Our patented granulation technologies
Effervescent tablet and effervescent instant drink formulations are popular with consumers as they are easy to ingest and offer an enhanced taste experience. As these dosage forms are designed to dissolve rapidly and completely in water – but must also remain stable towards moisture during production, shipping, and storage – specialist granulation technologies are required.
Granulation is also needed:
- To better bond primary powder particles together. This improves processability and allows compression into effervescent tablets – or manufacture as instant drinks.
- To reduce the amount of dust within a powder. This improves the overall flowability and ensures that the API is homogeneously distributed in the blend.
- To alter the morphology of powder particles to an optimal particle size distribution. This reduces the number of particles with unwanted awkward shapes (such as needle-shaped particles), which are difficult to process.
Overall, the physical process of granulation reduces the accessible surface area of effervescent components in a powder, which is especially important for moisture sensitive products. Less surface area means that the product will be more stable because active ingredients cannot react readily via surface interactions. Similarly, altering the granule size and shape offers control over the bioavailability of the API, so it can be tuned according to requirements. At HERMES PHARMA, we use advanced wet granulation technologies, such as TOPO and Continuous Flow granulation, to prolong the shelf life of effervescent formulations and ensure they maintain optimum product performance, even in regions with high-moisture climates.
TOPO granulation
Our patented TOPO granulation technology is perfectly suited for the manufacture of effervescent formulations containing at least one solid crystalline organic acid and at least one alkaline carbonate. TOPO stabilizes these components in air while maintaining their rapid reactivity in water, ensuring fast dissolution of the product.
The single-pot TOPO granulation technology consists of a vacuum granulation step that produces a homogenous granulate, which is easy to tablet and process, as well as extremely moisture resistant.
Usually the organic acid employed in effervescent is citric acid. One of the pioneering aspects of TOPO is that it can modify the surface of the reactive citric acid by coating it with an alkaline carbonate, causing less reactive citrates to subsequently develop on the acid’s surface. These citrates continue to form a thick protective layer that reduces the reactivity of the citric acid to moisture in the atmosphere.
This is why TOPO-manufactured products possess long shelf lives and are suitable for use in tropical regions – even countries in IV+ climatic zones. Moreover, as only pure water is used for granulation, TOPO ensures there are no solvent residues in the finished product.
Continuous Flow granulation
Continuous Flow (CF) granulation is a further development of TOPO technology specifically designed for high throughput requirements. It uses an inclined drum, with the primary particle powder being fed in at one end and collected from the other. CF allows us to manufacture up to 10 tons of granules every day and is a very economical approach for the production of our effervescent tablets and granules. Both TOPO and CF are beneficial technologies for stable effervescent products, especially when they contain sensitive APIs, such as acetylsalicylic acid.
Key benefits of TOPO and CF granulation technologies
In addition to forming highly stable effervescent tablets and instant drinks, our granulation technologies have many other benefits:
- Manufacturing can take place under standard atmospheric conditions and up to a humidity level of 30 percent.
- Low drying temperatures and short drying times decrease likelihood of thermal degradation.
- As performed within a vacuum, TOPO prevents uncontrolled chain reactions occurring.
- TOPO saves on laboratory water costs, as only a small amount of water is needed. This makes it an environmentally-friendly and sustainable technology.
- Suitable for APIs that are sensitive to acidic or alkaline components
- No solvent residues are present in the finished product.
- Products dissolve quickly in water, as the release of carbon dioxide starts immediately.
