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The United States Pharmacopeia (USP) recently updated Chapter 1094 (Capsules dissolution and related quality attributes), focusing on capsules' dissolution and related quality attributes. This updated version, effective from December 1st, 2023, introduces significant changes. What does that mean for soft gel capsules?

In this article, we summarize and discuss the main changes relating to softgel capsules.

As niche dosage forms, softgel capsules require extensive expertise for successful development. Partnering with the right contract development and manufacturing organisation (CDMO) is essential to avoid inefficiencies, increased development costs, and protracted timelines.

The shell of a soft gelatin capsule consists of the gelling agent gelatin, a plasticizer, water and optionally colorants. Compared to hard capsules, the soft capsule shell requires a higher amount of plasticizers and typically also has a higher water content.

While the shell of soft gelatin capsules is often simplistically regarded as mere packaging material for the capsule content, it can have a significant impact on the product stability and compatibility. A thorough approach to the shell development is therefore crucial. This article gives an overview on raw material selection, critical aspects and common quality issues during capsule shell development.

Historically, fill formulations for soft capsules were developed mainly with the solubility of the drug substance in mind. Nowadays soft capsule formulations are employed for advanced pharmaceutical drugs delivery systems with the aim to increase both solubility and finally, bioavailability