

A Objectives of the Guideline

(1)

B Background

(1)

C Scope of the Guideline

(1)

II Guidelines

(4)

A General Principles

(1)

B Data Presentation

(1)

C Extrapolation

(1)

D Data Evaluation for Retest Period or Shelf-Life Estimation for Drug Substances or Products Intended for Room-Temperature Storage

(1)

1 No Significant Change at Accelerated Condition

(1)

2 Significant Change at Accelerated Condition

(1)

E Data Evaluation for Retest Period or Shelf-Life Estimation for Drug Substances or Products Intended for Storage below Room Temperature

(1)

1 Drug Substances or Products Intended for Storage in a Refrigerator

(1)

2 Drug Substances or Products Intended for Storage in a Freezer

(1)

3 Drug Substances or Products Intended for Storage below -20°C

(1)

F General Statistical Approaches

(1)

Appendices

(4)

Appendix A: Decision Tree for Data Evaluation for Retest Period or Shelf-Life Estimation for Drug Substances or Products (Excluding Frozen Products)

(1)

Appendix B: Examples of Statistical Approaches to Stability Data Analysis

(5)

B.1 Data Analysis for a Single Batch

(1)

B.2 Data Analysis for One-Factor, Full-Design Studies

(1)

B.3 Data Analysis for Multifactor, Full-Design Studies

(1)

B.4 Data Analysis for Bracketing Design Studies

(1)

B.5 Data Analysis for Matrixing Design Studies

(1)

References

(2)

Chapter 12 Stability Data Package for Registration Applications in Climatic Zones III and IV

(2)

I Introduction

(1)

A Objectives of the Guideline

(1)

B Background

(1)

C Scope of the Guideline

(1)

II Guidelines

(1)

A Continuity with the Parent Guideline

(1)

B Storage Conditions

(1)

1 General Case

(1)

2 Aqueous-Based Drug Products Packaged in Semipermeable Containers

(1)

3 Tests at Elevated Temperature and/or Extremes of Humidity

(1)

C Additional Considerations

(1)

References

(1)

Chapter 13 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use

(16)

I. Introduction

(16)

Part I:

Chapter 1 Quality Management

(1)

Principle

(1)

Quality Assurance

(1)

Good Manufacturing Practice for Medicinal Products (GMP)

(1)

Quality Control

(1)

Product Quality Review

(1)

Quality Risk Management

(1)

Chapter 2 Personnel

(1)

Principle

(1)

General

(1)

Key Personnel

(1)

Training

(1)

Personnel Hygiene

(1)

Chapter 3 Premises and Equipment

(1)

Principle

(1)

Premises

(1)

Production Area

(1)

Storage Areas

(1)

Quality Control Areas

(1)

Ancillary Areas

(1)

Equipment

(1)

Chapter 4 Documentation

(1)

Principle

(1)

General

(1)

Specifications for Starting and Packaging Materials

100

(1)

Specifications for Intermediate and Bulk Products

100

(1)

Specifications for Finished Products

100

(1)

Manufacturing Formula and Processing Instructions

100

(1)

Packaging Instructions

101

(1)

Batch Processing Records

101

(1)

Batch Packaging Records

101

(1)

Procedures and Records

101

(1)

Sampling

102

(1)

Testing

102

(1)

Other

102

(1)

Chapter 5 Production

102

(1)

Principle

102

(1)

General

102

(1)

Prevention of Cross-Contamination in Production

103

(1)

Validation

103

(1)

Starting Materials

103

(1)

Processing Operations: Intermediate and Bulk Products

104

(1)

Packaging Materials

104

(1)

Packaging Operations

104

(1)

Finished Products

104

(1)

Rejected, Recovered, and Returned Materials

104

(1)

Chapter 6 Quality Control

105

(1)

Principle

105

(1)

General

105

(1)

Good Quality Control Laboratory Practice

105

(1)

Documentation

105

(1)

Sampling

106

(1)

Testing

106

(1)

Ongoing Stability Program

106

(1)

Chapter 7 Contract Manufacture and Analysis

107

(1)

Principle

107

(1)

General

107

(1)

The Contract Giver

107

(1)

The Contract Acceptor

107

(1)

The Contract

108

(1)

Chapter 8 Complaints and Product Recall

108

(1)

Principle

108

(1)

Complaints

108

(1)

Recalls

108

(1)

Chapter 14 Impurities: Guideline for Residual Solvents

109

(8)

I Introduction

109

(1)

II Scope of the Guideline

109

(1)

III General Principles

109

(3)

A Classification of Residual Solvents by Risk Assessment

109

(1)

B Methods for Establishing Exposure Limits

110

(1)

C Options for Describing Limits of Class 2 Solvents

110

(1)

D Analytical Procedures

111

(1)

E Reporting Levels of Residual Solvents

111

(1)

IV Limits of Residual Solvents

112

(1)

A Solvents to Be Avoided

112

(1)

B Solvents to Be Limited

112

(1)

C Solvents with Low Toxic Potential

112

(1)

D Solvents for Which No Adequate Toxicological Data Were Found

112

(1)

Glossary

112

(1)

Appendix 1 List of Solvents Included in the Guideline

113

(2)

Appendix 2 Additional Background

115

(1)

A2.1 Environmental Regulation of Organic Volatile Solvents

115

(1)

A2.2 Residual Solvents in Pharmaceuticals

115

(1)

Appendix 3 Methods for Establishing Exposure Limits

115

(2)

Chapter 15 Electronic Records and Signatures (CFR 21 Part 11 Compliance)

117

(4)

