The role of silica in the pharmaceutical process is so great!


Medicine has been closely related to people’s lives since ancient times. The production of medicines started from traditional medicine, and later evolved to the separation and extraction of natural medicines from natural substances, and then gradually developed and established an industrial production system for chemical medicines, while pharmaceutical excipients, in the pharmaceutical industry plays a vital role.

Pharmaceutical excipients refer to the excipients and additives used in the production of drugs and the formulation of prescriptions. In addition to excipients, acting as carriers, and improving stability, they also have important functions such as solubilization, solubilization, and sustained and controlled release. Important ingredients that affect the quality, safety and efficacy of medicines.

As a widely used inorganic material, silicon dioxide is also a very useful pharmaceutical excipient in the pharmaceutical field. The auxiliary material, silica, with the structural formula mSiO2·nH2O, is a white powder with good fluidity, high purity and no pollution. It has the characteristics of small particle size, large specific surface area, and many pores. adsorption performance. The addition of silicon dioxide as a pharmaceutical excipient can effectively improve the quality and performance of pharmaceutical preparations, especially tablets, and greatly improve the market competitiveness of pharmaceuticals. Its application in pharmaceutical preparations has received more and more attention.

For lubricants

In many capsules, dispersible tablets and other medicines, the pharmaceutical excipient silicon dioxide can be used as a lubricant, which can prevent the pellets from sticking, and the dispersible tablet dissolves in water faster, with good dispersion uniformity and controllable quality.

For glidants

During pharmaceutical tableting, a certain amount of glidant will be added in order to smoothly feed and discharge the tablet, reduce sticking and reduce the friction between granules and granules, tablet and die hole wall, and make the surface smooth and beautiful. Wet granulation and tableting process is the most widely used tableting process and is suitable for relatively stable drugs. It is difficult for most drugs to have good fluidity, compressibility, and drug release properties required by tablets at the same time. Therefore, by wet granulation and adding other glidants, the preparation requirements of different materials and different tablets can be met.

The pharmaceutical excipient silicon dioxide is added as a glidant, and the prepared tablet is well formed and has a good taste.

For anti-adhesion

When medicinal silica is applied to gel patch, the gel patch can have the advantages of large drug loading, good transdermal effect, good skin compatibility and no irritation. The new direction of drug system development has become a new type of preparation with great potential.

For adsorbents

Using the pharmaceutical excipient silicon dioxide as the adsorption material in the solid preparation can greatly improve the in vitro dissolution rate and solve the problem of low bioavailability of traditional drugs.

For antistatic agent

The phenomenon of electrostatic adsorption of powder often occurs in the process of preparing particles in a fluidized bed, and it is necessary to add an antistatic agent to eliminate electrostatic adsorption of powder. There are a large number of hydrophilic groups on the surface of the pharmaceutical excipient silica, which absorb moisture in the air on the surface of the powder coating to form an electrophilic film or rely on proton transfer to reduce the surface resistance, thereby exerting an antistatic effect.

After the microcrystalline cellulose and the pharmaceutical excipient silicon dioxide are mixed in an appropriate ratio, a new type of pharmaceutical excipient, namely silicified microcrystalline cellulose, is prepared by spray drying. The excipient has good fluidity, compressibility, and anti-hygroscopicity. Therefore, it can be used as a functional diluent for direct compression tablets, solve the process problems such as uneven distribution of active ingredients in tablets, and can meet the preparation requirements of tablet cores, orally disintegrating tablets and dispersible tablets.

In addition, due to the strong adsorption, hydrophilicity, biocompatibility and surface polyhydroxylation of nano-silica, it can be used as a carrier and modified to prepare biosensors and biomarkers with excellent performance. test material.

The continuous improvement of drug safety and effectiveness and the full development of the consistency evaluation of generic drugs and original drugs have put forward higher requirements for the quality of pharmaceutical excipient silicon dioxide. It is the future development trend to modify the pharmaceutical excipient silica to obtain more excellent performance.

At present, some new research direction technologies are still immature. For example, the research of mesoporous silica nanoparticles in the medical field mostly focuses on the cell test stage, and the relevant animal tests are relatively few, let alone clinical experiments. The development of silica in the field of medicine still requires the joint efforts of the material industry and medical research.


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