Liposome Drug Products: Chemistry Manufacturing and Control Issues

7/20/01


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Table of Contents

Liposome Drug Products: Chemistry Manufacturing and Control Issues

Introduction

PPT Slide

Reasons for Making LDPs

Unique Physicochemical and Biopharmaceutical Characteristics

Influence of Lipids on Membrane Properties

Membrane Properties: Lipid Composition

Issue for Concern

Classification of Liposomes

Classification of Liposomes: Size and Lamellarity

Classification of Liposomes: MPS Uptake and Coating

Active Moiety

Demonstration of Sameness after Manufacturing Changes

Uniqueness of LDPs Characterization

Uniqueness of LDPs: Characteristics

How can Changes in Manufacturing be Assessed?

Factors Affecting Sameness

Factors Affecting Sameness: Raw Materials and Their Specifications

Factors Affecting Sameness: Manufacturing Process and Controls

Factors Affecting Sameness: Storage and Reconstitution

Release of Drug

Stability/Compatibility with infusion Fluids and Plasma

Approved Liposome Drug Products

CMC Issues for Liposome Drug Products

Author: CDER USER