Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods

Babazadeh miyandoab, Amir Ali; Barghi, Leila; yousefi, nesa; Ghaderi, Faranak

doi:10.52547/rabms.8.2.69

Volume 8, Issue 2 (5-2022) Journal of Research in Applied and Basic Medical Sciences 2022, 8(2): 69-74 | Back to browse issues page

‎ 10.52547/rabms.8.2.69

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Babazadeh miyandoab A A, Barghi L, yousefi N, Ghaderi F. Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods. Journal of Research in Applied and Basic Medical Sciences 2022; 8 (2) :69-74
URL: http://ijrabms.umsu.ac.ir/article-1-135-en.html

Evaluation of Ampicillin- Lactose Incompatibility Reactions at Solid-State Using Physicochemical Methods

Amir Ali Babazadeh miyandoab

, Leila Barghi

, Nesa Yousefi

, Faranak Ghaderi ^*

Research Center for Experimental and Applied Pharmaceutical Sciences, Urmia University of Medical Sciences, Urmia, Iran , f.ghaderi1390@gmail.com

Abstract: (1765 Views)

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.

Keywords: Incompatibility, Ampicillin, Lactose, Differential scanning calorimetry, Fourier-transform infrared spectroscopy

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Type of Study: orginal article | Subject: Special

References

1. Purushottam SS, Bhaskarrao GS, Bhanudas SR. Gelified emulsion: a new born formulation for topical delivery of hydrophobic drugs. World jurnal of pharmacy and pharmaceutical sciences 2013;3:233-51. [URL]

2. Blecher L. Excipients-The important components. Pharm Process 1995;12(1):6-7.

3. Moreton RC. Excipient interactions. Excipient development for pharmaceutical, biotechnology, and drug delivery systems. CRC Press; 2006. p. 113-28. [DOI:10.1201/9781420004137-11]

4. Kumar V, Banker GS. Maillard reaction and drug stability. In: Labuza TP, Monnier V, Baynes J, O'Brien J, editors. Maillard Reactions in Chemistry, Food and Health: Elsevier; 2005. p. 20-7. [DOI:10.1533/9781845698393.1.20] [PMID]

5. da Silveira LM, Fiorot AB, Xavier TP, Yoshida MI, de Oliveira MA. Drug-excipient compatibility assessment of solid formulations containing meloxicam. Eur J Pharm Sci 2018;112:146-51. [DOI:10.1016/j.ejps.2017.11.015] [PMID]

6. Haines P, Reading M, Wilburn F. Differential thermal analysis and differential scanning calorimetry. In: Brown ME, Gallagher PK, editors. Handbook of thermal analysis and calorimetry. Elsevier; 1998. p. 279-361. [DOI:10.1016/S1573-4374(98)80008-3]

7. Baravkar A, Kale R, Sawant S. FTIR Spectroscopy: principle, technique and mathematics. International Journal of Pharma and Bio Sciences 2011;2(1):513-9. [URL]

8. Sims JL, Carreira JA, Carrier DJ, Crabtree SR, Easton L, Hancock SA, et al. A new approach to accelerated drug-excipient compatibility testing. Pharm Dev Technol 2003;8(2):119-26. [DOI:10.1081/PDT-120018476] [PMID]

9. Donowitz GR, Mandell GL. Beta-lactam antibiotics. N Engl J Med 1988;318(7):419-26. [DOI:10.1056/NEJM198802183180706] [PMID]

10. Wade A, Weller PJ. Handbook of pharmaceutical excipients. Washington: American pharmaceutical association; 1994. P.84-7.

11. Brownley Jr CA, Lachman L. Browning of spray‐processed lactose. J Pharm Sci 1964;53(4):452-4. [DOI:10.1002/jps.2600530428] [PMID]

12. Serajuddin AT, Thakur AB, Ghoshal RN, Fakes MG, Ranadive SA, Morris KR, et al. Selection of solid dosage form composition through drug-excipient compatibility testing. J Pharm Sci1999;88(7):696-704. [DOI:10.1021/js980434g] [PMID]

13. Huang Y, Cheng Y, Alexander K, Dollimore D. The thermal analysis study of the drug captopril. Thermochimica acta 2001;367 :43-58. [DOI:10.1016/S0040-6031(00)00687-0]

14. Namli H, Turhan O. Background defining during the imine formation reaction in FT-IR liquid cell. Spectrochim Acta A Mol Biomol Spectrosc 2006;64(1):93-100. [DOI:10.1016/j.saa.2005.07.020] [PMID]

15. Hellwig M, Henle T. Baking, ageing, diabetes: a short history of the Maillard reaction. Angew Chem Int Ed Engl 2014;53(39):10316-29. [DOI:10.1002/anie.201308808] [PMID]