ArticleEuropean journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V2021
Chrono modulated multiple unit particulate systems (MUPS) via a continuous hot melt double extrusion technique: Investigation of the formulation and process suitability.
Article in European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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7 authors at 2 institutions in 1 country.
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Abstract
The current study is aimed at the development of chrono modulated multiple unit particulate systems (MUPS) of nifedipine (ND) by a continuous double extrusion process. ND, a poorly soluble drug was formulated into an amorphous solid dispersion (ASD) to improve its solubility. Further, the ASD was converted into MUPS to control the drug release through a combination of pulsatile and sustained release portions. In the preparation of the ASD, the polymer HPMCAS LG was employed at different concentrations. MUPS were formulated by using Eudragit® FS100, Eudragit® RSPO, Klucel™ HF and lipids Precirol® ATO 5, Geleol™, Compritol® ATO5. The differential scanning calorimetry and powder X-ray diffraction studies of MUPS revealed the amorphous nature of ND. Scanning electron microscopy (SEM) studies depicted the surface morphology of the ASD and the gradual change in the surface of the coated MUPS during in-vitro release studies. The in-vitro drug release profiles of ASD indicated significant improvement (p < 0.05) of solubility of ND and MUPS demonstrated a combination of pulsatile and zero-order controlled release up to 12 h. Accelerated stability studies for MUPS at 40 °C/75% RH revealed the formulations were stable. These findings suggest hot melt double extrusion as a potential alternative for conventional techniques to produce MUPS.
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