A new approach:

The Innovation of Romaco Tecpharm

Traditionally, the sugar coating process has consisted of applying multiple layers of sugar solution to the tablet cores. This method, while effective, has certain limitations. Conventional spraying, for example, can result in uneven distribution of the coating, affecting the quality and uniformity of the final product. In addition, the long drying times required for heat-sensitive products limit the efficiency of the process and can cause product degradation.

Romaco Tecpharm has developed an innovative solution that addresses these challenges. In a standard sugar coating process, two main phases can be distinguished:

1. Initial Bulking Phase: In this stage, a diluted mother solution is applied to create a solid base on which to build the final coating.

2. Finishing Phase: A more concentrated mother solution is used to achieve the desired thickness and shine. During this phase, talc is added to improve the flowability of the dragees and facilitate drying.

To optimize these phases, Romaco Tecpharm has implemented a direct and automated dosing system. This system replaces conventional spraying with a single liquid tube that distributes the coating more evenly and accurately.

In addition, an automatic talc dosing system has been incorporated, ensuring that the powder is applied homogeneously to the dragees.

Coating Process

Process Phases Step by Step

1. Preheating: In this phase, the tablets are preheated to the desired temperature for the subsequent application of the solution. This phase is carried out by applying an airflow with controlled humidity and an automatically regulated temperature. Once the desired product temperature is reached, dosing begins.

2. Dosing: In this phase, the diluted mother solution is applied. The dosing is carried out through a collector with different outlets that apply the solution directly to the tablet bed.

During this period, it is important to eliminate the airflow so that the solution is applied uniformly over the entire bed without drying immediately after application. To eliminate the airflow inside the drum, the airflow is diverted through the equipment bypass, keeping the PIDs fixed in order to recover the desired airflow and vacuum for the process as quickly as possible. The controlled dosing of the solution is done through a peristaltic pump connected to the solution reactor. A balance is used to control the amount of dosed solution.

3. Homogenization Phase: After product dosing, the airflow is returned to the equipment, and in this phase, talc is added to reduce friction between tablets, helping the homogeneity of the dosing and the optimal movement of the tablets.

4. Drying Phase: After the addition of talc, a drying phase is necessary to completely dry the dragee in order to remove the residual moisture that remains in the tablet.

After achieving the desired weight gain for the dragee, phases 2, 3, and 4 are repeated, applying a mother solution to finish achieving the desired bulking of the dragee, giving it the final shiny appearance and the correct shape. The addition of a more diluted solution at the beginning is done to achieve greater adhesion at the beginning and to aid in the drying of the final layers. This bulking phase can occur depending on the product, adding talc or not.

Final Drying Phase: During this phase, the inlet temperature is reduced to the temperature of the tablets and maintained for a time in order to remove the residual moisture that remains in the dragees. This phase is important at a microbiological level since by eliminating the water we help control microbial growth.

Wax Phase: In this phase, a layer of wax is applied in order to protect the sugar coating, provide a shiny and attractive finish to the dragee, and act as an additional barrier to moisture. In this phase, carnauba wax or beeswax is usually used, both safe for pharmaceutical and food use.

Cooling Phase: During this phase, the inlet temperature is decreased in order to bring the dragee to room temperature. During this phase, a curing of the coating is carried out, and we ensure that there is no thermal breakage when unloading the tablet.

Thanks to the high efficiency of our technology, we have drastically reduced processing times, achieving a reduction of up to 70%. In addition, we have fully automated all process adjustments, which guarantees the repeatability and consistency of results, eliminating the variability associated with manual adjustments. Our highly efficient drying process, which includes a desiccant rotor, allows us to achieve a performance greater than 90%, minimizing product loss and optimizing the use of materials.

The incorporation of an automatic device for the addition of solids, such as talc, ensures a uniform and precise distribution of these components in the coating. This is essential to achieve the desired properties in the final product.