title: The development and evaluation of a subcutaneous infusion delivery system based on osmotic pump control and gas drive.
abstract: A novel, self-administration drug delivery system for subcutaneous infusion was developed and evaluated. The device includes two main components: an osmotic tablet controlled gas actuator and a syringe catheter system. The sodium carbonate in the osmotic pump tablet will release into the surround citric acid solution and produce CO2gas, which will drive the drug solution into subcutaneous tissue. The key formulation factors of the osmotic tablet that would influence the infusion profiles of the device were investigated by single factor exploration. The formulation was optimized via a response surface methodology. With an 18 ± 4 min of lag time, the delivery system was able to infuse at an approximate zero-order up to 5.90 ± 0.37 h with a precision of 9.0% RSD (n = 6). A linear correlation was found for the infusion profile and the fitting equation was Y = 0.014X - 0.004 (r = 0.998). A temperature change of 4 °C was found to modify the flow rate by about 12.0%. In vivo results demonstrated that the present subcutaneous infusion device was similar to the commercial infusion pump, and it could bring a long and constant ampicillin plasma level with minimized fluctuations.
authors.affiliation: a Department of Pharmaceutics , Beijing Institute of Pharmacology and Toxicology , Beijing , PR China.|b Department of Pharmacy , Wuhan General Hospital of Guangzhou Military Command , Wuhan , PR China , and.
authors.forename: Xiangyang
authors.initials: X
authors.lastname: Xie
authors.affiliation: a Department of Pharmaceutics , Beijing Institute of Pharmacology and Toxicology , Beijing , PR China.
authors.forename: Yang
authors.initials: Y
authors.lastname: Yang
authors.affiliation: a Department of Pharmaceutics , Beijing Institute of Pharmacology and Toxicology , Beijing , PR China.
authors.forename: Yanfang
authors.initials: Y
authors.lastname: Yang
authors.affiliation: a Department of Pharmaceutics , Beijing Institute of Pharmacology and Toxicology , Beijing , PR China.
authors.forename: Zhiping
authors.initials: Z
authors.lastname: Li
authors.affiliation: a Department of Pharmaceutics , Beijing Institute of Pharmacology and Toxicology , Beijing , PR China.
authors.forename: Hui
authors.initials: H
authors.lastname: Zhang
authors.affiliation: c Department of Pharmacy , The 215th Clinic of 406th Hospital of the Chinese People's Liberation Army , Dalian , China.
authors.forename: Qiang
authors.initials: Q
authors.lastname: Chi
authors.affiliation: a Department of Pharmaceutics , Beijing Institute of Pharmacology and Toxicology , Beijing , PR China.
authors.forename: Xingshi
authors.initials: X
authors.lastname: Cai
authors.affiliation: a Department of Pharmaceutics , Beijing Institute of Pharmacology and Toxicology , Beijing , PR China.
authors.forename: Xingguo
authors.initials: X
authors.lastname: Mei
mesh_terms: D000818:Animals; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004285:Dogs; D016503:Drug Delivery Systems / Q000379:methods*; D005260:Female; D005740:Gases / Q000008:administration & dosage*; D055104:Infusions, Subcutaneous / Q000379:methods; D009995:Osmosis / Q000187:drug effects*; D013607:Tablets / Q000008:administration & dosage
chemical_list: D005740:Gases; D013607:Tablets
keywords: Ampicillin sodium; gas drive; osmotic pump; self-administration; subcutaneous infusion