title: Molecular insights into shellac film coats from different aqueous shellac salt solutions and effect on disintegration of enteric-coated soft gelatin capsules.
abstract: The purpose of this investigation was to study the effect of using different salts of shellac on the disintegration properties of shellac-based enteric coatings. In the last two decades, shellac has been increasingly used as an aqueous solution for enteric coating purposes, with the ammonium salt being the form typically used. Little investigation has been performed on using other salts, and therefore, this was the focus of our work. Enteric coatings, based on different shellac salts (ammonium, sodium, potassium and composite ammonium-sodium), were applied onto soft gelatin capsules. Disintegration testing of the coated soft gelatin capsules showed that alkali metal salts promote faster disintegration than ammonium salts. In order to determine the causes behind these differences, the solubility, thermal and spectroscopic properties of films cast from the different salts were investigated. The results show that films cast from ammonium-based salts of shellac are, unlike those cast from alkali metal-based salts, water-insoluble. Spectroscopic evidence suggests that this might be due to partial salt dissociation resulting in loss of ammonium as ammonia and reduced degree of shellac ionization during drying. In addition, oxidation of shellac aldehyde groups of the ammonium-based shellac salts could also play a role. And possible higher extent of shellac hydrolysis during the preparation of alkali metal salts might also be a factor. Therefore, the nature of the shellac salt used in the preparation of shellac-based aqueous coating solutions is a significant formulation factor affecting product performance.
authors.affiliation: Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Staudinger Weg 5, 55099 Mainz, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Al-Gousous
authors.affiliation: Pennconsult, Mainz, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Penning
authors.affiliation: Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Staudinger Weg 5, 55099 Mainz, Germany. Electronic address: langguth@uni-mainz.de.
authors.forename: P
authors.initials: P
authors.lastname: Langguth
mesh_terms: D002214:Capsules; D005780:Gelatin / Q000737:chemistry* / Q000493:pharmacokinetics*; D019999:Pharmaceutical Solutions; D012116:Resins, Plant / Q000737:chemistry* / Q000493:pharmacokinetics*; D012492:Salts; D013608:Tablets, Enteric-Coated; D014867:Water / Q000737:chemistry*
chemical_list: D002214:Capsules; D019999:Pharmaceutical Solutions; D012116:Resins, Plant; D012492:Salts; D013608:Tablets, Enteric-Coated; D014867:Water; C003934:shellac; D005780:Gelatin
keywords: Disintegration; Enteric coating; Salt; Shellac; Soft gelatin capsule