Effect of solvents and cellulosic polymers on quality attributes of films loaded with a poorly water-soluble drug

Eylul Cetindag, John Pentangelo, Thierry Arrieta Cespedes, Rajesh N. Davé

Research output: Contribution to journalArticlepeer-review

Abstract

The combined effect of solvent, cellulosic polymer, and a poorly water-soluble drug, fenofibrate (FNB) on solution-cast pharmaceutical film quality attributes, e.g., morphology, drug recrystallization, content uniformity, mechanical properties, dissolution rate and supersaturation level, was investigated. Film morphology, content uniformity, and mechanical properties were impacted by the extent of FNB recrystallization which was strongly affected by FNB solubility in the solvent as compared to the polymer type, hydroxypropyl methylcellulose or hydroxypropyl cellulose. FNB recrystallization affected drug dissolution rates and supersaturation under non-sink conditions. Specifically, the area under the curve linearly correlated with recrystallization. After one-year storage, FNB recrystallization reached very high levels even for the films with no initial recrystallization, suggesting low initial crystallinity does not guarantee stability. Thus, uncontrolled recrystallization and poor time-stability would be unavoidable for solution-cast films. Overall, both the polymer and the solvent strongly impact drug recrystallization, film structure, mechanical properties, dissolution rate, and supersaturation.

Original languageEnglish (US)
Article number117012
JournalCarbohydrate Polymers
Volume250
DOIs
StatePublished - Dec 15 2020

All Science Journal Classification (ASJC) codes

  • Organic Chemistry
  • Polymers and Plastics
  • Materials Chemistry

Keywords

  • Amorphous
  • Oral films
  • Recrystallization
  • Slurry casting
  • Solvent casting
  • Supersaturation

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