Scintigraphic verification of adherence of a chitosan formulation to the human oesophagus

It is well known that adherence of a drug product, e.g. a gelatine capsule, to the oesophagus can cause oesophageal injury, which can be severe if the medicinal agent has corrosive properties. In a recent study we investigated by means of gamma scintigraphy whether chitosan granules dispensed in gel...

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Bibliographic Details
Published in:European journal of pharmaceutics and biopharmaceutics 2004, Vol.57 (1), p.145-147
Main Authors: Säkkinen, Mia, Marvola, Janne, Kanerva, Hanna, Lindevall, Kai, Ahonen, Aapo, Marvola, Martti
Format: Article
Language:English
Subjects:
Adherence
Adhesiveness - drug effects
Administration, Oral
Adult
Capsules - administration & dosage
Capsules - adverse effects
Capsules - chemistry
Chemistry, Pharmaceutical
Chitosan
Chitosan - administration & dosage
Chitosan - chemistry
Chitosan - radiation effects
Clinical Trials as Topic
Cobalt Radioisotopes
Esophagus - cytology
Esophagus - drug effects
Esophagus - pathology
Forecasting
Gamma Rays
Gamma scintigraphy
Gastric Mucosa - cytology
Gelatin - administration & dosage
Gelatin - adverse effects
Gelatin - chemistry
Gelatine
Humans
Image Processing, Computer-Assisted
Male
Oesophagus
Time Factors
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Summary:It is well known that adherence of a drug product, e.g. a gelatine capsule, to the oesophagus can cause oesophageal injury, which can be severe if the medicinal agent has corrosive properties. In a recent study we investigated by means of gamma scintigraphy whether chitosan granules dispensed in gelatine capsules had gastro-retentive properties. In one of ten volunteers the formulation lodged in the oesophagus. This case is reported here. The capsule adhered initially to the distal oesophagus. The capsule shell had started to disintegrate within 5 min, with some radioactivity detectable in the stomach. However, about two thirds of the radioactivity remained detectable in the oesophageal region for 1.75 h. This could be explained on the basis that there had been adherence not only of the gelatine shell but also of chitosan granules to the oesophageal mucosa. In evaluating potential for causing oesophageal injury it is not enough to consider only the mucoadhesive properties of the outermost layer of a drug product, because the filler may also have such properties. When new excipient materials are introduced, evaluation of their mucoadhesive tendencies is important.
ISSN:0939-6411
1873-3441
DOI:10.1016/S0939-6411(03)00098-5