Innovations in delivery systems: Softigel by Procaps
One might describe Unigel as ‘complicated.’ It is an oral dosage form where tablets, granules, pellets or capsules are placed inside a large, soft gelatin capsule. The technology allows for different configurations for fixed-dose combinations, such as a softgel within a softgel, one or two tablets within a softgel, granules within a softgel, or any combination of these to address challenges of multi-active formulations.
“Innovation sits at the heart of our business; therefore, we continuously develop new products and formats, having always in mind that our goal is to deliver an enjoyable consumer experience through our advanced Softgel technologies, and we've been doing this for 43 years now,” Carlos Andres Perez Rebolledo, commercial and technical director at Unigel Technology, explained to NutraIngredients-USA.
Procaps, a Colombian-based corporation, developed this first-to-market technology, which is designed to combine multiple Active pharmaceutical ingredient (API) formulations into one single soft gelatin capsule, offering different release modes, bioavailability enhancement, lower manufacturing costs (vs. two separate doses) and adherence to different therapies.
The ‘Eureka’ effect
“The origins of Unigel technology arise from the need of having a soft gelatin capsule combining two different API’s that were not compatible in a tablet dosage form. It sounded simple, but the challenge was to find a solution for this need, so our Innovation & Development team came up with a eureka idea of formulating a barrier avoiding permeation from the liquid phase into the tablet core but at the same time without affecting the dissolution rate of the API contained in this dosage form. Encapsulating that tablet into a softgel required the design of a complete new system for being able to make it possible in the encapsulation machine, meaning that the designed system needed to have the ability to fill the soft gelatin capsule with the liquid and the covered the tablet at the same time. All the latter was done, machine adaptation, synchronization process and new formulations were the foundations of this patented technology, called Unigel.”
The company said Unigel is one of the only patented techniques available for fixed-dose combinations. The delivery system allows for single or multiple active ingredients with different release profiles, multiple active ingredients with chemical incompatibility concerns and multiple active ingredients where at least one is a liquid or a semi-solid, offering unique options for nutraceutical products.
Customizing a unique formula
Perez told us that by using this technology, it is possible to create a personalized recipe with the preferred ingredients for the specific target or market. “It allows us to think in different formulas for a wide spectrum target in the dietary supplement industry, meaning that it is possible to have products in different categories such as: Prenatal, Cardio, Vision, Brain, Digestive Health, Immune health, Joint relief, Sleep aid, Beauty, Sports; among others, delivering to the consumers benefits such as taking less pills a day, and having the amount of the key actives you need in one single product. These are just some examples of the ingredients that could be used in a product formulation. There is a wide list of liquid ingredients such as: Omega-3´s, but also CLA, Vitamin E, Borage oil, EPO, Coconut oil, Liquid Collagen, MCT’s among other available ingredients that could be combined in precise doses along with solid ingredients such as minerals, vitamins, CoQ10, collagen, antioxidants like lutein, lycopene or with botanical extracts, for example.”
Perez said Unigel is useful for those cases when you try to combine liquid ingredients and one or more of them are dark and thick, and the other is a clear liquid or solution.
“With Unigel this can be solved by placing the dark thick liquid in an inner smaller softgel and leaving the clear liquid for the outer softgel, this gives you the benefit of having less interactions between the ingredients but also gives you that visually appealing experience for the finished product.”
Response
The first product using this technology was launched in Latin America. It contained a combination of omega-3 high concentrated oil with Atorvastatin.
“In a short period, this became the most prescribed product among cardiologists due to the benefits it offers. We have been continuously expanding our differentiated Unigel technology working hand in hand with some customers which have resulted in different successful launches.”
Some of those launches include SUP Women Essentials and SUP Men Essentials in Australia, VitaSight in the US, as well as Unigel CLA plus GSP, also in the US.
Looking ahead
Perez told NutraIngredients-USA that they have their pulse on three key categories moving market growth: Aging, fitness, and self-care. “From young to old and whether it’s a daily walk or a marathon, consumers understand the importance of having a healthy lifestyle.”
The company said in the future they hope to work with a variety of categories such as sports health, beauty from within, everyday nutrition, immunity boost, prenatal health, weight management and more.
