Annotation
The evaluation of quality of raw materials, semi-finished and finished pharmaceutical dosage forms has a dominant role in the production of pharmaceutical products. Key factors include the uniformity of dosage units, mechanical resistance, biopharmaceutical aspects (dissolution profile) and microbiological quality.
Modern test methods of pharmaceutical technology include the characterization of solid phase, crystallinity and/or amorphous state (X-ray powder diffraction, thermal analysis), the evaluation of surface properties (wettability, porosity and pore distribution, water sorption and desorption), and particle size estimation (laser diffraction, optical microscopy, aerodynamic parameters). The subject is supplemented by general physico-chemical methods such as the pH, relative density, refractive index, optical rotation, viscosity, boiling point and solidification point estimation,as well as the osmolality, drying loss, melting point and dropping point.
The specific pharmaceutical methods include the penetrometry, the density of solids, sieve analysis, powder flow, powder fineness, specific surface area. However, the tests for final preparations e.g. the strength and friability of tablets, the disintegration time of tablets or suppositories, the dissolution of the drug from different dosage forms and specific methods for evaluation of sterile dosage forms (sterility, pyrogens, particle contamination, etc.) are important.