What are the advantages and disadvantages of dry granulation?
Dry granulation technology can be carried out using a roller flat granulation machine. The extract of traditional Chinese medicine with a specific relative density was spray-dried to obtain dry extract powder. After adding some auxiliary materials, the powder was pressed into thin slices using a dry extrusion granulator and then crushed into particles. This method requires fewer excipients and helps improve the stability, disintegration, and dispersion of the particles. Typically, dry extract powder with 0.5-1 times the excipients can be used. However, it should be noted that the dry extract obtained by spray drying has strong wettability. Therefore, the key to applying this method is finding suitable excipients that have some adhesion and are not prone to moisture absorption, such as lactose, pre-gelatinized starch, mannitol, water-soluble acrylic resin, and cellulose derivatives.
Dry granulation is a method in which drugs, diluents, disintegrants, and lubricants are mixed evenly, compressed into strips or sheets, and then crushed into the required particle size. Solid preparation production remains the most common form in the production of pharmaceutical products. However, due to the poor material fluidity of some products, granulation is necessary to improve the material’s fluidity. Granulation is a common operation to improve the properties of powders in the production of solid dosage forms.
The purpose of dry granulation is generally to improve the flow of materials, eliminate the degradation caused by wet granulation, enhance product stability, prevent material stratification, and increase bulk density. Dry granulation technology offers many advantages compared to the more mature wet granulation technology, but it also presents some challenges. Let’s explore the advantages and disadvantages of dry granulation technology.
Dry granulation is a process of combining materials. The choice of dry granulation process offers both product and process advantages.
Easy to operate:
Compared with wet granulation, dry granulation requires simple equipment and straightforward processing, making it easy to master. The process does not require consideration of liquid evaporation during treatment and offers good operational performance. One of the main advantages of dry granulation over wet granulation is that it does not require water or any organic solvent. Therefore, this method is particularly suitable for certain drugs that are sensitive to moisture or heat. Additionally, the dry granulation process is environmentally friendly with no exhaust emissions, reducing environmental pollution. Dry granulation technology is efficient and easy to automate, making it simple to scale up with low operational costs. The finished product’s particle size is uniform, packing density increases, fluidity improves, and disintegration can be controlled, making subsequent processing, storage, and transportation convenient. If the drug or excipient has poor fluidity or is sensitive to heat or moisture, dry granulation technology can be used. However, there are some technical challenges in dry granulation technology. Let’s explore the problems and solutions in the dry granulation process.
Low cost:
Dry granulation does not require the use of expensive water treatment equipment or additional devices, which saves costs and makes it more economical than wet granulation.
High output:
Dry granulation can produce a variety of granular products due to its fast and simple process, allowing for higher yields.
Disadvantages of Dry Granulation:
Granulation is Difficult to Control: The dry granulation process is easily influenced by factors such as temperature, pressure, material moisture content, and the nature of the granular materials, making it challenging to control. This process is highly dependent on the experience of the operator. Issues such as unpressed material or fine powder leakage can occur. For example, using a concave roller for sealing can help prevent leakage between roller side seals, which would otherwise produce uncompacted material. Additionally, the leaked fine powder may need to be re-granulated, but if its composition differs from the overall composition, it can lead to an uneven final product. Reprocessing the material multiple times can negatively affect its compressibility. It is important to maintain a vacuum around the equipment to prevent powder splashing.
Large Particle Size Distribution Range: Due to the difficulty in controlling the granulation process and the various influencing factors, the size distribution range of the obtained particles can be large. Unlike wet granulation, the dry granulation process cannot be precisely controlled.
Loss of Material Compressibility: The loss of material compressibility is a common issue in dry granulation and is more pronounced at higher grinding pressures. This loss occurs mainly in plastic materials and can also affect brittle materials. To achieve the required particle characteristics, higher roller pressure may be necessary in dry granulation. However, to avoid the loss of material compressibility, the roller pressure should be reduced as much as possible while still maintaining product quality. Excessive compression can lead to discoloration, overheating, severe cracking, or plasticization of the material strip.
Material Sticking to Rollers: Adding lubricants can help control the material moisture within the optimal range. Selecting auxiliary materials with high Tg such as dextrin or maltodextrin, and using cooling water to reduce roller surface temperature effectively, can help control the appropriate roller pressure and the relative humidity of the production environment to avoid material sticking to rollers.
Strip Delamination: Controlling the consistency of material particle size distribution, density, and other properties can help reduce the risk of strip delamination.
