Thermal characterization of antimicrobial drug ornidazole and its compatibility in a solid pharmaceutical product

Soares, Mônica Felts de La Roca; Sobrinho, José Lamartine Soares; Silva, Keyla Emanuelle Ramos da; Alves, Lariza Darlene Santos; Lopes, Pablo Queiroz; Correia, Lidiane Pinto; Souza, Fábio Santos de; Macêdo, Rui Oliveira; Rolim-Neto, Pedro José

doi:10.1007/s10973-010-1185-y

Cited by 22 publications

(4 citation statements)

References 19 publications

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“…The sterilisation procedures using irradiation have many advantages, such as high efficiency, no temperature requirements, possibility of sterilisation in packages but on the other hand, the ionisation radiation applied can damage a given drug being sterilised [9] so the effect of sterilisation radiation should be checked before its application. One of the most widely used methods of analysing the drugs purity and possible changes occurring during processing of drug is the differential scanning calorimetry (DSC) [10][11][12]. The aim of this study was to check the effect of radiation sterilisation on disulfiram in solid phase by DSC and spectroscopic methods.…”

Section: Introductionmentioning

confidence: 99%

DSC and spectroscopic studies of disulfiram radiostability in the solid state

Marciniec

Dettlaff

Naskrent

et al. 2011

J Therm Anal Calorim

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The effect of ionising radiation on the physicochemical properties of disulfiram (Antabuse, Esperal, bisdiethylthiocarbamoil disulphide) has been studied by DSC, FTIR, EPR, MS, TLC and HPLC. Sterilisation was carried out in the solid state, at room temperature and normal air humidity using the electron beam of 9.96 Mev from accelerator. All the measurements were made simultaneously for the irradiated and nonirradiated substance. It has been found that the drug studied in solid phase when subjected to an electron beam corresponding to the irradiation in the doses 10-100 kGy shows the presence of free radicals (EPR), and a change in colour from white to pale green-grey that disappears after solution in water or methanol. After the irradiation with the dose of 100 kGy, its melting point and enthalpy slightly decreased. Also the content of the active substance decreases (HPLC-1.5%, UV-3.6%, iodometric titration method-2.7%) and trace amounts of the radiolysis products appear (HPLC). The substance irradiated with the doses 10-50 kGy does not show changes in the melting point, in the content and presence of the radiolysis products. The EPR results have shown that free radicals disappear after about a year and the discolouring disappears with them. The results of this study have shown that disulfiram can be subjected to sterilisation by irradiation with no deterioration of its physico-chemical properties, but a long time of storage needed to remove free radicals and discolouration questions the economic justification for this type of sterilisation.

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Section: Introductionmentioning

confidence: 99%

DSC and spectroscopic studies of disulfiram radiostability in the solid state

Marciniec

Dettlaff

Naskrent

et al. 2011

J Therm Anal Calorim

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“…Indeed, interactions between potential physical and chemical drugs and excipients increase the chemical structure, stability and bioavailability of the drug. This may affect the efficacy of the drug (Oliveira et al, 2010, Soares et al, 2011, Soares-Sobrinho et al, 2010, Tita et al, 2011, Verma et al, 2005, Viana et al, 2008. There are two types of chemical incompatibilities in the literature.…”

Section: Introductionmentioning

confidence: 99%

Study of Stability and Drug-Excipient Compatibility of Estriol

Canbay

Polat

Doğantürk

2019

Bilge International Journal of Science and Technology Research

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Estriol, is a major urinary estrogen hormone. Differential scanning calorimetry (DSC) and Fourier-transform infrared spectroscopy (FTIR) were used to assess the compatibility between estriol and drug excipients (1:1; w/w). In this study, thermodynamic and spectroscopic data obtained from pure estriol and mixtures of pure estriol with pharmaceutical excipients were compared. Preliminary studies using thermal and spectroscopic technique implied the compatibility of mannitol, calcium phosphate dibasic, sucrose, butylated hydroxyanisole, cellulose, lactose, magnesium stearate, talc and sodium carboxymethyl cellulose with the drug estriol. As a result of the experimental study, there is incompatibility of estriolmannitol, estriol-sucrose, estriol-lactose and estriol-magnesium stearate.

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“…Indeed, potential physical and chemical interactions between drug and excipients can affect the chemical nature, stability, and bioavailability of a drug and thus its effectiveness [1][2][3][4][5][6]. In the literature, two types of chemical incompatibilities have been described: (i) excipient-promoted intrinsic degradation of the drug, such as hydrolysis or oxidation and/or (ii) a covalent reaction between the drug and the excipient [5,7].…”

Section: Introductionmentioning

confidence: 99%

Study of stability and drug-excipient compatibility of estradiol and pharmaceutical excipients

Gao

Jin

Yang

et al. 2014

J Therm Anal Calorim

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Estradiol (E 2 ) is the main drug used in menopause therapy. This study aimed to evaluate the drugexcipient compatibility of binary mixtures (BMs) (1:1 BMs, w/w), initially by differential scanning calorimetry (DSC), and subsequently, by complementary techniques such as X-ray powder diffraction (XRPD) and high performance liquid chromatography (HPLC) if there was any evidence of interaction. The samples were stored under accelerated stability conditions (40°C at 75 % relative humidity). The DSC curves of estradiol and the BMs with excipients (corn starch, lactose, xanthan gum, microcrystalline cellulose, magnesium stearate, dibasic calcium phosphate, and talc) were obtained. The results show that estradiol was compatible with all the selected excipients. XRPD and HPLC analysis were instrumental in interpreting the DSC results and excluding relevant pharmaceutical incompatibilities in all cases. Overall, the compatibility of the selected excipients with estradiol was successfully evaluated using a combination of thermal and spectroscopic methods, and the formulations developed using the compatible excipients were found to be stable.

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Thermal characterization of antimicrobial drug ornidazole and its compatibility in a solid pharmaceutical product

Cited by 22 publications

References 19 publications

DSC and spectroscopic studies of disulfiram radiostability in the solid state

DSC and spectroscopic studies of disulfiram radiostability in the solid state

Study of Stability and Drug-Excipient Compatibility of Estriol

Study of stability and drug-excipient compatibility of estradiol and pharmaceutical excipients

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