What is Microcrystalline Cellulose (MCC)?
Microcrystalline cellulose is widely used in pharmaceuticals, primarily as a binder/diluent in oral tablet and capsule formulations where it is used in both wet-granulation and direct-compression processes. In addition to its use as a binder/diluent, Microcrystalline Cellulose (MCC) also has some lubricant and disintegrant properties that make it useful in tablet manufacturing.
MCC is purified, partially depolymerized cellulose synthesized by acid-hydrolysis of alpha cellulose (I?-allomorph). It was discovered in 1955 by O. A. Battista and P. A. Smith and was first commercialized under the brand name Avicel®. In 1962, they reported its preparation scheme by the American Viscose Company of microcrystalline cellulose (MCC), hence the origin of the product name “Avicel”. In 1964 FMC, Corporation introduced Avicel® PH to the pharmaceutical industry as an ingredient for direct compression tableting where the “PH” designation indicates that the product is suitable for pharmaceutical use . The MCC was first registered in the supplement to the National Formulary, twelfth edition, in 1966.
Manufacturing & Synthesis of Microcrystalline Cellulose (MCC)
Microcrystalline cellulose manufacturers and suppliers use controlled hydrolysis with dilute mineral acid solutions of a-cellulose, obtained as a pulp from fibrous plant materials. Following hydrolysis, the hydrocellulose is purified by filtration and the aqueous slurry is spraydried to form dry, porous particles of a broad size distribution.
Manufacturing of MCC can be done by different processes such as reactive extrusion process, enzyme mediated process, the steam explosion process and acid hydrolysis process. The acid hydrolysis process is preferred due to its shorter reaction duration comparing to the other processes. Furthermore, it can be applied by a continuous process rather than a batch-type process and it consumes limited quantity of acid and can produce fine particles of the MCC. Microcrystalline Cellulose (MCC) manufacturing synthesis procedure of reported by Ohwoavworhua et al. and applied with slight modification by Ohwoavworhua et al. can be concluded as follow: A 50 g quantity of the ?-cellulose was hydrolyzed with 0.8 l of 2.5 N hydrochloric acid at a boiling temperature of 105° for 15 min. The fraction passing through 710 µm sieve was obtained and stored at room temperature in a desiccator.
Some of the key Microcrystalline Cellulose (MCC) Manufacturers & Suppliers in the global market are Asahi Kasei Corporation, MINGTAI CHEMICAL CO., LTD., J. RETTENMAIER & SÖHNE GmbH + Co KG, BLANVER FARMOQUÍMICA LTDA, Accent Microcell Pvt. Ltd., FMC Corporation, JUKU ORCHEM PRIVATE LIMITED, DFE Pharma GmbH & Co. KG, Libraw Pharma, Sigachi Industrial Pvt. Ltd., and Avantor Performance Materials, Inc these all are registered suppliers of Microcrystalline Cellulose (MCC) in US, EU & ASIA.
Specifications of Microcrystalline Cellulose (MCC)
For Microcrystalline Cellulose (MCC) manufacturing, cellulose, collected from fibrous material, undergoes controlled hydrolysis with dilute mineral acid. It has high absorbent powers, and can be used as a suspending agent, tablet disintegrant and tablet & capsule diluent According to I.P./USP/BP specifications. Various grades of Microcrystalline Cellulose (MCC) are available and are manufactured according to the specifications mentioned in USP, EU and other monographs.
Drying of the Microcrystalline Cellulose (MCC)
There are different techniques can be used by Microcrystalline Cellulose (MCC) manufacturers & Suppliers for drying, namely freeze-drying (lyophilization) using liquid nitrogen, fluid-bed drying, hot air oven drying and desiccation with silica-gel to less than 5% (w/w) water content. MCC is commonly dried by spray-drying the neutralized slurry obtained from the hydrolysis process. By varying spray drying conditions, it can be manipulating the degree of agglomeration and moisture content. Smaller particle sizes below 50 ?m can be obtained by further milling MCC.
