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In Vitro Drug Release Testing of Special Dosage Forms Advances in Pharmaceutical Technology 1st Edition by Nikoletta Fotaki, Sandra Klein ISBN 9781118341476 1118341473

Name: In Vitro Drug Release Testing of Special Dosage Forms Advances in Pharmaceutical Technology 1st Edition by Nikoletta Fotaki, Sandra Klein ISBN 9781118341476 1118341473
SKU: EB-35011430
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In Vitro Drug Release Testing of Special Dosage Forms Advances in Pharmaceutical Technology 1st Edition Nikoletta Fotaki (Editor) Digital Instant Download

Author(s): Nikoletta Fotaki (editor), Sandra Klein (editor)

ISBN(s): 9781118341476, 9781118675779, 9781118675830, 1118341473, 1118675770, 1118675835, 2019024444, 2019024445

Edition: 1

File Details: PDF, 4.10 MB

Year: 2019

Language: English

SKU: EB-35011430 Category: Medicine - Pharmacology Tags: Nikoletta Fotaki (editor), Sandra Klein (editor)

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In Vitro Drug Release Testing of Special Dosage Forms Advances in Pharmaceutical Technology 1st Edition by Nikoletta Fotaki, Sandra Klein – Ebook PDF Instant Download/Delivery: 9781118341476 ,1118341473
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ISBN 10: 1118341473
ISBN 13: 9781118341476
Author: Nikoletta Fotaki, Sandra Klein

Guides readers on the proper use of in vitro drug release methodologies in order to evaluate the performance of special dosage forms In the last decade, the application of drug release testing has widened to a variety of novel/special dosage forms. In order to predict the in vivo behavior of such dosage forms, the design and development of the in vitro test methods need to take into account various aspects, including the dosage form design and the conditions at the site of application and the site of drug release. This unique book is the first to cover the field of in vitro release testing of special dosage forms in one volume. Featuring contributions from an international team of experts, it presents the state of the art of the use of in vitro drug release methodologies for assessing special dosage forms’ performances and describes the different techniques required for each one. In Vitro Drug Release Testing of Special Dosage Forms covers the in vitro release testing of: lipid based oral formulations; chewable oral drug products; injectables; drug eluting stents; inhalation products; transdermal formulations; topical formulations; vaginal and rectal delivery systems and ophthalmics. The book concludes with a look at regulatory aspects. Covers both oral and non-oral dosage forms Describes current regulatory conditions for in vitro drug release testing Features contributions from well respected global experts in dissolution testing In Vitro Drug Release Testing of Special Dosage Forms will find a place on the bookshelves of anyone working with special dosage forms, dissolution testing, drug formulation and delivery, pharmaceutics, and regulatory affairs.

In Vitro Drug Release Testing of Special Dosage Forms Advances in Pharmaceutical Technology 1st Edition Table of contents:

Part I: Oral Dosage Forms

1 Lipid‐Based Oral Formulations

1.1 Introduction

1.2 Levels of Release Testing for Lipid‐Based Dosage Forms

1.3 Case Examples

1.4 Conclusions and Future Directions

References

2 Chewable Oral Drug Products

2.1 Introduction

2.2 The Oral Cavity

2.3 Drug Substances Used in Chewable Dosage Forms

2.4 Technology

2.5 Pharmacopoeial Requirements

2.6 Summary and Conclusion

References

Part II: Non‐oral Dosage Forms

3 Injectables

3.1 Introduction

3.2 Significance of In Vitro Release Testing

3.3 Considerations in Method Development

3.4 In Vitro Release Methods

3.5 Dialysis Method

3.6 Accelerated In Vitro Release

3.7 In Vitro – In Vivo Correlations (IVIVCs)

References

4 Drug‐Eluting Stents

4.1 Drug‐Eluting Stents: Combination Products at the Interface of Medical Devices and Medicinal Products

4.2 DES Characteristics

4.3 In Vivo Stent Position and the Resulting Challenges for In Vitro Release Testing of Coronary Stents

4.4 Guidelines, Prerequisites, and General Recommendations on DES Testing

4.5 Currently Used Test Methods

4.6 Toward More Biorelevant Testing Conditions and New Challenges for DES Testing

4.7 Non‐Vascular Stents

4.8 Drug‐Coated Balloons: An Alternative to DESs for a Wide Range of Indications?

4.9 Concluding Remarks

References

5 In Vitro Dissolution for Inhalation Products

5.1 Introduction

5.2 The Environment of the Human Lungs

5.3 Regulatory Perspectives and Current Practices for Testing Inhaled Products

5.4 Simulated Lung Fluids

5.5 Pulmonary Biopharmaceutical Classification System

5.6 Conclusions

References

6 Topicals and Transdermals

6.1 Introduction

6.2 In Vitro Release Studies for Topical Dosage Forms

6.3 In Vitro Release Studies for Transdermal Systems

6.4 Conclusions

References

7 Vaginal and Intrauterine Delivery Systems

7.1 Vaginal and Uterine Anatomy and Physiology Relevant to Drug Delivery

7.2 Vaginal and Intrauterine Drug Delivery

7.3 Standard Dissolution Test Methods for Vaginal and Intrauterine Delivery Systems

7.4 Predictive Dissolution Test Methods for Vaginal and Intrauterine Delivery Systems

References

8 Rectal Dosage Forms

8.1 Rectal Anatomy and Physiology Relevant to Drug Delivery

8.2 Rectal Drug Delivery

8.3 Standard Dissolution Test Methods for Rectal Dosage Forms

8.4 Predictive Dissolution Test Methods for Rectal Dosage Forms

References

9 Ophthalmic Dosage Forms

9.1 Introduction

9.2 The Tear Film

9.3 Delivery Volume

9.4 Ophthalmic Formulations

9.5 In Vitro Testing for Ophthalmic Formulations

9.6 Concluding Remarks

References

10 Regulatory Considerations

10.1 Introduction

Part One: Review of Documents Related to In Vitro Release Testing

10.2 Compendial Chapters with Legal Implications

10.3 Compendial Chapters, Non‐binding

10.4 Guidances Related to In Vitro Release Testing

Part Two: Role of Method Development in Setting Clinically Relevant Specifications

10.5 Considerations in Early Method Development

10.6 Choice of Media

10.7 Discriminatory Power of the Method

10.8 In Vitro Release Testing for Special Dosage Forms

10.9 Resources

Bibliography

Acknowledgments

References

Index

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Tags: Nikoletta Fotaki, Sandra Klein, Vitro Drug Release, Special Dosage, Pharmaceutical Technology