Application of DSC, IST, and FTIR study in the compatibility testing of nateglinide with different pharmaceutical excipients

Pani, Nihar Ranjan; Nath, Lila Kanta; Acharya, S.; Bhuniya, Biswanath

doi:10.1007/s10973-011-1299-x

Cited by 78 publications

(22 citation statements)

References 16 publications

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“…The presence of excipients can induce in solid formulation, mainly physical and chemical interactions, while in vivo can lead to physiological ones [9]. Several instrumental techniques were employed in the analysis of newly obtained derivatives [10], but as well in evaluation of compatibility/incompatibility of active pharmaceutical ingredients (API) with excipients, namely thermoanalytical ones [11][12][13], FTIR spectroscopy [14], DSC [15] and XRD [16]. For a complete understanding of solid-state stability and decomposition, kinetic analysis can be performed on both bioactive/potentially bioactive molecules [17][18][19][20].…”

Section: Introductionmentioning

confidence: 99%

Selection of solid-state excipients for simvastatin dosage forms through thermal and nonthermal techniques

Ledeți

Vlase

et al. 2015

J Therm Anal Calorim

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The importance of developing new pharmaceutical final formulations is nowadays well known. In this paper, we present the study of compatibility between bioactive antihyperlipidemic agent simvastatin and eight currently used pharmaceutical excipients for developing solid dosage forms, namely starch, microcrystalline cellulose, lactose monohydrate, polyvinylpyrrolidone, colloidal silica, talc, magnesium citrate and sorbitol. The compatibility investigations were carried out under ambient temperature by FTIR spectroscopy studies and PXRD patterns and then completed by the use of thermal analysis (TG/DTG/HF) data to study the influence of temperature over stability of binary mixtures.

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Section: Introductionmentioning

confidence: 99%

Selection of solid-state excipients for simvastatin dosage forms through thermal and nonthermal techniques

Ledeți

Vlase

et al. 2015

J Therm Anal Calorim

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“…This shift could be attributed to some solid-solid interaction, although it does not necessarily indicate any incompatibility (33,34). It was reported that minor changes in the melting endotherm of drug could be due to mixing of drug and excipient, which lowers the purity of each component in the mixture and may not necessarily indicate potential incompatibility (30,31). Accordingly, for a better understanding of the changes in the binary mixtures, physical mixtures of mesalazine with Carbopol® and PVP were subjected to FT-IR studies and their spectra were compared to FT-IR spectrum of mesalazine.…”

Section: Stability Studymentioning

confidence: 99%

Once Daily, High-Dose Mesalazine Controlled-Release Tablet for Colonic Delivery: Optimization of Formulation Variables Using Box–Behnken Design

2011

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Abstract. The aim of this work was to statistically optimize a novel high-dose, mesalazine colonic delivery matrix system, potentially suitable for once daily administration, using simple wet granulation method. A hydrophobic-hydrophilic polymeric blend was used to manipulate drug release. A three-factor, three-level Box-Behnken design was used to construct polynomial models correlating the dependent and independent variables. Independent formulation variables were the percentages of the hydrophilic polymer Carbopol® 940, hydrophobic polymer Eudragit® RS, and the superdisintegrant croscarmellose sodium. The cumulative percentages of drug released at 6, 10, and 14 h were selected as dependent variables and restricted to 7.5-22.5% (Y 1 ), 42.5-57.5 % (Y 2 ), and 72.5-87.5% (Y 3 ), respectively. A second-order polynomial equation fitted to the data was used to optimize the independent formulation variables. Based on Box-Behnken experimental design, different mesalazine release profiles were obtained. The optimized formulation containing 5.72% Carbopol®, 9.77% Eudragit® RS, and 1.45% croscarmellose sodium was prepared according to the software determined levels. It provided a release profile which was very close to the targeted release profile, where the calculated values of f 1 and f 2 were 8.47 and 67.70, respectively, and followed zero-order release kinetics.

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“…Therapeutic incompatibilities are the modification of the therapeutic effect of Compatibility studies are usually aimed at identifying the most common incompatibility, for example, an incompatibility in dosage form can be identified as any of the following changes: change in appearance, decrease in potency, loss in mechanical properties, changes in dissolution profile, loss through sublimation and increase in degradation products [4] [5] [6] [7]. A number of experimental techniques (i.e., DSC, X-ray powder diffraction, optical and Electron Microscopy, FT-IR spectroscopy, etc.)…”

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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Application of DSC, IST, and FTIR study in the compatibility testing of nateglinide with different pharmaceutical excipients

Cited by 78 publications

References 16 publications

Selection of solid-state excipients for simvastatin dosage forms through thermal and nonthermal techniques

Selection of solid-state excipients for simvastatin dosage forms through thermal and nonthermal techniques

Once Daily, High-Dose Mesalazine Controlled-Release Tablet for Colonic Delivery: Optimization of Formulation Variables Using Box–Behnken Design

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

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