(175ap) Evaluation on Plant-Based Softgels (SeaGel® Technology) Versus Gelatin Softgels for Pharmaceutical Applications

The popularity of softgels as a preferred oral drug and dietary supplement dosage forms is growing steadily. Softgels are adept at enclosing a wide range of liquid and semi-solid formulations and can effectively deliver active ingredients with poor solubility and allow improved bioavailability. Various gelatin grades have been specifically developed to mitigate the risk of gelatin crosslinking with active ingredients, which could otherwise compromise the dissolution performance of softgels. However, these gelatin grades are still sensitive to temperatures greater than 40 °C, presenting challenges filling API formulations at temperatures greater than 40 °C, as well as storage and shipment of gelatin softgels. Additionally, consumers are increasingly favoring plant-based products to align with different dietary needs (vegan, halal, kosher, etc).

In this study, the dynamic mechanical spectra of various wet and dry films using either gelatin film formulations or plant-based materials using IFF’s SeaGel^® technology were investigated. Furthermore, the stability of the softgels was investigated on softgels encapsulated with a model fill formulation of a poorly soluble active pharmaceutical ingredient (API), Ibuprofen (IB), using either gelatin or SeaGel^® as the shell-forming material.

The dynamic mechanical spectrum demonstrated that all gelatin grades (and formulations) had tan d > 1 when temperatures (T) were > 40 °C. The only exception was the formulation with Gelatin S (which was designed for improved stability)/glycerin where tan d > 1 when T > 45 °C. While SeaGel^® wet films demonstrated tan d < 1 at all temperatures and for all formulations. This means that SeaGel^® wet films behave more like an elastic solid and will be able to enable high temperature fill materials. Additionally, the SeaGel® softgels showed consistent mechanical stability while gelatin capsules showed decreased hardness over various aging conditions. Furthermore, SeaGel^® softgels showed slightly delayed disintegration (~ 5 min delay) compared to model gelatin capsules at the time of capsule production, but more consistent disintegration behavior than that of gelatin softgels over accelerated aging conditions. The SeaGel® softgels also showed approximately equivalent API dissolution behavior as that of model gelatin capsules at the time of capsule production. This is consistent with similar findings of other scientists. ¹

In summary, evaluation of physical, chemical, and dissolution performance of softgels plays a pivotal role in ensuring quality and consistency during drug product life cycle. SeaGel^® softgels demonstrated their resilience to high-temperature filling process and exhibited their superior stability against gelatin capsules at various aging conditions up to 12 months of aging time.

References

1. Chen, T. Humidity Influence to the Thermal and Mechanical Properties of Gelatin Capsules. https://www.tainstruments.com/pdf/literature/TA409.pdf.