The tablet manufacturing process is a series of steps that are followed step by step to produce a quality product. All steps have their unique processing and testing to proceed to the next step.
Tablets are solid dosage forms that are taken orally and are manufactured with a combination of various ingredients. Active ingredients are mixed with excipients to manufacture the tablets. Quantity and type of excipients are selected according to the type of tablets. The process of tablet manufacturing has several steps including granulation, compression, and coating.
Granulation is the most important step of tablet manufacturing. Granulation is the process of changing powder into granules. Granulation improves the flow of the material which makes the compression process easy. There are two main types of granulations, one is wet granulation and other is dry granulation. As the name shows wet granulation involves the addition of a liquid to the powder and then the powder is converted into granules. While in dry granulation no liquid is used and granules are formed without the use of liquids. The selection of the granulation method depends upon the type of raw material and the properties of the final product required.
Rapid mixer granulator (RMG) is the main equipment used for granulation. Binders are added with powder in the granulator. The speed of the granulator is adjusted according to the required size and shape of the granules. Drug release from the dosage forms depends upon the granulation. Binders play an important role in the drug release process.
Hot air is used in a fluid bed dryer to dry the material. It has a perforated bowl to place the material and hot air is passed through the material. This hot air removes the moisture and solvents from the material. FBD bags are used to dry the material in the FBD. These have finger-like structures to increase the surface area to dry the material easily and prevent the loss of material by airflow. Moisture content is checked manually from time to time until the required moisture level is achieved by the drying process before the compression.
Compression is an important step of tablet manufacturing and the physical properties of a tablet as size, shape, hardness, thickness, and friability are affected by the compression. Dissolution of the tablet and release of active ingredients are also affected by the compression of the tablet.
There are many methods used for coating but spraying and dipping are common. In the dipping method, the tablets are dipped in a coating solution and removed to dry. It is required a coating pan to dip and an oven to dry the tablets. In the spray method of coating the coating solution is sprayed using the spray gun. Tablets are placed in a perforated coating pan and the coating solution is sprayed slowly. Air passes through the holes of the perforated pan to dry the tablets during the coating process. The coating of the tablets depends upon the type of coating solution used. The coating makes it possible to prevent enteric-coated tablets to dissolve in the stomach where conditions are acidic.
After approval from quality control, the batch is transferred to the packaging area. Tablets are packed according to the requirement of the customers where these are packed in blisters, strips or in bottles. After proper packaging tables are shipped to the market for sale.
The whole process of tablet manufacturing is a complex process and has different stages. Every tablet passes through these steps and finally reaches the market for patients. The quality of the tablet must be maintained throughout the process. All steps must be followed strictly otherwise the quality of tablets and the safety of the patients will be compromised and the purpose of medicine manufacturing will not be complete.
Tablets are solid dosage forms that are taken orally and are manufactured with a combination of various ingredients. Active ingredients are mixed with excipients to manufacture the tablets. Quantity and type of excipients are selected according to the type of tablets. The process of tablet manufacturing has several steps including granulation, compression, and coating.
Blending
After dispensing, API and excipients are added to the blender in a specified manner and mixed together to form a uniform mixture. Different types of blenders are used to mix the materials. V-cone blenders and double-cone blenders are commonly used in pharmaceuticals. Octagonal blenders are also used for large batches where the quantity of material is greater. Blending helps to make a homogeneous mixture where active material mixes well throughout the excipients. Blending plays an important role in tablet manufacturing because it ensures the even distribution of active ingredients throughout the tablet.
Granulation
Granulation is the most important step of tablet manufacturing. Granulation is the process of changing powder into granules. Granulation improves the flow of the material which makes the compression process easy. There are two main types of granulations, one is wet granulation and other is dry granulation. As the name shows wet granulation involves the addition of a liquid to the powder and then the powder is converted into granules. While in dry granulation no liquid is used and granules are formed without the use of liquids. The selection of the granulation method depends upon the type of raw material and the properties of the final product required.Rapid mixer granulator (RMG) is the main equipment used for granulation. Binders are added with powder in the granulator. The speed of the granulator is adjusted according to the required size and shape of the granules. Drug release from the dosage forms depends upon the granulation. Binders play an important role in the drug release process.
Drying
Granules are dried to remove the excess moisture and solvents used in the granulation process. There are different methods used for drying but tray dryer and fluid bed drier is commonly used. In pharmaceutical manufacturing fluid bed dryers are widely used.Hot air is used in a fluid bed dryer to dry the material. It has a perforated bowl to place the material and hot air is passed through the material. This hot air removes the moisture and solvents from the material. FBD bags are used to dry the material in the FBD. These have finger-like structures to increase the surface area to dry the material easily and prevent the loss of material by airflow. Moisture content is checked manually from time to time until the required moisture level is achieved by the drying process before the compression.
Compression
Compression is the process of tablet making. Here granules are compressed into tablets of desired shape and size. Tablet press machines are used to compress the granules into tablets. Very high pressure is applied to the dies by the punches. Material is filled between punches and dies. A compression machine can have multiple dies and punches.Compression is an important step of tablet manufacturing and the physical properties of a tablet as size, shape, hardness, thickness, and friability are affected by the compression. Dissolution of the tablet and release of active ingredients are also affected by the compression of the tablet.
Coating
The coating is the outermost smooth layer of a tablet. It gives a lot of advantages to the tablets including improved appearance and stability, reduce dissolution rate and masks the unpleasant taste. The coating of tablets gives a unique identification to the tablets of a brand.There are many methods used for coating but spraying and dipping are common. In the dipping method, the tablets are dipped in a coating solution and removed to dry. It is required a coating pan to dip and an oven to dry the tablets. In the spray method of coating the coating solution is sprayed using the spray gun. Tablets are placed in a perforated coating pan and the coating solution is sprayed slowly. Air passes through the holes of the perforated pan to dry the tablets during the coating process. The coating of the tablets depends upon the type of coating solution used. The coating makes it possible to prevent enteric-coated tablets to dissolve in the stomach where conditions are acidic.
Polishing and Branding
When tablets are manufactured and coated, it is required to polish the tablets to remove any sharp edges. It makes the tablet smooth and shiny. Any information printed on the tablets is known as branding. Branding is not a common concept and it is used rarely by companies. Edible food-grade inks are used in branding. Sometimes the name of the tablet or the strength of the active material is printed on it.Quality Checks and Packaging
It is essential to check the quality of the product before its packaging. It ensures that the product is of desired quality and meets the specification. Quality control analysts conduct a series of tests specified for the product. Physical tests, assay, dissolution, disintegration test and content unifirmity are the most common tests done for every batch of the product.After approval from quality control, the batch is transferred to the packaging area. Tablets are packed according to the requirement of the customers where these are packed in blisters, strips or in bottles. After proper packaging tables are shipped to the market for sale.
The whole process of tablet manufacturing is a complex process and has different stages. Every tablet passes through these steps and finally reaches the market for patients. The quality of the tablet must be maintained throughout the process. All steps must be followed strictly otherwise the quality of tablets and the safety of the patients will be compromised and the purpose of medicine manufacturing will not be complete.
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