Poorly Soluble Drugs

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Beschreibung

This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development.

Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.



Inhalt

  1. The Modern Pharmaceutical Development Challenge: BCS Class II and IV Drugs
  2. Gregory K. Webster, Robert G. Bell, and J. Derek Jackson

  3. Solubility Determinations for Pharmaceutical API
  4. Kofi Asare-Addo and Barbara R. Conway

  5. Use of Surfactants in Dissolution Testing
  6. Amit Gupta

  7. Intrinsic Dissolution Evaluation of Poorly Soluble Drugs
  8. Michele Georges Issa and Humberto Gomes Ferraz

  9. Oral Delivery of Poorly Soluble Drugs
  10. Dev Prasad, Akash Jain, and Sudhakar Garad

  11. A Staged Approach to Pharmaceutical Dissolution Testing
  12. Gregory K. Webster, Xi Shao, and Paul D. Curry, Jr.

  13. Development and Application of in vitro Two-Phase Dissolution Method for Poorly Water-Soluble Drugs
  14. Ping Gao, Yi Shi, and Jonathan M. Miller

  15. The Use of Apparatus 3 in Dissolution Testing of Poorly Soluble Drug Formulations

G. Bryan Crist

9. Use of Apparatus 4 in Dissolution Testing, Including Sparingly and Poorly Soluble Drugs

Rajan Jog, Geoffrey N. Grove, and Diane J. Burgess

  1. Dissolution of Nanoparticle Drug Formulations
  2. John Bullock

  3. Dissolution of Lipid-Based Drug Formulations
  4. Stephen M. Cafiero

  5. Dissolution of Stabilized Amorphous Drug Formulations
  6. Justin R. Hughey

  7. Dissolution of Pharmaceutical Suspensions
  8. Beverly Nickerson, Michele Xuemei Guo, Kenneth J. Norris, and Ling Zhang

  9. Dissolution Testing of Poorly Soluble Drugs: "Biorelevant Dissolution"
  10. Mark McAllister and Irena Tomaszewska

  11. Clinically Relevant Dissolution for Low-Solubility Immediate-Release Products
  12. Paul A. Dickinson, Talia Flanagan, David Holt, and Paul W. Stott

  13. The QbD Approach to Method Development and Validation for Dissolution Testing
  14. Alger D. Salt

  15. Regulatory Considerations in Dissolution and Drug Release of BCS Class II and IV Compounds
  16. Robert G. Bell and Laila Kott

  17. Dissolution of Liquid-Filled Capsules Based Formulations
  18. Rampurna Prasad Gullapalli

  19. Current and Emerging Non-compendial Methods for Dissolution Testing

Namita Tipnis and Diane J. Burgess

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Produktinformationen

Titel
Poorly Soluble Drugs
Untertitel
Dissolution and Drug Release
Autor
EAN
9789814745468
Format
E-Book (pdf)
Hersteller
Taylor & Francis Ltd.
Genre
Medizin
Veröffentlichung
06.01.2017
Digitaler Kopierschutz
Adobe-DRM
Dateigrösse
25.39 MB
Anzahl Seiten
728
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