Factors Leading to Prolonged Disintegration Time of Soft Gel Capsules and Solutions

Factors Leading to Prolonged Disintegration Time of Soft Gel Capsules and Solutions:

Based on comparative testing observations in the lab, the disintegration time of certain soft gel capsule supplements was found to increase, particularly in capsules containing some herbal extracts.

Research Findings:

l Complexity of TCM Material: Traditional Chinese Medicine (TCM) materials are complex and contain aldehydes (e.g., some volatile oils or extracts). Aldehydes can tan gelatin, which lead to denaturation of collagen micelles and consequently prolonging disintegration time.

l Oxidation of Capsule Shell: When additives like propylene glycol or sorbitol are included in the capsule shell, these components are prone to oxidation during storage, generating aldehydes which further promote gelatin cross-linking.

l Improper Storage Conditions: Cross-linking can be exacerbated by unsuitable storage conditions.

I. Impact of Gelatin Cross-linking on Soft Gel Capsule Quality:

- Visual Changes: Capsule surface hardens, becomes sticky, or develops cracks.

- Brittleness: Makes transportation difficult and increases susceptibility to moisture absorption under high humidity.

- Delayed Release of Active Ingredients: Affects bioavailability; prevents full drug release and reducing product efficacy.

- Degradation: Cross-linking reactions may be accompanied by oxidative degradation of the filled material, leading to non-compliance with standards.

II. Solutions and Quality Control Recommendations:

Formulation Optimization:

- Reduce aldehyde-containing components or add aldehyde scavengers (e.g., cysteine).

- Use non-aldehyde dispersion media (e.g., replace PEG400 with vegetable oil).

- Add antioxidants (0.5%~1% glycine) to the shell or adjust pH value (optimal pH 2.5~3.5 to inhibit cross-linking).

Process Improvement:

Control shell drying temperature (<35℃) and humidity.

Use gelatin with lower cross-linking risk (e.g., fish gelatin or hydroxypropyl methylcellulose (HPMC) as alternatives).

Storage Management:

Strictly control temperature (below 25°C), humidity (RH ≤ 60%), and protect from light.

Use aluminum blister packaging or desiccants in conjunction with oxygen scavengers.

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