Parenteral Products

Parenteral Products

The Preparation and Quality Control of Products for Injection

1st Edition - January 1, 1969

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  • Author: M. J. Groves
  • eBook ISBN: 9781483141756

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Description

Parenteral Products: The Preparation and Quality Control of Products for Injection deals with modern pharmaceutical practice in the preparation, quality control, and storage of injectable drug solutions. The book gives a basic background of parenteral solutions, the routes of administration, the effects of the different administrations of injection solutions, and the formulation of these products. The text discusses the theories of filtration, the different methods used, such as screen filters, depth filters, and the possible choices of filtration to capture any preselected unwanted particle size. Developments on sterilization of the product are given attention, citing techniques and equipment. The working and preparation conditions are discussed, since the sterile intravenous solutions, whether in large or small quantities, are done in quite the same procedures, with the similar equipment, and same organization. Equally important in the discussion are the monitoring and control of contamination by particulates through the application of standards known as the Coulter principle and the light-blockage method. The pharmaceutical problems encountered during the administration of large volume drip solutions are analyzed. This book is helpful for pharmacists, pharmaceutical students and professors, and those working in the pharmaceutical industry and hospital/health sector.

Table of Contents


  • Preface

    Chapter 1 Perspective on the Use of Parenteral Solutions

    Introduction

    Routes of Administration

    The Effect of Route on the Duration of Drug Activity

    The Origins of the Intravenous Therapy

    The Development of Hypodermic Medication

    The Sterilization of Injection Solutions

    The United States Pharmacopoeial Clarity Test

    References

    Chapter 2 The Formulation of Parenteral Products

    Units

    The Tonicity of Injection Solutions

    The Choice of Solvent

    Oily Solvents

    Colloidal Dispersions

    The Formulation of Parenteral Emulsions

    Amino Acids and Other Parenteral Nutrients

    The 'Browning' Reaction of D-Glucose on Autoclaving

    References

    Chapters 3 Filtration

    Introduction

    Classification of Filtration Operations

    Theories of Filtration

    The Relative Advantages and Disadvantages of Screen and Depth Filters

    Pretreatment

    The Criteria of an Ideal Filter

    The Choice of Filtration Media

    Discussion: The Choice of A Filtration System For Parenteral Products

    References

    Chapter 4 Sterilization

    Introduction

    The Meaning of Sterilization

    Methods of Sterilization

    The Kinetics of Microbial Death

    Factors Affecting the Survival of Micro-Organisms

    The Control of Sterilization Processes

    The Steam Autoclave

    Continuous Autoclaves

    References

    Chapter 5 The Working Environment

    Introduction

    The Manufacturing Process

    Codes of Good Manufacturing Practice

    Clean Water

    Clean Containers

    Clean Air

    Laminar Flow Cabinets

    Clean Rooms

    References

    Chapter 6 The Monitoring and Control of Particulate Contamination

    Introduction

    Sampling

    The Particle Size of Particulate Contamination

    Visual Methods of Inspection

    Projection Methods for the Inspection of Ampoules

    Machine Methods Used for the Inspection of Ampoules Made on the Large Scale

    Automatic or Semi-Automatic Inspection Methods for The Inspection of Ampoules Made on A Large Scale

    Filtration Methods and the Identification of Contamination

    Electrical Sensing Zone Methods of Analysis

    Turbidimeters and Nephelometers

    Other Instruments Using Light Scattering Principles of Detection

    Detection of Particles by the Light-Blockage Principle

    Detection of Particulate Contamination By Means of A Screen Filtration Pressure Method

    Conclusions

    References

    Appendix 1 Publications Using Electrical Zone Sensing Methods To Determine Parenteral Fluid Contamination

    Chapter 7 The Size Distribution of Particulate Contamination and Standards of Cleanliness

    Introduction

    The Size Distribution of Powders and Powdered Materials

    The Experimental Evidence for The Size Distribution of Contamination In Parenteral Solutions

    The Ephemeral Nature of Particulate Contamination

    Suggested Standards of Cleanliness

    Applications of Standards and the Log-Log Size Distribution

    Progress Towards An Objective Standard of Cleanliness

    Discussion: The Problems of Applying Standards for Cleanliness

    References

    Chapter 8 The Nature, Origin and Hazards of Particulate Contamination

    Introduction

    Nature and Origin of Particulate Contamination

    The Size and Number of Contaminating Particles

    The Hazard Due To Injected Particulate Contamination

    Conclusion

    References

    Chapter 9 Pharmaceutical Problems Associated With the Administration of Large Volume Parenteral Fluids

    Introduction: The Setting-Up of a Large Volume Drip Solution

    Pharmaceutical Incompatibilities of Drugs Added To Intravenous Solutions

    The Loss of Therapeutic Effectiveness of Drugs During Administration

    Microbiological Hazards Associated With Intravenous Fluid Therapy

    The Inspection of Containers and Giving Sets Prior To Administration

    The Use of Terminal Filters

    The Effectiveness of Terminal Filters

    Discussion: The Implications of Pharmaceutical Incompatibilities For The Hospital Pharmaceutical Service

    References

    Index




Product details

  • No. of pages: 324
  • Language: English
  • Copyright: © Butterworth-Heinemann 1969
  • Published: January 1, 1969
  • Imprint: Butterworth-Heinemann
  • eBook ISBN: 9781483141756

About the Author

M. J. Groves

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