In Vitro-In Vivo Evaluation of an Oral Ghost Drug Delivery Device for the Delivery of Salmon Calcitonin

J Pharm Sci. 2018 Jun;107(6):1605-1614. doi: 10.1016/j.xphs.2018.02.004. Epub 2018 Feb 13.

Abstract

An orally administered site-specific Oral Ghost Drug Delivery (OGDD) device was developed and evaluated for the administration of salmon calcitonin. In vitro drug release studies have been undertaken using biorelevant media and aspirated gastrointestinal fluid from a large white pig in addition to characterization of a formulated trimethyl chitosan blend formulated and prepared into a loaded mini-pellet system. In vivo drug release analysis in a large white pig model has further been undertaken on the OGDD device and a commercial intramuscular injection to ascertain the release properties of the OGDD device in an animal model in comparison with the currently used treatment option for the administration of salmon calcitonin. Results of this study have detailed the success of the prepared system during both in vitro and in vivo analyses with the OGDD providing a greater control of release of salmon calcitonin when compared to the commercial product.

Keywords: drug transport; oral absorption; peptide delivery; pharamcokinetics; polymer synthesis; proteins.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Animals
  • Calcitonin / administration & dosage*
  • Calcitonin / pharmacokinetics*
  • Calcium-Regulating Hormones and Agents / administration & dosage*
  • Calcium-Regulating Hormones and Agents / pharmacokinetics*
  • Chitosan / analogs & derivatives
  • Delayed-Action Preparations / chemistry*
  • Drug Delivery Systems / instrumentation*
  • Drug Liberation
  • Equipment Design
  • Hydrogel, Polyethylene Glycol Dimethacrylate / chemistry
  • Injections, Intramuscular
  • Swine

Substances

  • Calcium-Regulating Hormones and Agents
  • Delayed-Action Preparations
  • Hydrogel, Polyethylene Glycol Dimethacrylate
  • salmon calcitonin
  • Calcitonin
  • Chitosan