Characterization of the Microcrystalline Cellulose (MCC)
Microcrystalline Cellulose (MCC) excipient manufacturers and suppliers use different techniques to characterize the Microcrystalline Cellulose (MCC) such as infrared spectroscopy (FTIR), X-ray diffraction (XRD), thermogravimetric analysis (TGA), differential thermal analysis (DTA) or differential scanning calorimetry (DSC), nuclear magnetic resonance (NMR), atomic force spectroscopy (AFM), scanning electron microscopy (SEM), transmission electron microscopy (TEM), hi-resolution transmission electron microscopy (Hi-TEM).
Physicochemical Properties of Microcrystalline Cellulose (MCC)
The organoleptic characteristic, identification tests, solubility and presence of organic impurities such as starch, dextrin and water-soluble substances can be done according to credit procedures such as the British Pharmacopoeia (BP) specifications. Microcrystalline Cellulose (MCC) manufacturers and suppliers perform pH determination of the supernant obtained by shaking 2 g of the MCC powder with 100 ml of deionized water for 5 minutes. Total ash content in the MCC can be determined by weighing the residue remained after combustion at 550° until all the carbon is eliminated.
For particle size analysis by microcrystalline Cellulose (MCC) suppliers , it can be determined using a sieve shaker, containing standard sieves arranged in a descending order according to their opening size. About 20 grams of the MCC powder is placed on the top sieve and shaking for 5 min. The weight of MCC retained on each sieve is determined. The average diameter can be calculated as reported by Ansel et al. The real density (Dr) of cellulose powders can be determined by the xylene displacement method and computed according to the following Equation: Dr = [w/{(a+w)- b}×SG], where w represents weight of powder, SG represents specific gravity of xylene, a represents sum weights of bottle and solvent and b represents the sum weights of bottle, solvent and the Microcrystalline Cellulose (MCC) powder. For the moisture content (MC) determination, about 2 g of the MCC sample was weighed (A) and oven-dried at 105-C for 8 hours, and then weighed again (B). The MC was calculated using the following formula: [(A-B)/A] ×100.
Spectroscopic Studies of the Microcrystalline Cellulose (MCC)
Microcrystalline Cellulose (MCC) excipient manufacturers use optical microscope (10X, 40X or 100 X magnifications) for speculating hydrolysis progress as well as preliminary assessment of the MCC particles. Scanning electron microscopy (SEM) and/or transmission electron microscopy (TEM) study is widely used by Microcrystalline Cellulose (MCC) manufacturers to characterize the MCC particles. For X-ray differaction (XRD), the wide angle X-ray diffraction spectra of the MCC can be recorded on a proper X-ray differactometer such as a XRD 7000 Shimadzu diffractometer (Japan).
The crystallinity index of the Microcrystalline Cellulose (MCC) can be determined by using the following equation: Ic=[(I002-Iam)/( I002)]x100 [20], where I002 represents the intensity of crystalline peak arising from and alphacellulose while Iam is the crystallographic plane arising from remained amorphous cellulose plus amorphous impurities (lignin and pectin).
Assay of Microcrystalline Cellulose (MCC)
Microcrystalline Cellulose (MCC) excipient manufacturers use monographs to test the formulation used with it which is transfer about 125 mg of the sample, accurately weighed, to a 300 ml Erlenmeyer flask, using about 25 ml of water. Add 50.0 ml of 0.5N potassium dichromate and mix. Carefully add 100 ml of sulfuric acid and heat to boiling. Remove from heat, allow to stand at room temperature for 15 min and cool in a water bath. Transfer the contents into a 250 ml volumetric flask, rinse flask with distilled water, add rinsings to the volumetric flask and dilute with water almost to volume.
Allow the volumetric flask to reach room temperature (250 ), then make up to volume with water and mix. Titrate a 50.0 ml aliquot with 0.1N ferrous ammonium sulfate using 2 or 3 drops of ortho-phenanthroline TS as the indicator and record the volume required as S in ml. Perform a blank determination and record the volume of 0.1N ferrous ammonium sulfate required as B in ml.
Stability and Storage Conditions of Microcrystalline Cellulose (MCC)
Microcrystalline cellulose is a stable, though hygroscopic material. The bulk material should be stored in a well-closed container in a cool, dry place.
