In vitro and in vivo preclinical evaluation of a minisphere emulsion-based formulation (SmPill®) of salmon calcitonin

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences
Tanira AguirreDavid J Brayden

Abstract

Salmon calcitonin (sCT, MW 3432Da) is a benchmark molecule for an oral peptide delivery system because it is degraded and has low intestinal epithelial permeability. Four dry emulsion minisphere prototypes (SmPill®) containing sCT were co-formulated with permeation enhancers (PEs): sodium taurodeoxycholate (NaTDC), sodium caprate (C10) or coco-glucoside (CG), or with a pH acidifier, citric acid (CA). Minispheres protected sCT from thermal degradation and the released sCT retained high bioactivity, as determined by cyclic AMP generation in T47D cells. Pre-minisphere emulsions of PEs combined with sCT increased absolute bioavailability (F) compared to native sCT following rat intra-jejunal (i.j.) and intra-colonic (i.c.) loop instillations, an effect that was more pronounced in colon. Minispheres corresponding to ~2000I.U. (~390μg) sCT/kg were instilled by i.j. or i.c. instillations and hypocalcaemia resulted from all prototypes. The absolute F (i.j.) of sCT was 11.0, 4.8, and 1.4% for minispheres containing NaTDC (10μmol/kg), CG (12μmol/kg) or CA (32μmol/kg) respectively. For i.c. instillations, the largest absolute F (22% in each case) was achieved for minispheres containing either C10 (284μmol/kg) or CG (12μmol/kg), whilst the...Continue Reading

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Citations

Feb 14, 2016·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Saad M AlshehriTansir Ahamad
Apr 16, 2016·Advanced Drug Delivery Reviews·Zhigao NiuMaría J Alonso
Apr 20, 2016·Advanced Drug Delivery Reviews·Orlagh M FeeneyChristopher J H Porter
Aug 3, 2016·Journal of Controlled Release : Official Journal of the Controlled Release Society·Tanira A S AguirreDavid J Brayden
Dec 29, 2020·Journal of Pharmaceutical Sciences·Tahnee J DeningMichael J Hageman
Oct 13, 2017·International Journal of Pharmaceutics·Stephanie LongetEd C Lavelle
Jan 20, 2021·ACS Biomaterials Science & Engineering·Zuwei WangYongjun Zhang
Oct 26, 2021·Medicinal Research Reviews·Malihe PooresmaeilAhmad Shaabani

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