Spray dried dispersions

In-process controls such as stratined sampling, process analytical technology (PAT) application, and blend homogeneity. Assess modincation of dissolution through optimization of API characteristics and then perform assessment of specialized technologies [hot-melt extrusion (HME), spray-dried dispersion, solid dispersion, etc.] for long-term resolution... 

Friesen, D.T., Shanker, R., Crew, M., Smithey, D.T., Curatolo, W.J., Nightingale, J.A.S. Hydroxypropyl methyl-cellulose acetate succinate-based spray-dried dispersions An overview. Mol. Pharm. 2008,5(6), 1003-1019. 

Porter El, W. W. O EX>nnell, K. Schmitt, B. Petermann, O. GuElaudeu, S. Brackhagen, M. Sprehe, M. Impact of HPMCAS Polymer Properties on the in vitro Performance of Spray Dried Dispersions., AAPS Annual Meeting, 2013, San Antonio, Texas. 

Fiiesen DT, Shanker R, Crew M, Smithey DT, Curatolo WJ, Nightingale JA (2008) Hydrox-ypropyl methylceUulose acetate succinate-based spray-dried dispersions an overview. Mol Pharm 5(6) 1003-1019... 

HPMCAS was extensively researched in the field of amorphous spray-dried dispersions, HME, and controlled precipitation and was proven to significantly enhance the solubilization of APIs, as well as physical stability and manufacturing... 

Amorphous solid dispersions are leveraged at varying stages in development for a number of reasons. For extruded dispersions, a limited number of polymer systems summarized in Table 6.3 form the backbone of the compositional definition. In early development, they are most commonly used to support elevated exposures necessary for preclinical assessment and/or assure phase stability when a crystalline form is not readily isolated. At this stage of development, the amount of material available for development will be restricted. As discussed previously, this constraint can challenge the utility of extruded systems where minimum batch sizes are significantly larger than for development of spray-dried dispersions or coprecipitated material. 

Development of a Manufacturing Process of a Spray-Dried Dispersion Under a Quality by Design Approach... 

Design and Development of HPMCAS-Based Spray-Dried Dispersions... 

This chapter presents an overview of amorphous spray-dried dispersions (SDDs), which have been successfully used as a platform technology to enhance the oral bioavailability of hundreds of compounds with low aqueous solubility. SDDs can be prepared with several nonionic polymers, such as polyvinylpyrrolidone (PVP) and cellulosic polymers, as well as with ionic polymers, such as hydroxypropyl... 

Further differentiation was observed in the stability of the ASD upon storage at accelerated stress conditions of temperature and humidity for 6 months. Crystalline peaks were observed for spray-dried dispersion, whereas ASD by MBP process remained amorphous as seen from Fig. 12.5 (Shah et al. 2012). Corresponding to this observation, the bioavailability of ASD by MBP was 100%, while that of spray-dried ASD was 52 % when evaluated in a dog PK study. 

Material produced from spray-drying processes are generally spherical and hollow due to process in which the solution of dissolved drug and polymer are sprayed as fine droplets and then rapidly dried in an inert stream of warm air. Spray-dried dispersions are oftentimes porous and fragile due to the escape of solvent through the solid matrix. Processing factors that influence the particle properties of the spray-dried dispersion (drying temperature, spray rate, droplet size, air flow, etc.) will influence the dissolution rate. 

Emulsions of different oils in ternary HPMC/NaCMC/SDS mixture having 0.7% HPMC, 0.3% NaCMC and three characteristic SDS concentrations i.e. 0.00% (no HPMC-SDS complex formation), 0.35% (maximum of HPMC/SDS interaction), 1.00% (end of HPMC-SDS interaction) were prepared and spray dried. Dispersion properties (mean diameter and standard deviation) of the emulsions and suspensions of microcapsules in water are shown in Table 1. As it can be seen in Table 1 oil type influences dispersion properties of emulsions, and thus suspensions. Largest droplet diameter in all emulsions is obtained at 0.00% SDS, i.e. where no HPMC/SDS complex and coacervate formation takes place. On the other hand, largest diameter of suspended microcapsules occurs at 1.00% SDS. 

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