What is the Advantage and Disadvantage of Granulation Series Exporter

23 Dec.,2024

 

What are the Advantages of Wet Granulation

- Wednesday, February 8,

You can find more information on our web, so please take a look.

The granulation process is vital in the pharmaceutical and packaging industry. It helps in making various forms of solid dosage medication. Most tablets are first in powder forms. So, there is a need to repackage them into the shapes they take in different pharmaceutical brand packages.

The process that helps in creating these industry-standard products is granulation. In this article, you will learn more about this process and the advantages and disadvantages of wet granulation. You will also get a bonus section on top-quality wet granulation machines available in the market.

Wet Granulation Procedure

Granulation is of two types: wet and dry. Indeed, other methods also exist, such as melt granulation and spray drying, and some pharmaceutical companies use them. Yet, wet and dry granulation are the most popular in the industry. Both procedures involve making powder particles stick together to produce solid dosages - certainly there exists difference between dry and wet granulation.

Dry granulation is the cheaper of the two. It is the best method for making drugs when there is a critical need for temperature and moisture control. It involves compacting the dry powder granules into one another during the granulation process.

The result of this approach is densification. But wet granulation involves using water or other fluids in the granulation process. The material's properties for making a particular drug determine the fluid choice.

Wet Granulation Superiority

In the wet granulation process, excipients are the extra materials in a drug apart from the active ingredient. It includes additives for colors and texture. Some help bind the tablet's particles together, while others preserve them.

Wet granulation does not need special excipients, while dry granulation usually needs such inputs. It is necessary to compensate for its deficiency. Thus, the chances are high that the drugs produced through this procedure will be more potent.

One of the major reasons wet granulation is popular is its content uniformity provision. Professional drug-makers do not want to make medication that appears substandard. So, they place a high value on the uniformity of their tablets. Wet granulation makes this process easier, especially when dealing with soluble low-dose medication. Wet granulation often struggles to achieve homogeneity with such drugs.

Drugs with poor dissolution rates are nightmares to drug makers. They take time, and manufacturers have no choice but to wait until the process ends. But wet granulation helps to overcome this challenge by speeding up the process. Increasing these drugs' dissolution speed makes the formulation and production procedure faster.

While producing, handling, transporting, and storing drugs, there is a chance of segregation of components. This occurrence is possible, especially when dealing with a uniform powder mix.

But, wet granulation reduces the chances of this event taking place. Thus, it limits variability in the form of inter-batch and intra-batch differences. This advantage increases the professionalism of pharmaceutical companies, enhancing their reputation in the industry.

5 Advantages of Wet Granulation 

Wet granulation is the oldest and the most population technique in the pharmaceutical industry. Below are some of the advantages of wet granulation:

1. Masking of Tabulation Deficiencies 

Creating a tablet with a perfect shape can be challenging, especially when the material lacks such qualities. Yet, with the aid of wet granulation, this is achievable because this process masks the defects of the materials used in the production of the drug.

But, dry granulation will submit to the characteristics of the material. Thus, the tablets produced through wet granulation are usually more spherical. They also often have better flow properties.

2. Better Compressibility

One of the challenges of dry granulation is that it usually leads to the use of high pressure during compression. No pharmaceutical products manufacturer will face this problem with wet granulation.

This procedure offers better compressibility, thereby cutting out the need for high pressure during compression. This method saves time and effort in aspect. Moreover, it extends the life of the machine by reducing machine wear.

3. Aids Tablet Coating

Due to factors such as the smell of the active ingredient, tablet coating is sometimes necessary in the pharmaceutical process. Yet, it is a procedure that takes place after the completion of the manufacturing process.

So, dry granulating will not be effective at that point. Instead, wet granulation makes this procedure easy because the tablet remains malleable for post-processing operations. This is one of the reasons many pharmaceutical companies invest in wet granulators despite their higher cost.

4. Reduces the Risk of Air Entrapment 

One of the enemies of tablet compressibility is air entrapment. Once air is trapped between the particles of the powder form of the drug, it becomes difficult to compress. Meanwhile, a tablet loses its professional appeal without excellent compression. Thus, pharmaceutical companies often try their best to prevent this situation.

