[2] Suez Canal Univ, Dept Pharmaceut, Fac Pharm, Ismailia, Egypt
[3] Univ New Mexico, Coll Pharm, Dept Pharmaceut Sci, Albuquerque, NM 87131 USA
来源:
AAPS PHARMSCITECH
|
2016年
/
17卷
/
03期
关键词:
antiadherents;
drug release;
Eudragit polymers;
film coating;
mechanical properties;
MECHANICAL-PROPERTIES;
COATING FORMULATIONS;
IN-VITRO;
PELLETS;
PLASTICIZERS;
QUANTIFICATION;
DISPERSION;
TACKINESS;
CELLULOSE;
MIXTURES;
D O I:
10.1208/s12249-015-0397-7
中图分类号:
R9 [药学];
学科分类号:
1007 ;
摘要:
Antiadherents are used to decrease tackiness of a polymer coating during both processing and subsequent storage. Despite being a common excipient in coating formulae, antiadherents may affect mechanical properties of the coating film as well as drug release from film-coated tablets, but how could addition of antiadherents affect these properties and to what extent and is there a relation between the physical characteristics of the tablet coat and the drug release mechanisms? The aim of this study was to evaluate physical characteristics of films containing different amounts of the antiadherents talc, glyceryl monostearate, and PlasACRYL(TM) T20. Eudragit RL30D and Eudragit RS30D as sustained release polymers and Eudragit FS30D as a delayed release material were used. Polymer films were characterized by tensile testing, differential scanning calorimetry (DSC), microscopic examination, and water content as calculated from loss on drying. The effect of antiadherents on in vitro drug release for the model acetylsalicylic acid tablets coated with Eudragit FS30D was also determined. Increasing talc concentration was found to decrease the ability of the polymer films to resist mechanical stress. In contrast, glyceryl monostearate (GMS) and PlasACRYL produced more elastic films. Talc at concentrations higher than 25% caused negative effects, which make 25% concentration recommended to be used with acrylic polymers. All antiadherents delayed the drug release at all coating levels; hence, different tailoring of drug release may be achieved by adjusting antiadherent concentration with coating level.