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- E-ISSN 2288-8985
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Gliclazide compatibility with some common chemically reactive excipients; using different analytical techniques
Analytical Science and Technology / Analytical Science and Technology, (P)1225-0163; (E)2288-8985
2021, v.34 no.2, pp.46-55
https://doi.org/10.5806/AST.2021.34.2.46
(Tabriz University of Medical Sciences, Faculty of Pharmacy, Iran)
(Student Research Committee, Tabriz University of Medical Sciences. Iran)
(Tabriz University of Medical Sciences and NIMAD, Iran)
(Student Research Committee, Tabriz University of Medical Sciences. Iran)
(Tabriz University of Medical Sciences and NIMAD, Iran)
Hamideh,
N.
J.
, Mohammad,
S.
, &
Farnaz,
M.
(2021). Gliclazide compatibility with some common chemically reactive excipients; using different analytical techniques. Analytical Science and Technology, 34(2), 46-55, https://doi.org/10.5806/AST.2021.34.2.46
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Abstract
Evaluation of drug-excipient compatibility is one of the basic steps in the preformulation of pharmaceutical dosage forms. Some reactive excipients have been known so far which may cause stability problems for drug molecules in pharmaceutical dosage forms. The aim of this study was to evaluate drugexcipient compatibility of gliclazide with some common pharmaceutical excipients, known for their ability to incorporate in drug-excipient interactions. Binary mixtures were prepared using lactose, magnesium stearate, polyvinylpyrrolidone, sodium starch glycolate, polyethylene glycol 2000 and dicalcium phosphate. Based on the results; gliclazide was incompatible with all tested excipients; but not with dicalcium phosphate. DSC (Differential Scanning Calorimetry) results were in accordance with HPLC (High Pressure liquid chromatography) data and were more predictive than FTIR (Fourier Transform Infrared Spectroscopy). Drug and reactive excipients incompatibility was fully discussed and documented. It is advisable to avoid incompatible excipients or carefully monitor the drug stability when incorporating such excipients in final formulation designs.
- keywords
- incompatibility, excipient, gliclazide, differential scanning calorimetry, fourier transform infrared spectroscopy, high performance liquid chromatography
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