Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods
Background & Aims: 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 o...
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| Format: | Article |
| Language: | English |
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Urmia University of Medical Sciences
2022-05-01
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| Series: | Journal of Research in Applied and Basic Medical Sciences |
| Subjects: | |
| Online Access: | http://ijrabms.umsu.ac.ir/article-1-135-en.pdf |
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| author | Amir Ali Babazadeh miyandoab Leila Barghi nesa yousefi Faranak Ghaderi |
| author_facet | Amir Ali Babazadeh miyandoab Leila Barghi nesa yousefi Faranak Ghaderi |
| author_sort | Amir Ali Babazadeh miyandoab |
| collection | DOAJ |
| description | Background & Aims: 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.
Materials & Methods: 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. The direct compression method was applied to formulate the tablet samples. The samples were stored at 60° C in the oven and possible incompatibilities were examined for four consecutive weeks by observing the DSC thermograms and FTIR spectra.
Results: According to the results, it is recommended to eschew the formulation of ampicillin with lactose for possible incompatibilities.
Conclusion: 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. |
| first_indexed | 2024-03-12T14:53:41Z |
| format | Article |
| id | doaj.art-73bebc5add844b3d83b3ac0f344d0424 |
| institution | Directory Open Access Journal |
| issn | 2717-0098 |
| language | English |
| last_indexed | 2024-03-12T14:53:41Z |
| publishDate | 2022-05-01 |
| publisher | Urmia University of Medical Sciences |
| record_format | Article |
| series | Journal of Research in Applied and Basic Medical Sciences |
| spelling | doaj.art-73bebc5add844b3d83b3ac0f344d04242023-08-15T04:57:18ZengUrmia University of Medical SciencesJournal of Research in Applied and Basic Medical Sciences2717-00982022-05-01826974Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical MethodsAmir Ali Babazadeh miyandoab0Leila Barghi1nesa yousefi2Faranak Ghaderi3 School of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran Department of Pharmaceutics, School of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran Department of Pharmaceutical and Food Control, School of Pharmacy, Urmia University of Medical Sciences, Urmia, Iran Research Center for Experimental and Applied Pharmaceutical Sciences, Urmia University of Medical Sciences, Urmia, Iran Background & Aims: 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. Materials & Methods: 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. The direct compression method was applied to formulate the tablet samples. The samples were stored at 60° C in the oven and possible incompatibilities were examined for four consecutive weeks by observing the DSC thermograms and FTIR spectra. Results: According to the results, it is recommended to eschew the formulation of ampicillin with lactose for possible incompatibilities. Conclusion: 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.http://ijrabms.umsu.ac.ir/article-1-135-en.pdfincompatibilityampicillinlactosedifferential scanning calorimetryfourier-transform infrared spectroscopy |
| spellingShingle | Amir Ali Babazadeh miyandoab Leila Barghi nesa yousefi Faranak Ghaderi Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods Journal of Research in Applied and Basic Medical Sciences incompatibility ampicillin lactose differential scanning calorimetry fourier-transform infrared spectroscopy |
| title | Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods |
| title_full | Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods |
| title_fullStr | Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods |
| title_full_unstemmed | Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods |
| title_short | Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods |
| title_sort | evaluation of ampicillin lactose incompatibility reactions at solid state using physicochemical methods |
| topic | incompatibility ampicillin lactose differential scanning calorimetry fourier-transform infrared spectroscopy |
| url | http://ijrabms.umsu.ac.ir/article-1-135-en.pdf |
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