Safety and efficacy of self-assembling bubble carriers stabilized with sodium dodecyl sulfate for oral delivery of therapeutic proteins

Po Yen Lin, Er-Tuan Chuang, Yi Hsuan Chiu, Hsin Lung Chen, Kun Ju Lin, Jyuhn Huarng Juang, Ching Hua Chiang, Fwu-Long Mi, Hsing Wen Sung

Research output: Contribution to journalArticle

9 Citations (Scopus)

Abstract

Sodium dodecyl sulfate (SDS) is generally regarded as a potent permeability enhancer in oral formulations; however, one concern related to the use of any permeation enhancer is its possible absorption of unwanted toxins during the period of epithelial permeability enhancement. In this work, the safety and efficacy of an SDS-containing bubble carrier system that is developed from an orally administered enteric-coated capsule are evaluated. The bubble carriers comprise diethylene triamine pentaacetic acid (DTPA) dianhydride, sodium bicarbonate (SBC), SDS, and insulin. Upon exposure to the intestinal fluid, DTPA dianhydride hydrolyzes to yield acids, and SBC rapidly reacts with these acids to generate CO2, producing bubble carriers, each containing a self-assembling water film. The hydrophilic insulin is entrapped in the self-assembled water film, which is stabilized by SDS. The SDS in the bubble carrier system can act as a dissolution enhancer in the dispersion of insulin molecules, as a surfactant that stabilizes the bubble carriers, as a protease inhibitor that protects the protein drug, and as a permeation enhancer that augments its oral bioavailability. Hence, a significant increase in the plasma insulin level and an excellent blood glucose-lowering response in diabetic rats are effectively achieved. Moreover, the enhancement of epithelial permeation by this SDS-containing formulation does not promote the absorption of intestinal endotoxins. The above facts indicate that the bubble carrier system that is stabilized by SDS can be used as a safe and potent carrier in the oral delivery of therapeutic proteins.
Original languageEnglish
Pages (from-to)168-175
JournalJournal of Controlled Release
Volume259
DOIs
Publication statusPublished - Aug 10 2017

Fingerprint

Sodium Dodecyl Sulfate
Safety
Proteins
Insulin
Sodium Bicarbonate
Acids
Therapeutics
Permeability
Water
Intestinal Absorption
Protease Inhibitors
Endotoxins
Surface-Active Agents
Biological Availability
Capsules
Blood Glucose
Pharmaceutical Preparations

Keywords

  • Blood glucose-lowering effect
  • Diabetes mellitus
  • Endotoxin
  • Oral protein delivery
  • Permeability enhancer

Cite this

Safety and efficacy of self-assembling bubble carriers stabilized with sodium dodecyl sulfate for oral delivery of therapeutic proteins. / Lin, Po Yen; Chuang, Er-Tuan; Chiu, Yi Hsuan; Chen, Hsin Lung; Lin, Kun Ju; Juang, Jyuhn Huarng; Chiang, Ching Hua; Mi, Fwu-Long; Sung, Hsing Wen.

In: Journal of Controlled Release, Vol. 259, 10.08.2017, p. 168-175.

Research output: Contribution to journalArticle

Lin, Po Yen ; Chuang, Er-Tuan ; Chiu, Yi Hsuan ; Chen, Hsin Lung ; Lin, Kun Ju ; Juang, Jyuhn Huarng ; Chiang, Ching Hua ; Mi, Fwu-Long ; Sung, Hsing Wen. / Safety and efficacy of self-assembling bubble carriers stabilized with sodium dodecyl sulfate for oral delivery of therapeutic proteins. In: Journal of Controlled Release. 2017 ; Vol. 259. pp. 168-175.
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