Latest updates to USP <1094>: key insights for softgel capsules

The United States Pharmacopeia (USP) has recently revised Chapter 1094 (Capsules dissolution and related quality attributes), focusing on capsule dissolution and related quality attributes.  The changes came into effect on December 1, 2023. 

Below is a concise overview of the significant updates for softgel capsules specifically.

1. Crosslinking

• The section on crosslinking has been expanded, detailing indicators such as pellicle formation and altered dissolution rates.

• Analytical methods like UV-Vis spectroscopy and FTIR are proposed for crosslinking confirmation.

• The chapter now advises on intentional crosslinking during dissolution method development. 

2. Dissolution Testing

• The updated chapter clarifies aspects like rupture time testing and apparatus selection challenges, acknowledging issues like capsule floating or mesh clogging.

• Notably, it introduces sections on enzyme use and Tier 1/Tier 2 testing, with specific examples for Tier 2 testing of softgel and hard capsules.

3. Quality Issues

• A new focus on capsule brittleness discusses water exchange dynamics. However, while this is relevant for both soft and hard capsules, the USP focuses the consideration on hard capsules only.

• A classification of capsule defects into minor, major, and critical categories has been introduced, with specific examples.

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