Liposome Drug Products

7/20/01


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Table of Contents

Liposome Drug Products

Traditional Drug Delivery Systems (DDS)

Liposomes Represent a DDS That Actually Enters the Central Compartment

Evolution of Liposome Design

Marketed Liposome Products

Proposed Liposome Classification Based on Pharmacologic Behavior

Proposed Liposome Classification (Cont.)

Proposed Liposome Classification (Cont.)

Relative Rates of MPS Clearance

Evolution of IV Therapeutic Liposomes

Liposome Pharmacology: Critical Influences

Critical Influences: Drug Itself

Critical Influences: Liposome Size

Critical Influences: Structural Lipid Matrix

Critical Influences: Surface Properties

Comparison of Liposomal Doxorubicin Products: Myocet Vs. DOXIL

Comparison of Liposomal Doxorubicin Products: Myocet Vs. DOXIL

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Myocet Pharmaceutical Properties

Myocet Morphology

Myocet Product Format

Myocet Pharmacy Preparation Steps

Myocet Pharmacy Preparation Steps (Continued)

Why Load Drug in Pharmacy Setting? In Vitro Drug Release Myocet at 37oC

Myocet Pharmacokinetics

Myocet Pharmacokinetic Parameters

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DOXIL Pharmaceutical Properties

DOXIL Product Format

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DOXIL In vitro Release at 37oC

DOXIL Pharmacokinetics

Doxil Pharmacokinetic Parameter Estimates (n = 83)

Doxil Stability (Aqueous Suspension, 8oC)

DOXIL Tissue Distribution

Chaotic and Mosaic Vessels in Tumors

Extravasation of Doxil

Pegylated Liposome Extravasation in Angiogenic Blood Vessels

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Serial Gamma Scintigrams of KS Patient after Pegylated Liposomes Containing 111In-DTPA

Gamma Scintigram of Lung Cancer Patient 96 Hours after Pegylated Liposomes Containing 111In-DTPA

Gamma Scintigrams of Patient with T4 Squamous Cell Carcinoma of the Tongue (96 Hours after Pegylated Liposomes Containing 111In-DTPA)

Clinical Dosing Profiles: Myocet Vs. DOXIL

Myocet Vs. DOXIL: Conclusions

Summary