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Article # : SC18 |
Sema Çalış, Ph.D. Professor |
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Oral multiple w/o/w emulsion formulation of a peptide salmon calcitonin: in vitro-in vivo evaluation
S. T. Dogru* MSc, S. Çalış PhD and F. Öner* PhD
*Department of Pharmaceutical Biotechnology, Faculty of Pharmacy and Department of Pharmaceutical Technology, Faculty of Pharmacy, Hacettepe University, 06100 Ankara, Turkey
Summary Background: Salmon calcitonin (sCT) is a polypeptide hormone consisting of 32 amino acid residues (MW approx. 3400 Da), which can be used successfully for the treatment of osteoporosis, Pagefs disease and hypercalcaemia. Only nasal and parenteral preparations of sCT are currently available, and as injections are poorly accepted by patients, nonparenteral preparations for oral, rectal and nasal administration are highly desirable. However, oral sCT is poorly bioavailable, being susceptible to enzymatic degradation in the gastrointestinal tract. Objectives: To design a formulation of sCT suitable for oral use.
Method:
A water/oil/water (w/o/w) type multiple
emulsion
formulation was designed for oral
application of sCT. sCT was placed in the inner
water
phase,
and a protease inhibitor, aprotinin,
was
included in the outer water phase of this
system
to investigate the influence of protease
inhibitors in the
presence
of sCT. The effectiveness of the formulation was evaluated in vitro
by
placing
emulsion samples in a dialysis medium
and
in vivo by using a rat
model.
Key words Calcitonin, Oral emulsion, Protease inhibitor, Rat model, w/o/w emulsion
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