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Hot melt extrusion versus spray drying: hot melt extrusion degrades albendazole. | LitMetric

AI Article Synopsis

  • * Phase diagrams helped identify suitable polymer mixtures, while degradation tests showed that ABZ is stable in acidic conditions but degraded when exposed to certain chemicals and high temperatures.
  • * Spray-dried formulations with specific acids and polymers significantly enhanced dissolution rates compared to bulk ABZ and maintained stability over time, proving to be more effective than those produced by hot melt extrusion.

Article Abstract

The purpose of this study was to enhance the dissolution properties of albendazole (ABZ) by the use of amorphous solid dispersions. Phase diagrams of ABZ-polymer binary mixtures generated from Flory-Huggins theory were used to assess miscibility and processability. Forced degradation studies showed that ABZ degraded upon exposure to hydrogen peroxide and 1 N NaOH at 80 °C for 5 min, and the degradants were albendazole sulfoxide (ABZSX), and ABZ impurity A, respectively. ABZ was chemically stable following exposure to 1 N HCl at 80 °C for one hour. Thermal degradation profiles show that ABZ, with and without Kollidon VA 64, degraded at 180 °C and 140 °C, respectively, which indicated that ABZ could likely be processed by thermal processing. Following hot melt extrusion, ABZ degraded up to 97.4%, while the amorphous ABZ solid dispersion was successfully prepared by spray drying. Spray-dried ABZ formulations using various types of acids (methanesulfonic acid, sulfuric acid and hydrochloric acid) and polymers (Kollidon VA 64, Soluplus and Eudragit E PO) were studied. The spray-dried ABZ with methanesulfonic acid and Kollidon VA 64 substantially improved non-sink dissolution in acidic media as compared to bulk ABZ (8-fold), physical mixture of ABZ:Kollidon VA 64 (5.6-fold) and ABZ mesylate salt (1.6-fold). No degradation was observed in the spray-dried product for up to six months and less than 5% after one-year storage. In conclusion, amorphous ABZ solid dispersions in combination with an acid and polymer can be prepared by spray drying to enhance dissolution and shelf-stability, whereas those made by melt extrusion are degraded.

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Source
http://dx.doi.org/10.1080/03639045.2016.1220577DOI Listing

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