Determination the Content Per Puff of developing formulations free off ethanol of Salbutamol Sulfate Metered Dose Inhalers (Accelerated Stability Study)

Authors

  • Mohammad Haroun Tishreen University
  • Maarof Alkayer Tishreen University
  • Wasim Abd Al-wahed Aleppo University
  • Alaa Faysal Aldabet Tishreen University

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.

Author Biographies

Mohammad Haroun, Tishreen University

Assistant Professor-Quality control and Medicinal Chemistry Department-Faculty of Pharmacy

Maarof Alkayer, Tishreen University

Professor-Analytical and Food Chemistry Department-Faculty of Pharmacy

Wasim Abd Al-wahed, Aleppo University

Assistant Professor-Pharmaceutics and Pharmaceutical Technology Department-Faculty of Pharmacy

Alaa Faysal Aldabet, Tishreen University

Postgraduate Student (PhD Candidate)-Quality control and Medicinal Chemistry Department-Faculty of Pharmacy

Published

2022-01-17

How to Cite

1.
Haroun M, Alkayer M, Abd Al-wahed W, Aldabet AF. Determination the Content Per Puff of developing formulations free off ethanol of Salbutamol Sulfate Metered Dose Inhalers (Accelerated Stability Study). Tuj-hlth [Internet]. 2022Jan.17 [cited 2022May16];43(6):129-41. Available from: http://journal.tishreen.edu.sy/index.php/hlthscnc/article/view/11542