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Preliminary evaluation of a novel oral delivery system for rhPTH1-34: in vitro and in vivo.

Abstract：

:rhPTH1-34 is clinically used for osteoporosis treatment. However, this peptide drug has no oral bioavailability because of proteolysis and low membrane permeability in gastrointestinal gut. This study explored the possibility of absorption enhancement for rhPTH1-34 through the oral delivery of the microemulsion. The microemulsion (85:15, oil/water) consisting of Labrasol, Crodamol GTCC, Solutol HS 15, d-α-tocopheryl acetate (6:2:1:1, w/w) and saline water was developed and characterized, including particle size, morphology, drug loading efficiency and permeability, stability and pharmacokinetics. The microemulsion showed high drug loading efficiency (83%) and permeability, and significantly higher resistance to proteolysis in vitro study. The relative oral bioavailability was 5.4% and 12.0% when delivered to gastric and ileum. Besides, osteoporosis rats were induced and treated with oral rhPTH1-34 microemulsion (0.05 mg/kg), injection (0.01 mg/kg) and vehicle, respectively, for 8 weeks. The proximal tibia bone mineral content and density in oral rats (0.188 ± 0.008 g, 0.283 ± 0.014 g/cm(2)) was significantly increased compared to the control rats (0.169 ± 0.006 g, 0.266 ± 0.011 g/cm(2)), reaching to the sham rats. And the proximal tibia microstructure of oral rats was improved greatly, approaching sham level too. These findings revealed that oral microemulsion may represent an effective oral delivery system for rhPTH1-34.

journal_name

Int J Pharm

journal_title

International journal of pharmaceutics

authors

Guo L,Ma E,Zhao H,Long Y,Zheng C,Duan M

doi

10.1016/j.ijpharm.2011.08.029

subject

Has Abstract

pub_date

2011-11-25 00:00:00

pages

172-9

issue

1

eissn

0378-5173

issn

1873-3476

pii

S0378-5173(11)00791-5

journal_volume

420

pub_type

杂志文章

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