HERA’s production technology is focused on pharmaceuticals in solid forms, including tablet, film-coated tablet, hard gelatine capsule, granules/powder for oral. Given the importance of granulation in the production of oral dosage forms — most fine pharmaceutical compounds require granulation to improve their flowability and processing properties prior to tableting
Some granulation technologies available to pharmaceutical manufacturers are summarized below:
Granulation is one of the most important stages in preparation process of solid form drugs (OSD: Oral Solid Dosage Forms).
Granulated quality depends on more granulation process and in process parameter control. A good granulation process should ensure that standards for uniformity of granulated particle, smoothness, compressibility (when compression), bioavailability, electrostatic properties and uniformity of content, uniformity of tablet/capsule weight and stability of solid form drug...
There are two methods by which tablets are manufactured:
- Granulation (Wet granulation, Dry granulation, Fluid bed dryer granulation)
- Direct compression
Manufacturing process is dependent on several factors, including the compression properties of the therapeutic agents, the particle size of the therapeutic agent, excipients and the chemical stability of the therapeutic agent during the manufacturing process.
- It is most commonly used method for the manufacturing of tablets.
- Water is frequently used as the binder solution (and heat is employed to dry the formed granules), it is important to ensure that the therapeutic agent is chemically stable during the granulation process.
- Tablet quality is directly affected by the choice and concentration of binder and the type and volume of binder solution.
- Reduces segregation of formulation components during storage and processing. Leading to reduced intra and inter batch variability.
- It uses low concentration of therapeutic agent.
- It is not dependent on the inclusion of special grades of excipients (is spray dried excipients used in direct compression method).
- When tablet ingredients are sensitive to moisture and unable to withstand elevated temperature during drying and when the tablet ingredient have insufficient cohesive properties, slugging may be used to form granules.
- Both roller compaction and slugging require conventional grades of excipients.
- These methods are not generally associated with alterations in drug morphology during process.
- No heat or solvent are required.
- Wet granulation and dry granulation methods having series of unit operations, both time consuming and potentially costly.
- Potentially more attractive option for the manufacture of tablets involves powder mixing and subsequent compression of the powder mix, thereby obviating the need for granulation. This process is called direct compression.
- The mechanism of particle-particle interactions in tablets produced by direct compression are similar to those operative in tablets produced by dry granulation and roller compaction.
- There are fewer processing steps and therefore the method is potentially more cost effective than other methods.
- Direct compression does not require the use of water or other solvents. Therefore negates potential problems regarding the stability of therapeutic agent in the presence of the solvents. In addition heating is not required in direct compression.
- Lubrication is performed in the same vessel as powder mixing, thereby reducing both transfer losses and contamination of equipment.
Fluid Bed Dryer Granulation
One of modern methods to granulate is a granulation process with Fluid Bed Dryer.
- The short drying time, about 30-50 minutes (depending on material) is suitable for heat-unstable compound (vitamins, proteins, hormones...).
- There is no local over-heat in powder/granulate/particle.
- The granulation time is short, the uniformity is high.
- It’s easy to sample to monitor product quality during operating.
- Spray gun can assemble at difference site such as: regarding chamber, product chamber or bottom chamber.
- It is possible to accurately adjust the pump flow to spray gun with peristaltic pump.
- If you add a on-line sensor for instant measurement and continuous particale size, you can monitor the whole granulation process.
Granulation in fluid bed dryer is the process of agglomerating the suspended particles in the drying chamber by means of airflow into the drying chamber and by liquid (binder solution) sprayed into the drying chamber. The particles suspended in the drying chamber are slowly wetted with the binder solution and become capable of adhering to the other particles to slowly form a granule.
In this method, the granulation process is carried out in fluid bed dryer equipped with binder spray gun. Adding binder solution by spray gun can be done by top-down spraying, horizontal spraying or spraying from the bottom up into the drying chamber containing the powder mixture.