The good news is that wet granulation offers an effective solution in this aspect. This is one of the reasons this procedure offers higher powder compressibility in comparison to dry granulation.

5. Limits the Level of Dust

The last thing pharmaceutical product manufacturers want is the contamination of drugs during the production process. Drugs are meant to heal people and not make them sick. One of the ways to avoid contamination during this process is the prevention of dust. Wet granulation reduces the chances of exposure to dust, and this also protects the employees involved in the process.

Demerits Of Wet Granulation 

Despite the many advantages of wet granulation, it also has limitations. Here are some of them:

1. The Process is Complex Without Machines

Some pharmaceutical companies opt for dry granulation and other methods because wet granulation can be complex. The technique is not easy, especially in the absence of the right equipment. So, whoever is planning to take advantage of the benefits of this procedure must be ready to invest in machines. With the aid of top-class wet granulators, the process is seamless. Without them, it is best to consider other approaches.

2. It is More Expensive

The cost-effective attraction of dry granulation is one of the reasons it appeals to many companies. Wet granulation requires more capital, and that is the reason startups and small companies in the industry avoid it. Yet, any pharmaceutical firm that wants to move on to the next level has to invest in such machines. They are always worth the extra cost.

3. It Requires More Effort And Energy Consumption

Pharmaceutical companies without a steady supply of energy will struggle with this technique. It requires a stable supply of electricity to power the machines for carrying out this process. So, it is advisable that a company is willing to invest in renewable sources of energy before considering this method. This is particularly important to companies that do not have access to a stable electricity supply. Yet, the fact that most such firms operate in cities will help solve this challenge.

4. Not Suitable For Moisture Control

When dealing with moisture-sensitive materials, wet granulation is not the best approach. Yet, the lack of plenty of such substances in the pharmaceutical process ensures that this is not a significant challenge.

Jiangyin Chenyuan Machinery Product Page

Top-Class Granulation Machines

It is good to know the advantages and disadvantages of wet granulation technique. It will enable you to deal with the challenges. The complex process of wet granulation requires excellent machines for its success. Without them, the process becomes long and demanding. So, any pharmaceutical company that wants to take advantage of the many benefits of this method needs wet granulators.

The good news is that iPharMachine has some of the best products that make the process seamless. CYK Series Oscillating Granulator and CZK-G100 Granulator are two of the top granulators of the company. They have the following features:

 

  • Its advance granulating method saves energy.
  • It has a long service life.
  • It has a simple and reasonable structure despite its sophistication.
  • It is suitable for the chemical, food, and pharmaceutical industries.

 

  • It has a simple design that makes it simple to operate.
  • It is energy-saving, thanks to its advance granulating method.
  • It offers uniformity and compressibility.
  • It has a sturdy design for longevity.

Final Words

We have highlighted the advantages and disadvantages of wet granulation method. It is obvious that wet granulation has several benefits that make it superior to dry granulation. It offers better uniformity and perfect shapes. Thus, it is not surprising that it remains the oldest and most popular granulation method. We also identified some of the disadvantages of this process. They include its demanding time and energy.

Besides, the process is more complex in comparison to dry granulation. Yet, you can navigate these challenges by investing in high-grade wet granulators. CYK60-90-160 Granulator and CZK-G 100 Granulator by iPharMachine have the features you need in a top-class granulator. Moreover, the company has a reputation for producing top-quality pharmaceutical equipment and machines. So, investing in any of these machines guarantees that you will get value for your money. 

The Benefits of the Dry Granulation Method in ...

Before we look at the benefits, let&#;s first answer the question...

What are the basic principles of the dry granulation method and roller compaction technology?

Simply stated, it is one of the process steps in the pharmaceutical OSD manufacturing process, where raw ingredient powders are conditioned ready to be formed into tablets. It is a granulation method that takes the dry, primary ingredient powders and compresses these smaller particles together into larger granules, in order to lock-in ingredient ratios and ensures the right amount of excipient is included in every single tablet, as well as create the granule properties necessary for feeding the subsequent process steps.

These larger granules are created with Roller Compactor equipment that compresses the powders between two rotating rolls to create a compact/ribbon. This is then milled to create a powder at a target particle size and distribution, that will flow through to the tablet presses, where it is compacted into a tablet.


