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 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.
Bauer
J F
JF
PPD Analytical Development Center, Abbott Laboratories, 1401 Sheridan Road, D.4P2, North Chicago, Illinois 60064-6293, USA. John.Bauer@Abbott.com@internet
Dziki
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Quick
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JE
D000900:Anti-Bacterial Agents / Q000008:administration & dosage / Q000737:chemistry*; D003890:Desiccation; D004355:Drug Stability; D004917:Erythromycin / Q000008:administration & dosage / Q000737:chemistry*; D005079:Excipients / Q000737:chemistry; D008276:Magnesium Hydroxide / Q000737:chemistry; D012995:Solubility; D019265:Spectroscopy, Near-Infrared; D013607:Tablets; D014867:Water / Q000737:chemistry; D014961:X-Ray Diffraction
D000900:Anti-Bacterial Agents; D005079:Excipients; D013607:Tablets; D014867:Water; D004917:Erythromycin; D008276:Magnesium Hydroxide