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Solid-state stability assessment of controlled release tablets containing Carbopol 971P
V R Goskonda1, I K Reddy, M J Durrani
1Division of Basic Pharmaceutical Sciences, Northeast Louisiana University, Monroe 71209, USA.
Summary
Dyphylline tablets showed stability at various temperatures but degraded at high humidity. Increased moisture absorption at 37°C/91%RH led to changes in crystallinity and dissolution, possibly due to dyphylline converting to its hydrate form.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Direct compression is an efficient tablet manufacturing method.
- Understanding drug product stability under exaggerated conditions is crucial for formulation development.
Purpose of the Study:
- To evaluate the stability of dyphylline tablets under accelerated temperature and humidity conditions.
- To investigate the impact of exaggerated storage conditions on the physical and chemical properties of dyphylline tablets.
Main Methods:
- Tablets were prepared using direct compression.
- Stability testing involved exposure to temperatures (4-55°C) and humidity (11-91% RH) for 12 months.
- Analysis included X-ray diffractometry (XRD), differential scanning calorimetry (DSC), and dissolution testing (USP Apparatus 2).
Main Results:
- Tablets showed significant moisture sorption at 37°C/91% RH.
- Dissolution profiles indicated instability at higher humidity (increased f1, decreased f2 values).
- XRD and DSC data suggested a change in crystallinity and potential conversion of dyphylline to its hydrate form at high humidity.
Conclusions:
- Dyphylline tablets are susceptible to degradation under high humidity conditions.
- The observed changes in dissolution are likely attributed to the formation of dyphylline hydrate.
- Formulation strategies should consider humidity control for long-term stability.