دراسة العلاقة بٌن امتصاص الرطوبة عند درجة حرارة ثابتة و زمن إعادة التشكٌل للمساحٌق المعدةً للاستخدام الصيدلاني

الملخص EN

The aim of this study was to evaluate the relation between differences in reconstitution times of six different marketed samples of ceftriaxone sodium for injection, and moisture sorption isotherm.

The reconstitution time was measured precisely as the point at which the freeze- dried ceftriaxone sodium preparation became a transparent solution by the addition of sterile water for injection.

Isotherm profile was carried out using dynamic vapor sorption (DVS).

Solid form characterization was carried out by powder X-ray diffraction (PXRD).moisture content was determined by AMB Halogen Moisture Balance.

No differences were detected in the solid form of the marketed samples and no polymorphism was present.

Isotherm profile was corresponding with Type IV, two hysteresis loops were noticed due to mesopores presence.

An inverse relationship between moisture content and reconstitution time was observed.

In the case of selected samples of ceftriaxone sodium powder for injection, the moisture content and porosity had a significant effect on reconstitution time; however, the solid-state form did not.