Enhanced enteric properties and stability of shellac films through composite salts formation

Eur J Pharm Biopharm. 2007 Nov;67(3):690-8. doi: 10.1016/j.ejpb.2007.04.008. Epub 2007 Apr 20.

Abstract

The objective of this study was to improve the properties of shellac by composite salts formation. The shellac samples were prepared in various salt forms by dissolving them with 2-amino-2-methyl-1-propanol (AMP) and ammonium hydroxide (AMN) at various ratios of AMP:AMN. The results demonstrated that aqueous solubility of the shellac salts was improved as the ratio of AMP:AMN increased. The absorbance ratio of the FTIR peaks assigned to CO stretching of carboxylate and carboxylic acid (ABS1556/ABS1716) was increased with the increase of the AMP fraction, suggesting that the solubility enhancement was due to more ionization of AMP salts. Moisture adsorption studies indicated that shellac salts were more hygroscopic as AMP content increased. After storage at 40 degrees C, 75% RH, the acid value and insoluble solid of AMP salts were relatively constant even after storage of up to 180 days, suggesting that AMP should protect polymerization. The ABS1556/ABS1716 values of the shellac salts were rapidly decreased after storage, especially for those consisting of a high percentage of AMN. Thus, AMP should bind much tighter at the carboxylate binding site as compared with AMN, resulting in more solubility and stability. In conclusion, optimized shellac properties could be easily accomplished by composite salts formation.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adsorption
  • Ammonium Hydroxide
  • Calorimetry, Differential Scanning
  • Chemical Phenomena
  • Chemistry, Pharmaceutical
  • Chemistry, Physical
  • Differential Thermal Analysis
  • Drug Stability
  • Hardness
  • Hydroxides / chemistry
  • Indicators and Reagents
  • Propanolamines / chemistry
  • Resins, Plant / chemistry*
  • Salts
  • Solubility
  • Spectroscopy, Fourier Transform Infrared
  • Tablets, Enteric-Coated / chemistry*

Substances

  • Hydroxides
  • Indicators and Reagents
  • Propanolamines
  • Resins, Plant
  • Salts
  • Tablets, Enteric-Coated
  • shellac
  • Ammonium Hydroxide
  • 2-amino-2-methyl-1-propanol