Tablets play a crucial role in modern dietary supplements and their production. With the development of the health industry and advancements in industrial production technology, tablet manufacturing processes have also significantly improved. While tablet shape, size, weight, and content vary significantly depending on the dietary supplement, dosage, efficacy, and method of administration, the manufacturing processes and procedures generally remain the same. This article focuses on the tablet manufacturing process and procedures.
Introduction to tablet manufacturing
Tablets are solid preparations in the form of round or irregular tablets, made by uniformly mixing dietary supplements with excipients through compression or other methods. They can be categorized as standard tablets, coated tablets, sustained-release tablets, controlled-release tablets, chewable tablets, and effervescent tablets. Tablet compression techniques include wet granulation, dry granulation, direct powder compression, and semi-dry granule (blank granule) compression.
While the basic operating methods for tablet production have remained the same, tablet manufacturing technology has evolved significantly. Efforts are ongoing to further understand the physical properties of powders and particles and the factors that influence the bioavailability of dosage forms after oral administration. Equipment continues to improve, for example, in terms of tableting speed and uniformity. Although tablet shapes vary widely, they can be round, oval, rectangular, cylindrical, or triangular. Tablet size and weight vary greatly depending on the dosage of the dietary supplement and the intended method of administration. Tablets can be divided into two main categories, depending on whether they are compressed or molded.
Compressed tablets are often produced on a large scale, while molded tablets are usually produced on a small scale. Due to the relatively low production volume of molded tablets and the need for dry or sterile conditions during manufacturing, this type of tablet has gradually been replaced by other production methods or dosage forms and is now less common.
Tablet characteristics
Advantages of tablets
The dosage is accurate. The dosage and content of dietary supplements in tablets are in accordance with regulations, with little variation in content, and the dosage is accurate when taken per tablet. The tablet manufacturer can also emboss the tablets with grooves, so that they can be divided into two halves or four parts, making it easier to take smaller doses without losing accuracy.
The tablets have stable quality and will not break or deform during normal transportation and storage, keeping the drug content constant for a long time. Tablets are dry solid dosage forms. After compression, they are small in size and have a relatively small area of contact with light, air, moisture, and dust, so the impact on stability is generally relatively small.
Dietary supplements with unpleasant color, taste, or odor can be coated to conceal them.
To facilitate identification, the tablets can be embossed with the name of the main drug and the dosage, or the tablets can be dyed in different colors for easy identification;
The cost is low, tablets can be mass-produced using automated machinery, sanitary conditions are easy to control, and packaging costs are low.
Disadvantages of tablets
Children may not be able to swallow it easily;
If the preparation and storage are not done properly, the product will gradually deteriorate, making it difficult to disintegrate or dissolve in the gastrointestinal tract;
Tablets containing volatile components have a decreased content when stored for a longer period of time.
Absorption is too slow. Tablets are absorbed more slowly than other dosage forms.
Key raw materials
The raw materials for tablet production mainly include two categories: dietary supplement active ingredients and excipients. Here are some examples of active ingredients
The active ingredients of dietary supplements mainly depend on the needs of the product. The active ingredients will vary depending on the function of the supplement.
For example, vitamins. The active ingredients are mainly vitamins A, B, C, etc. They can supplement the different vitamins needed by the human body.
Minerals. Its active ingredients are mainly calcium, iron, zinc, magnesium, etc. They can promote the health of bones and teeth. In addition, they can also enhance immunity.
Probiotics. For example, lactobacillus, bifidobacteria, etc. They can regulate intestinal health and improve digestive function.
Tablet production processes and procedures
The tablet production process includes ten steps: pretreatment of raw materials and auxiliary materials, batching, granulation, drying, whole grains, mixing, tablet coating, inner packaging and outer packaging .
Pretreatment of raw materials
Qualified materials should be removed from their packaging in the buffer zone or properly cleaned before entering the preparation room. The environment and air cleanliness levels for raw material pretreatment must be consistent with the registered process, with measures in place to capture dust and prevent cross-contamination. Raw materials should be visually inspected and weighted before pretreatment, and liquid raw materials should be filtered if necessary. Raw materials should undergo pulverization and screening.
Crushing is the process of mechanically breaking large solid materials into usable quantities. Other methods are also used in the pharmaceutical industry to reduce solid dietary supplements to a fine powder.
Sieving. After crushing, the powders are coarse and fine, with great differences. In order to meet the requirements, the operation process of separating the coarse powder from the fine powder is called sieving, and this mesh tool is called a sieve or sieve.
Ingredients and Mixing
During tablet production, the drug powder and excipients, after being weighed according to the recipe, must be mixed several times to ensure tablet quality. Tablet content variations, disintegration time, hardness variations, and content segregation are often caused by improper mixing. The powder and excipients are not mixed uniformly all at once. First, an appropriate amount of diluent is added for dry mixing, followed by wet mixing with the addition of a binder and wetting agent to create a soft, appropriately soft tablet.
Granulation
Most tablets require granulation before tableting, a process dictated by the raw material’s physical properties. Granulation primarily enhances flowability and compressibility. This improves material flowability, reduces fine powder adsorption and trapped air, and reduces tablet cracking, preventing powder stratification and fine powder flyaway.
