The Influence of Excipients on the Stability of the Moisture Sensitive Drugs Aspirin and Niacinamide: Comparison of Tablets Containing Lactose Monohydrate with Tablets Containing Anhydrous Lactose
- 1 January 2001
- journal article
- research article
- Published by Taylor & Francis Ltd in Pharmaceutical Development and Technology
- Vol. 6 (2), 159-166
- https://doi.org/10.1081/pdt-100000742
Abstract
The purpose of this study is to test the hypothesis that in tablet formulations, moisture-sensitive drugs formulated with lactose monohydrate have the same stability as formulations containing anhydrous lactose, and to characterize the kinetics of niacinamide degradation in the solid state. Aspirin and niacinamide decomposition were used as indicators of stability. Aspirin and niacinamide tablets containing either lactose monohydrate or anhydrous lactose were separately investigated at different temperatures and relative humidities; the stability tests were done at 25 degrees C--60% RH, 40 degrees C--80% RH, 60 degrees C--60% RH, 60 degrees C--80% RH, and 80 degrees C--80% RH. Official U.S. Pharmacopeia methods were used for the aspirin and niacinamide assays. Statistical analysis showed that tablets containing lactose monohydrate have the same stability as tablets containing anhydrous lactose, which means that even though water is present in the crystal structure, the bound water does not influence the reaction rate. In addition, niacinamide degradation in the solid-state can be described by a third order rate equation.Keywords
This publication has 9 references indexed in Scilit:
- Preformulation Studies Involving Moisture Uptake in Solid Dosage FormsPharmaceutical Research, 1991
- Decomposition of Aspirin in the Solid State in the Presence of Limited Amounts of Moisture III: Effect of Temperature and a Possible MechanismJournal of Pharmaceutical Sciences, 1988
- Effect of Moisture on the Stability of Solid Dosage FormsDrug Development and Industrial Pharmacy, 1988
- States of Water Associated with SolidsDrug Development and Industrial Pharmacy, 1988
- Nonlinear Estimation of Kinetic Parameters for Solid-State Hydrolysis of Water-Soluble DrugsJournal of Pharmaceutical Sciences, 1986
- Decomposition of Aspirin in the Solid State in the Presence of Limited Amounts of MoistureJournal of Pharmaceutical Sciences, 1985
- Modelling decomposition in the solid state: stability of salsalate in suspension in the presence of excipientsInternational Journal of Pharmaceutics, 1983
- Solid‐State Decomposition of para‐Substituted Salicylic AcidsJournal of Pharmaceutical Sciences, 1975
- Decomposition Of Aspirin In The Solid State**College of Pharmacy, University of Michigan. Ann ArborJournal of the American Pharmaceutical Association (Scientific ed.), 1958