Разработка пленкообразующего состава и технологии нанесения полимерной оболочки на таблетки Индотрил

Abstract

Introduction. In previous researches we grounded expedience of «Indotril» tablets development; formulation and technology of Indotril tablet cores were developed. Received tablet cores should be covered by protective polymeric film with the purpose of unpleasant taste elimination, increase of tablets expiration date. Objective. The aim of our investigation was to develop the film forming composition and technology of polymeric film coating on «Indotril» tablets in pseudo-fluidized layer. Materials and Methods. As “Indotril” tablets cores should be covered by protective polymeric film we performed research designed to select efficient film forming solution. Thus modern filming agents were studied, besides such factors were investigated: concentration of film forming suspension, increase of tablet coat in mass, air temperature under gas distribution grid. Obtained tablets were checked according to pharmacopeia methods. Results and discussion. First we studied tablet compression force influence on main parameters of «Indotril» cores tablets: on crushing strength, abrasion in pseudo-fluidized layer unit and disintegration. Then for further investigation we chose «Indotril» cores tablets with crushing strength near 70 H, abrasion - up to 0,5% and disintegration time - not more than 10 minutes. We performed research to select film forming solution for covering “Indotril” tablets in pseudo-fluidized layer unit. As filming agents we used different samples of hydroxypropyl methylcellulose (HPMC) by Japan company Shin-Etsu Chemical Co and English company Colorcon. Water HPMC solutions were prepared which contained plasticizer (propylene glycol), pigment (titanium IV dioxide) and dye (tartrazine). Coating process of “Indotril” tablets was performed in laboratory pseudo-fluidized layer unit with the air temperature 75oC under gas distribution grid. Variance analysis of experimental data on quality of coat surface showed insignificance as for nature of studied filming agents. Homogeneity in bulk of coated “Indotril” tablets also did not differ significantly as for filming agents’ nature. Divergence in mass of coated tablets did not differ significantly from uncoated ones; it testifies identity of filming process over all tablets surface. Strength of coated “Indotril” tablets as compared with uncoated ones increases in average on 15-20 H. Variance analysis of experimental data concerning tablets disintegration resistance showed that there was no significant difference between studied filming agents. While defining disintegration time statistical significance of filming agents’ nature was determined. Ranking is the following: 6% solution of HPMC Pharmacoat 603 > 5% solution of Opadray II WHITE > 5% solution of HPMC Pharmacoat 606 > 4% solution of HPMC Pharmacoat 615. But the difference between filming agents’ nature is not more than 2 minutes. Opadray II WHITE has been chosen for further study; it comes to the enterprise (“Arterium” Corporation) where the results of investigation are planned to be introduced for the manufacture of other tablet dosage forms. On the next stage of our investigation we defined optimal values of quantitative factors, notably the influence of air temperature under gas distribution grid, concentration of film forming suspension and film thickness on the properties of coated “Indotril” tablets. Conclusion. Influence of filming agent nature on properties of coated tablets «Indotril» was studied, namely on appearance, homogeneity in bulk, mechanical strength, disintegration time . Opadray II WHITE was proposed for coating “Indotril” tablets by protective polymeric coat in pseudo-fluidized layer. Worked out formulation of filming agent solution and technology of its application were included into technological regulation of «Indotril» tablets production.