Tablet manufacturing is an important process in the pharmaceutical industry. Choosing the best manufacturing process plays a vital role. These tablet manufacturing methods include wet and dry granulation and direct compression. This decision depends on the characteristics of the sets of APIs and economic criteria. This article discusses the main considerations that manufacturers have to make when selecting the optimal method of tablet production.
Compressive Properties of the API
The first criterion that needs to be evaluated when selecting a tablet manufacturing process is the compression characteristics of the API. Some APIs possess good compression properties, which means that they can be directly compressed into tablets without affecting their physical properties. This technique is cheap and easy to implement but is best suited for APIs that are easy to flow and can be compressed directly into a whole.
Stability of the API
Another issue is the stability of such API during the manufacturing process plays another vital role. Certain APIs are affected by heat, moisture, or oxidation which makes them decompose or lose their efficacy. Thus, dry granulation, for example, or the direct compression method is more suitable if moisture or heat cannot be used due to fugitive ingredients being sensitive to moisture or heat.
The Particle Size of Formulation Ingredients
The size of the particles of the formulation components, the API, and the excipients, have a major influence on the choice of the most suitable tablet manufacturing process. Fine powders have low flow characteristics and may result in poor weighing accuracy while coarse powders may result in poor tablet bonding. Manufacturers have to select a process that will give the best particle size distribution for uniformity in mixing and compression. Wet granulation for instance can be used to adjust the size of particles to the required size to have a uniform product. On the other hand, direct compression is normally applied where the powders are correctly proportioned in size and flow character and can be compressed directly without going through the granulation step.
Availability
Another factor is the presence of needed tools and equipment, and the expense of obtaining them, if necessary. Some processes are unique to a specific equipment like high shear granulators for wet granulation or tablet press for direct compression. The type of equipment used depends on the level of production as well as the requirements of the API in question. Manufacturers also need to take into account the cost of each process that is to be implemented. In any large production scale, activities such as direct compression are normally cheaper than the others because they are less complex and energy-consuming. Granulation methods on the other hand are more elaborate and may require other steps which may be costly to the producer.
Conclusion
In conclusion, several factors have to be considered when selecting the most appropriate tablet manufacturing process, these include; Compression properties and stability of the API, particle size of formulation ingredients, availability of equipment, cost of production, and compliance with, regulatory requirements. Each process – wet granulation, dry granulation, and direct compression has its merits and demerits. By considering these factors, manufacturers can choose the right method to create high-quality tablets that will meet clinical and economic needs.
