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In-process controls (IPC) for soft capsules
While the release tests for solid dosage forms and softgel capsules are typically well defined in the pharmacopeias, IPC testing is rarely discussed. This article gives an overview on the most common IPC testing methods for each step of softgel manufacture.
1. Gelatin mass preparation
As the characteristics of the gelatin mass may impact the processability, appearance and physical stability of the capsules, appropriate IPC testing include the following:
The manufacturing process of softgel capsules
Soft capsules are commercially manufactured applying the rotary-die technology, a technique that traces its roots back to the 19th century with the innovations of the pharmacist Robert P. Scherer. It involves a series of operations which are performed in parallel to each other and are typically highly standardised at each manufacturer: gel mass preparation, filll mass preparation, encapsulation, drying, inspection and (bulk) packaging.
What are softgel capsules?
Soft capsules are a solid oral dosage form a liquid or semi-solid capsule fill containing the active ingredient dosed into a hermetically sealed capsule shell.
While soft capsules have been known and patented first in the 1830s, the most common process for their commercial-scale production, the rotary-die encapsulation, was patented by R.P. Scherrer in 1933.