Encapsulation process for medicines and dietary supplements

The process of encapsulating medicines and dietary supplements is a crucial element in pharmaceutical and supplement production. Capsules are a popular dosage form due to their convenience, precise dosing, and ability to mask unpleasant tastes of active substances. Learn more about this process and the key differences between encapsulating medicines and dietary supplements.

The Capsule Encapsulation Process for Medicines – Key Information

Encapsulation is the process of enclosing active and auxiliary substances in hard or soft capsules. Capsules consist of a shell, which can be made of gelatin, cellulose, or other materials, as well as a filling that is often in the form of powder, granules, semi-liquids, or liquids.

The encapsulation process can be carried out using different technologies, depending on the type of capsule and the composition of the filling.

Hard capsules consist of two parts: a body and a cap, which are joined together after filling. The encapsulation process for hard capsules includes filling the capsules with a mixture, sealing them, and conducting quality control.

Soft capsules are made from more flexible material and are typically used to enclose semi-liquids and liquids. The encapsulation process for soft capsules includes forming the capsules, filling them with liquid, and sealing them to prevent leakage.

Quality Control and Packaging – Later Stages of the Encapsulation Process

Each stage of production is monitored, and capsule samples are regularly tested to ensure compliance with quality standards. The tests include chemical composition analysis, hardness, solubility, active substance content, and external appearance.

Pharmacopoeial tests (such as hardness, friability, disintegration time, and dissolution) are standard procedures in capsule quality control. These tests ensure that the capsules meet pharmacopoeial requirements and are safe and effective for patients.

At the final stage, the capsules are packed in blisters, bottles, sachets, or other packaging that provides protection against moisture, light, and contamination.

Encapsulation of Dietary Supplements and Medicines – What Are the Differences?

The encapsulation process for medicines is more stringent than for dietary supplements due to the need to meet strict regulatory requirements and ensure high quality and safety of pharmaceutical products. Medicines must undergo extensive clinical trials and registration processes before being approved for sale.

Before mass production of medicine capsules begins, active substances go through preclinical and clinical trials. Preclinical studies include in vitro and in vivo tests that assess the safety and effectiveness of active substances. Then, in clinical trials, medicines are tested on humans in several phases to evaluate their effects, dosage, and potential side effects.

The encapsulation process for medicines must be validated to ensure that each production batch meets specific quality criteria. Validation includes testing the process, equipment, analytical methods, and final product. Validation documentation is necessary to obtain approval for production and sale of the drug.

Dietary supplements in capsules, similar to tablets, do not undergo such extensive clinical trials but must meet basic safety and quality requirements. In many countries, they are classified as food products rather than pharmaceuticals.

The formulation of dietary supplements includes the appropriate selection of active ingredients, such as vitamins, minerals, and plant extracts (which support health rather than provide therapeutic effects), as well as excipients, which are selected with more flexibility compared to medicines.

Importantly, the manufacturer is responsible for ensuring that dietary supplements are safe and properly labeled, but the registration process is less rigorous compared to medicines.

Summary

The encapsulation process for medicines and dietary supplements differs in terms of regulations, ingredients, production procedures, and quality control. Medicines require strict control and rigorous testing to ensure their safety and effectiveness, while dietary supplements are subject to less stringent requirements, allowing for greater flexibility in production and marketing.

High quality and safety of capsules are essential for success in the pharmaceutical and supplement market. Therefore, it is crucial to ensure that every stage of encapsulation, whether for medicines or supplements, complies with legal requirements and imposed regulations.

Also, check out our article on the differences between probiotics, prebiotics, and postbiotics.