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13 Jun 2023

Soft capsule technology: modified pea starch as a vegetal origin alternative to gelatin in capsule shell

The latest soft capsule technology from Roquette using modified pea starch as an alternative to gelatin. 

Gelatin has been used as shell polymer in the manufacture of soft gelatin capsules (softgels) for about the past century. Its rheological and thermal properties offer adequate balance for subsequent process steps including gel solution preparation/transportation, film casting, and capsule sealing/drying. 

Even though this material represents the current gold standard for soft capsules, it presents certain technical challenges such as cross-linking. In other words, it may react with some capsule active fills during storage, leading to a delay in the release time. Moreover, gelatin-based soft capsules are sensitive to heat during production, as well as during storage. Finally, both the cross-linking tendency and heat sensitivity limit the options for fill materials, especially those requiring higher processing temperatures.

Multiple vegetal origin materials were investigated as potential replacement for gelatin. Various modified starches (corn, tapioca, etc.), alone or in combination with some hydrocolloids (carrageenan, alginates, gellan gum, etc.) were used to develop non-gelatin shell formulations over the last two decades.  Some of the existing commercial options are associated with important initial investment such as the need to modify the equipment (tumble dryers, etc.), or to buy special feature parts (gel mixer, spreader boxes, etc.). From a process standpoint, they are also often associated with limitations such as lower production speed, longer drying time, and capsule defects like leakage or stickiness in comparison with gelatin. 

Riding the wave of sustainability, “vegan” or “clean label,” pharmaceutical and nutraceutical companies are now trying to combine the best of both worlds. Actually, they are looking at vegetarian alternatives that display similar or even higher technical performance than gelatin for the production of soft capsules: using standard equipment at full speed, to deliver optimal capsules with additional fill material options and better stability.

See the full white paper here

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