The process of tabletting medicines and dietary supplements

Tableting is a technological process in which active and auxiliary substances are transformed into tablet form. Tablets are one of the most commonly used forms of drug and dietary supplement administration, due to their ease of use, precise dosing, and chemical stability. See how the process of tableting drugs and dietary supplements proceeds step by step.

The Drug Tableting Process – What Do the Individual Stages Look Like?

What does the drug tableting process involve? See how the specific stages proceed step by step.

1. Preparation of Raw Materials

Active Pharmaceutical Ingredients (APIs) are the basic components of drugs – they have a precisely defined therapeutic effect. Auxiliary substances, such as fillers, binders, disintegrants, lubricants, and coating agents, perform important technological and stabilizing functions. The selection of appropriate auxiliary substances depends on the physicochemical properties of the active substances and the requirements for the tablets.

2. Mixing and Granulation

Mixing is the process in which active and auxiliary substances are evenly distributed to ensure the homogeneity of the mixture. This is a very important stage because uneven distribution of ingredients can lead to variations in doses in individual tablets.

Granulation is a process that improves the physical properties of the powder mixture, increasing its flowability and compressibility. It can be carried out dry (dry granulation) or wet (wet granulation). Granules are easier to tablet and provide better tablet quality.

3. Compression

Compression is the stage in which granules or powders are converted into tablets. This process takes place in tablet presses, which can be single or multi-punch. During compression, the mixture is subjected to high pressure, which leads to the formation of uniform, well-defined tablets.

Compression parameters, such as compression force, dwell time, and press rotation speed, determine the quality of the tablets. Optimization of these parameters allows to obtain tablets with appropriate hardness, friability, and solubility.

4. Coating

Tablet coating is the process in which a thin layer of coating material is applied to the surface of the tablets. Coating can perform various functions, such as masking taste, protecting against light and moisture, controlling the release of active substances, and improving the appearance of tablets.

There are several types of tablet coating, including sugar coating, polymer (film) coating, and enteric coating. The choice of coating method depends on the pharmacological and technological requirements of the tablets.

5. Quality Control

Quality control is an integral part of the drug and dietary supplement tableting process. Each production stage is monitored, and tablet samples are regularly tested for compliance with quality standards. Tests include:

• chemical composition, hardness, and solubility analysis,
• active substance content analysis,
• external appearance analysis.

Pharmacopeial tests, such as hardness, friability, disintegration time, and dissolution tests, are standard procedures in tablet quality control. These tests ensure that the tablets meet pharmacopeial requirements and are safe and effective for patients.

6. Packaging

Tablet packaging is the final stage of production, which aims to protect the tablets from external factors and ensure their stability and durability. Tablets are packaged in blisters, bottles, sachets, or other packaging that guarantees protection against moisture, light, and contaminants.

The type of packaging depends on the characteristics of the tablets and market requirements. Blisters are often used for single-dose packaging, and bottles are used for larger quantities of tablets and often contain additional moisture-absorbing agents.

The Dietary Supplement Tableting Process vs. the Drug Tableting Process

The dietary supplement tableting process is similar to drug production, but there are some regulatory differences. Dietary supplements do not require such detailed clinical trials but must meet safety and quality requirements.

In the case of drugs, the formulation is adjusted based on the results of clinical trials and other regulatory requirements. This process includes:

• optimization of the tablet composition,
• selection of auxiliary substances,
• determination of production parameters.

The formulation must ensure stability, bioavailability, and appropriate release kinetics of the active substances. In the case of dietary supplement formulation, the selection of active ingredients and auxiliary substances must be considered first. An important element is also consumer preferences, such as taste, tablet size, and ease of swallowing.

Dietary supplement manufacturers must comply with GMP principles and have appropriate quality certificates. Collaboration with a reputable manufacturer ensures the stability, effectiveness, and safety of supplements.

After the tableting process is completed, dietary supplements are packaged and prepared for distribution. Marketing of dietary supplements requires appropriate labeling that informs consumers about the composition, dosage, and potential health benefits. Supplements are distributed to stores, pharmacies, and sold online, which requires an effective marketing and logistics strategy.

Summary

It is worth noting that the drug tableting process is more rigorous than that of dietary supplements, due to the need to meet strict regulatory requirements and ensure high quality and safety of pharmaceutical products. Drugs must undergo thorough clinical trials and registration processes before being placed on the market.

Compliance with GMP principles and thorough monitoring of the production process allows to obtain tablets (both in the case of drugs and supplements) that are safe, effective, and compliant with regulatory requirements. 

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