1. Solubility assessment
Material Properties:
Gelatin is a natural polymer material with good biocompatibility and solubility. The solubility of gelatin hollow capsules mainly depends on factors such as the type, purity, molecular weight distribution and other factors of gelatin.
Dissolution conditions:
Gelatin dissolves easily in hot water to form a colloidal solution. When assessing solubility, it is necessary to consider the influence of water temperature, pH, ionic strength and other factors on the dissolution rate and solubility of gelatin.
Experimental Methods:
Standard solubility test methods can be used to place a certain amount of gelatin hollow capsules in water at a specific temperature and pH value, and observe and record their dissolution time and dissolution state.
Dissolving Effect:
Assess whether the dissolved solution is homogeneous, transparent, and free of undissolved particles or impurities.
2. Stability assessment
Physical Stability:
Check whether the gelatin hollow capsule is deformed, cracked, adhered and other phenomena during storage. The physical stability of the capsule can be assessed by observing its appearance, measuring changes in size and weight.
Chemical Stability:
Gelatin hollow capsules may be chemically degraded due to light, heat, humidity and other factors during storage. When evaluating chemical stability, the molecular weight distribution, viscosity, color change and other indicators of gelatin in the capsule can be measured.
Microbial stability:
Gelatin is an organic substance that is susceptible to contamination by microorganisms. Therefore, it is necessary to assess the microbiological limits of gelatin hollow capsules to ensure that they meet the relevant standards.
Long-term stability test:
Long-term stability testing is an important means to evaluate the stability of gelatin hollow capsules. Capsules can be subjected to pre-defined storage conditions (e.g., temperature, humidity, light, etc.) and periodically monitored for changes in physical, chemical and microbiological indicators.
Accelerated Stability Testing:
In some cases, accelerated stability testing can be used to quickly assess the stability of gelatin hollow capsules. By increasing the test conditions (e.g., temperature, humidity, etc.), the degradation process of the capsule is accelerated, so as to predict its stability under normal storage conditions.