Aktualʹnì Pitannâ Farmacevtičnoï ì Medičnoï Nauki ta Praktiki (Oct 2018)

The study of structural-mechanical characteristics of suppositories with clopidogrel

  • Ye. А. Redkina,
  • V. V. Gladyshev,
  • B. S. Burlaka

DOI
https://doi.org/10.14739/2409-2932.2018.3.145218
Journal volume & issue
no. 3
pp. 281 – 285

Abstract

Read online

Abstract During last years clopidogrel keeps leading positions among medicines with platelet antiaggregation mechanism. The rectal dosage form with clopidogrel, namely suppository containing 0.075 g of active substance on hydrophilic base with addition of 2 % twin-80 was proposed by the Department of Medicinal Preparations Technology (Zaporizhzhia State Medical University on the base of complex investigations. The aim of present work is the study of structural-mechanical characteristics of rectal dosage form with clopidogrel depending on the temperature of technological process of supposirory manufacturing. The study of structural-mechanical characteristics of suppository mass with clopidogrel was carried out using the rotational viscosimeter “Rheotest2”with cylinder device at the human body temperature (37 ºС) and at temperature of manufacturing technological process. Results. Results testify presence of structure in suppository mass system, because limit shear stress increases and effective viscosity decreases with deformation speed rising. Conclusions. Study of consistent characteristics of suppository mass with clopidogrel on polyethylenoxyde base with addition of 2 % twin-80 at the human body temperature was carried out. It was established that it is structural system with expressed thixotropic properties and with the uniform distribution of active substance and excipients both at the moment of manufacturing and during administration or long storage. It was revealed that increasing of temperature of suppository mass to 50 ºС doesn't lead to essential modification of its structural-mechanical characteristics and transformation into Newtonian system. Taking obtained results into account it was determined that temperature rate of manufacturing of rectal suppositories with clopidogrel on the hydrofiflic base (processes of mixing, homogenization, pouring into forms) within 50–55 ºС creates sufficient fluidity of mass for unhampered technological process and thixotropy of suppository mass providing the uniform distribution of active substance and excipients in this dosage form.

Keywords