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• W799392008 abstract "DRY FOAMS IN PHARMACEUTICAL FORMULATION ANGELA SPRUNK Major challenges for drug product developers are insufficient oral bioavailability and food effect of newly discovered active pharmaceutical ingredients (APIs). Dry foam granulation technology was developed to overcome poor oral bioavailability, by ensuring an optimal achievable wetting of the active compound and inhibition of API agglomeration. Briefly, first the API is suspended in a surfactant solution and thereby wetted thoroughly. Then, a filler is added embedding the API in its matrix. The resulting paste is exposed to reduced pressure at room temperature for foaming, residual water is removed at moderately accelerated temperatures. The resulting dry foam is downstream processed to granules and either filled into capsules or compressed to tablets. Investigating a new formulation technology it is important to learn about the key factors, such as process parameters and formulation aspects, influencing the performance and characteristics of the resulting product. Process parameters, such as pressure, temperature, paste water content, were investigated employing experimental design and different manufacturing equipment. Paste water content and process temperatures were identified as key parameters, influencing the morphology of the resulting dry foams as well as the drying kinetics. A model equation for the dimensionless water content of dry foams was established and transferred to the manufacturing equipment vacuum belt dryer for the foaming period after introducing correction factors. A basic understanding of the interplay between pressure, temperature and paste water content, as well as heat transfer, air flow rate and resulting dry foam morphology and the drying kinetic was established. It was found that the dissolution behavior of the resulting dry foam tablets was not affected by the process parameters changing within the explored ranges. Therefore, paste water content, process pressure and manufacturing equipment can be adapted to processability and desired batch size. Investigating formulation aspects, the influence of different fillers and surfactants on the morphology, granule characteristics and dissolution behavior of dry foam tablets was exhibited. Distinct differences between dry foams prepared using spray dried glucose syrup, maltodextrin DE 21, and fast dissolving low molecular fillers, such as isomalt, or a mixture of mannitol and maltodextrin DE 21, were revealed. Using maltodextrin DE 21 resulted in a foam with a sponge like, porous structures with low specific surface area and slowly disintegrating tablets. The use of isomalt and mannitol resulted in foams with more dense, less porous structures with high specific surface area and fast disintegrating tablets. Depending on the model compound the surfactant used for dry foam preparation exhibited a major effect on dissolution behavior of the resulting dry foam tablets. Seeking for key characteristics identifying APIs benefiting from being formulated by dry foam granulation, a set of nine model compounds, with different physicochemical properties, was investigated by comparing granule and dissolution characteristics with fluid bed granules of the same model compound and surfactant. Interestingly, the very three model compounds with high lipophilicity and a low melting point exhibited a superior dissolution behavior of dry foam compared to fluid bed granule tablets, whereas the other model compounds resulted only in similar dissolution behavior. Especially for the model compound orlistat, dry foam granulation technology showed beneficial dissolution behavior using all three filler systems, in comparison to fluid bed granules as well as to the market formulation ALLI® 60mg capsules. Therefore, dry foam granulation technology is an additional formulation method, which in some cases can lead to beneficial dissolution behavior due to improved wettability and inhibition of agglomeration tendencies." @default.
• W799392008 created "2016-06-24" @default.
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• W799392008 date "2014-01-01" @default.
• W799392008 modified "2023-09-24" @default.
• W799392008 title "Dry Foams in pharmaceutical formulation" @default.
• W799392008 hasPublicationYear "2014" @default.
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