Handbook of Pharmaceutical Manufacturing Formulations Series, Vol. 4: Semisolid Products

The fourth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, Semi-Solid Products covers semi-solid drugs.

• Presents the world's largest reference source on pharmaceutical formulations
• Includes readily accessible formulations listed as chemical entities, dosage forms or pharmacological classifications
• Provides instant substantial time and cost-savings in pharmaceutical research and development
• Speeds generic drug formulation regulatory submissions

Semi-Solid Products includes formulations of ointments, lotions, gels, and suppositories, from publicly available but widely dispersed information from FDA New Drug Applications (NDA), patent applications, and other sources of generic and proprietary formulations. Each entry begins with a fully validated scaleable manufacturing formula and a summary of manufacturing process.

The book provides a detailed discussion on the difficulties encountered in manufacturing semi-solid drugs, the common elements of formulations.

The section on regulatory and manufacturing guidance deals with such topics as changes to approved NDAs and aNDAs, post-approval changes to semisolid drugs, SUPAC for non-sterile semisolid dosage form equipment, stability testing of drugs substances and drug products, guidelines on evaluation of stability data in retest periods, skin irritation and sensitization testing of generic transdermal products, and photosafety testing, in addition to providing quick tips on resolving the common problems in formulating semisolid products.

Section I: Regulatory and Manufacturing Guidance

Chapter 1: Changes to Approved New Drug Applications or Abbreviated New Drug Applications

Reporting Categories
General Requirements
Assessing the Effect of Manufacturing Changes
Components and Composition
Manufacturing Sites
Manufacturing Process
Specifications
Package
Labeling
Miscellaneous Changes
Multiple Related Changes

Chapter 2: Postapproval Changes to Semisolid Drugs

Preservative
Manufacturing Changes
Process
Manufacturing Site

Chapter 3: Scale-Up and Postapproval Changes for Nonsterile Semisolid Dosage Forms: Manufacturing Equipment

Particle Size Reduction and Separation
Mixing
Transfer
Packaging

Chapter 4: Stability Testing of Drug Substances and Drug Products

Stability Testing for New Drug Applications
Stability Testing for Abbreviated NDAs
Stability Testing for Investigational Ndas
Approved Stability Protocol
Reporting Stability Data
Specific Stability Topics
Considerations for Specific Dosage Forms
Stability Testing for Postapproval Changes

Chapter 5: Guidelines for Evaluation of Stability Data in Retest Periods

Guidelines
Decision Tree for Data Evaluation for Retest Period or Shelf Life Estimation for Drug Substances or Products (excluding frozen products)

Chapter 6: Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products

Study Designs

Chapter 7: Photosafety Testing

Background
Testing Considerations
Testing For Enhancement of UV-Associated Skin Carcinogenesis (Direct Photochemical Carcinogenicity or Indirect Effects In Skin)

Chapter 8: Guidance on Formulating Semisolid Drugs

Potency Uniformity
Equipment And Production Control
Cleaning Validation
Microbiological
Change Control
Transdermal Topical Products

Section II: Formulations of Semisolid Drugs

Chapter 9
Chapter 10
Chapter 11

Index