Esophageal transit of risedronate cellulose-coated tablet and gelatin capsule formulations.
Int J Pharm
; 186(2): 169-75, 1999 Sep 20.
Article
en En
| MEDLINE
| ID: mdl-10486435
Risedronate sodium is an orally active antiresorptive agent and a member of the pyridinyl class of bisphosphonates. It has been approved for the treatment of Paget's disease of the bone and is under development as a chronic therapy for the treatment and prevention of osteoporosis. A novel cellulose film-coated tablet formulation was developed to optimize esophageal transit of this bisphosphonate. The aim of the present study was to compare the esophageal transit of the film-coated tablet formulation of risedronate with its original gelatin capsule dose form. A total of 25 elderly, healthy volunteers (mean 66 years), who were dysphagia-free, participated in this randomized cross-over study. On separate occasions, volunteers swallowed radiolabeled placebo formulations with 50 ml water. Dynamic images with participants in a sitting position were recorded for 10 min using a gamma camera. Scintigraphic imaging showed a delay in esophageal transit (greater than 15 s) in 28% of patients in the capsule group but in none of the tablet group (P<0.05). The mean transit times of the capsules and tablets were 23.8 and 3.3 s, respectively. Esophageal transit of film-coated tablets was faster than gelatin capsules, suggesting that film-coated tablets would be the appropriate formulation for all pivotal trials with risedronate and for subsequent commercialization.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Bloqueadores de los Canales de Calcio
/
Ácido Etidrónico
/
Esófago
Tipo de estudio:
Clinical_trials
Límite:
Aged
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Aged80
/
Female
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Humans
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Male
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Middle aged
Idioma:
En
Revista:
Int J Pharm
Año:
1999
Tipo del documento:
Article
Pais de publicación:
Países Bajos