Croscarmellose sodium

Fig. 20 Effect of lubricant level on hydrochlorothiazide dissolution from hard gelatin capsules (filler, dicalcium phosphate disintegrant, croscarmellose sodium, type A). (From Ref. 132.)... 

Excipients Croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone, sodium lauryl sulfate, and titanium dioxide... 

Croscarmellose sodium is derived by internally cross-linking the ether, sodium car-boxymethylcellulose. This water-soluble polymer is composed of repeating units of... 

To prepare croscarmellose sodium, crude cellulose is steeped in sodium hydroxide solution [1] and treated with sodium monochloroacetate to form carboxymethylcellu-lose sodium. After completion of the reaction, the excess sodium monochloroacetate slowly hydrolyzes to glycolic acid. The glycolic acid converts a few of the sodium earboxymethyl groups to the free acid and catalyzes the cross-linkage to form croscarmellose sodium. The by-products sodium chloride and sodium glycolate can be removed by extraction with alcohol to achieve 99.5% purity. Croscarmellose sodium may be milled to break the polymer fibers into shorter lengths and hence improve flow properties. 

Ferrero, C., Munoz, N., Velasco, M.V., Munoz-Ruiz, A., and Jimemez-Castellanos, M.R., Disintegrating efficiency of croscarmellose sodium in a direct compression formulation, Int. J. Pharm., 147 11-21 (1997). 

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... 

Ac-Di-Sol (croscarmellose sodium) Dissolution aid and disintegrant Repeat-dose toxicity with routine end points (90 days—diet rat) and embryo-fetal study (rat) No adverse toxicity or embryo toxicity 28... 

Freeman C, Weiner ML, Kotkoskie LA, et al. Subchronic and developmental toxicity studies in rats with Ac-DiSol croscarmellose sodium. Int J Tox 2003 22 149. 

Modification of physicochemical property of the existing excipient has been the most successful strategy in the development of new excipients in the past three decades (24). This model has been successfully adopted for the introduction of excipients with better performance grades, such as pregelatinized starch, croscarmellose sodium, and crospovidone (25). However, the quantum of functionality improvement is limited due to a restricted range of possible modifications. 

Gohel MC, Jogani PD. Functionality testing of a multifunctional directly compressible adjuvant containing lactose, polyvinylpyrrolidone, and croscarmellose sodium. Pharm Technol 2002 64-82. 

Each 200 mg ribavirin capsule contains capsule shell of gelatin and titanium dioxide Inactive ingredients microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, pharmaceutical ink, shellac, anhydrous ethyl alcohol,... 

Croscarmellose sodium Tablet disintegrant Shellac Coating agent... 

Yong et ah [175] developed an effective omeprazole buccal adhesive tablet with excellent bioadhesive force and good drug stability in human saliva. The omeprazole buccal adhesive tablets were prepared with various bioadhesive polymers, alkali materials, and croscarmellose sodium. Their physicochemical properties, such as bioadhesive force and drug stability in human saliva, were investigated. The release and bioavailability of omeprazole delivered by the buccal adhesive tablets were studied. As bioadhesive additives for omeprazole tablet, a mixture of sodium alginate and hydroxypropylmethyl cellulose was selected. The omeprazole tablets prepared with bioadhesive polymers alone had bioadhesive forces suitable for a buccal adhesive tablet, but the stability of omeprazole in human saliva was not satisfactory. Magnesium oxide is an alkali stabilizer for omeprazole buccal adhesive tablets. Croscarmellose sodium enhanced the release of omeprazole from the tablets but it decreased the bioadhesive forces and stability of omeprazole tablets in human saliva. 

Mavik Trandolapril 1,2,4 mg Tablet Hypertension The ethyl ester prodrng of a nonsulfhydryl angiotensin converting enzyme (ACE) inhibitor Com starch, croscarmellose sodium, hypromellose, iron oxide, lactose, povidone, sodium stearyl fumarate Abbott Laboratories... 

Migraine 5-HT1D/1B receptor agonist Croscarmellose sodium, hypromellose, lactose, magnesium stearate, MCC GSK... 

The impurity peak at RRT 3.4 was observed in all samples exposed to accelerated conditions. Structural identification of this peak could not be established since this component did not show any response in the mass spectral analysis. The presence of this peak in large amounts in both active and placebo tablets lead to the conclusion that the late eluting impurity observed at RRT 3.4 was indeed a degradation product of one or more of the excipient components present in the tablets. Because of the large amounts of this impurity in the samples, a study using the individual excipients was conducted to identify the source of this degradant. The study lead to the conclusion that the excipients exposed to accelerated conditions in powder form did not produce the degradation product. However, when the same excipients were compressed into pellets and exposed to the same conditions, lactose, microcrystaUine cellulose and croscarmellose sodium compacts showed the presence of the peak at RRT 3.4. 

Croscarmellose sodium" 1-5 Swells on contact with water... 

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