Interaction study between pefloxacin mesilate and some diluents using DSC supported with isothermal method

Misra, Manju; Misra, A. K.; Panpalia, G. M.

doi:10.1007/s10973-007-8531-8

Cited by 13 publications

(4 citation statements)

References 13 publications

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“…In the DSC analysis of the mixture it was not possible to correctly identify the thermal events of each individual compound because it seems that there was a drug-excipient For this reason, the T onset , T peak , and enthalpy (DH) values were not attributed for this mixture ( Table 2). Calcium hydrogen phosphate dihydrate was compatible with ciprofloxacin hydrochloride [52] and pefloxacin mesilate [53]. If the drug is compatible with the excipient at high temperatures it is compatible at room temperature.…”

Section: Dsc Compatibility Studiesmentioning

confidence: 99%

Fluconazole–excipient compatibility studies as the first step in the development of a formulation candidate for biowaiver

Teleginski

Maciel

Mendes

et al. 2014

J Therm Anal Calorim

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The biowaiver of bioequivalence studies on class I drugs of the biopharmaceutics classification system (BCS) is aimed mainly at reducing the costs and the exposure of health volunteers to a new pharmaceutical formulation. Fluconazole is an important antifungal agent but in the literature it is not clear whether it belongs to BCS class I or III. Compatibility studies are considered to be the first step in product development and on considering a biowaiver candidate these gain even greater importance since the final product will not be submitted to in vivo tests. The aim of this study was to qualitatively determine the composition of a commercially available fluconazole formulation in the form of capsules with regard to the presence of critical excipients and to carry out compatibility studies by differential scanning calorimetry (DSC). One formulation did not contain sodium lauryl sulfate and contained mannitol, in contrast to the reference formulation, which could hinder the acceptance of the biowaiver. The interaction of fluconazole with microcrystalline cellulose and calcium hydrogen phosphate dihydrate was observed; however, no indication of incompatibility was found in the DSC analysis of the commercial pharmaceutical formulations. These interactions were also studied by Fourier transform infrared spectroscopy, where small changes in the bands were observed, and by X-ray Powder diffraction and scanning electron microscopy that did not evidence any modification in the solid state characteristics.

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Section: Dsc Compatibility Studiesmentioning

confidence: 99%

Fluconazole–excipient compatibility studies as the first step in the development of a formulation candidate for biowaiver

Teleginski

Maciel

Mendes

et al. 2014

J Therm Anal Calorim

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“…In addition, the optimal analytical toolkit to support blending has yet to be assembled and hence the conventional method of analysis using HPLC is done which often needs higher quantity of sample [4]. DSC on the contrary, needs sample in the range of 2-3 mg only [28]. Fig.…”

Section: Linearity and Sensitivity Estimation Using Dscmentioning

confidence: 99%

“…One such technique is thermal analysis, which forms the backbone of any preformulation exercise. Thermal methods like DSC have been extensively used for estimation of drug-excipient interaction [26][27][28][29] studies, purity estimation [30], polymorphic transition [31,32], polymer characterization etc [33]. However making use of DSC in estimating mixing uniformity in a blend is something which is not being explored so far.…”

Section: Introductionmentioning

confidence: 99%

Exploring mixing uniformity of a pharmaceutical blend in a high shear mixture granulator using enthalpy values obtained from DSC

2015

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“…A number of experimental techniques (i.e., DSC, X-ray powder diffraction, optical and Electron Microscopy, FT-IR spectroscopy, etc.) have been used to investigate the interaction between drug and excipients [8] [9] [10] [11] [12]. Differential Scanning Calorimetry is a quick technique to investigate excipient-drug incompatibility derived from the appearance, disappearance or shifts of peaks and/or variation in the corresponding ∆H (enthalpy of transition).…”

Section: Introductionmentioning

confidence: 99%

Incompatibility of Paracetamol with Pediatric Suspensions Containing Amoxicillin, Azithromycin and Cefuroxime Axetil

Maswadeh¹

2017

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The main objective of this work was to use the Differential Scanning Calorimetry (DSC) and FTIR spectroscopy to study the possible drug-drug or drug-excipient (s) interaction in case of concomitant oral administration of paracetamol with the most common used antibiotics for children. Amoxicillin, azithromycin, cefuroxime axetil and their commercially available suspensions, Amoxil ® , Azithromax ® and Zinnat ® were used. DSC curves for paracetamol, pure antibiotics, commercially available antibiotics and all binary mixtures used in this study showed drug-drug or drug-excipient (s) physical interaction and indicated a possible chemical interaction. To confirm chemical drug-drug or drug-excipient (s) interaction additional ATR-IR spectra for all samples used in this study were obtained. Results obtained from ATR-IR spectra showed drug-excipient (s) interaction in Zinnat ® , Azithromax ® and binary mixture Azithromax ® -paracetamol, while chemical drug-drug interaction was not observed. From this study it can be concluded that the concomitant oral administration of paracetamol with commercially available antibiotics used in this study is not recommended and duration of two hours between the oral administrations of these drugs is strongly recommended to avoid drug-drug or drug-excipient (s) interaction.

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Interaction study between pefloxacin mesilate and some diluents using DSC supported with isothermal method

Cited by 13 publications

References 13 publications

Fluconazole–excipient compatibility studies as the first step in the development of a formulation candidate for biowaiver

Fluconazole–excipient compatibility studies as the first step in the development of a formulation candidate for biowaiver

Exploring mixing uniformity of a pharmaceutical blend in a high shear mixture granulator using enthalpy values obtained from DSC

Incompatibility of Paracetamol with Pediatric Suspensions Containing Amoxicillin, Azithromycin and Cefuroxime Axetil

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