Determination the Content Per Puff of developing formulations free off ethanol of Salbutamol Sulfate Metered Dose Inhalers (Accelerated Stability Study)
Abstract
Salbutamol sulfate metered dose inhaler (MDI) which is available as suspension is a drug of choice in treating acute asthma attack. Ethanol is considered the common co-solvent used in MDI formulation which has a lot of problems related to the performance of MDI.
This research suggested PEG400 and Isopropyl Myreistate (IPM) as alternative co-solvent to ethanol. Different concentrations were used (1-3-5%).The initial results indicate that PEG400(1%) is a good probably alternative co-solvent to Ethanol depending on visual observation and content per puff by HPLC (n=10).
Suggested Formulation free off ethanol were prepared as following:
- S-PEG400 contains a fixed amount of salbutamol sulfate and PEG400(1%).
- S-PEG400-OA contains a fixed amount of salbutamol sulfate and PEG400(1%) plus oleic acid (0.01%) as surfactant.
- S-PEG400-PVP contains a fixed amount of salbutamol sulfate and PEG400(1%) plus PVP-K30(0.0001%) as suspending agent.
Accelerated Stability study was realized (40°C/75%RH) by determining content per puff of above formulations at (0-3-6 month) and the results were compared with control S-ETOH which contain ethanol(10%) (n=10). The results were statistically analyzed using t-student and the results demonstrated that formulation S-PEG400-PVP which is free off ethanol passed the accelerated stability test and there isn’t any significant effect when comparing with control S-ETOH (p-value>0.05), So PEG400(1%) is a suitable alternative co-solvent to ethanol with addition of 0.0001% of PVPk30.
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