title: [Optimization of a floating osmotic pump system of ambroxol hydrochloride using central composite design-response surface methodology and its pharmacokinetics in Beagle dogs].
abstract: This paper reported that a new type of floating osmotic pump of ambroxol hydrochloride was designed. Third method apparatus (Chinese Pharmacopeia 2010, appendix XD) was employed to simultaneously evaluate the release and floating behavior in vitro. The system was optimized using central composite design-response surface methodology. Similar factor (f2) between the release profile of self-made formulation and the target release profile was chosen as dependent factor. The amount of glucose (A, mg), pore former (B, %) and weight of coating (C, %) were employed as independent factors. Optimized formulation was: A (100.99 mg), B (1.70%), C (4.21%). The value of f2 (89.14) was higher than that of market capsules (69.02) and self-made tablets (72.15). It was showed that self-made capsules possessed character of zero-order release (r = 0.994 4) and drug release completely (>90%). It was showed in result of in vivo study that tmax and Cmax of self-made capsules were significantly lower than that of market capsules and self-made tablets. The correlation coefficient between the fraction of absorption in vivo and the release rate in vitro was 0.985 1, and relative bioequivalence of self-made capsules was 110.77%. Accordingly, self-made capsules displayed obviously characteristics of controlled release both in vivo and in vitro.
authors.affiliation: School of Pharmacy, Hebei Medical University, Shijiazhuang 050017, China.
authors.forename: Feng
authors.initials: F
authors.lastname: Zhao
authors.forename: Yin-Ling
authors.initials: YL
authors.lastname: Ma
authors.forename: Xiao-Li
authors.initials: XL
authors.lastname: Jin
authors.forename: Jing
authors.initials: J
authors.lastname: Wang
authors.forename: De-Ying
authors.initials: DY
authors.lastname: Cao
mesh_terms: D000042:Absorption; D000284:Administration, Oral; D000551:Ambroxol / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics*; D000818:Animals; D019540:Area Under Curve; D002214:Capsules; D003692:Delayed-Action Preparations; D004285:Dogs; D004339:Drug Compounding / Q000379:methods; D016503:Drug Delivery Systems; D005079:Excipients; D005260:Female; D005947:Glucose / Q000737:chemistry; D008297:Male; D009995:Osmosis; D009997:Osmotic Pressure; D016062:Porosity; D011897:Random Allocation; D012995:Solubility; D013810:Therapeutic Equivalency
chemical_list: D002214:Capsules; D003692:Delayed-Action Preparations; D005079:Excipients; D000551:Ambroxol; D005947:Glucose