کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2487487 1114418 2008 13 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Development of a liquid enzyme-based ceruminolytic product
موضوعات مرتبط
علوم پزشکی و سلامت داروسازی، سم شناسی و علوم دارویی اکتشاف دارویی
پیش نمایش صفحه اول مقاله
Development of a liquid enzyme-based ceruminolytic product
چکیده انگلیسی
Various compositions for removal of human cerumen are marketed but they are not very effective. Therefore, a proteolytic enzyme‐based ceruminolytic product was developed containing the enzyme, methyl trypsin, and sodium bicarbonate. Efficacy was optimized based on in vitro testing using both human and artificial cerumen preparations. Both qualitative (visual observation) and quantitative (spectrophotometric) assessments of ceruminolytic efficacy were employed. Optimal enzyme stability was observed for the aqueous formulation at pH 4, while greater ceruminolytic efficacy was observed at pH 8. The optimal concentration range of enzyme was 150-300 absorbance U/mL based on efficacy and stability considerations. An aqueous formulation containing both methyl trypsin and sodium bicarbonate was shown to be more effective than two commercial products, Murine® Ear Wax Removal Drops and Cerumenex® Ear Drops. A two‐part packaging system was employed to provide adequate shelf‐life. Long‐term stability studies confirmed that the formulation maintained >75% enzyme stability for 24 months at 5 and 25°C and after reconstitution at room temperature for up to 1 day. © 2008 Wiley‐Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:4970-4982, 2008
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical Sciences - Volume 97, Issue 11, November 2008, Pages 4970-4982
نویسندگان
, , , , , ,