1. Materials and structure of capsule shell
Properties of HPMC: HPMC, as a cellulose derivative, is chemically inert and has good compatibility, which helps the capsule shell remain stable when dissolved. However, HPMC of different specifications and viscosities may affect the dissolution rate of the capsule.
Thickness and uniformity of capsule shell: The thickness and uniformity of the capsule shell have a direct impact on the dissolution performance. Thicker capsule shells may take longer to completely dissolve, and uneven capsule shells may cause uneven dissolution.
2. Storage conditions
Temperature and humidity: The moisture content of HPMC hollow capsules in the specified packaging will vary during long-term storage, but it is usually within an acceptable range. However, extreme temperature or humidity conditions may affect the physical properties and dissolution performance of the capsule shell.
Light: Although light has little effect on the direct dissolution performance of HPMC hollow capsules, long-term light exposure may cause degradation of the capsule shell material, thereby affecting its stability.
3. Dissolution medium
Composition of the medium: The pH value, ionic strength and solvent composition of the dissolution medium will affect the dissolution performance of HPMC hollow capsules. For example, some solvents may interact with HPMC, thus affecting its dissolution rate.
Temperature of the medium: Generally, as the temperature increases, the movement speed of molecules increases, which helps the dissolution of the capsule shell.
4. Drug properties and compatibility
Drug solubility: The solubility of the drug is one of the key factors affecting the dissolution performance of HPMC hollow capsules. Poorly soluble drugs may take longer to release from the capsule.
Drug stability: Some drugs may degrade or react during the dissolution process, thus affecting the dissolution performance of the capsule and the release of the drug.
Drug interaction with the capsule shell: Some drugs may interact with HPMC, such as forming complexes or chemical reactions, thus affecting the dissolution rate of the capsule.
5. Preparation process
Molding process: Preparation processes such as dip molding may affect the structure and properties of the capsule shell, thereby affecting its dissolution performance.
Drying and curing: Factors such as temperature and time during drying and curing may also affect the dissolution performance of the capsule shell.