| Autor: |
Donald J. Clancy, Jeegna Patel-Jones, Gordon Hutton |
| Rok vydání: |
2018 |
| Předmět: |
|
| Popis: |
Increasing disintegration times observed during stability testing of an immediate-release drug product containing sodium bicarbonate were investigated and modeled using an accelerated stability modeling approach. The activation energy and humidity sensitivity of the increase in disintegration times were inconsistent with the decomposition of sodium bicarbonate via the formation of water and carbon dioxide, and X-ray analysis found no evidence of the formation of “Trona” (a different crystalline form of sodium bicarbonate and sodium carbonate created by the reaction of water). Increasing disintegration times appeared to be associated with the formation of rod-like particles observed using scanning electron microscopy. A predictive model for disintegration times was developed, based on an exponential effect of relative humidity; this model indicates that control of the product's starting moisture content or use of a desiccant is key to achieving a 2-year shelf life for the disintegration test. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
|
