Abstract
Dual-chamber systems (DCS) offer self-administration and home care use for lyophilized (Lyo) biologics. Only a few products have been launched in DCS so far - presumably due to its complex and costly drug product manufacturing process. Within this paper two improved processes (both based on tray filling technology) for freeze-drying pharmaceuticals in DCS are described. Challenges with regards to heat transfer were tackled by (1) performing the freeze drying step in a "needle-down" orientation in combination with an aluminum block or (2) freeze drying the drug product "externally" in a metal cartridge with subsequent filling of the lyo cake into the DCS. Metal mediated heat transfer was shown to be efficient in both cases and batch (unit to unit) homogeneity with regards to sublimation rate was increased. It was difficult to influence ice crystal size using different methods when in use with an aluminum block due to its heat capacity. Using such a metal carrier implies a large heat capacity leading to relatively small ice crystals. Compared to the established process, drying times were reduced by half using the new processes. The drying time was however, longer for syringes compared to vials due to the syringe design (long and slim). The differences in drying times were less pronounced for aggressive drying cycles. The proposed processes may help to considerably decrease investment costs into DCS fill finish equipment.
- Received October 12, 2015.
- Accepted January 13, 2016.
- Copyright © 2016, Parenteral Drug Association
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