The composition of a drug product can be complex. It includes several components: diluent, filler, and disintegrant. Let’s take a look at these components. Each component contributes to the final product’s stability. Its role is critical for the production of effective medication. What makes a tablet binder useful? In this article, we’ll discuss the benefits and drawbacks of each.
The granules formed in the granulating process need a disintegrant agent to be effective. Disintegrants are substances that release carbon dioxide upon contact with water. The simplest disintegrants consist of solid chemical compounds such as citric acid, tartaric acid, or tartaric carbonate. In order to dissolve rapidly, these materials must be exposed to a low level of compression pressure. In addition, starches must be able to wick water and body fluid, so their concentration is crucial. High concentrations of starch are often difficult to compress into a tablet.
The disintegrant adds lubrication properties to the tablets and granules so they can disintegrate more rapidly in the gastrointestinal tract after administration. Disintegrants can be added to a tablet before granulation, during the lubrication step prior to compression, or in both steps. Since granulation produces solid compacts, disintegrants must be designed with caution.
The quality of the diluent tablet binder plays a critical role in determining the final tablet feature. Too much or too little granulating liquid results in hard or fragile granules. The right amount of granulating liquid reduces the viscosity and ensures better spreading. The right amount of PVP or a similar diluent should be used in small quantities.
Traditionally, gelatin has been used as a diluent tablet binder. However, gelatin has a higher tendency to increase the particle size. It forms liquid bridges and leads to enlargement. Microcrystalline cellulose, on the other hand, does not have the same effect and does not form liquid bridges. The result was significantly larger SGS particles than SMS.
Another consideration is the mixing time. A higher wet mass time will produce hard granules that may not be suitable for direct compression tabletting. However, a lower wet mass time will result in tablets with the desired flowability and low dustability properties. These properties are critical for achieving high filling weight and uniform coverage in tablet formulations. Further, a hard tablet can be more difficult to manufacture if it is not hard enough to be molded.
Flow aids are important for ensuring uniform distribution of a drug during tablet granulation. The degree of compression affects the amount of air that can be sucked into the tablet, and it can also influence the time needed for the drug to dissolve in the tablet. A DEM can simulate the process of granulation by providing important parameters for accurate descriptions of unit operations. This thesis demonstrates the utility of DEM simulation for granulation, Check out this site.
In addition to the active pharmaceutical ingredient (API), a drug formulation will contain various other materials. A tablet formulation will typically contain a bulking agent, an API, and several excipients to improve the quality of the resulting tablet. Excipients are added to aid in tablet rigidity, dissolution, and the flow of the powder through the granulation process. However, the amount and type of excipients needed to make tablets will determine whether a specific flow aid is necessary.
Various types of fillers are used in the manufacturing of tablets. The most common ones are lactose, glucose, sucrose, mannitol, calcium phosphate, and calcium carbonate. However, cellulose derivatives have also been used in tablet manufacturing. A suitable filler is tasteless, palatable, and compatible with active pharmaceutical ingredients. It also should be capable of carrying a high concentration of API.
After separating the fine particulate drug from the binder and filler, the resulting mass is then dry-mixed. The final step involves the addition of common excipients such as disintegrants, lubricants, and colourants. Figure 30.5 shows the sequence of unit operations in the granulation process. It is important to note that each type of drug substance presents different challenges when it comes to granulation.
MS is a highly-molecular-weight polymeric carbohydrate consisting of large numbers of glucose monomers linked by glycosidic bonds. Amylose and amylopectin comprise approximately twenty-eight percent of the total MS. Amylopectin’s short chains form double-helices and give starch granules a semi-crystalline structure. Nevertheless, MS does not provide good friability in tablets.