Modified-Release Drug Delivery Technology (Drugs and the Pharmaceutical Sciences)

✍ Scribed by Michael J. Rathbone, Jonathan Hadgraft, Michael S. Roberts

• Publisher: Informa Healthcare
• Year: 2002
• Tongue: English
• Leaves: 962
• Edition: 1
• Category: Library

✦ Synopsis

Describing formulation challenges and their solutions in the design, development, and commercialization of modified-release drugs delivery systems, this book contains eighty papers that review recent developments in design and manufacturing techniques. It includes detailed descriptions of extended release drug products for the oral, nasal, ophthalmic, pulmonary, vaginal, dermal and transdermal pathways. With the exception of the final section addressing regulatory issues, each section covers a particular route for drug delivery and opens with an overview of the anatomical, physiological, and pharmaceutical basics of each route before moving on to cover specific technologies.

✦ Table of Contents

I. INTRODUCTION......Page 1
REFERENCES......Page 7
A. Demonstration of Safety and Ef.cacy Primarily Based on Clinical Trials......Page 4
REFERENCES......Page 15
REFERENCES......Page 22
III. CONTROLLED-RELEASE NEW DRUG APPLICATIONS......Page 2
VII. GENERIC EQUIVALENCE OF AN APPROVED CONTROLLED-RELEASE PRODUCT......Page 8
REFERENCES......Page 32
IV. CODE OF FEDERAL REGULATIONS: BIOAVAILABILITY STUDY REQUIREMENTS FOR CONTROLLED-RELEASE PRODUCTS......Page 3
IV. CLINICAL REQUIREMENTS......Page 5
B. Demonstration of Safety and Ef.cacy Based on PK, PK/PD Trials......Page 6
Table of Contents......Page 41
REFERENCES......Page 12
REFERENCES......Page 13
Table of Contents......Page 54
VII. CONCLUSION......Page 11
REFERENCES......Page 14
Table of Contents......Page 68
Table of Contents......Page 77
B. Bioequivalence Requirements......Page 9
B. Release Pro.le and Bioavailability......Page 17
Table of Contents......Page 95
VIII. SCALE-UP AND POSTAPPROVAL CHANGES FOR MODIFIED-RELEASE FORMULATIONS......Page 10
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VI. COMPETITIVE ADVANTAGE AND FUTURE DIRECTIONS......Page 21
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REFERENCES......Page 16
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A. IVIVC......Page 23
B. Setting Dissolution Speci.cations......Page 28
X. CONCLUSION......Page 31