Innovation and Technology of Hard and Soft Capsules in the Pharmaceutical Industry

Definition of Capsule According to the Indonesian Pharmacopoeia Edition VI

Capsules are one of the most commonly used forms of medication in the pharmaceutical world. Based on the Indonesian Pharmacopoeia Edition VI (FI Edition VI, 2020), capsules are solid preparations that consist of active drug substances packaged in hard or soft shells that can dissolve in water. Generally, capsules are divided into two main types, namely hard shell capsules and soft shell capsules, each with specific characteristics and functions. In hard-shell capsules, the contained drug substances are generally in dry form, such as powder or granules. Meanwhile, soft shell capsules usually contain drug substances in liquid form, such as oil or drug solutions in oil.

Capsule Shell: Materials and Functions

Capsule shells, whether hard or soft, are generally made from gelatin, a natural substance derived from animal collagen. Gelatin has properties that make it ideal for pharmaceutical use due to its ability to dissolve in the body and not react with the active ingredients it contains. In soft shell capsules, the elasticity of the shell can be enhanced by adding plasticizers such as glycerin or sorbitol, which makes these capsules more flexible and suitable for storing drugs that are prone to evaporation or instability when exposed to air.
For soft gelatin capsules, the active ingredient, which is usually in liquid form, will be suspended or dissolved in a liquid carrier, which in the past was usually an oil such as vegetable oil. However, currently, liquid carriers that are not water and have better compatibility with water, such as lower molecular weight polyethylene glycol, are more commonly used. This type of liquid carrier has the advantage of reducing issues related to bioavailability.

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Capsule Manufacturing Process

There is an important difference between the processes of making hard capsules and soft capsules. In hard capsules, the shell and the active ingredient are made separately. The process begins with the formation of the shell, which is then filled with dry medicinal substances, such as powder, granules, or pellets. This allows for flexibility in the filling process, making hard capsules more commonly used in the pharmaceutical industry for various types of medications. Unlike hard capsules, in soft capsules, the shell and the filling of the active ingredient are done simultaneously. The medicinal substance filled into this capsule usually comes in liquid form, either as a solution or a suspension of the active ingredient in a liquid carrier.

Additional Composition in Capsules

In addition to the basic ingredients, both in hard and soft shell capsules, pigments or dyes permitted by regulations, such as titanium dioxide, are often added to provide attractive colors and differentiate the products in the market. Not only that, preservatives can also be added to extend the shelf life and maintain the stability of the active ingredients in the capsule.

For you, business operators in the pharmaceutical or healthcare industry, it is important to continuously understand the latest developments in drug formulation technology, including capsules. This article is just a small part of the more in-depth information on pharmaceutical topics that we will share at IML Research.

Make sure to keep following the latest articles from IML Research, which will provide in-depth insights into innovation and regulation in the pharmaceutical world. We are ready to assist you with information and research services that can support your business success.

Author: Devira

 

References : 

Ansel, H.C., Popovich, N.G., Allen, L.V., 2011, Pharmaceutical Dosage Form and Drug delivery System Ninth Edition, London, New York, 225-235.

Departemen Kesehatan RI. Farmakope Indonesia edisi VI. Departemen Kesehatan Republik Indonesia. Jakarta: Kementrian Kesehatan Republik Indonesia; 2020. 

Rabadiya, B. and Rabadiya, P. (2013) ‘Review : Capsule Shell Material From Gelatin To Non Animal Origin Material’, Pharmaceutical Research and BioScience, 2(3), pp. 42–71.

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