The pros and cons of manufacturing soft gel capsules
Soft gel capsules are a reliable and effective way of providing poorly soluble active pharmaceutical ingredients (APIs) to patients. However, there are a few key things to bear in mind when it comes to soft gel capsule formulation and manufacturing.
An overview of soft gel capsules
Available since the 1930s, soft gel capsules are primarily composed of water, a pacifier, gelatin and a plasticiser which securely contain the APIs.
A simple but effective method, these tablets have revolutionised the way medicines are consumed. By reducing the amount of excipient needed and offering a wide range of flavours, colours and finishes, gel capsules have become extremely popular amongst patients.
Why are more manufacturers producing soft gel capsules?
Most importantly, soft gel capsules help deliver poorly bioavailable APIs. This is especially significant today as approximately 40% of new chemical entities currently being worked on are thought to have poor biopharmaceutical properties . Usually, such entities cannot be readily absorbed by the body, however, soft gel capsules overcome this problem because the APIs they contain are already in fast-acting solutions that can be quickly ingested.
Producing the shell material
Although there are many advantages to soft gel capsules, there are some drawbacks when it comes to manufacturing. The shell is largely made up of Gelatin, which is a highly water soluble material, and is therefore sensitive to humidity and heat, which can significantly reduce the shelf life of some capsules.
Gelatin’s solubility also means that the liquid gel contained in the capsules must be oil-based, rather than water-based. This means that developers need to find ways of dissolving their APIs in oily suspensions so that the drug can work effectively.
In addition to these drawbacks, the increasing demand for companies to use animal-friendly products means that gelatin is becoming increasingly unpopular. Subsequently, pharmaceutical businesses are now looking into the alternative animal-friendly materials that will also work.
The cost of production
Despite the benefits that come with producing such an effective product, medicines like these can be relatively expensive to make. The specialist technology needed to manufacture the capsules, for example, can be costly to install, especially for manufacturers used to making traditional tablets.
However, many pharmaceutical businesses can reduce costs by outsourcing to contract development and manufacturing organisations (CDMOs) specialising in making the gels needed for this kind of capsule.
It is easy to see why so many pharmaceutical businesses are choosing soft gel capsules. Quick to manufacture and popular with patients, more and more manufacturers are being asked to produce gel capsules on a mass scale.
Despite the advantages that such tablets bring, it is essential that pharmaceutical businesses remember the key restrictions when it comes to producing this kind of product. To find out more about our gel capsule services please get in touch.
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