Protein formulation and delivery

著者

• McNally, Eugene J.
• Hastedt, Jayne E.

書誌事項

Protein formulation and delivery

edited by Eugene J. McNally, Jayne E. Hastedt

（Drugs and the pharmaceutical sciences, v. 175）

Informa Healthcare, c2008

2nd ed

注記

Includes bibliographical references and index

内容説明・目次

内容説明

This title is intended to assist pharmaceutical scientists in the development of stable protein formulations during the early stages of the product development process, providing a comprehensive review of mechanisms and causes of protein instability in formulation development, coverage of accelerated stability testing methods and relevant analytical methods, and an overview of the drug substance manufacturing process. Preformulation and the development of traditional solutions and lyophilized formulations frequently used for intravenous delivery and non-traditional formulations are also addressed. Because many developments in the field have emerged since the publication of the First Edition, this Second Edition addresses important new patient-friendly developments in the field, such as formulation for implantable devices, needle-free formulation and delivery approaches, and oral delivery of proteins.

目次

Overview of Protein Formulation and Delivery. Proetin Delivery (General Aspects). Compare and Contrast Small Molecule and Large Molecule Formulation and Delivery. Chemical and Physical Considerations in Protein and Peptide Stability. Analytical Methods and Stability Testing of Biopharmaceuticals. The Importance of a Thorough Preformulation Study. Solution Formulation of Proteins/Peptides. Special Considerations in High Concentration Protein Formulations or Formulation for Implantable Devices. Freeze-Drying Concepts: The Basics. Rational Choice of Excipients for Use in Lyophilized Formulations. Formulation of Proteins for Pulmonary Delivery. Formulation of Proteins for Incorporation into Drug Delivery Systems. Needle Free Delivery Approaches. Single Crystal Formulation Approaches (Altus Approach). High Throughput Screening-Transform Approach. Oral Delivery-Oral Heparin. Formulation of Proteins for Delivery into Liposome Formulations. Expiration Dating and Specification Setting for Biologics

「Nielsen BookData」 より

詳細情報

• NII書誌ID(NCID): BA86603488
• ISBN:
  • 9780849379499
• LCCN: 2007023435
• 出版国コード: us
• タイトル言語コード: eng
• 本文言語コード: eng
• 出版地: New York
• ページ数/冊数: viii, 351 p.
• 大きさ: 24 cm
• 分類:
  • LCC : RS431.P75
  • NLM : W1
  • NLM : QU 55.9
  • DC22 : 615/.19
• 件名:
  • LCSH : Protein drugs -- Dosage forms
  • MESH : Protein Conformation
  • MESH : Drug Delivery Systems
  • MESH : Drug Design
  • MESH : Drug Stability
  • MESH : Proteins -- administration & dosage
• 親書誌ID:
  • BA03948165