Oral Drug Delivery is considered as the universally preferred route of administration. However, the first stop in oral administration is stomach which is highly acidic and thus, it may damage acid-sensitive (acid-labile) pharmaceutical/nutraceutical ingredients. On the other hand, some medications are gastro-irritant and therefore harmful to the stomach.
Acid-sensitive or gastro-irritant pharmaceutical/nutraceutical substances are formulated in a “gastro-resistant” or in a better expression, in an “Enteric” Form.
Enteric dosage forms are designed to resist the acidic environment of the stomach and to disintegrate in the higher pH environment of the intestinal fluid.
Making Enteric tablets is simply done by coating the tablets by an acid-insoluble polymer in a pan coating machine, however this simple process becomes difficult and challenging when it comes to the soft gelatin capsules (Softgels).
Softgels are among the most attractive oral dosage forms, and they have many advantages over tablets: they are easy to swallow, suitable for liquid APIs and their bioavailability is higher than tablets because they don’t need to go through the dissolution step before absorption.
The only draw-back for softgels is that their Enteric formulation is not as simple and straightforward as tablets. The process of coating for softgels is challenging due to the application of temperature and humidity and capsules are often deformed during the process or flake after drying.
Softgels are composed of a gelatin-base shell enrobing a liquid fill. If softgels can be made with built-in gastro-resistant shells, they can be manufactured in bulk in a similar way to the standard classic non-enteric softgels.

GelEntroCeutics transform the challenging traditional gastro-resistant formulation of softgels to an attractive, easy, one-step encapsulation process.
From prototype formulation development to industrial scale-up, we are specialized in the formulation of intrinsically acid-resistant (Enteric) softgels.
Our technology could be adopted in formulation of those pharmaceuticals/nutraceuticals substances which are damaged in acidic pH of stomach, and you want to have them in Softgel forms. It is also suitable for gastro-irritant medications to avoid the stomach upset caused by them.
The composite of an acid-insoluble polymer along with an optimized amount of a proper plasticizer, is used to make enteric softgels in just one single step of encapsulation.
The Enteric softgel, so obtained comply with all the USP criteria for enteric soft gelatin capsules.
The followings are Certificate of Analysis for a few intrinsically gastro-resistant (Enteric) softgel formulations which have been tested by Eurofin Canada: