Applications, Benefits, and Regulatory Insights for Microcrystalline Cellulose (MCC) in Pharmaceuticals and Beyond

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Since its discovery in 1955, microcrystalline cellulose (MCC) has maintained its position in the market as one of the most popular binding agents used in the pharmaceutical industry. However, the applications of MCC are not restricted to just capsules and tablets. The versatility of MCC makes it a popular product in various industries.

Its capability to bind, bulk, disintegrate, and lubricate makes it a useful product in a wide range of applications. This crystalline cellulose is a natural, fiber-rich component that is not toxic and is chewable. In this blog, let us dive deeper into microcrystalline cellulose, their applications, benefits, and regulatory requirements.

What is Microcrystalline Cellulose?

The chemical name for microcrystalline cellulose is (C6H10O5)n. MCC is a white free-flowing powder derived from refined wood pulp. It is a chemically non-reactive substance. MCC does not degrade during digestion. Additionally, it does not have any appreciable absorption. In bulk quantities, it is offered as a dietary bulk and might result in a laxative effect.

The pharmaceutical industry widely uses MCC as an excipient in their drug formulations. The compressibility properties of cellulose find applications in solid drug dosages like tablets. It helps the tablets to be made in solid form but can be dissolved quickly. The GRAS (generally recognized as safe) selection committee has granted MCC a safe-for-consumption status if used in normal quantities.

Applications of MCC in Pharmaceutical Areas

Each cellulose derivative will have its unique pharmaceutical properties. MCC is one of the most versatile agents which is widely used in the pharmaceutical sector.

A  few pharmaceutical industry veterans consider MCC as an “inexhaustible treasure” because of its applications in a vast number of processes. Tablets can be more compressible with the use of microcrystalline cellulose. Additionally, it can be used as a binding agent in both wet and dry manufacturing processes.  The use of microcrystalline cellulose in tablets is to ensure a consistent tablet weight.

The thickness and viscosity of MCC make it a crucial cellulose that can be used as an ingredient in liquid dosage forms.  Higher crystallization and bigger particle size grades work effectively with colloidal silicon dioxide to manufacture silicide and second-generation grades.  MCC is an effective bioadhesive leveraged in bioadhesive drug delivery systems.

Applications of MCC Beyond the Pharmaceutical Sector

Various processed food manufacturers use MCC as an anti-caking agent. The beauty industry uses it as a texturizer for cosmetics. Microcrystalline cellulose is a refined wood pulp that has unique hydroswelling characteristics. Reactive extrusion, ultrasonication, and steam explosion are a few ways to synthesize MCC.

In recent times, MCC also has found its application in the 3D printing niche.

Microcrystalline Cellulose Advantages

MCC can be crystallized to different particle sizes. This cellulose; because of its microcrystalline structure, provides a large surface area with porosity and moisture retention characteristics. Its efficient binding properties and cohesiveness make it one of the best extrusion aids on the market.

Where and When Should One Use Microcrystalline Cellulose?

Following are the applications of MCC that one should consider:

  • MCC can be used in solid dosage forms right from hard gelatin capsules to dispersible tablets.
  • MCC is a rare filler that is water-insoluble and hydrophilic. Hence it is an ideal solution for use in wet granulation procedures.
  • MCC can be blended with dry lactose if it’s too costly to act as only filler. A rapid disintegration occurs before it is compressed.
  • In wet powder blends this cellulose can be used to achieve wicking action.
  • The primary use of MCC is as a binder and diluent.

What are the Regulations Around  Microcrystalline cellulose?

●       USA

The Food and Drug Administration (FDA) considers MCC to be safe for consumption in normal quantities for all animal species.  There are no consumption safety issues for MCC beyond its food-grade requirements. Ash content with any cellulose should be not more than 0.6%. All the regulations related to cellulose fall under national organic program regulations. In order to enhance the absorption or modification of viscosity; MCC can be combined with ancillary ingredients.

The United States Pharmacopeia (USP) has stringent regulations. These compliance policies govern everything from particle size distribution to packaging and storage. Cellulose is a stage four substance that needs to have a restricted aerobic microbial count. The storage needs to be in tight containers to minimize exposure to nominal loss.

  • EU

Europe’s safety authority regulates MCC as a technological food additive under their Annex II Regulation No 1333/2008. The oral acute toxicity with MCC is low, genotoxicity is less likely, and no absorption to worry about. Hence, MCCs are safe for consumption if the purity criteria are met, which are defined under regulation No 231/2012. Europe recommends member states track consumption of MCC and report if a risk is identified.

Conclusion

The 3D printing industry is exploring opportunities to leverage MCC to develop quick prototypes and variable materials. Different manufacturers produce microcrystalline cellulose with variant properties depending on  the pulp type used as raw material and  the extraction process applied.  MCC is a widely used excipient for direct compression. Additionally, MCC is an effective binding agent, tablet disintegrator, absorbent, lubricant, anti-adherent, and filler or diluent.

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