| خلاصه مقاله | Introduction:
Salbutamol is a beta-agonist receptor that is used in asthmatic and chronic obstructive pulmonary
disease (COPD) patients. This medicine is available in different dosage forms; syrup, metered dose
inhaler (MDI) and dry powder inhaler (DPI). In order to formulate a medicine, drug – excipient
compatibility is one of the most crucial matters in order to achieve the best quality parameters which
could directly influence the patient's safety. For DPI formulations FDA approved excipients are lactose,
glucose and mannitol. Also, recently leucine has been used frequently in DPI formulation. In this study
compatibility of salbutamol with the mentioned excipient was investigated.
Methods and materials:
Visually examination, thermo-analytical techniques such as differential scanning calorimetry (DSC)
and Fourier transform infrared spectroscopy (FTIR), chromatographic method (HPLC) were used to
evaluate any potential incompatibility. Binary mixtures of salbutamol sulfate and excipients were
prepared in different ratios (1:1, 1:10 and 1:67.5 similar to commercial form) and stored 2 months at
elevated temperature and humidity (40 °C and adding 20% w/w water). samples were analyzed before
and after storage.
Results:
DSC, FTIR and HPLC results confirmed each other except for glucose. All methods confirmed that
there is an incompatibility potential with the excipients. HPLC results show the amount of salbutamol
was decreased after storage except for glucose while DSC and FTIR show the sign of incompatibility.
Conclusion: Findings reveal that excipients used for DPI formulation could be incompatible with
salbutamol. In order to find the degradation compounds and pathways, further studies are needed. |