The purpose of dry granulation includes the following:
Transform the material into the desired structure and shape.
Facilitate accurate quantification, dispensing, and management.
Reduce dust pollution from powders.
Create a non-segregating mixture of different particle systems.
Enhance the product’s appearance.
Prevent caking during the production process of some solid phases.
Improve the flow characteristics of separated raw materials.
Increase the volume and mass of powder for easier storage and transportation.
Reduce the risk of handling toxic and corrosive materials.
Control the dissolution rate of the product.
Adjust the void ratio and specific surface area of the final product.
Improve heat transfer efficiency and support combustion.
Adapt to various biological processes.
Scope of Application of Dry Granulation:
Dry granulation is suitable for various substances, such as heat-sensitive and moisture-prone materials. Therefore, it is widely used in the food, pharmaceutical, agricultural, and other industries. Additionally, the dry granulation process is relatively simple and more cost-effective.
Conclusion:
In summary, dry granulation has its own unique advantages, disadvantages, and scope of application. When selecting a process, it is essential to consider the nature of the material itself, the production environment, the process requirements, and other factors comprehensively to choose the most suitable granulation method.
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About LKMixer
LKMixer is a professional manufacturer for fertilizer production line, grinder, mixer and granulator, shredder. These machines are widely used in food, pharmaceutical, cosmetic, health care products and chemical industries. The Food materials like Peanut, mushroom, seeds, potato, bean, tobacco, salt, cannabis, tea, Sugar, corn, Coffee, rice, pepper, grain as so on. Grinders have many types such as Pulse Dust Grinder which suitable for zero pollution environment, Turbine Mill which is suitable for coffee bean, 12-120mesh all can meet, Ultrafine Grinding Mill covers 80-200mesh, and also Winnowing Dust Grinder or other grinding machines like SF Hammer. Welcome to contact us for details. Contact us for more information. Proposal, catalog, quotation. Mobile/WhatsApp: +86 18019763531 Tel: +86 21 66037855 Email: sales@lkmixer.com
We have 20 years manufacturing experiences; 15600 cubic meters factory area; 5000sets annual capacity; 55 professional engineers;
What’s your main maket?
South America: Brazil, Colombia, Peru, Bolivia, Uruguay, Paraguay ;Romania; USA with UL Certification Middle East: Saudi, Arabia, Oman, Turkey Europe: Russia, Australia, Belarus, Ukraine, Poland
Can you support OEM?
– Yes, OEM or ODM. Machine can be customized according to customer detail requirement, including capacity and voltages, motor certifications. – Drawing and raw materials also can be customized.
We majorly produce CRUSHER, GRINDER, MIXER, and also have auxiliary machines like DRYER, GRANULATOR, VIBRATING SIFTER, CONVEYOR, etc. We can customize whole production line according to your capacity, material, output sizes of mesh and mm of granule and powder.
CAN YOU GIVE ME GUIDE ON OTHER MACHINE ? TO FULL MY PRODUCTION LINE
YES ! Our f have factory build more than 20 years now, we can design and customize whole line, besides of the grinding machine, mixing machine, we can also fully support to provide the washing machine, cutting machine, drying machine, packing machine, filling machine. Though we are not producing these machine, but our brother companies co-work together for over 20 years, we have rich experience in providing you a full effective production line, fully automatically or semi-automatically.
HOW TO VISIT YOUR COMPANY?
Our Factory located in Jiangsu Province, very near to Shanghai, you can fly to Shanghai Pudong Airport, we pick you up and take you by car 2 hours ride, can reach our factory, welcome your visit.
WHAT’S YOUR BEFORE & AFTER SERVICE ?
1) Before your purchasing, we need to know your detail request, such as what kind of material you want to grind and mixing, what final product powder or granule you want to reach. Because different material and powder sizes request of different machine to do. We can provide professional advice and rich experience help to choose machine. Most of the products we have already did before for other customer, trail test or run mass production, so we knows which machine is best in performance of grinding and mixing. This is of very importance in helping you choose the right model. We also wish this can help our customer a lot. Even the material we didn’t do before, we will prepare the same material and to do the trail test and send video to you for your reference. 2) One Year guarantee of machine quality. If the machine have problem within one year, we will send you the spare parts to you for replacement, but this not including the damage caused by human causes. We also have 24 hours on line guide for customer, if you have operation difficulty, we will guide by video and on line communication with our engineer for your emergency debug. 3) For small machine, we sell with whole machine, it’s no need to install, and easy to operation, no problems for operation. While for large machine, its’s also not difficult to install with video guideline, but if you need, we can assign our technicians to go abroad, the round ticket, food and residents will be paid by customer.
