en Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods تخصصي Special پژوهشي orginal article <span style="font-size:12pt"><span style="line-height:16.0pt"><span new="" roman="" style="font-family:" times=""><b><i><span style="font-size:9.0pt">Background & Aims</span></i></b><b><span style="font-size:9.0pt">: </span></b>&nbsp;<span style="font-size:9.0pt">One of the significant steps in the preformulation of pharmaceutical dosage forms is to examine active pharmaceutical ingredient (API) compatibility with the excipients applied with it. Drug-excipient incompatibility affects the stability, effectiveness, safety, and quality of the final product. Therefore, it is vital, for fruitful drug production, to sort out excipients compatible with the active pharmaceutical ingredient. The aim of this study was to evaluate the compatibility of ampicillin with lactose through differential scanning calorimetry (DSC) and Fourier-transform infrared spectroscopy (FTIR) physicochemical methods. </span></span></span></span><br> <span style="font-size:12pt"><span style="line-height:16.0pt"><span new="" roman="" style="font-family:" times=""><b><i><span style="font-size:9.0pt">Materials & Methods</span></i></b><span style="font-size:9.0pt">: To formulate powder samples, 300 mg ampicillin and lactose powder was discharged into a vial in a ratio of 1: 1, and 20% v/w water was added and then vortexed. Also, samples of pure drug and pure excipient were prepared by the same method.&nbsp; The direct compression method was applied to formulate the tablet samples. The samples were stored at 60&deg; C in the oven and possible incompatibilities were examined for four consecutive weeks by observing the DSC thermograms and FTIR spectra. </span></span></span></span><br> <span style="font-size:12pt"><span style="line-height:16.0pt"><span new="" roman="" style="font-family:" times=""><b><i><span style="font-size:9.0pt">Results</span></i></b><span style="font-size:9.0pt">: According to the results, it is recommended to eschew the formulation of ampicillin with lactose for possible incompatibilities.</span></span></span></span><br> <span style="font-size:12pt"><span style="line-height:16.0pt"><span new="" roman="" style="font-family:" times=""><b><i><span style="font-size:9.0pt">Conclusion</span></i></b><span style="font-size:9.0pt">: Based on the obtained results and the changes in the main peaks of absorption of the drug-excipient mixture in the fourth week compared to the first day, there is the possibility of incompatibility in the mixture of ampicillin and lactose. Also, the observation of discoloration in the powder and tablets in the fourth week compared to the first day indicates the occurrence of a kind of incompatibility in the drug-excipient mixture.</span></span></span></span> Incompatibility, Ampicillin, Lactose, Differential scanning calorimetry, Fourier-transform infrared spectroscopy 69 74 http://ijrabms.umsu.ac.ir/browse.php?a_code=A-10-90-3&slc_lang=en&sid=1 Amir Ali Babazadeh miyandoab amirali7779@gmail.com 10031947532846002663 10031947532846002663 No School of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran Leila Barghi leila.barghi@gmail.com 10031947532846002664 10031947532846002664 No Department of Pharmaceutics, School of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran nesa yousefi nyousefii1394@gmail.coml 10031947532846002665 10031947532846002665 No Department of Pharmaceutical and Food Control, School of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran Faranak Ghaderi f.ghaderi1390@gmail.com 10031947532846002666 10031947532846002666 Yes Research Center for Experimental and Applied Pharmaceutical Sciences, Urmia University of Medical Sciences, Urmia, Iran