FUMED METAL OXIDES

CAB-O-SIL® MULTIFUNCTIONAL EXCIPIENT APPLICATION OVERVIEW

FOR PHARMACEUTICALS
CAB-O-SIL FUMED SILICA IN SOLID DOSAGE FORMS LIQUID AND SEMI-SOLID DOSAGE FORMS
TASTE MASKING AGENT
Can be used as part of a
STABILIZATION,
microencapsulation system to mask ANTI-SETTLING
FREE FLOW taste or protect sensitive ingredients Can enable the stabilization of
Improves flow for tableting and capsule from degradation. Can be loaded dispersions of solids in liquids and
filling, leading to increased production in the microcapsule wall to help prevent the formation of sediments
yields and tablet weight uniformity. nucleate crystalline domains, or can in liquid suspensions.
be loaded at the core/microcapsule
wall interface to increase stability or
alter the viscosity.
THICKENING
MOISTURE ADSORPTION Can convert non-polar liquids
Due to its hydrophilic chemical TABLET COATING into spreadable gels. Promotes
structure, can act as a scavenger of gel stability at body temperature,
Can stabilize highly concentrated
moisture and help stabilize drugs that enabling applications where precise
pigment suspensions, preventing
require an acidic pH for optimal stability. area-dosing is required.
them from settling in liquid tablet
In granulation processes, can enable
coatings. Can be added to build-up
uniform particle size distribution
powders to improve flow and
via disintegration of large wet
promote fast drying.
agglomerates and redistribution of
the moisture in the mixture. TRANSPARENCY
Clear gels can be formulated if the
refractive index of the product
SPRAY DRYING AID CAPSULE ANTI-BLOCKING matches that of CAB-O-SIL fumed
silica (1.46).
Can increase throughput by reducing Can be added to the capsule shell wall
clogs in the spray dryer atomizer and to form a smooth film. Can promote
decreasing the amount of product high-speed filling of gelcaps by
sticking to the walls. Can improve the reducing adhesion of the liquid filling
drying profile of tacky materials or to the machinery. STABILITY AND
act as a nucleation aid. UNIFORM DISTRIBUTION
Can improve the consistency and
stability of a suppository. Can
CONTROLLED DRUG RELEASE increase the softening point without
TYPICAL PROPERTIES Adjusting the concentration of fumed
affecting the melting point.
CAB-O-SIL Surface Tapped silica can facilitate the control of drug
Features release rates. For poorly soluble drugs,
fumed silica Area Density
it can increase the dissolution rate.
M-5P 200 m /
2 g
< 60 g/l Easy to disperse This is achieved by dissolving the
drug in an organic solvent with the
SPRAYING AID
The data above are typical test values intended as guidance fumed silica and evaporating the In topical aerosol products can help
only, and are not product specifications. Product specifications mixture to dryness. Fumed silica can reduce clogs in the atomizer and
are available from your Cabot representative. also decrease dissolution rates in prevent the formation of sediments.
controlled-release liquid dosage forms
by increasing viscosity.
CAB-O-SIL® MULTIFUNCTIONAL EXCIPIENT FOR PHARMACEUTICALS APPLICATION OVERVIEW

PERFORMANCE AS A GLIDANT CAB-O-SIL FUMED SILICA

Glidants are designed to improve the flow
Product Product Characteristics
properties of powders and reduce friction and
static charge in high speed tablet and capsule ◆ Cabot’s easiest to process glidant. Due its lower density, this product is easier to disperse in both
M-5P solid and liquid formulations.
machines. Glidants also prevent bridging in the
hopper, and enable increased tablet hardness, ◆ Due to its higher purity, M-5P fumed silica is recommended over lower purity precipitated silicas.
uniformity in tablet weight and content. These
Regulatory Compliance:
features are key to ensure product regulatory
CAB-O-SIL M-5P fumed silica is in compliance with:
compliance, maintain high productivity, reduce
◆ USP 37/NF 32 colloidal silicon dioxide monograph.
waste from tablet breakage and minimize
◆ EP 8th Ed. (2014) silica colloidal anhydrous monograph.
content variability.
◆ JP 16th Ed (2011) light anhydrous silicic acid monograph.

PERFORMANCE REQUIREMENTS
Untreated Fumed Silica Purity:
Low bulk All CAB-O-SIL fumed silicas are produced through a pyrogenic process that results in one of the purest
density
Higher

commercially available forms of colloidal silicon dioxide as defined by the US Pharmacopeia. In contrast,
the production of precipitated silica requires the addition of a mineral acid to an alkaline silicate solution,
CAB-O-SIL M-5P
Fumed silica resulting in a lower purity product that contains higher moisture, sulfates and chloride impurities. These
impurities can have the following impact:
 igh sulfates and chloride content can affect the stability of some active ingredients. Fumed silica has a
H
Purity

◆
lower level of ionic sulfates and chloride than precipitated silica.
Precipitated Silica
◆  igh levels of moisture can affect moisture-sensitive compounds. Fumed silica has a lower level of
H
High bulk moisture than precipitated silica.
density
Ease of Handling:
Lower

Cabot Product A powder’s “ease of use” is assessed according to its fluffiness, ease of handling, and storage. At higher bulk
Competitive Product
densities and particle sizes the product is less fluffy and easier to handle and store.
More Difficult Easier
Ease of Use / Dusting

The CAB-O-SIL name is a registered trademark of Cabot Corporation.

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Technical Support
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