In the present era, the pharmaceutical industry produces oral solid dosage like tablets, which is indeed a critical aspect of drug formulation. There are different excipients that are used to facilitate the manufacturing of these dosage forms. Among all of them, one excipient that has gained great recognition in current scenario is Directly Compressible Granules (DCGs). These are specialized excipients designed to ease the processing of tablet formulation by enabling direct compression, a very crucial step in production of solid oral dosage forms.
DCGs have changed the game of manufacturing tablets and have innovated a new way for processing pharmaceutical tablets’ production. By the mode of this article, you will unwrap the various benefits of DCGs and will also understand why they have become an indispensable tool in the market.
What Are Directly Compressible Granules (DCGs)?
Before unfolding the benefits, let’s understand what DCGs are and how they create a difference from conventional granules, in the tablet manufacturing process.
DCGs are specialized excipients used in pharmaceutical manufacturing to facilitate direct compression (a process where powders are compressed into tablets without granulations). The compressible granules consist of active pharmaceutical ingredients (APIs) along with other substances, which helps them to execute better flowability and compressibility.
The traditional formulations require granulation (i.e., the process of formation of larger particles or granules from fine powders through agglomeration) before compression, which makes it an expensive and time-consuming choice. On the other hand, DCGs flow freely, possess excellent compressibility and are stable enough to be compressed into tablets without processing granulation steps. This unique ability of DCGs to avoid the granulation process in tablet manufacturing makes it a better and an efficient choice to go for.
The Key Benefits of Diffused Compressible Granules (DCGs)
1. Simplified Manufacturing Process
One of the most significant and efficient benefits of DCGs is their simple tablet production process. DCGs are pre-formulated excipients that are ready for direct compression.
Their physical properties are designed in a manner they flow effortlessly during compression and formulate stable tablets with desired hardness and dissolution characteristics. It ultimately eases manufacturers since they can now skip the granulation phase and can save associated cost, labour and time.
2. Cost-effectiveness
The simpler the manufacturing, the more efficient the cost. Just by eliminating the process of granulation a huge amount of money can be saved as this will aid to reduce costs associated with manpower, equipment and materials used.
Also, DCGs can help to reduce the overall costing of tablet production as it streamlines operations, reduces raw material wastage and eventually reduces the cost.
Moreover, DCGs have high bulk densities, i.e., they require smaller volume of ingredient to achieve the required tablet weight. It helps to conserve the material and further contributes to cost-effectiveness of tablet making.
3. Improved Tablet Uniformity and Quality
DCGs contribute to enhancing tablet quality, especially in content uniformity and tablet hardness. Directly compressible excipients are designed in such a way they flow uniformly during the compression process, ensuring equal distribution of tablet mixture in each tablet. This helps in maintaining an equilibrium in dosage of active pharmaceutical ingredient (API) and excipients in each tablet, which is an important part for maintaining therapeutic efficacy.
DCGs also possess very efficient compressibility, which aids the manufacturers to formulate tablets with consistent hardness and appearance. This is an important factor in tablets that require precise control over dissolution rates, which then impacts bioavailability and therapeutic outcomes. Maintaining uniformity during the production process reduces the need for reprocessing and batch adjustments that ultimately reduces the cost and time consumption.
4. Better Control of Product Characteristics
DCGs provide better control over the features of the final tablet. Compared with traditional granulation processes, those granules may exhibit different degrees of flowability, compressibility, or moisture content which can fluctuate the tablet uniformity and other relevant profiles. Whereas, DCGs are precisely formulated to have ideal qualities for direct compression, improving the consistency of tablet properties.
For example: DCGs can easily be moulded in a specific manner to provide required disintegration properties, which are important for the drugs that need to release their active ingredients in a specific manner. Manufacturers go for DCGs as they enable them to meet the requirement of formulation as per the intended functioning of the tablets.
5. Reduced Risk of Contamination
DCGs require the least handling and do not use any solvents, which indeed reduces the risk of contamination. Unlike traditional tablet manufacturing method that use various solvents and blinders in wet granulation for their manufacturing.
The direct compression process is dry and does not involve any wet agents that can incorporate any impurities or affect the stability of API. Since this process is less labour oriented and requires very less manpower, therefore there are fewer chances of human error during production, decreasing the chances of contamination. In a nutshell, direct compression ensures the high quality and fulfilment of regulatory standards.
6. Flexibility in Formulation
One of the major advantages of DCGs is their flexibility in formulation development. These excipients have the ability to combine with a wide variety of active pharmaceutical ingredients (API) and other excipients as well to create tablets of required properties. The versatile nature of DCGs can be understood by their ability to formulate immediate release tablets, and complex release including extended release, controlled release as well.
Therefore, formulators can design tablets with a release profile as per their requirements, while still benefiting from a simplified manufacturing process. This terrific quality to achieve different release characteristics without managing complex granulation methods makes DCGs an ultimate choice for formulators working on experimental and innovative drug delivery systems.
7. Faster Time to Market
While developing a new medicine or responding to market demands, time to market becomes a huge hurdle to cross. However, the use of DCGs aids in speeding up the formulation and manufacturing process, allowing the companies to bring new products more frequently to the market. Removing the granulation step not only shortens the manufacturing time, but also the regulatory submissions and testing timelines. This is how it makes the production faster and simpler.
In today’s competitive market it’s a boon to produce high quality medicine in less time, it can help the companies to grow by meeting consumers’ needs on time with full affordability and availability.
Conclusion
Directly Compressible Granules (DCGs) have totally revolutionized the scenario of pharmaceutical industry by offering various benefits of oral solid dosage forms. From ensuring ease in production and improving cost effectiveness to elevating the tablet quality and environmental sustainability.
DCGs provide a range of advantages to tackle the numerous challenges of modern drug development and manufacturing.
By removing the traditional granulation steps and evolving better control over tablet making, DCGs allow faster production, cheaper cost and improved availability.
As the pharmaceutical sector continues to grow, the usage of DCGs are likely to be a key factor in enhancing production processes and providing high quality, and effective medicines to patients all around the globe.
