Cellulose and carboxymethylcellulose sodium

In this chapter, analysis of the excipient in Nasonex (mometasone naral spray) is used as a typical example to demonstrate how to select a proper analytical method. Nasonex Nasal Spray contains Mometasone Furoate, microcrystalline cellulose, and carboxymethylcellulose sodium NF, citric acid USP, sodium citrate USP, benzalkonium chloride solution NF, glycerin USP, polysorbate 80 NF, phenylethyl alcohol USP, and water USP. 

The total cellulose (microcrystalline cellulose and carboxymethylcellulose sodium) quantitation is achievable through use of one of the following (1) total solid subtraction, (2) indirect quantification of sodium carboxymethylcellulose (NaCMC), or (3) direct quantification of the hydrolyzed monosaccharide. 

Microcrystalline cellulose and carrageenan microcrystalline cellulose and carboxymethylcellulose sodium microcrystalline cellulose and guar gum powdered cellulose silicified microcrystalline cellulose. 

Comments mixtures of microcrystalline cellulose and carboxymethylcellulose sodium that are dispersible in water and produce thixotropic gels are suitable as suspending vehicles in pharmaceutical formulations. The amount of carboxymethylcellulose present can vary between 8.3% and 18.8% w/w depending upon the grade of material. 

The purified pancreatic lipase prepared by Desnuelle and his collaborators has been subjected to chromatography on DEAE cellulose, car-boxymethylcellulose, and calcium phosphate columns. These all readily absorb lipase, but elution is difficult and often possible only by using a sodium carbonate solution (222). Lipase of pancreatic juice of pig and dog has also been purified by chromatography on diethylaminoethyl-cellulose and carboxymethylcellulose columns (224). 

Carboxymethylcellulose Sodium. Carboxymethyl ether of cellulose sodium salt (Citmcel) (8) is a white granular substance soluble in water depending on the degree of substitution. It is equally soluble in cold and hot water and may be prepared by treating alkaU cellulose with sodium chloroacetate. 

AVT Barg BD BDHR BF BOF BOOM BOP BS W BSI BTA Btu/lb BW BWR BX CA CANDUR CDI CFH CFR CHA CHF CHZ Cl CIP CMC CMC CMC COC All-Volatile treatment bar (pressure), gravity blowdown blowdown and heat recovery system blast furnace basic oxygen furnace boiler build, own, operate, maintain balance of plant basic sediment and water British Standards Institution benzotriazole British thermal unit(s) per pound boiler water boiling water reactor base-exchange water softener cellulose acetate Canadian deuterium reactor continuous deionization critical heat flux Code of Federal Regulations cyclohexylamine critical heat-flux carbohydrazide cast iron boiler clean-in-place carboxymethylcellulose (sodium) carboxy-methylcellulose critical miscelle concentration cycle of concentration... 

Although untreated starches do not swell sufficiently, certain modified forms, such as sodium starch glycolate, do swell in cold water and are better as disintegrants. Various cellulose derivatives, including methylcellulose and carboxymethylcellulose, have been used in this role, but with limited success due to the marked increase in viscosity they produce around the dispersing tablet mass. 

Sodium carboxymethylcellulose is formed by the reaction of sodium chloroacetate with basic cellulose solutions. The sodium form of carboxymethylcellulose is known as CMC or as a food grade product as cellulose gum. It is soluble in both hot and cold water. 

Avicel RC and CL are water-dispersible, colloidal, microcrystalline cellulose products made for use in liquid preparations. Avicel RC and CL are coprocessed mixtures of microcrystalline cellulose and sodium carboxymethylcellulose. The amount of NaCMC can be determined using the IC method. About 10 g of Nasonex and about 25 mg of NaCMC NF are separately refluxed with 30 mL of glacial acetic acid for 2 h. The refluxed mixture is transferred to a 100-mL volumetric flask and diluted to volume with purified water, and mixed. The ion chromatograph (IC) was equipped with a suppressed conductivity detector, a 4-mm CSRS suppressor, current at 50 mA, a 250 mm x 4-mm Ion CS 12A column and a 50 mm x 4 mm Ion CG 12A guard column. The mobile phase is 0.13% methanesulfonic acid in water with a flow rate of 1 mL/min. Equal... 

Each 5 mL of VANTIN oral suspension contains cefpodoxime proxetil equivalent to 50 mg or 100 mg of cefpodoxime activity after constitution and the following inactive ingredients artificial flavorings, butylated hydroxy anisole, carboxymethylcellulose sodium, microcrystalline cellulose, carrageenan, citric acid, colloidal silicon dioxide, croscarmellose sodium, hydroxypropylcellulose, lactose, maltodextrin, natural flavorings, propylene glycol... 

Spherical pellets containing 5% triamcinolone acet-onide were prepared by Villar-Lopez and coworkers byextrusion/spheronization after formulation with microcrystalline cellulose and/or a hydrophilic excipient such as lactose, sodium carboxymethylcellulose, or p-cyclodextrin. Their suitability for coating, with a view toward colonic drug delivery, was assessed in terms of their size, sphericity, and dissolution test... 

Similar analyses of moisture uptake data available in the literature for other cellulose and starch derivatives used as pharmaceutical excipients are presented in Table 5. Considering the uncertainties associated with the estimated moisture uptake values from published graphs, the values of are all quite consistent with each other and with a stoichiometry of one water molecule per anhydroglucose unit. It is interesting to note that the two samples derived from cellulose, sodium carboxymethylcellulose and sodium croscar-mellose, did not require any correction for degree of crystallinity to conform to close to a 1 1 stoichiometry. It appears quite likely, therefore, that the change in chemical structure and the processing of these materials essentially eliminates the crystallinity of cellulose. 

Carboxymethylcellulose calcium is used in oral and topical pharmaceutical formulations, similarly to carboxymethylcellulose sodium, and is generally regarded as a nontoxic and nonirritant material. However, as with other cellulose derivatives, oral consumption of large amounts of carboxymethylcellulose calcium may have a laxative effect. 

Alkali cellulose is prepared by steeping cellulose obtained from wood pulp or cotton fibers in sodium hydroxide solution. The alkaline cellulose is then reacted with sodium monochloro-acetate to produce carboxymethylcellulose sodium. Sodium chloride and sodium glycolate are obtained as by-products of this etherification. 

Several coprocessed mixtures of microcrystalline cellulose with other excipients such as carrageenan, carboxymethylcellulose sodium, and guar gum are commercially available see Section 17. 

Although hypromellose and HPMCAS are the dominant cellulosics utilized in the solubilization of poorly soluble drug compounds, most cellulosics accepted as an excipient for pharmaceutical formulation have been studied. These polymers, shown in Table 27.4, include MC, hypromellose phthalate (HPMC-P), EC, carboxymethyl ethylcellulose, hydroxypropyl cellulose, and sodium carboxymethylcellulose. 

Methyl(hydroxypropyl)cellulose sodium carboxymethylcellulose/sodium dodecyl sulfate and water 2010KA1... 

It is necessary to swell the cellulose fibers prior to treatment with sodium chloroacetate this is done with aqueous caustic. Sodium chloroacetate reacts with the hydroxyl groups on cellulose, of which theoretically there are three per glucose monosaccharide. The reaction is usually run in aqueous organic diluent in which both the cellulose and the carboxymethylcellulose are swellable, but insoluble. The term degree of substitution (DS) describes the average number of carboxymethyl groups attached to each glucose monosaccharide. 

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