AAPS PharmSciTech

, Volume 12, Issue 2, pp 746–754 | Cite as

Investigation into Stability of Poly(Vinyl Alcohol)-Based Opadry® II Films

  • Otilia M. Y. Koo
  • John D. Fiske
  • Haitao Yang
  • Faranak Nikfar
  • Ajit Thakur
  • Barry Scheer
  • Monica L. Adams
Research Article Theme: Advances in Pharmaceutical Excipients Research and Use: Novel Materials, Functionalities and Testing

Abstract

Poly(vinyl alcohol) (PVA)-based formulations are used for pharmaceutical tablet coating with numerous advantages. Our objective is to study the stability of PVA-based coating films in the presence of acidic additives, alkaline additives, and various common impurities typically found in tablet formulations. Opadry® II 85F was used as the model PVA-based coating formulation. The additives and impurities were incorporated into the polymer suspension prior to film casting. Control and test films were analyzed before and after exposure to 40°C/75% relative humidity. Tests included film disintegration, size-exclusion chromatography, thermal analysis, and microscopy. Under stressed conditions, acidic additives (hydrochloric acid (HCl) and ammonium bisulfate (NH4HSO4)) negatively impacted Opadry® II 85F film disintegration while NaOH, formaldehyde, and peroxide did not. Absence of PVA species from the disintegration media corresponded to an increase in crystallinity of PVA for reacted films containing HCl. Films with NH4HSO4 exhibited slower rate of reactivity and less elevation in melting temperature with no clear change in melting enthalpy. Acidic additives posed greater risk of compromise in disintegration of PVA-based coatings than alkaline or common impurities. The mechanism of acid-induced reactivity due to the presence of acidic salts (HCl vs. NH4HSO4) may be different.

KEY WORDS

acid salts and stability pharmaceutical coating polyethylene glycol poly(vinyl alcohol) 

Notes

ACKNOWLEDGMENT

The authors would like to acknowledge BMS for providing the opportunity and summer internship funding to H. Yang to conduct this work and Colorcon Inc for providing Opadry ® samples.

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Copyright information

© American Association of Pharmaceutical Scientists 2011

Authors and Affiliations

  • Otilia M. Y. Koo
    • 1
  • John D. Fiske
    • 2
  • Haitao Yang
    • 3
    • 4
  • Faranak Nikfar
    • 1
  • Ajit Thakur
    • 1
  • Barry Scheer
    • 2
  • Monica L. Adams
    • 1
  1. 1.Drug Product Science and TechnologyBristol-Myers Squibb CompanyNew BrunswickUSA
  2. 2.Analytical and Bioanalytical DevelopmentBristol-Myers Squibb CompanyNew BrunswickUSA
  3. 3.School of PharmacyUniversity of PittsburghPittsburghUSA
  4. 4.Bristol-Myers Squibb CompanyNew BrunswickUSA

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