Granulation for the Nutritional Market
Granulation
The term “granulated” is derived from the Latin word “granulatum” meaning grained, a process that evolved from delivering powder by hand rolling into a pill by using honey or sugar and had been used for centuries to combine ingredients that could not be blended together.
Today, granulation is the process of joining fine powders into larger agglomerates that are free-flowing, dust-free and easy to compress creating a more robust product that can be tableted or encapsulated. By creating larger particles within the granulation process, the resulting powder has improved flow characteristics, is more readily soluble or compressible, reduces segregation for multicomponent powder blends, improves content uniformity, and eliminates excessive amounts of fine particles. Adding a granulation step in the formulation process can alleviate many challenges often faced by formulators. In production, the development of a stable, granulated intermediate, typically supports significantly higher outputs on tableting and encapsulation equipment increasing the productivity for manufacturers.
Types of Granulation
Although granulation methods are broadly classified into two types, wet or dry granulation, the choice of technology can play a crucial part in the final end product.
Choosing the optimum method of granulation requires not only analysis of the attributes of the various components to be granulated, but also the intended use and purpose of the granulated product. A proper evaluation is imperative to ensuring an efficient manufacturing process and in producing a high-quality product.
The final granulated product is dependent many variables, however the most common are particle size of the starting material, binder type, concentration and volume, granulation time, type of granulator and drying rate (temperature and time). The final product may also be affected by the incorporation of sweeteners, coloring agents and flavors.
Wet Granulation
Wet granulation is the oldest and most common granulation technique and can be accomplished using different types of equipment, including low shear mixers, high shear mixer granulators, fluid bed granulation and extrusion-spheronization. Regardless of the which wet granulation technique is used, the resulting granulation must typically be dried to remove excess moisture prior to further processing.
Dry Granulation
Dry granulation is a process is which the granules are formed without using a liquid binder solution. Dry granulation maybe more suitable for products that are sensitive to moisture or heat. Dry granulation process is accomplished by technical force, typically either slugging or roller compaction. In the slugging process, a tablet or “slug” is created followed by a grinding process. In roller compactors, the powder is pressed between two counter-turning rollers to deliver a persistent sheet or lace of materials, which is then milled to the target particle size. A benefit of dry granulation is the ability to produce the granules without the need for a drying step.
Granulation for Nutraceuticals
Granulation processes have been used extensively within the pharmaceutical manufacturing as well as other powder processing industries. In the nutritional industry, the use of granulation is now becoming widely used to improve efficacy and quality of the product, expand dosage types and product offerings, improve brand recognition and customer adherence, while improving the reliability and repeatability of manufacturing, improving manufacturing processes while lowering costs and improving the supply chain process.
Granulation for Efficacy and Quality
By improving flow properties of the formulation and hence the content uniformity of the unit dose and compressibility by the means of granulation, allows the manufacturer the ability to produce a product with several quality benefits such as:
• Increasing the bulk density of a product
• Facilitating metering or volumetric dispensing
• Controlling the rate of in-vivo release
• To produce dust free formulations
• Improving product appearance
• To produce uniform mixtures
• Reduced segregation and fines
• To improve compaction characteristics of mix
• Controlled blend uniformity.
Improved quality in a product can often be linked to improved efficacy, ultimately resulting in improved customer retention and adherence.
Expand Dosage Type Options and Product Offerings With Granulation
The tableting and encapsulation capabilities for products that have been granulated allows the manufacturer to respond to market trends and customer preference with dosage types options, such as size, color and flavor variations in addition to modified release and combination products.
Conventional release products can raise risks that include low solubility, poor permeability, fast metabolism, short half-life and in certain nutraceuticals (e.g., ANIs/food ingredients) formulations may even undergo chemical change or degradation in stomach acid. Modifying the release rate of a capsule or tablet with solutions that protect and support the efficacy of gut health active ingredients can solve many of these issues. Choosing the correct dosage type, such as immediate-release vs. delayed-release vs. sustained-release delivery is imperative in the efficacy of a nutraceutical, such as a probiotic.
Improve Brand Recognition and Customer Adherence
Difficulty in swallowing tablets and capsules is a widespread problem affecting people of all ages. There are even concerns that it may pose a serious compliance problem among patients. Consumers who cannot swallow a product cite one or more of three problems; that products are too large, get stuck in the throat and have an unpleasant taste or smell.
Combination capsules, such as a tablet in a capsule or a capsule in a capsule, provide manufacturers more flexibility in formulation development, allowing for combination of two non-compatible formulations in a single dose, achieving dual release profiles in a single dosage form, and the increased product aesthetics.
Lowering Operational Costs and Improving the Supply Chain Process
One major benefit in granulating in-house is the savings in raw material costs; pre-granulated products are significantly more costly and reliance on third parties for important supply chain activities, such as raw material procurement, processing and distribution raises concerns related to quality assurance, timely delivery and adherence to responsible business practices.
Through the elimination of third-party manufacturing, there can be additional benefits, such as reduced or elimination of shipping costs, lowered inventory costs through “just in time” manufacturing, and shorter lead times. All of these factors mean you can improve your control over and scale production at you own pace without having to incur additional costs for storage and transport.
Cost aside, setting up in-house granulation can provide a competitive edge in the market with closer control of timelines, faster response to market trends and customer demands and ultimately have a closer and continual monitoring of your product.
Optimize With Granulation
In conclusion, granulation technology offers manufacturers of nutritional supplements a wide range of benefits in product development, manufacturing and competitiveness within the consumer marketplace. To profit from these benefits, an evaluation of granulation technology for existing and planned product portfolio, and subsequent investment into state-of-the-art equipment is the first step. NIE
References:
Handbook of Pharmaceutical Granulation Technology, Drugs and the Pharmaceutical Sciences, Dilip M. Parikh.
The Granulation of Medicines by Thomas Skinner https://books.google.com/books/about/The_Granulation_of_Medicines.html?id=Iza0zQEACAJ.
Shanmugam S. Granulation techniques and technologies: recent progresses. Bioimpacts. 2015;5(1):55-63. doi:10.15171/bi.2015.04.
Development of Nutraceutical Product, January 2015. International Journal on Advanced Science Engineering and Information Technology 5(3):201.
Nutrition Industry Executive, Follow Your Gut https://niemagazine.com/follow-your-gut/ Evelyn Reinson.
A Hard Pill to Swallow: Improving Palatability by Dr. Nicola Davies on Sep 4, 2015.
Adding a granulation step in the formulation process can alleviate many challenges often faced by formulators. Ken Abramowitz | May 23, 2013.
About Supply Chain Management Systems by David Ingram.
https://smallbusiness.chron.com/supply-chain-management-systems-43344.html.
Efficiencies in Manufacturing, Klaus Gröschel, John Carey.
Evelyn Reinson is an international marketing manager at ACG, responsible for global marketing strategies of the company’s product range of capsules, films & foils, engineering, and inspection worldwide. For more information, visit www.ACG-world.com.
