Drug powder is the main body of most drug formulations, and its efficacy depends not only on the type of drug, but also to a large extent on the properties of the powder that makes up the agent, including particle size, shape, surface properties and other kinds of parameters. The specific surface area and pore size structure of drug powders are related to the properties of powder particles such as particle size, hygroscopicity, solubility, dissolution and compaction, which play an important role in the purification, processing, mixing, production and packaging capabilities of pharmaceuticals.
In addition, the validity, dissolution rate, bioavailability and efficacy of drugs also depend on the specific surface area of the material. Generally speaking, the larger the specific surface area of pharmaceutical powders within a certain range, the faster the dissolution and dissolution rate will be correspondingly accelerated, which ensures the uniform distribution of drug content; however, too large a specific surface area will lead to the adsorption of more water, which is not conducive to the preservation and stability of drug efficacy. Therefore, accurate, rapid and effective testing of the specific surface area of pharmaceutical powders has always been an indispensable and critical part of pharmaceutical research.
Case Study of CIQTEK Application in Pharmaceutical Powder
We combines the actual characterization cases of different drug powder materials to clearly show the methods and applicability of this technology to characterize the physical properties of different drug surfaces, and then make some basic analysis on the expiration date, dissolution rate and efficacy of drugs, and help the pharmaceutical industry to develop with high quality.
The V-Sorb X800 series specific surface and pore size analyzer is a high throughput, fast and economical instrument, which can realize rapid testing of specific surface area of incoming and outgoing finished products, pore size distribution analysis, quality control, adjustment of process parameters, and prediction of drug performance, etc.
Automatic BET Surface Area & Porosimetry Analyzer CIQTEK EASY-V Series
1、Scanning electron microscope and specific surface and pore size analyzer in montmorillonite dispersion
Montmorillonite is obtained from the purification and processing of bentonite, which has unique advantages in pharmacology because of its special crystal structure with good adsorption capacity, cation exchange capacity and water absorption and swelling capacity. For example: as API, drug synthesis, pharmaceutical excipients, etc.
Montmorillonite has a laminar structure and a large specific surface area, which can have a strong adsorption effect on toxic substances; it is electrostatically combined with digestive tract mucus proteins and plays a protective and repairing role on the digestive tract mucosa.
SEM5000 observed fine lamellar crystalline masses attached to the surface of montmorillonite.
SEM5000 can clearly identify the individual lamellar crystallites at a high magnification of 100,000 and can analyze their pore size.
2、Scanning electron microscopy with specific surface and pore size analyzer in magnesium stearate
Magnesium stearate: in the shape of flaky crystals, mainly used as lubricant or anti-adhesive for tablets and capsules; its uncertain chemical composition leads to different physical properties of magnesium stearate, thus affecting its lubrication function, which needs to strengthen the key performance testing of incoming materials and control the lubrication process parameters in actual use.
Specific surface area plays a key role in the lubricating function property of magnesium stearate. The larger the specific surface area, the stronger its polarity, the greater the adhesion, can form a thin but uniform layer of magnesium stearate on the surface of the particles, the corresponding and the lubricity of the synthetics is better; and the lower specific surface area of magnesium stearate, easy to enrich in the surface of the particles.
SEM5000 clearly observes the growth of magnesium stearate flake layer
SEM5000 observed the magnesium stearate flakes at high magnification of 100,000
3、Scanning electron microscopy with specific surface and pore size analyzer in ibuprofen particles
The ibuprofen particles are columnar in shape with uniform particle size and clear surface morphology of the particles; further observe the surface details of individual particles to study their wrapping uniformity, mixing effect and crystalline characteristics.
The specific surface area plays a key role in the lubricating functional properties of magnesium stearate. The larger the specific surface area, the stronger its polarity, the greater the adhesion, which can form a thin but uniform layer of magnesium stearate on the surface of the particles, and the corresponding and synthetic lubricity will be better; while magnesium stearate with lower specific surface area is easily enriched on the surface of the particles.
Ibuprofen particles taken by SEM3200
SEM3200 can clearly observe the surface morphology of ibuprofen particles
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Electron Paramagnetic Resonance