Pharmacopeial Specifications:
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Identification: Infrared spectroscopy and chemical tests
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Viscosity (if liquid): 100–1000 cSt
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Loss on Drying: NMT 5% (for powder)
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Silica Content (for powder): ~4–7%
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pH (emulsion): Typically neutral (~6.5–7.5)
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Microbial Limits: Complies with pharmacopeial guidelines
Applications in Pharmaceutical Formulation:
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Used as an oral antiflatulent to relieve gas and bloating.
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Included in chewable tablets, capsules, suspensions, and emulsions.
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Acts as a process aid to reduce foaming in manufacturing.
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Common concentrations:
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30% emulsion: Used in oral drops and suspensions.
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50% emulsion: Used in more concentrated liquid oral formulations.
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100% powder: Incorporated into solid dosage forms (tablets/capsules).
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Comments:
Simethicone is physiologically inert, non-absorbable, and generally well-tolerated. It works by decreasing surface tension, allowing gas bubbles in the GI tract to coalesce and be expelled. It is not systemically absorbed and is often combined with antacids. Emulsion forms require antimicrobial preservatives for stability.