Grades of Microcrystalline Cellulose (MCC)
Microcrystalline Cellulose (MCC) manufacturers produces several different grades of microcrystalline cellulose for commercial availibility that differ in their method of manufacture, particle size, moisture, flow, and other physical properties.The larger-particle-size grades generally provide better flow properties in pharmaceutical machinery. Low-moisture grades are used with moisture-sensitive materials. Higher-density grades have improved flowability. Several coprocessed mixtures of microcrystalline cellulose (MCC) with other excipients such as carrageenan, carboxymethylcellulose sodium, and guar gum are commercially available.
Application of Microcrystalline Cellulose (MCC)
Microcrystalline cellulose manufacturers use MCC widely in pharmaceuticals, primarily as a binder/diluent in oral tablet and capsule formulations where it is used in both wet-granulation and direct-compression processes. In addition to its use as a binder/diluent, microcrystalline cellulose also has some lubricant and disintegrant properties that make it useful in tablet manufacturing.
Microcrystalline Cellulose (MCC) manufacturers use it as tablet disintegrant and binder / diluent are major application. In capsulation technology Microcrystalline Cellulose as capsule binder / diluent is its major function.
MCC as a binder for tablets by direct compression (DC) and in vitamin supplements, in food as an anticaking, thickener, texturizer, emulsifier and bulking agent as well as a fat substitute and in cosmetic as filler due to its superior dry binding properties.
Regulatory Status
Microcrystalline Cellulose (MCC) is GRAS listed. Accepted for use as a food additive in Europe. Microcrystalline Cellulose (MCC) suppliers and manufacturers have registered their product in FDA Inactive Ingredients Database (inhalations; oral capsules, powders, suspensions, syrups, and tablets; topical and vaginal preparations). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Nonmedicinal Ingredients. There are more than thirty (30) type IV US DMFs are registered. Microcrystalline cellulose (MCC) Registered Manufacturers & Suppliers are seppic, basf, jrs pharma lp, asahi kasei corp, sigachi industries pvt ltd, kerry.
Microcrystalline Cellulose (MCC) manufacturers supplied it as Avicel (Dupont), Emocel (JRS Pharma), Celphere (Asahi Kasai), Lubritose (Kerry).
Market Status of Microcrystalline Cellulose (MCC)
The MCC market is projected to witness a CAGR of 7.2% between 2015 and 2020, in terms of value. It is expected to witness substantial growth due to the increased acceptance of Microcrystalline Cellulose MCC pharmaceutical excipient and the high demand of MCC in processed food industry. MCC is extensively used in food products such as baked foods, dairy products, desserts, frozen foods, and others as bulking agent and fat substitute, helping in enhancing mouthfeel, body, and consistency of the food product. Microcrystalline Cellulose (MCC) manufacturers / suppliers applied in the pharmaceutical industry as it exhibits chemical inertness and lack of taste and odor. As an excipient, MCC is used widely in almost every kind of oral dosage like pellets, tablets, capsules, sachets, and others. Development of multifunctional excipients by microcrystalline Cellulose (MCC) manufacturers and co-processed excipients is also expected to play a vital role in market growth during the forecast period. This increase in demand can be attributed to the need to address the solubility issues of recently developed Active Pharmaceutical Ingredients (API). In the cosmetics & personal care segment, it is used as a texturizer and thickening agent. MCC is also used in instrumentations and industrial applications.
North America is the largest market for MCC. The food processing and pharmaceutical manufacturing industries in the region are the major end users of MCC. The European market also contributes significantly to the global market and is also the major market of MCC for food & beverage application. However, Asia-Pacific is projected to witness highest growth of MCC between 2015 and 2020. Presence of developing economies such as China, India, and others makes the region the most promising market for MCC. Moreover, many North American and European Microcrystalline Cellulose (MCC) manufacturers find it more cost-effective to outsource their manufacturing processes to Asia-Pacific Microcrystalline Cellulose (MCC) manufacturers or set up their own manufacturing facilities in the region. This research study is aimed at identifying the emerging trends and opportunities in the global Microcrystalline Cellulose (MCC) manufacturers market along with detailed classifications. Currently, the global MCC market is dominated by various Microcrystalline Cellulose (MCC) suppliers FMC Corporation (U.S.), DuPont (U.S.), DFE Pharma (Germany), Asahi Kasei Corporation (Japan), and Tembec Inc. (Canada), among others.
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