دراسة في الزجاج لتوزع أبعاد جسيمات الجرعة المحررة لصيغ مطورة خالية من الايتانول لأشكال ارذاذية معايرة الجرعة حاوية على السالبوتامول سلفات: دراسة ثبات مسرع

الملخص EN

This research suggested PEG400 and Isopropyl Myreistate (IPM) as alternative co-solvent to ethanol.

Different concentrations were used (1-3-5%).The initial results indicates that PEG400(1%) is a good propably alternative co-solvent to Ethanol depending on visual observation and in-vitro Aerodynamic particle size distribution(APSD) test(n=5).

All Suggested Formulation free off ethanol were prepared using a fixed amount of salbutamol sulfate and PEG400(1%) as S-PEG400, and others by addition of suspension stabilizer to previous formulation like oleic acid (0.01%) as surfactant in S-PEG400-OA and PVPK30(0.0001%) as suspending agent in S-PEG400-PVP.

In vitro accelerated Stability study was done (40°C/75%RH) by APSD test for at (0-3-6 month) and the results were compared with control S-ETOH which contains ethanol(10%).

The results were statistically analyzed using tstudent.

The results demonstrated that PEG400(1%) is a suitable alternative co-solvent to ethanol with addition of 0.0001% of PVP-k30 because S-PEG400-PVP has a fine particle fraction(FPF˃35%),mass median aerodynamic diameter(MMAD) within (1-5µ) and there isn’t any significant effect when comparing with control S-ETOH (p-value˃0.05).