Despite wide commercial application of hypromellose acetate succinate (HPMCAS) in spray-dried amorphous solid dispersion (ASD) drug products, little information is available in the references on downstream processing of spray-dried dispersions with HPMCAS. Poor flow and high dilution factor are a challenge in formulating spray-dried ASDs into tablets, leaving little space for other excipients facilitating binding and disintegration. Direct compression is not possible due to the poor powder flow of spray-dried ASDs. Moisture has to be avoided due to the plasticizing properties of water on the ASD, resulting in reduced stability of the amorphous state. Thus, dry granulation by roller compaction and subsequent tablet compression is the preferred downstream process. We report the investigation of downstream processing by roller compaction and tablet compression of a high load formulation with 75% of spray-dried amorphous solid dispersion (Nifedipine:HPMCAS 1:2). A head to head comparison of microcrystalline cellulose/croscarmellose (MCC/cl-NaCMC) as binder/disintegrant vs. MCC and low-substituted hydroxypropyl cellulose (L-HPC) as excipient for binding and disintegration showed improved re-workability of the formulation with MCC/L-HPC after roller compaction. Upon transfer to the rotary press, a 45% higher tensile strength of tablets is observed after dry granulation with MCC/L-HPC.
The first stage of the H-2 rocket used a 110-ton thrust liquid oxygen, liquid hydrogen, pump-fed engine, the LE-7. This engine required high-pressure and high-power liquid oxygen and liquid hydrogen turbopumps to achieve the two-stage combustion cycle in which the combustion pressure is around 13 MPa. Furthermore, it was very important to operate both turbopumps at higher rotational speeds to obtain a smaller, lighter-weight engine because the LE-7 had not low-speed, low-pressure pumps ahead of both the main pumps. The present paper shows the design, test results, and modifications that had been performed until a flight-type liquid oxygen turbopump for the LE-7 engine was completed. The liquid oxygen turbopump had been developed by the use of three models, that is, research, prototype, and flight models.
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