For plastically deforming semicrystalline excipients, such as microcrystalline cellulose mcc, the mechanical properties of tablets can be related to surface area. Prosolv smcc, silicified microcrystalline cellulose, is a unique combination of microcrystalline cellulose mcc and colloidal silicon dioxide csd. Hd90, mannitolcolloidal silicon dioxide and microcrystalline cellulosecolloidal silicon. Microcrystalline cellulose mcc market size statistics 2026. The results suggested that, under comparable testing conditions, compacts of silicified microcrystalline cellulose exhibited greater strength than those of microcrystalline. Silicified microcrystalline cellulose, nf microcrystalline cellulose, ph. An adi not specified was established at the 49th jecfa 1998. Compared to traditional mcc, the unique surface structure of prosolv smcc enables excellent blend homogeneity and content uniformity. Microcrystalline cellulose mcc is defined as a purified, partially depolymerized nonfibrous form of cellulose. Mcc is produced by treating cellulose acquired from plant materials using conventional method that is acid hydrolysis. Microcrystalline cellulose applications, microcrystalline.
Microcrystalline cellulose is a widely used excipient, an inert substance used in many pill and tablet formulations. Article in english, polish marczynski z1, zgoda mm, jambor j. Silicified microcrystalline cellulose manufacturer from mumbai. Microcrystalline cellulose, nf 9004346 c1679 spectrum. Comparable performance of the three analogous competitive grades is shown. Microcrystalline cellulose is a commonly used excipient in the pharmaceutical industry.
Sep 15, 2018 microcrystalline cellulose is a commonly used excipient in the pharmaceutical industry. Prosolv smcc is silicified microcristalline cellulose, a patented combination of 98% microcristalline cellulose mcc and 2% colloidal silicone dioxide csd a portfolio of high functionality excipients that imparts superior flow, compaction and dispersion to a formulation. Application of silicified microcrystalline cellulose prosolv as a polymer carrier of epilobium parviflorum schreb. The characterization of samples was performed by thermogravimetric analysis, xray diffraction, and scanning. Adsorption of an amine drug onto microcrystalline cellulose and silicified microcrystalline cellulose samples article pdf available in drug development and industrial pharmacy 294. Direct compression with silicified and nonsilicified. Loss of hardness of microcrystalline cellulose tablets a t increased humidities may be explained by the adsorption of water onto the surfaces of the cellulose crystals. Microcrystalline cellulose mcc is used as a texturizer, an anticaking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in pasteurized cream, fermented milk, cheese, processed fruit, dried vegetables, etc. Silicified microcrystalline cellulose pdf semantic scholar. The most common form is used in vitamin supplements or tablets.
Silicified microcrystalline cellulose inactive ingredient. Microcrystalline cellulose in tableting pdf free download. Excipients play a major role in the development of tablets and capsules for the health science industry. Microcrystalline cellulose, nf is an excipient in pharmaceutical formulations acting as a binder in tablet formation. The mechanical properties of compacts of unlubricated microcrystalline cellulose and silicified microcrystalline cellulose were evaluated using the diametric tensile test.
Opinion on microcrystaline cellulose european commission. As an insoluble fiber, microcrystalline cellulose is not absorbed into the blood stream, so it cannot cause toxicity when taken orally. Nonwood fibre production of microcrystalline cellulose from. In this study, the physicochemical properties of a locally produced microcrystalline cellulose derived from premature stems of sprouts of indian bamboo bambusa vulgaris coded mccbv was evaluated and compared with a commercial grade avicel ph101. Physicochemical properties of microcrystalline cellulose. Silicified microcrystalline cellulose smcc has been compared with a standard grade of microcrystalline cellulose mcc using several physicochemical techniques in order to elucidate any chemical or polymorphic changes in the material that could be attributed to the silicification process. Application of silicified microcrystalline cellulose prosolv. Research development of silicified microcrystalline cellulose. The mechanical properties of compacts of microcrystalline. If breathing is irregular or stops, perform artificial respiration. Opinion on microcrystaline cellulose expressed on 19th september 1997 terms of reference to reevaluate the safety in use of microcrystalline cellulose mc in the light of additional information received with respect to its general uses as set out in directive eec953 on food additives other than colours and sweeteners.
Abstract silicified microcrystalline cellulose smcc is a new type of pharmaceutical excipient obtained by spray drying from a suspension composed of. Microcrystalline cellulose is widely used as stabilizer, anticaking agent, fat substitute and emulsifier in food production. Top 5 vendors in the global microcrystalline cellulose market. Staniforth, stephen edge pharmaceutical technology research group, department of pharmacy, uni6ersity of bath, cla6erton down, bath, ba2 7ay, uk received 5 january 1998. In addition to enhanced strength, silicified microcrystalline cellulose compacts exhibited greater. Physicochemical comparison between microcrystalline. Tablets can be formed that are hard, but dissolve quickly. Sep 25, 2017 londonbusiness wiretechnavio has announced the top five leading vendors in their recent global microcrystalline cellulose market 20172021 report. Abstract silicified microcrystalline cellulose smcc is a novel tableting excipient which has been reported to exhibit improved binding. Portions of this monograph that are national usp text, and are not part of the harmonized text, are marked with symbols to specify this fact. Effect of lubricants on flow properties and tablet strength. Application of silicified microcrystalline cellulose prosolv as a polymer. Functional performance of silicified microcrystalline cellulose versus. Microcrystalline cellulose mcc is a term for refined wood pulp and is used as a texturizer, an anticaking agent, a fat substitute, an emulsifier, an extender, and a bulking agent in food production.
