With advances in technology transforming drug delivery systems, these are exciting times for the pharmaceutical industry. Not only are companies finding innovative ways to optimise manufacturing processes, but more importantly, new technologies are being developed that improve the lives of patients.
One example of such an emerging innovation in this field is Unigel™, a first-to-market technology developed by Sofgen Pharmaceuticals. The Softigel brand by Sofgen Pharmaceuticals allows pharmaceutical and nutraceutical firms to combine different products into a single pill, reducing the number of tablets that patients are expected to take throughout the day. This reduces the likelihood of forgetting to take important medication.
Pharmaceutical technology spoke with Carlos Perez, technical and commercial director, Unigel Technology about how it works and why it is the ideal platform for businesses who want to launch new products and especially new combinations.
How does Unigel work?
“Unigel is designed to combine multiple API formulations into one soft gelatin capsule, offering different release modes, bioavailability enhancement, lower manufacturing costs and superior adherence to different therapies. The technology provides different configurations for fixed-dose combinations, like a softgel within a softgel, one or two tablets within a softgel, granules within a softgel, or any combination of these. This helps address the long-standing challenges of multi-active formulations, offering new possibilities for prescription, OTC and nutraceutical products.”
How did the research and development process go?
“Innovation is at the very heart of our business. We were working for a long time on trying to combine two different APIs that were not compatible in a tablet dosage form. We formulated a barrier-avoiding permeation from the liquid phase into the tablet core, without affecting the dissolution rate. We did this by encapsulating a smaller tablet into a soft gelatin capsule. Encapsulating that tablet into a softgel required the design of a new system to make it possible in the encapsulation machine. Because of this, the designed system needed to have the ability to fill the soft gelatin capsule with the liquid and cover the tablet at the same time.”
What types of ingredients/combinations can be used inside the Unigel?
“The versatility of Unigel technology is really its key point of difference. It allows us to think in different ways about formulas for a wide spectrum of challenges in the pharmaceutical and dietary supplement industries. For the first time it is possible to have products in different categories, such as prenatal, cardio, immune health and beauty.
“One of the main attributes of Unigel is that it offers a new way of combining previously incompatible active ingredients. So you can now combine single or multiple active ingredients with different release profiles, multiple active ingredients with chemical incompatibility concerns, or ingredients where at least one is a liquid or a semisolid. This opens up a huge range of potential benefits to patients and consumers, through this multi-purpose dosage form.
“It is particularly useful when you are trying to combine liquid ingredients and one or more ingredient that is dark and thick, and the other is a clear liquid or solution. In a traditional softgel, the result would be a dark or opaque product, but 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 fewer interactions between the ingredients, but also makes for a more physically appealing product, which is gaining more importance today for consumers.”
How does this affect factors such as release time, bioavailability and efficacy?
“Unigel is the only fixed-dose combination that offers the benefits of a softgel, such as delivering a dissolved API already available for absorption, or using liquid or semisolid excipients that increase intestinal permeation, promoting lymphatic absorption. These are all ways to overcome bioavailability issues for active ingredients with low solubility or permeability.
“Since Unigel includes two or more dosage forms in one, we can formulate each phase to offer a rapid release or delayed action in the inner dosage form. In other words, we could have a Unigel product that combines a rapid onset portion (liquid phase) and a tablet, with either immediate release or modified release for a total full extended action.”
What has been the response to the Unigel so far?
“The first product launched in Latam using this technology was a combination targeting cardiovascular health, combining Omega-3 high concentrated oil with Atorvastatin. In a short period, this became the most prescribed product among physicians.
“The second product launched was a Rosuvastatin and Fenofibric acid in a single softgel, which offered a smaller dose than previous versions of the product in another fixed-dose combination form, with the benefits of the soft gelatin capsule. We have been continuously expanding our differentiated Unigel technology, working in partnership with our customers around the world to launch multivitamin combinations, vision health and weight management products, as well as hydrophilic APIs combinations in different territories.”
Sofgen Pharmaceuticals continues to work with companies across the world, forming partnerships to develop new and effective combinations. For more information about Unigel technology, or to contact Procaps about developing a multiple API formulation product, visit their website.
