Abstract:

BACKGROUND: The ethyl cellulose is a commonly used insoluble polymer material that has a good film formation properties and mechanical properties, and can be used as the sustained-release coating material.
OBJECTIVE: To prepare mestinon cellulose film-coated sustained-release formulation and to study its properties.
METHODS: The core of the formulation was optimized by single factor method based on sustained-release material of hydroxypropylmethylcellulose and indicator of in vitro cumulative release. And the film coating was optimized by the orthogonal methodology based on ethyl cellulosesustained-release material. The mestinon cellulose film-coated sustained-release formulation was successfully prepared and the in vitro release behavior and stability to light and heat was investigated.
RESULTS AND CONCLUSION: The hydroxypropylmethylcellulose K15M was determined as sustained-release material and 95% ethanol solution was determined as binder by single factor investigation. Orthogonal design method was used to optimize coating prescription: the coating weight was 10%, the content of porogen was 3% and the amount of the anti-adhesion promoter was 0.1%; the accumulated release rates of mestinon cellulose film-coated sustained-release were (19.52±0.72)%, (42.31±0.61)% and (86.50±0.72)% at 2, 4 and 8 hours, respectively. The mestinon cellulose film-coated sustained-release possessed good sustained-release characteristics and stability in light and hot.