Role of an isomorphic desolvate in dissolution failures of an erythromycin tablet formulation

The investigation of dissolution failures for erythromycin dihydrate tablet formulation over a 12‐month period using a near‐infrared spectroscopy technique revealed the role of a desolvated dihydrate in the retardation of dissolution. Near infrared spectroscopy (NIR) indicated a dehydrated dihydrate...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 1999-11, Vol.88 (11), p.1222-1227
Main Authors: Bauer, John F., Dziki, Walter, Quick, John E.
Format: Article
Language:English
Subjects:
Anti-Bacterial Agents - administration & dosage
Anti-Bacterial Agents - chemistry
Biological and medical sciences
Desiccation
Drug Stability
Erythromycin - administration & dosage
Erythromycin - chemistry
Excipients - chemistry
General pharmacology
Magnesium Hydroxide - chemistry
Medical sciences
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
Solubility
Spectroscopy, Near-Infrared
Tablets
Water - chemistry
X-Ray Diffraction
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Summary:The investigation of dissolution failures for erythromycin dihydrate tablet formulation over a 12‐month period using a near‐infrared spectroscopy technique revealed the role of a desolvated dihydrate in the retardation of dissolution. Near infrared spectroscopy (NIR) indicated a dehydrated dihydrate of erythromycin is produced during formulation and gradually binds with Mg(OH)2. The binding delays the process of dissolution. NIR was used to successfully predict that humidifying the tablets would reverse the binding and increase the dissolution rate.
ISSN:0022-3549
1520-6017
DOI:10.1021/js9900102