The inherent instability of biological drugs is a limitation that has a direct impact on the drug delivery sector. Therapeutic proteins must either be stored under special conditions or formulated to retain their efficacy from the time of manufacture until they are dispensed. Liquid protein drugs require refrigeration until dispensed ' a distribution strategy referred to as the 'Cold Chain'. Alternatively, proteins can be formulated as powders (lyophilization). Lyophilized proteins must be reconstituted prior to injection. Lyophilized drugs are sold with reconstitution vial systems, or packaged in special injection devices (e.g., pens, needle-free injectors, two-part syringes) that allow reconstitution to take place in the device prior to injection. As biological drugs continue to grow in terms of therapeutics and total prescriptions, the impact of specialty devices will increase.

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Point-of-Delivery Drug Reconstitution Systems
Published on January 2011
Report Summary
The inherent instability of biological drugs is a limitation that has a direct impact on the drug delivery sector. Therapeutic proteins must
either be stored under special conditions or formulated to retain their efficacy from the time of manufacture until they are dispensed.
Liquid protein drugs require refrigeration until dispensed ' a distribution strategy referred to as the 'Cold Chain'. Alternatively, proteins
can be formulated as powders (lyophilization). Lyophilized proteins must be reconstituted prior to injection. Lyophilized drugs are sold
with reconstitution vial systems, or packaged in special injection devices (e.g., pens, needle-free injectors, two-part syringes) that
allow reconstitution to take place in the device prior to injection. As biological drugs continue to grow in terms of therapeutics and total
prescriptions, the impact of specialty devices will increase.
Table of Content
Executive Summary
Market Dynamics
Prolonging the Shelf Life of Biological Drugs
Distribution Strategies
Formulation Strategies
Lyophilization and Reconstitution at the Point of Use
Healthcare Economics and Reconstitution Systems
What's Driving the Growth in Engineered Reconstitution Systems'
Biological Drugs Proliferating
The Trend toward Self-Administration
Shifting Demographics
Innovation in Disposable Device Designs
Therapeutic Demand Drivers
Competitive Landscape
Risk Factors
Drug Reconstitution Systems ' Commercial Devices
Vial Adapters
ADD-Vantage Vial (Hospira)
E-Z-Link (DuoJect)
MixJect (West)
Needle-Free Vial Adapter (Bioject)
Smart-Rod XR (DuoJecT)
Protector Vial Adapters (Carmel Pharma)
Tevadapter (Teva)
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Vial Adapter Kit (Bioject)
Vial Adapters (GVS)
Vial Adapter (PA Consulting)
Vial-Mate (Baxter)
Vial-to-Vial Systems
Mix2Vial (West)
Needle-less Transfer Devices
Baxject/Baxject II (Baxter)
Needleless Transfer Device (West)
SmartSite Needle-free Valve
Direct Connect to Vial
AIRLESS DC (DuoJect)
Clip'n'Ject (West)
Flexi-Q DV (Elcam Medical)
Inter-Vial Plus (DuoJect)
Direct Connect to Cartridge
Pen-Prep XR (DuoJect)
Dual Chamber Syringes
BD Liquid Dry Injector (Becton Dickinson)
Lyo-Ject (Vetter)
MiniQuick (Vetter)
Dual Chamber Cartridges
Vetter Lyo Karpule V-LK (Vetter)
Lyo-Twist Trio/Vario (Ypsomed)
Closed Drug Transfer
Codan Cyto (Codan)
Cyto-Set (B.Braun)
EquaShield (PlastMed)
OnGuard/Tevadaptor (B. Braun/Teva)
PhaSeal (Carmel Pharma)
Securmix/Securmix Lock (Eurospital)
SureConnect (Baxa)
Texium/SmartSite (CareFusion)
Reconstitution System Design Factors
Stability and Material Selection Issues
Disposable Drug Cartridges
Single vs Multi-Dose Devices
Human Engineering/Ergonomics
Drug Reconstitution - Therapeutic Sector Analysis
Antibiotics/Antivirals
Antibodies
Autoimmune Diseases
Arthritis
Crohn's Disease
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Lupus
Multiple Sclerosis
Psoriasis
Blood Proteins
Hepatitis
Hemostats
Hormone Replacement
Oncology
Osteoporosis
Reproductive Health
Vaccines
Market Factors
Syringe Disposal
Regulatory Issues
Patient Compliance
Healthcare Economics
Drug Reconstitution Systems - Company Profiles
+C18
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