Mar 27, 2011 in this study, microcrystalline cellulose mcc was prepared from the acid hydrolysis of bacterial cellulose bc produced in culture medium of static acetobacter xylinum. Silicified microcrystalline cellulose, nf microcrystalline cellulose, ph, eur and silica, collodal ahydrous, ph. Microcrystalline cellulose is the same as cellulose, except that it meets usp standards. Pdf adsorption of an amine drug onto microcrystalline.
All spectrum chemical nf grade products are manufactured, packaged and stored under current good manufacturing practices cgmp per 21cfr part 211 in fda registered and inspected facilities. Highdensity form of the ingredient prosolv smcc hd 90 was shown in. Safety data sheet 109122 microcrystalline cellulose 102 ph. Silicified microcrystalline cellulose united states. The microcrystalline cellulose, obtained from the stalk of sorghum caudatum, obtained by sodium hydroxide delignification followed by sodium hypochlorite bleaching and acid hydrolysis was examined for its physicochemical and tableting properties in comparison with those of the wellknown commercial microcrystalline cellulose grade, avicel ph 101. The changes in plain microcrystalline cellulose tablets brought about by storage in various environmental conditions are not permanent as evidenced by the data in table it.
Prosolv smcc silicified microcrystalline cellulose markan. The new usp microcrystalline cellullose monograph pdf download available united states pharmacopoeia the revision to the harmonized standard for microcrystalline cellullose has been approved by the pharmacopeial discussion group pdg as described in its pdg signoff cover sheet. If you are a society or association member and require assistance with obtaining online access instructions please contact our journal customer services team. Silicified microcrystalline cellulose hd 90m is a supplement product distributed by gwi usa. Microcrystalline celluloses avicel ph101, ph102, ph200 and a 7525% mixture of ph101 and ph200 were compared with silicified microcrystalline cellulose prosolv smcc 90 as fillerbinders for. Microcrystalline cellulose prepared at the 55th jecfa 2000 and published in fnp52 add 8 2000, superseding specifications prepared at the 51st jecfa 1998 and published in fnp 52 add 6 1998. Microcrystalline cellulose is refined from insoluble plant fiber.
The new usp microcrystalline cellullose monograph pdf. Applications and uses of microcrystalline cellulosefoodchem. Silicified microcrystalline cellulose pharmaceutical technology. Pdf silicified microcrystalline cellulose based pellets and their. Microcrystalline cellulose is made from fibrous cellulose mainly wood pulp, which consists of an ordered region microcrystal and a lessordered region amorphous regions microcrystalline cellulose is a white, odorless tasteless, extra flowing powder which is relatively free from organic and non organic contaminants. Silicification reduces the cohesiveness of the powder bed. Technoeconomic analysis of simplified microcrystalline. The aim of this study was to evaluate silicified microcrystalline cellulose smcc, microcrystalline cellulose mcc, and physical mixture of mcccolloidal. Various dissolution conditions were also studied, including varying paddle speed, usp apparatus and the ph and ionic strength of the dissolution media. Effect of lubricants on the flow properties and tablet strength of silicified microcrystalline cellulose summary the effects of magnesium stearate, sodium lauryl sulphate sls and talc as lubricants on some powder and tablet properties of silicified microcrystalline cellulose smcc were studied. Microcrystalline cellulose is purified, partially depolymerize cellulose is a white or almost white, odorless, tasteless crystalline powder, consisting of porous particles. Brazil silicified microcrystalline cellulose, nf microcrystalline cellulose, ph.
Place about 10 mg of microcrystalline cellulose on a watch glass, and disperse in 2 ml of iodinated zinc chloride solution. In this study, we compared sem analysis, flowability and tablet profile of silicified microcrystalline cellulose with microcrystalline cellulose. Silicified microcrystalline cellulose, tablet andor capsule diluent silicified microcrystalline cellulose, tablet disintegrant silicified microcrystalline cellulose, tablet andor capsule lubricant behenoyl polyoxylglycerides, coating agent palm oil, emulsifying andor solubilizing agent palm oil robert lafaver reagent specifications. Microcrystalline cellulose and silicon dioxide are listed in the positive list for food canada silicified microcrystalline cellulose, nf product master file 2006116 with health canada microcrystalline cellulose and silicon. Commercially mcc is produced by woody plants and purified cotton. The side effects of microcrystalline cellulose synonym. Prosolv smcc silicified microcrystalline cellulose jrs pharma. It is also used in plaque assays for counting viruses, as an alternative to. Grades of microcrystalline cellulose are of different particle size and moisture content, have different properties and fields of application. Synthesis and characterization of microcrystalline cellulose. The location of silicon dioxide in silicified microcrystalline cellulose. International journal of pharmaceutics 169 1998 183 194 physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose michael j.910 878 937 691 1092 487 716 493 471 1189 470 397 890 117 1075 399 1052 809 593 572 14 975 1238 544 159 1408 826 1468 862 913 167 875 309 763 1206 1494 259 636 535 1453 518 453 115 1365 16 924 813 850