OSD stands for oral solid dosage. It has different forms; it can be a tablet, a capsule, gummies, or pills. OSD refers to a drug that is ingested through the mouth and absorbed in the bloodstream. It is the most popular form of medicine readily available to patients. It is also the most common one prescribed by physicians to cure different illnesses.
This kind of drug is popular for several reasons; it’s easy to administer, and the manufacturing process has been well-researched and developed. The US Food and Drug Administration has specific requirements for OSD manufacturers. For one, FDA expects that these drugs are manufactured based on good scientific data. To establish the effectiveness of a drug, experts must conduct USP dissolution testing.
According to Harvard, dissolution is the rate-controlling stage for drugs; it evaluates the performance of a drug based on the degree of absorption. The degree of absorption is necessary because a specific drug goes into a person’s system and cures diseases.
Aside from dissolution, there are several processes involved in drug manufacturing.
Wet Granulation
Wet granulation is the process involving mixing solids and liquids. In this process, powder particles are joined together to create granules. These granules are then bound together by a liquid solution.
Wet granulation has two types: high shear and low shear. High shear is when the binding process involves using a motor-driven blade to create an intense force. The equipment used in this process is a high shear granulator. In low shear, it’s a lesser intense process. When a fluid bed granulator is used, the binding process has a softer, low shear force.
Dry Granulation
This process involves the combination of solids only; hence, it’s called dry granulation. In this process, powder particles are combined to create a denser granule. The final product is usually a compressed or encapsulated form.
As compared to wet granulation, it does not use an additional binder. Granules are compressed together through high-intensity force. The process involves press rolls and milling about compressing the particles. The most common equipment used for this process is a roller compactor.
Direct Compression
Like dry granulation, this process involves the combination of solids only. However, it uses only slow-intensity force to combine powder particles. It intends to mix ingredients uniformly. In this process, a tumble blender is used.
Particle Coating
This specific process, like wet granulation, uses a combination of liquids and solids. However, it is used to coat the powder granules. A fluid bed coater is the equipment used in this process.
Stages
Discussed above are the different mixing processes used in manufacturing oral solid drugs. Below are the steps that are done during OSD’s manufacturing.
Ingredient and Formulation
Like cooking, the first stage of manufacturing OSD is determining the ingredients and materials needed for the process. This includes APIs, excipients, and fillers. According to the World Health Organization, an active pharmaceutical ingredient (API) refers to a substance that provides pharmacological activity to cure or mitigate diseases. Excipients, on the other hand, mean other components aside from APIs.
After determining the ingredients, these substances are weighed and dispensed into the process vessel. This process is done in a controlled environment.
Granulation and drying unit operation
In this stage, various ingredients are combined. This process produces granules that can be compressed and encapsulated. This process usually involves dry granulation and wet granulation, which were discussed above.
Blending, compression, and encapsulation
Blending is the process of combining all the ingredients. It can happen more than once in an operation to ensure that a homogeneous solution is formed.
As the blending process is completed, the product is compressed and undergoes encapsulation. This produces the tablet or capsule form of an OSD. For some drugs, this is the final stage of the process. For others, tablet coating is still done.
Tablet coating
In this process, coating or film is applied to a tablet; it usually helps improve the taste of the medicine. Through this layer, a drug can also be easily swallowed.
What to consider
Considerations must be kept in mind when manufacturing OSD. The first and most important part of the manufacturing process is collaboration. A great OSD facility closely collaborated with key members such s owners, engineers, and technology vendors. The owners and engineers must also do strategy and proper planning. This ensures that the facility operates smoothly.
Close collaboration with operators is of the essence. They are the ones who are going to use the facility, and most often than not, they know better than engineers in terms of which equipment is needed in the manufacturing process.