The Pharmaceutical Dry Granulation method

Pharmaceutical dry granulation is the leanest method for conditioning powders. Because it is a continuous manufacturing process, there is no need to construct batch sizes to meet equipment constraints. With few process variables, it is relatively simple to validate, optimize and scale.

Compared to the commonly used practice of Wet Granulation, it is a more economical methodology for granulating powders and is more suitable for use on heat or moisture-sensitive compounds. Compared to Direct Compression it removes the issues of blend segregation and flowability that can result in sub-standard tablets.

The advantages of the Dry Granulation method

Improved powder flow as the ideal particle size distribution can be attained by adjusting the compaction and milling process. With a better granular mix, material flows more easily, which means that conveying and feeding into downstream processes become trouble-free, as caking and bridging are eliminated.

Enhanced compressibility at the tablet pressing stage can be achieved as the powders are conditioned correctly. The goal of Dry Granulation is to compress the powder but leave some compactibility so that the powder can still be formed in a tablet press.

Control particle hardness by adjusting the compression and milling stage parameters. Crush strength and disintegration can be important properties that are brought under control.

Control dissolution and dispersion rates by modifying hardness and particle size distribution.

Lower equipment CapEx costs. Dry Granulation does not use as many pieces of equipment as the Wet Granulation process. Dry Granulation only involves a Roll Compactor, mill & sieve and charging and discharging equipment. Whereas, Wet Granulation involves a high shear granulator, fluid bed drier, mills & sieves, charging and discharging equipment, which can run into multiple millions of dollars and takes up a lot of factory space, consumes significant amounts of energy, and requires significant manpower to operate the system.

Scalability is much more straightforward with Dry Granulation &#; results achieved on the lab or pilot scale models can be replicated at the production scale.

Read more: How to optimise the manufacture of tablets using the dry granulation method

The disadvantages of the Dry Granulation method

With any manufacturing process step, there will be some disadvantages, it won&#;t work for every single type of powder or drug.

Raw material properties matter &#; the characteristics of the API and excipient powders are important. They must compress under pressure to form a solid compact. This can be tested on bench-scale equipment to ensure the formulation has the desired compressibility characteristics.

Heat-sensitive materials can be poor candidates. Because Dry Granulation doesn&#;t require a drying step, it is possible the heat applied to the product is reduced compared to other methods. However, there can be situations, even with Dry Granulation, where the powder can heat slightly from the pressure of the rolls. This can typically be mitigated by using a roll cooling feature.

When should I choose Dry Granulation compared to Wet Granulation or Direct Compression?

Specifying Dry Granulation will depend on the characteristics of the powders used in the manufacturing process. The table below shows an outline of which powder conditioning method to choose depending on the flowability and compressibility of the OSD powders. As a broad overview, materials must easily blend together

  COMPRESSIBILITY FLOWABILITY   HIGH LOW HIGH Direct Compression Wet Granulation LOW Dry Granulation

 

Dry Granulation is an inherently continuous process and exhibits improved robustness, content uniformity, scalability and are compatible with monitoring during the manufacturing process, which lends itself to being suitable for continuous manufacture.

Where does Fitzpatrick fit?

Whilst we said that Dry Granulation as a process is relatively straightforward, compared to the alternative processes, there are still a number of pieces of equipment that need to be brought together to create a system. It isn&#;t just a case of buying a Roller Compactor and plugging it in.

The system needs to be designed and the parameters adjusted to create the ideal powder characteristics that will make you successful in your OSD process.

Read: How to select a roller compactor to meet your process needs.

Our team of experts are on hand to help and guide you along the way and we have innovative designs that help ensure you achieve great results. Fitzpatrick&#;s CCS Series of Roller Compactors are fully contained and scalable from lab to production. We can help you select the right model and get it set up to fulfill your application requirements. 

Don&#;t just take our word for it - see how we helped a healthcare provider in India who had prolonged batch times, and particle size inconsistencies that were negatively affecting their dry granulation process.

You can also learn more about Fitzpatrick's Roller Compaction Equipment for Pharmaceutical Manufacturing here.

For more Granulation Series Exporterinformation, please contact us. We will provide professional answers.