Different raw materials have different granulation methods, which are mainly divided into whole powder granulation method, fine powder and thick extract mixed granulation method, whole extract granulation method and purified material granulation method, among which whole extract granulation method is more commonly used.
dry
The primary purpose of the drying process is to use heat to remove moisture from solid and paste-like dietary supplements , reducing the product ‘s moisture content, ensuring the quality of the dietary supplements , and meeting shelf life and stability requirements. The tablet drying process can increase the surface temperature of the dietary supplement by appropriately raising the air temperature , accelerating the evaporation rate of the dietary supplement’s moisture and ensuring drying effectiveness. Drying temperatures vary significantly depending on the type of dietary supplement used in tablets. Some dietary supplement ingredients are highly temperature-sensitive, so excessively high temperatures should be avoided, as they can cause loss of activity. During tablet drying, the airflow in the production space can be refreshed through blowers or exhaust devices. Silica gel, quicklime, and other dehumidifiers can also be used to absorb water vapor.
Whole grain
The pelletizing machine should be operated in a sealed manner or with an effective dust removal device. The pelletizing machine’s discharge pipe may be equipped with a metal detector or other effective means and methods to remove metal foreign matter that accidentally enters the pellets.
For granules that require screening of the granulated material according to the registered process, in addition to selecting the screen/sieve gong as required, the fine powder after screening must be handled strictly in accordance with the process regulations, such as whether to re-granulate.
Mixed
After drying and sizing, the granules are transferred to the mixing drum via a material transfer pipeline or other means. Measures should be taken to reduce dust exposure during the transfer process. Mixers such as tumble mixers, container mixers, and stirring mixers can be used for total mixing. Each mixing cycle is considered a batch.
The amount of material in the mixer should be confirmed. The mixed particles should be placed in a clean container with a label indicating the product name, specifications, batch number, weight, date and operator information.
Tablet pressing
Tablet compression is generally categorized into two methods: granule compression and direct compression. The advantages of direct powder compression include a simplified process and the absence of a wet heat step, making it suitable for heat-sensitive drugs. Compared to granule compression, it eliminates the granulation step involved in the “ingredient granulation” process, allowing tableting directly after mixing. This method offers advantages such as low cost and consistent product quality. However, it requires high material flowability and compressibility, which limits its application.
Wet granulation tableting is the most commonly used process for preparing tablets. It is suitable for drugs that are sensitive to moisture and heat (such as easily hydrolyzed ingredients). Compared with the wet granulation tableting process, the main difference lies in the different “ingredient granulation” method.
Insourcing and outsourcing
For plain tablets, the production process is complete after tablet compression, and the next step is inner and outer packaging to complete the entire production process of coating. For coated tablets, after tablet compression, they will enter the coating process. Our high-efficiency coating machine has stable performance and comprehensive functions. It can apply sugar coating, organic film coating, water-soluble film coating, etc. to tablets of various specifications, resulting in solid, dense, and smooth coated tablets.
Inspection, internal packaging, and external packaging. After the plain tablets or coated tablets are formed, they need to undergo professional inspection . Only qualified products can enter the internal packaging and external packaging processes.
Jiabeikang has aluminum-plastic tablet packaging machines, plastic bottle automatic packaging lines, etc. to meet customers’ different in-house and outsourcing needs. We have supplement packaging design for tailored brands.
Key Equipment and Technology
Advanced production equipment includes raw material mixers, tablet presses, filling machines, high-efficiency coating machines, high-speed bottle unscramblers, high-speed capping machines, electromagnetic induction aluminum foil sealing machines, etc. In addition, there are various tablet molds and multiple packaging production lines.
Tablet molds like Jiabeikang’s can produce tablets of different shapes, such as oval, oblong, etc.
Multiple packaging production lines can be used for bottling, bagging, canning, aluminum-plastic packaging, etc.
Quality requirements for dietary supplement tablets
High-quality tablets generally require the following things.
accurate content with minimal weight variation
Appropriate hardness and disintegration
Uniform color, glossy and attractive appearance
No deterioration within the specified timeframe
Meeting requirements for dissolution rate and bioavailability
Compliance with hygienic inspection requirements. These requirements, including those specific to specific varieties, ensure the quality of dietary supplements .
Tablet production also requires quality control testing, including hardness, disintegration time, content uniformity, microbiological testing, etc.
FAQ
The two main types of tablets are regular tablets and chewable tablets. Regular tablets are faster to produce and more readily available. They also provide faster absorption for dietary supplements. Chewable tablets, on the other hand, offer a more pleasant taste and are particularly suitable for children and those with swallowing difficulties.
Diluents: Also known as fillers, they are mainly used to increase the volume for easier tableting. Commonly used diluents include lactose, starch, and microcrystalline cellulose.
Binders: Used to enhance the viscosity of granules during granulation. Commonly used agents include hydropropyl methylcellulose, polyvinyl pyrrolidone (PVP), and starch slurry. If the material itself is sticky, water, ethanol, etc. can be used to stimulate its viscosity. Binders are also called wetting agents.
Disintegrants: Mainly used to promote the disintegration of tablets in the gastrointestinal tract. Commonly used are sodium carboxymethyl starch (CMS-Na), cross-linked sodium carboxymethyl cellulose (CCNa), low-substituted hydroxypropyl cellulose (L-HPC), etc.
Glidant: used to improve the fluidity of particles, commonly used are colloidal silicon dioxide, etc.
Lubricant: used to reduce friction and prevent sticking during tableting. Commonly used lubricants include magnesium stearate and talc.
Tablet coating refers to the process of applying a coating of a suitable material to the surface of a tablet. The coated tablet is called the “core,” the coating material is called the “coating,” and the finished tablet is called the “coated tablet .” The most important purpose of tablet coating is to isolate the tablet from air, light, and moisture. It also masks unpleasant odors.
Conclusion
In summary, the two most important stages in the tablet production process are granulation and tablet compression. The entire production process undergoes rigorous quality testing. Compared to other dosage forms, tablets offer superior stability, compact size, and ease of transportation. Furthermore, they offer lower production costs and, consequently, lower prices. However, they exhibit lower absorption rates and bioavailability.
