Compatibility studies of aceclofenac with retard tablet excipients by means of thermal and FT-IR spectroscopic methods

Aigner, Zoltán; Heinrich, R.R.; Sipos, Eszter; Farkas, Gyöngyi; Ciurba, Adriana; Berkesi, Ottó; Szabó‐Révész, Piroska

doi:10.1007/s10973-010-1105-1

Cited by 40 publications

(18 citation statements)

References 15 publications

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“…This could be the result of the stabilization of the (Fig. 3b) was comparable to reported data (Aigner et al 2011;Mutalik and Udupa, 2005). The DSC thermogram of physical mixture of eugenol and Carbopol (Fig.…”

Section: Differential Scanning Calorimetrysupporting

confidence: 91%

Unveiling the compatibility of eugenol with formulation excipients by systematic drug-excipient compatibility studies

et al. 2015

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Background: The drug-excipient compatibility studies were carried out with the possible excipients viz. Tween 80, Carbopol 940, chitosan, sodium alginate, and polycaprolactone (PCL) for their possible use in the formulation of eugenol loaded nanoemulsion gels and nanoparticles. Methods: The eugenol-excipient compatibility studies were carried out by visual observations, differential scanning calorimetry (DSC), infrared spectroscopy (FTIR), and high-performance thin-layer chromatography (HPTLC). Results: No notable change was observed in the samples on visual observation. From the results of the DSC studies, to a much extent, it was assumed that eugenol was not subjected to any interaction with the selected excipients for the proposed nanoemulsion gel and nanoparticles. But in some cases viz. polycaprolactone and Carbopol, though not to a significant level, slight deviation of the nature and position of the endothermic peaks of eugenol were observed. The results of the IR spectroscopy confirmed the compatibility of eugenol with Tween 80, Carbopol 940, chitosan, sodium alginate, and polycaprolactone. The retention factor of the HPTLC densitogram peaks for all the physical mixtures was well within the retention factor (R f ) value range observed for pure eugenol. Conclusions: The study results confirmed that eugenol is compatible with the selected excipients for the development of nanoemulsion gels and nanoparticles.

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Section: Differential Scanning Calorimetrysupporting

confidence: 91%

Unveiling the compatibility of eugenol with formulation excipients by systematic drug-excipient compatibility studies

et al. 2015

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“…A third event was observed at 136.43°C corresponding to the melting of fluconazole. Magnesium stearate was incompatible with nebicapone [35], aceclofenac [36], and acetylsalicylic acid [37].…”

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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“…Chemical interactions result in reduction of API quantity in the formulation that can lower its absorption and therapeutic effect. Physical interactions can alter physicochemical properties of the active ingredient, such as solubility, dissolution rate and finally bioavailability [5,6]. There is no universally accepted protocol in the literature or issued by regulatory agencies for evaluating API-excipient compatibility or interactions [7,8].…”

Section: Introductionmentioning

confidence: 99%

Compatibility studies of hydrocortisone with excipients using thermogravimetric analysis supported by multivariate statistical analysis

Rojek

Wesołowski

2016

J Therm Anal Calorim

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Application of thermogravimetry (TG) alone to study compatibility/incompatibility of active pharmaceutical ingredients (APIs) with excipients yields to misleading results due to overlapping of the thermal stages in the course of decomposition of both ingredients and their pharmaceutical mixtures. Hence, the purpose of this study was to assess the usefulness of multivariate statistical analysis as a supporting tool for interpretation of the TG traces during assessing compatibility of hydrocortisone as an API with selected excipients (mannitol, starch, lactose, methylcellulose, b-cyclodextrin, meglumine, chitosan, magnesium stearate and polyvinylpyrrolidone). The results show that two multivariate techniques, principal component analysis (PCA) and cluster analysis (CA), can be successfully used for interpretation of TG traces, while the TG is used alone as a screening technique to assess compatibility. The results obtained by using TG analysis, supported by PCA and CA, were approved by those of differential scanning calorimetry, infrared spectroscopy and X-ray powder diffraction. Incompatibilities were only found in mixtures of hydrocortisone with magnesium stearate and b-cyclodextrin.

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Compatibility studies of aceclofenac with retard tablet excipients by means of thermal and FT-IR spectroscopic methods

Cited by 40 publications

References 15 publications

Unveiling the compatibility of eugenol with formulation excipients by systematic drug-excipient compatibility studies

Unveiling the compatibility of eugenol with formulation excipients by systematic drug-excipient compatibility studies

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

Compatibility studies of hydrocortisone with excipients using thermogravimetric analysis supported by multivariate statistical analysis

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