soft capsule gelatin | Solution for Producing Gelatin Soft Capsules

Softgel Market

Gelatin made soft capsules, also known as softgel is a significant pharmaceutical and nutraceutical application of gelatin. The total quantity of the global capsule market is estimated to reach approximately 260 billion pieces which is equivalent to US$ 5.19 billion in 2025, with average annual compound growth rate of 4.6% and 5.5% respectively during the period of forecast.

Soft capsules account for a smaller proportion of prescription drugs but it is increasing much faster in comparison with traditional hard capsules and its role in health nutrition market is also more important than hard capsules.

Gelatin Soft Capsules VS Vegan Soft Capsules

The major differences between gelatin soft capsules and vegan soft capsules can be described in dissolution and oxygen permeability. According to the US Pharmacopoeia 2040, disintegration and dissolution of dietary supplements are required to be 100% broken within 15 minutes. Gelatin capsule is proven to meet such requirement while scientific article on disintegration and dissolution of modified starch vegan capsule is rarely found if not entirely missing in recent years. As to oxygen permeability, gelatin capsule is found having excellent oxygen block performance in carrying omega-3 which is very sensitive to oxygen. Gelatin soft capsules uses glycerin as inherent plasticizer has very good oxygen block rate when thickness is approximate to 500 microns. The oxygen pass rate is less than 5ml per square meter per day per bar at 20 Celsius degree and 30% humidity wherein no public record is found on oxygen permeability of carrageenan or modified starch made vegan capsules in recent years.

Main Challenge of Soft Capsules

Although gelatin soft capsule is popular choice of the market, the production of it could be tricky and not that easy to master for manufacturers. The main challenge of producing soft capsules is to find a perfect balance among stability, vitro drug release and vivo drug release. There’s no shortcut to take, to be frankly. For manufacturers, they need to learn to control critical check points on the manufacturing flow, find out key process parameters of soft capsules production and last but not least, to identify genuine factors which affect the performance of soft capsules. Those challenges limit the supply of gelatin soft capsules and push up the market price of it.

Main Concerns in the Production of Soft Capsules

Choosing the right content for soft capsules and sorting out key quality attributes are also difficult.

In the preliminary recipe formulating process, not only do we need to consider the influence of API properties on their own chemical stability, but also the impact of gelatin and other supplementary ingredients on soft capsules. We have also listed a chart here, with orange, yellow and green representing the level of risk. The orange area in the table represents high risk.

The viscosity of gelatin has an effect on moisture. High-viscosity gelatin requires more water to dilute the glue to ensure proper viscosity. In this way, it takes longer time to dry in the subsequent drying process. Then, gelatin with a large average molecular weight is prone to disintegration during subsequent drug storage and transportation. Regarding some complex chemical structures and reactive impurities, such as PEG, phenols, and polyoxymethylene glycerides, they are easy to produce aldehydes as a result of different product quality. This will lead to capsule adhesion. Besides, some non-ionic surfactants are prone to oxidative degradation. because its molecule contains polyoxymethylene, which can easily lead to cross-linking, disintegration and dissolution problems.

In addition, the type of plasticizer will also affect the type of adhesion and viscosity. Excessive use of titanium dioxide, a commonly used sunscreen, can cause leakage.

Foodmate’s Softgel Solution

Foodmate is one of the leading gelatin producer and solution provider in China. Whenever we are asked by the customers about how to solve a problem, the first steps we take is to walk through the entire production flow and pinpoint the root cause based on the actual production environment of our customers. Then our field engineer will provide feasible plan on tackling the causes. And finally, draft reports for the whole case, recommend following steps to take in order to remove potential risks of the problem. Just to make sure it will not come back in future.

We are more than a supplier of ingredients, Foodmate is your loyal mate and we work with our clients for the purpose of achieving mutual success.