Name: Cellulose, Silicified Microcrystalline
CAS No: See Section 8.
None adopted.
ProSolv
See Section 8.
See Section 8.
See Section 8.
Silicified microcrystalline cellulose is used as a filler in the formulation of capsules and tablets. It has improved compaction properties in both wet granulation and direct compression compared to conventional microcrystalline cellulose.(1–5) Silicified microcrystalline cellulose was specifically developed to address the loss of compaction that occurs with microcrystalline cellulose after wet granulation. Silicified microcrystalline cellulose also appears to have beneficial properties for use in the formulation of powderfilled capsules.(6,7)
Silicified microcrystalline cellulose is a synergistic, intimate physical mixture of two components: microcrystalline cellulose and colloidal silicon dioxide (for further information see Cellulose, Microcrystalline and Colloidal Silicon Dioxide). Silicified microcrystalline cellulose contains 2% w/w colloidal silicon dioxide
Both colloidal silicon dioxide and microcrystalline cellulose are listed as separate monographs in the JP, PhEur, and USP–NF, but the combination is not listed. See Cellulose, Microcrystalline and Colloidal Silicon Dioxide.
Acidity/alkalinity pH = 5.0–7.5 (10% w/v suspension) Density 1.58 g/cm(5) Density (bulk) 0.31 g/cm3 Density (tapped) 0.39 g/cm(5) Melting point The microcrystalline cellulose component chars at 260–2708C. Moisture content Typically less than 6% w/w. NIR spectra see Figure 1. Particle size distribution Typical particle size is 20–200 mm. Different grades may have a different normal mean particle size. Solubility Practically insoluble in water, dilute acids, and most organic solvents. The microcrystalline cellulose component is slightly soluble in 5% w/w sodium hydroxide solution.
Silicified microcrystalline cellulose is stable when stored in a wellclosed container in a cool, dry plac
See Cellulose, Microcrystalline and Colloidal Silicon Dioxide.
Silicified microcrystalline cellulose is manufactured by co-drying a suspension of microcrystalline cellulose particles and colloidal silicon dioxide such that the dried finished product contains 2% w/w colloidal silicon dioxide. The colloidal silicon dioxide appears physically bound onto the surface and inside the silicified microcrystalline cellulose particles. Extensive studies using different spectroscopic methods have failed to show any form of chemical interaction.(4,8,9)
See Cellulose, Microcrystalline and Colloidal Silicon Dioxide.
Observe normal precautions appropriate to the circumstances and quantity of material handled. Handling of silicified microcrystalline cellulose can generate nuisance dusts and the use of a respirator or dust mask may be necessary. Microcrystalline cellulose may be irritant to the eyes. Gloves, eye protection, and a dust mask are recommended. In the UK the longterm workplace exposure limits (8-hour TWA) have been set at 10 mg/m3 for total inhalable dust and 4 mg/m3 for respirable dust; short-term limit for total inhalable dust has been set at 20 mg/m3 Since the colloidal silicon dioxide is physically bound to the microcrystalline cellulose the general recommendations of gloves, eye protection, and a dust mask should be followed when handling silicified microcrystalline cellulose.
Silicified microcrystalline cellulose is a physical mixture of two materials both of which are generally regarded as nontoxic: Microcrystalline cellulose GRAS listed. Included in the FDA Inactive Ingredients Database (inhalations, oral capsules, powders, suspensions, syrups, and tablets). Included in nonparenteral medicines licensed in Europe and the USA. Included in the Canadian List of Acceptable Non-medicinal Ingredients. Colloidal silicon dioxide GRAS listed. Included in the FDA Inactive Ingredients Database (oral capsules and tablets). Included in nonparenteral medicines licensed in Europe and the USA. Included in the Canadian List of Acceptable Nonmedicinal Ingredients
Cellulose, microcrystalline; colloidal silicon dioxide
Colloidal silicon dioxide and microcrystalline cellulose are two of the materials that have been selected for harmonization by the Pharmacopeial Discussion Group. For further information see the General Information Chapter <1196> in the USP32–NF27, the General Chapter 5.8 in PhEur 6.0, along with the ‘State of Work’ document on the PhEur EDQM website, and also the General Information Chapter 8 in the JP XV. Silicified microcrystalline cellulose has greater tensile strength and requires lower compression pressures than regular grades of microcrystalline cellulose. Furthermore, silicified microcrystalline cellulose maintains its compactability after wet granulation; the compacts exhibit greater stiffness and they require considerably more energy for tensile failure to occur.(4,11,12)