应用防潮型薄膜包衣增强片剂使用期间的稳定性.PDFVIP

Utilization of a Moisture Barrier Film Coating to Enhance In-Use Tablet Stability Plinio Sandoval, David Ferrizzi, Jason Teckoe, Charles Cunningham and Ali Rajabi-Siahboomi AAPS Colorcon, Inc., Harleysille, PA USA Poster Reprint 2016 Purpose It is common practice for pharmacists or patients to remove medicines from their primary packaging and dispense into alternate containers holding the required quantity of dosages for the prescribed regimen. Once medicine is removed from its primary packaging, protection of the active pharmaceutical ingredient (API) from detrimental effects of the environment is compromised and degradation of the API may occur. In 2001, The European Agency for the Evaluation of Medicinal Products (EMA) issued a Note for Guidance on In-use Stability 1 Testing of Human Medicinal Products. This guidance proposes stability studies to ensure product quality for a period of time after the container is opened simulating the expected duration and use of the opened product. Based on the EMA guidance, this study examines the potential for i lm coating to provide enhanced stability of amoxicillin-clavulanic acid i xed-dose combination tablets, once they have been removed from their primary packaging and placed into an in-use tablet dispenser. Methods Amoxicillin and clavulanic acid are combined to produce an antibiotic with an increased spectrum of action against some amoxicillin-resistant bacteria. A i xed-dose combination of amoxicillin 875 mg and clavulanic acid 125 mg was selected for this study due to the high sensitivity of clavulanic acid to moisture. The uncoated ® tablets and tablets