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Colloidal Silica in Pharmaceutical Formulations: Properties, Safety, and Dosage Standards for Medicinal Excipients - Your Trusted Source for Quality Pharmaceutical Ingredients
2024.12.28
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Colloidal silica
CAS: 112945525
Molecular formula: SiO2
  1. Basic properties:
Colloidal silica possesses characteristics of small particle size and large specific surface area, which endows it with ideal fluidity. This property can effectively improve the fluidity of dry powder in various pharmaceutical processes, such as tablet pressing.
It can stabilize emulsions, serve as a thixotropic viscosity-increasing agent and suspending agent in gels and semi-solid formulations, and when combined with other components with similar refractive indices, it can form a transparent gel. Its viscosity change is related to the polarity of the liquid. The concentration of differential silica gel required for polar liquids is higher than that for non-polar liquids. Meanwhile, the pH value of the system affects the viscosity, while temperature has no significant effect on its viscosity. In non-inhalable aerosols, it is often used to enhance the suspension performance of particles, avoid the formation of hard precipitates, and reduce the occurrence of nozzle blockage. Additionally, it can be used as a disintegrant for tablets, and as a liquid adsorption dispersant in powders. In suppositories containing lipophilic matrices, it can increase viscosity, prevent precipitation during the molding process, and reduce the release rate of drugs.
  1. Management status:
Colloidal silica has been included in the GRAS (Generally Recognized as Safe) list. Additionally, it is listed in the FDA's "Guidelines for Inactive Components," applicable to oral capsules, suspensions, tablets, as well as transdermal and vaginal drug delivery formulations. In the UK, it is permitted for use in non-injection formulations.
  1. Safety assessment:
Colloidal silica is widely used in oral and some topical formulations and is generally regarded as a non-toxic and non-irritating pharmaceutical excipient. However, intraperitoneal and subcutaneous injection of this substance may cause local tissue necrosis and granuloma, making silica unsuitable for injection purposes. According to relevant research data, the LD50 (lethal dose 50%) for intravenous injection in rats is 15mg/kg, and the oral LD50 is 3.16g/kg.
  1. Route of administration:
The administration routes of colloidal silica include oral administration, inhalation, transdermal administration, sublingual administration, vaginal administration, and other methods.
  1. Compatibility taboo:
Colloidal silica and diethylstilbestrol have a compatibility issue, which requires special attention during the formulation process of drugs.
  1. Production source:
Colloidal silica is primarily prepared through the gas-phase hydrolysis of chlorosilanes, such as by using silicon tetrachloride and producing it through combustion in a hydrogen and oxygen flame at a high temperature of 1800℃.
  1. Dosage standard:
In different drug formulations, colloidal silicon dioxide has clear dosage limits. The maximum dosage for oral capsules is 11.66mg; for oral granules, it can reach up to 100.00mg; for oral powders, it is 4.5%; for oral tablets, it is 170.00mg; for rectal suppositories, it is 14.00mg; and for sublingual tablets, it is 1.00mg. These dosage standards provide crucial reference for the production of pharmaceutical formulations, ensuring that they function as medicinal excipients within a safe and effective range, thereby safeguarding the quality and efficacy of drugs.
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