HOW ABOUT YOUR PAYMENT TERM?
Our payment term is T/T. 50% payment in advance, rest of 50% payment finish before the goods shipped. When we finish the machine production we will do trail test and run the machine take videos for your green light. You pay the rest of 50% payment then.
What are the Factors Affecting Dry Granulation?
The Impact of Materials on Dry Granulation (1) Compressibility: Compressibility is an important factor that ensures the material can be pressed into strips. The compressibility of the material depends on whether it undergoes elastic deformation or plastic deformation when pressed, and generally, the compressibility of plastic auxiliary materials is better. (2) Moisture: When the moisture content of the material is too high, the material may become sticky during the rolling process. Conversely, when the moisture content is too low, the material may not be easily pressed into strips. (3) Material Viscosity: Viscosity refers to the material’s ability to bond and polymerize. Dry granulation requires careful control of the material’s viscosity range. The Influence of Equipment Parameters on Dry Granulation The general feeding speed, roller pressure, and roller speed significantly affect dry granulation. The order of influence on particle yield and brittleness is as follows: roller speed > roller pressure > horizontal feeding speed. Particle yield is positively correlated with roller pressure and horizontal feeding speed but negatively correlated with roller speed, while particle brittleness shows the opposite correlation.
What are the Precautions for Dry Granulation?
Given the complexity of dry granulation, developing a dry granulation process for pharmaceutical use can be challenging. Here, some key considerations are summarized, which may be helpful in the development of the dry granulation process. Designing the Experiment: The experiment design should take into account the mechanical properties of the material, such as materials that can form strips significantly even at low pressures. If such materials are used in dry granulation at a relatively high pressure range, the effect of dry granulation pressure on the strip characteristics and compressibility of the particles may not be observed. Continuity of the Dry Granulation Process: Should materials leaking through rollers be recycled? Recycling can help maintain high yields and reduce costs, but it may also lead to less fluid particles. Use of Lubricants: The use of internal and external lubricants can lead to significant differences in material properties. Compared to external lubricants, internal lubricants often result in worse tablet compressibility. Careful consideration and evaluation are necessary during process and prescription design. In general, it is best not to use lubricants unless necessary to handle powder, such as to avoid powder sticking to the roller. Density Distribution: The strips produced in the dry granulator usually exhibit an uneven density distribution. Flow Improvement: Although dry granulation is used to improve the flow of other powders with poor flow, the initial powder must meet flow requirements for the dry granulation feeding process to proceed smoothly.
Rules to Follow in Dry Granulation:
Control the Porosity of Material Strip: Strip porosity is a key parameter for controlling strip quality and successfully scaling up materials. For a given mixing formula, the strip porosity of the material is mainly determined by roller pressure, roller clearance, and feeding frequency. By adjusting these parameters, you can obtain material strips with the same porosity in different dry granulators. Avoid Excessive Compaction of Materials: It’s important to maintain the necessary pressure at a minimum to achieve the desired particle size distribution and fluidity bands. Over-compacted strips tend to produce less compressible particles, as these particles may not easily deform during the laminating process. Additionally, the granulation process parameters should be optimized to obtain particles with a uniform particle size distribution to ensure particle fluidity and tablet stability. Use Small Particles as Starting Material: The size of the starting material will affect the final tensile strength of dry granulated tablets. Generally, the smaller the adhesive particles of the same material, the better the tablet performance. However, the proportion and size of fine particles should not be too extreme to avoid negatively impacting the fluidity of the powder, which is crucial for material feeding during the dry granulation process. Balance the Mechanical Properties of the Starting Material: The starting material should maintain a reasonable balance of ductility and brittleness. During granulation, more plastic materials are often more sensitive to changes in parameters such as roll pressure, lubrication time, and strength. Brittle materials require a higher pressure when pressing.
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You may also interest in: About LKMixer LKMixer is a professional manufacturer for fertilizer production line, grinder, mixer and granulator, shredder. These machines are widely used in food, pharmaceutical, cosmetic, health care products and chemical industries. The Food materials like Peanut, mushroom, seeds, potato, bean, tobacco, salt, cannabis, tea, Sugar, corn, Coffee, rice, pepper, grain as…
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