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Handbook of Pharmaceutical Manufacturing Formulations Semisolids Products 1st Edition by Sarfaraz K Niazi ISBN 0849317495 9780849317521

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Handbook of Pharmaceutical Manufacturing Formulations Semisolids Products 1st Edition Sarfaraz K. Niazi Digital Instant Download

Author(s): Sarfaraz K. Niazi
ISBN(s): 9780849317521, 0849317495
Edition: 1
File Details: PDF, 2.18 MB
Year: 2004
Language: english
SKU: EB-1389474 Category: Tag:

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ISBN 10: 0849317495 
ISBN 13: 9780849317521
Author: Sarfaraz K Niazi

The sixth volume in the six-volume Handbook of Pharmaceutical Manufacturing Formulations, this book covers the sterile products, which include formulations of injections, ophthalmic products and other products labeled as sterile, 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 formulating and manufacturing sterile products, the common elements of formulation. The section on regulatory and manufacturing guidance deals with the topics inspection of sterile products manufacturing facilities, new drug application for sterilized products, in addition to providing quick tips on resolving the common problems in formulating sterile products as well as the scope of details included in the series for all dosage forms.

Handbook of Pharmaceutical Manufacturing Formulations Semisolids Products 1st Table of contents:

Part 1: Fundamentals of Semisolid Formulation

1. Basics of Semisolid Dosage Forms

  • 1.1 Definition and Characteristics of Semisolids
  • 1.2 Physicochemical Properties of Semisolid Formulations
  • 1.3 Selection Criteria for Semisolid Vehicles

2. Formulation Components and Their Functions

  • 2.1 Active Pharmaceutical Ingredients (APIs) in Semisolids
  • 2.2 Excipients: Role of Bases, Emulsifiers, and Stabilizers
  • 2.3 The Importance of Preservatives and Antioxidants in Semisolids

3. Rheological Properties and Flow Behavior of Semisolids

  • 3.1 Understanding Viscosity and Its Importance in Formulation
  • 3.2 Rheological Testing of Semisolid Products
  • 3.3 Flow Characteristics and Their Impact on Drug Delivery

Part 2: Semisolid Formulation Development

4. Preparation and Manufacturing Techniques for Semisolids

  • 4.1 Hot and Cold Process Methods
  • 4.2 Emulsification Techniques: O/W and W/O Systems
  • 4.3 Homogenization and Milling Techniques
  • 4.4 Mixing, Blending, and Shear Forces in Formulation Development

5. Formulation of Ointments, Creams, and Gels

  • 5.1 Ointment Formulations: Design and Characteristics
  • 5.2 Cream Formulations: Emulsion-based Systems
  • 5.3 Gel Formulations: Hydrogel, Organogel, and Other Systems

6. Design of Controlled Release Semisolid Systems

  • 6.1 Mechanisms of Controlled Release in Semisolid Dosage Forms
  • 6.2 Formulation Strategies for Sustained and Targeted Release
  • 6.3 Case Studies of Controlled Release Semisolid Products

Part 3: Quality Control and Stability of Semisolid Products

7. Stability Testing of Semisolid Formulations

  • 7.1 Types of Stability: Chemical, Physical, and Microbial Stability
  • 7.2 Accelerated Stability Studies
  • 7.3 Shelf-life Determination for Semisolid Products

8. Quality Control Testing for Semisolid Dosage Forms

  • 8.1 Testing for Homogeneity and Consistency
  • 8.2 In-vitro Release Testing and Skin Permeation Studies
  • 8.3 Microbial Contamination and Preservative Efficacy Testing

9. Packaging and Storage Requirements for Semisolid Products

  • 9.1 Packaging Materials and Compatibility
  • 9.2 Protecting Semisolids from Contamination and Degradation
  • 9.3 Storage Conditions for Maintaining Stability

Part 4: Regulatory Considerations and Market Trends

10. Regulatory Requirements for Semisolid Products

  • 10.1 FDA and EMA Guidelines for Semisolid Formulations
  • 10.2 Regulatory Classification of Semisolids
  • 10.3 Labeling, Testing, and Compliance Requirements

11. Nanotechnology and Advanced Drug Delivery Systems in Semisolids

  • 11.1 Nanoparticles and Nanocarriers in Semisolid Formulations
  • 11.2 Liposomes and Nanosomes in Drug Delivery
  • 11.3 Emerging Trends in Nanomedicine and Pharmaceutical Applications

12. Future Trends in Semisolid Formulation Development

  • 12.1 Advances in Drug Delivery Systems
  • 12.2 Market Trends and Opportunities in Semisolid Products
  • 12.3 Personalized Medicine and Semisolids

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Sarfaraz K Niazi,Pharmaceutical Manufacturing,Formulations Semisolids