Formation and production of tablets and capsules involve several steps and processes. Here is a general overview of how tablets and capsules are formed and produced:
1. Formulation: The first step is to develop a formulation for the tablet or capsule. This involves selecting the active pharmaceutical ingredient (API) and determining the appropriate dosage strength. Other excipients, such as binders, fillers, disintegrants, lubricants, and coatings, are also chosen to ensure the tablet or capsule's stability, appearance, and functionality.
2. Granulation: Granulation is the process of converting the powdered ingredients into granules. This can be done through various methods, including wet granulation, dry granulation, or direct compression. Wet granulation involves mixing the powders with a liquid binder, followed by drying and sizing the granules. Dry granulation involves compacting the powders into slugs or ribbons, which are then milled and sieved to obtain granules. Direct compression involves directly compressing the powders without any additional steps.
3. Blending: After granulation, the granules are blended to ensure uniform distribution of the API and excipients. This step helps to achieve consistent drug content in each tablet or capsule.
4. Tablet Compression: For tablet production, the blended granules are compressed using a tablet press machine. The granules are fed into the machine, and compression forces are applied to form tablets of the desired shape, size, and hardness. The tablet press may have multiple stations to allow for different processes, such as filling, compression, and ejection.
5. Coating: Tablets may undergo a coating process to improve their appearance, taste, and stability. Coatings can be applied to provide protection, control drug release, or enhance swallowability. Coating materials are typically dissolved or suspended in a solvent, and the tablets are sprayed or dipped in the coating solution. The coated tablets are then dried to remove the solvent.
6. Capsule Filling: For capsule production, empty capsules made of gelatin or other suitable materials are filled with the granules or powders. This can be done manually or using automated capsule filling machines. The filled capsules are then sealed to ensure their integrity.
7. Quality Control: Throughout the entire production process, quality control measures are implemented to ensure the tablets or capsules meet the required standards. This includes testing the raw materials, in-process checks, and final product testing for parameters like weight, hardness, disintegration, dissolution, and content uniformity.
8. Packaging: Once the tablets or capsules pass quality control, they are packaged into appropriate containers, such as blister packs, bottles, or sachets. Packaging materials are chosen to protect the product from moisture, light, and other external factors that may affect its stability. Labeling and batch information are also added to the packaging.
It is important to note that the specific details of tablet and capsule formation and production can vary depending on the pharmaceutical manufacturer, the type of drug, and the regulatory requirements of different countries.