Lyophilized Injectables to 2020
|出版商||Greystone Research Associates||商品編碼||322745|
The inherent instability of protein 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 requirement 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.
‘The number of drugs supplied in lyophilized form has been growing at an increased rate over the past several years, mirroring the increase in the introduction of biological drugs. For lyophilized drugs intended for self-administration, reconstitution must occur at the point of use. This report analyzes more than 450 drugs that are supplied in powder form and require reconstitution prior to administration'
A longer life span is expected to translate to a growing number of patients diagnosed with chronic conditions. To counteract the financial and medical infrastructure implications of this trend, pressure from the public sector and managed care organizations will place a premium on therapeutic self-administration, an expectation that is creating an increased interest in routes of administration that are patient-friendly and cost-effective. Pharma company decision makers have come to the realization that for many products, success no longer only depends on the medication itself but also on achieving a consumer-compatible form of packaging and application.