Development of a new evaluation method for gelatin film sheets

Area of Science:

• Materials Science
• Pharmaceutical Technology

Background:

• Gelatin film sheets are crucial for soft capsule manufacturing via the rotary die method.
• Evaluating film sheet properties is vital, especially when using alternative materials.
• Understanding these properties ensures capsule integrity and performance.

Purpose of the Study:

• To investigate the relationship between gelatin film sheet width and tensile strength.
• To determine the correlation between gelatin film sheet preparation time and tensile strength.
• To establish key indexes for gelatin film sheet quality control.

Main Methods:

• Linear regression analysis was employed to assess correlations.
• Tensile strength was measured at various time points (4, 8, 15, 30, 60 minutes) post-preparation.
• The width of the gelatin film sheets was systematically varied.

Main Results:

• A negative correlation was observed between film sheet width and tensile strength (R values of 0.9858 and 0.9167).
• Tensile strength exhibited a two-phase increase over time, indicating distinct strengthening mechanisms.
• High correlation coefficients (R=0.9952 and R=0.9494) confirmed time-dependent strengthening.

Conclusions:

• Gelatin film sheet tensile strength is inversely related to its width.
• Tensile strength increases with time in a biphasic manner, influenced by phase transition points.
• These findings provide critical parameters for optimizing gelatin film sheets in soft capsule production.