Simplified formulations with high drug loads for continuous twin-screw granulation.

摘要: Abstract As different batches of the same excipients will be intermixed during continuous processes, traceability is complicated. Simplified formulations may help to reduce problems related batch intermixing and traceability. Twin-screw granulation with subsequent tableting was used produce granules tablets, containing drug, disintegrant binder (binary ternary mixtures), only. Drug loads up 90% were achieved five disintegrants screened for keeping their disintegration suitability after wetting. Granule size distributions consistently mono-modal narrow. strength reached higher values, using mixtures. Tablets croscarmellose-Na as displayed tensile strengths 3.1 MPa times from 400 466 s, resulting in most robust disintegrant. Dissolution overall complete above 96% within 30 min. Na-starch glycolate offers 2.8 MPa at 25 s 1031 s, providing broadest application window, it corresponds some parts definitions orodispersible tablets. micronized crospovidone are not suitable immediate release, but showed possibilities highly drug loaded, prolonged release simplified offer great opportunities improve present performances comparable more complicated able correspond requirements authorities.