STUDY OF DIFFERENCES OF ORIGINAL AND GENERIC PREPARATIONS WHICH CONTAIN BETAMETHASONE DIPROPIONATE AND BETAMETHASONE SODIUM PHOSPHATE
DOI:
https://doi.org/10.11603/2312-0967.2017.3.8133Keywords:
glucocorticoids, betamethasone dipropionate, injectable suspension, original drug, generic, optical microscope, liquid particle counter, high performance liquid chromatography.Abstract
The aim of the work. The work is devoted to conduct a study that will reveal the difference between the original and generic drugs whose dosage forms have a two-phase content of betamethasone (betamethasone sodium phosphate in the aqueous solution and betamethasone dipropionate in the form of a suspension in this solution).
Materials and Methods. The original preparation of betamethasone sodium phosphate and betamethasone dipropionate in the form of a suspension and its generic analogues, adjacent to the Ukrainian market, have been used. To evaluate the amount of AMD suspension of preparations A, B, C, which was transferred to a solution of 15 % aqueous isopropanol, we have developed a technique using the device "Particle number and particle counter in liquid media" APSS-2000.
Results and Discussions. A visual study of the mechanical stability of suspensions in sealed ampoules was performed, which showed a different rate of settling of suspended particles in the investigated preparations. The possible influence of lidocain solvent on the velocity and degree of settling of particles was studied. It was revealed that generic preparations B and C differ significantly from the original preparation A in terms of particle size distribution. In the original preparation A, the bulk of the PMP suspension is made up of particles of smaller size than generics. The method for solubility determination has been developed by which it has been found that the slurry of the original preparation A for 130 min of exposure to the orbital shredder dissolves almost completely (99 %, while generics B and C during this time passes (dissolves) into the aqueous isopropanol phase, respectively, only 66 % and 53 % of the crystalline mass of the BMDP. It has been shown that the dynamics of dissolution of the PMP suspension of the investigational drugs can be traced using a "Particle number and particle counter in liquid media" APSS-2000.
Conclusions. It has been established that the original drug and its generics have significant differences in the distribution of particles in size. A method for determining the solubility of the original drug and generics has been developed. It has been shown that generics differ from the original drug by having a different particle size distribution.
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