Study of the size and shape of lisinopril dihydrate particles and auxiliary substances in order to obtain optimal pharmaceutical-technological properties of tablet mass
Keywords:lisinopril dihydrate, optical microscopy, laser diffraction, bulk density, powder flow
Topicality. The particle size of the active substance in medical product significantly affects its solubility, bioavailability, and therapeutic performance that is why the study of the “Particle size” index is compulsory for pharmaceutical development.
Aim. Study of the size and shape of lisinopril dihydrate particles and auxiliary substances in order to obtain optimal pharmaceutical – technological properties of tablet mass.
Materials and methods. The objects of study are lisinopril dihydrate, excipients, the obtained tablet mass, the samples of experimental series and the reference drug. Studies on the particle size determination of the active substance lisinopril dihydrate and excipients were performed by pharmacopoeial methods, such as optical microscopy (2.9.37), sieve analysis (2.9.12) and laser diffraction (2.9.31). The evaluation of the selected composition was carried out by pharmaceutical-technological tests according to SPhU.
Results and discussion. The results of size examination, form of particles as well as fractional composition of lisinopril dihydrate and each of the auxiliary agents were obtained. The technology of tablet mass production was determined and on the basis of experimentally determined pharmaco-technological properties of substances, such as tapped density before and after package, flow property, the optimal composition of the tablet mass with lisinopril dihydrate was developed.
Conclusions. In the result of comparative study of the pharmacological properties of the experimental series of tablets with lisinopril dihydrate, 10 mg and medical product Lizinopril-Ratiopharm, 10 mg, we confirmed the practicability of determining and standardizing the index size and shape of particles for active and auxiliary substances in the formation of solids.
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