Manufacturers have the choice of direct compression, wet granulation, and dry granulation in tablet production. Direct compression incorporates the processes of mixing and processing a tablet’s formulation ingredients before using compression to generate tablets directly from powdered excipients or, specifically, active pharmaceutical ingredients (APIs). Manufacturers use direct compression to shorten operation times and reduce equipment and resource needs for the production process.
Advantages of the Direct Compression Method
Direct compression offers numerous benefits in tablet production, including:
- Simplified, Shorter Processes: With direct compression, tablet manufacturing materials undergo the process in a relatively short time. This means fewer chances of contamination or microbial growth, resulting in easier adherence to manufacturing best practices. Manufacturers also have to deal with fewer documentation and validation requirements.
- Cost Savings: Direct compression has an economic advantage over wet granulation since it necessitates fewer resources. It requires less equipment, workforce, energy usage, production time, and space, all combined to result in increased savings.
- Improved Stability: Direct compression works well for heat- and moisture-sensitive APIs by skipping wetting and drying processes. In addition, it elevates the active ingredients’ stability by minimizing detrimental effects.
- Accelerated Disintegration: Manufacturing tablets through direct compression allows them to disintegrate into particles of APIs rather than granules, as occurs for tablets created with wet granulation. This dissolution difference speeds up the process and enables better absorption for tablets with APIs that are poorly soluble.
- Reduced Wear on Press Components: Manufacturers use direct compression to avoid the extreme compaction pressure that happens in tablet production via slugging and roller compaction. By using direct compression, the chance of wear in punches and dies lessens significantly.
Effects of APIs on Direct Compression
By mixing excipients and lubricants with APIs prior to compression, manufacturers can potentially simplify their production procedures and eliminate the need for any additional processing stages. However, to achieve this, manufacturers must ensure a precise selection of excipients since raw materials must have proper flowability and compressibility for a successful operation.
Using API amounts that are too high or too low can otherwise present challenges in formulations. Most APIs demonstrate poor compressibility, thus affecting tablet quality if the formulation demands high API content. Similarly, it can be an issue when a formulation requires only low amounts of APIs. In this case, the homogeneity is at risk because it is difficult to precisely blend a tiny amount of APIs in a large volume of excipients and still get the uniformity you require in the end product. When particles segregate so that there is uneven ingredient distribution going into the press, manufacturers will fail to generate batch-to-batch tablet consistency.
Direct Compression Method vs. Granulation
When deciding on a formulation method, it is important to consider the desired API dose and particle size, powder blend characteristics, and more. Of the direct compression and granulation options, direct compression is more straightforward and has fewer operational steps in manufacturing, making it easier for operators to control. The direct compression method also requires less labor and energy consumption than granulation, equating to cost savings for the manufacturer.
Granulation is further classified into wet and dry categories. In wet granulation, the binder’s role is vital to the structure’s development and granulation’s performance. Alternatively, dry granulation utilizes a roller compaction method in which manufacturers compress the formulation components in between rollers. This process forms ribbons for milling and generating appropriately sized granules. Ultimately, direct compression is popular with manufacturers because it provides the shortest and easiest route to highly effective tablet production.
Experts at Fette Compacting
The pharmaceutical industry is constantly changing, with major industry players revamping their business models and generic drugs flooding the market. While pharma companies are looking for cost-effective options, there is also a need for advancements in the sector. Fette Compacting America, Inc. delivers a high level of innovation for tablet manufacturers. As a leader in our industry, we manufacture state-of-the-art tablet press machines fully backed by our 24/7 customer support services to ensure your machines run efficiently.