Sec.11.2 Implementation

118

(1)

Sec.11.3 Definitions

118

(1)

Subpart B: Electronic Records

118

(1)

Sec.11.10 Controls for Closed Systems

118

(1)

Sec.11.30 Controls for Open Systems

119

(1)

Sec.11.50 Signature Manifestations

119

(1)

Sec.11.70 Signature/Record Linking

119

(1)

Subpart C: Electronic Signatures

119

(6)

Sec.11.100 General Requirements

119

(1)

Sec.11.200 Electronic Signature Components and Controls

119

(1)

Sec.11.300 Controls for Identification Codes/Passwords

120

(1)

Chapter 16 Product-Specific Bioequivalence Testing Protocols

121

(4)

Chapter 17 Formulation Considerations

125

(4)

1 Background

125

(1)

2 Ion Resin Complexes

125

(1)

3 Ion Exchange Resins

125

(2)

3.1 Drug Loading

126

(1)

3.2 Coating Drug-Resin Complexes

126

(1)

4 Cyclodextrins

127

(2)

Chapter 18 Pediatric Pharmaceutical EU Legislation

129

(4)

Background

129

(1)

The Main Points in the Regulation

129

(1)

Implications

130

(3)

Chapter 19 Pediatric Formulations

133

(4)

Specific Considerations on Formulations for Neonates

134

(1)

Collaboration on Pediatric Formulations

134

(1)

Conclusions

134

(1)

Bibliography

135

(2)

Chapter 20 SOP and Specification to Establish Electronic Submission to Regulatory Agencies

137

(6)

1 Purpose

137

(1)

2 Scope

137

(1)

3 Definitions and Abbreviations

137

(1)

4 Responsibilities

137

(1)

4.1 Information Technology

137

(1)

4.2 Regulatory Affairs

137

(1)

4.3 Publishing

137

(1)

5 Materials and Equipment

137

(1)

5.1 Materials

137

(1)

5.2 Equipment

138

(1)

6 Health and Safety

138

(1)

7 Procedure

138

(1)

7.1 Secure E-mail Setup

138

(1)

7.2 Requesting a Pre-Assigned Application Number

138

(1)

7.3 ESG Account Setup

138

(1)

8 References

138

(1)

9 Exhibits

139

(1)

Exhibit I - Pre-Assigned Application Number Request

139

(1)

Exhibit II - Sample Letters of Non-Repudiation Agreement

139

(1)

10 Revision History

139

(1)

11 ICH eCTD Specification

139

(2)

11.1 Introduction

139

(1)

11.2 Background

139

(1)

11.3 Scope

139

(1)

11.4 Requirements

140

(1)

11.5 Change Control

140

(1)

11.5.1 Introduction

140

(1)

11.5.2 Process

140

(1)

11.5.3 Procedure

140

(1)

11.6 Approach to Documentation and Use of the eCTD Specification

141

(2)

Appendix 1: Overall Architecture

143

(2)

Appendix 2: The eCTD Submission

145

(4)

Appendix 3: General Considerations for the CTD Modules

149

(8)

Appendix 4: File Organization for the eCTD

157

(44)

Appendix 5: Region-Specific Information Including Transmission and Receipt

201

(4)

Appendix 6: The eCTD XML Submission

205

(8)

Appendix 7: Specification for Submission Formats

213

(4)

Appendix 8: XML eCTD DTD

217

(8)

Appendix 9: Glossary

225

(2)

Appendix A: GMP Audit Template

227

(20)

Appendix B: Dissolution Testing

247

(2)

Appendix C: Excipients

249

(30)

Part II Manufacturing Formulations

Liquid Formulations

279

(120)

Abacavir Sulfate Oral Solution

279

(1)

Acetaminophen, Chlorpheniramine, and Pseudoephedrine Syrup

279

(1)

Acetaminophen Drops

280

(1)

Acetaminophen Oral Suspension

280

(1)

Acetaminophen Rectal Solution

281

(1)

Acetaminophen Suspension

281

(1)

Acetaminophen Syrup

281

(1)

Acetaminophen Syrup

282

(1)

Acetaminophen Syrup for Children

282

(1)

Acetaminophen Syrup

282

(1)

Acetaminophen Syrup

283

(1)

Acne Scrub

283

(1)

Acyclovir Oral Suspension (2% = 200 mg/10 mL)

283

(1)

Acyclovir Oral Suspension

284

(1)

Acyclovir Oral Suspension

284

(1)

Adapalene Solution

284

(1)

Albendazole Oral Suspension

284

(1)

Albendazole Suspension

285

(1)

Albuterol Inhalation Solution

285

(1)

Albuterol Inhalation Solution

285

(1)

Alginic Acid + Aluminum Hydroxide + Magnesium Silicate Tablets (500 mg + 100 mg + 25 mg)

286

(1)

Alpha-Bisabolol Aqueous Mouthwash Solution

286

(1)

Alpha-Bisabolol Buccal or Topical Solution

286

(1)

Alpha-Bisabolol Ethanolic Mouthwash Solution

286

(1)

Alpha-Bisabolol Mouthwash Solution

286

(1)

Aluminum Hydroxide + Magnesium Silicate Chewable Tablets (120 mg + 250 mg)

287

(1)

Aluminum Chloride Solution

287

(1)

Aluminum Hydroxide and Magnesium Carbonate Dry Syrup

287

(1)

Aluminum Hydroxide and Magnesium Hydroxide Antacid Suspension

287

(1)

Aluminum Hydroxide and Magnesium Hydroxide Antacid Suspension

288

(1)