Thermal decomposition of some diuretic agents

Valladão, Dênia Mendes de Sousa; Oliveira, Lincoln Carlos Silva de; Netto, José Zuanon; Ionashiro, Massao

doi:10.1007/bf01979243

Cited by 18 publications

(13 citation statements)

References 3 publications

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“…TGA was used to analyse the thermal degradation temperature of both polymers and APIs. HCTZ, was previously reported to be thermally stable over a wide range of temperatures (Valladao et al, 1996) (stable up to at least 301 °C). This was verified in our studies, while RAM was shown to thermally degrade just above its melting point (at 123 °C) (Supplemental Figure S 1).…”

Section: Physiochemical Characterizationmentioning

confidence: 99%

A comparative study between hot-melt extrusion and spray-drying for the manufacture of anti-hypertension compatible monolithic fixed-dose combination products

Kelleher

Gilvary

Madi

et al. 2018

International Journal of Pharmaceutics

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The purpose of this work was to investigate the application of different advanced continuous processing techniques (hot melt extrusion and spray drying) to the production of fixed-dose combination (FDC) monolithic systems comprising of hydrochlorothiazide and ramipril for the treatment of hypertension. Identical FDC formulations were manufactured by the two different methods and were characterised using powder X-ray diffraction (PXRD) and modulated differential scanning calorimetry (mDSC). Drug dissolution rates were investigated using a Wood's apparatus, while physical stability was assessed on storage under controlled temperature and humidity conditions. Interestingly both drugs were transformed into their amorphous forms when spray dried, however, hydrochlorothiazide was determined, by PXRD, to be partially crystalline when hot melt extruded with either polymer carrier (Kollidon® VA 64 or Soluplus®). Hot melt extrusion was found to result in significant degradation of ramipril, however, this could be mitigated by the inclusion of the plasticizer, polyethylene glycol 3350, in the formulation and appropriate adjustment of processing temperature. The results of intrinsic dissolution rate studies showed that hot-melt extruded samples were found to release both drugs faster than identical formulations produced via spray drying. However, the differences were attributable to the surface roughness of the compressed discs in the Wood's apparatus, rather than solid state differences between samples. After a 60-day stability study spray dried samples exhibited a greater physical stability than the equivalent hot melt extruded samples.

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Section: Physiochemical Characterizationmentioning

confidence: 99%

A comparative study between hot-melt extrusion and spray-drying for the manufacture of anti-hypertension compatible monolithic fixed-dose combination products

Kelleher

Gilvary

Madi

et al. 2018

International Journal of Pharmaceutics

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“…Wendlandt and Collins 2 used DTA and TG thermal analysis techniques as aids in the characterization and identification of commercial non-preescription analgesics. Other investigations of the use of thermal analysis techniques for the study of drug substances and for applications in routine pharmaceutical analysis and in the pharmaceutical industry have also been described [3][4][5][6][7][8][9][10][11][12][13][14][15][16] . No reference has been found on the application of TG and DSC in the study of trimethoprim, sulfamethoxazole, ampicillim, tetracycline hydrochloride, rifampim and association of sulfamethoxazole with trimethoprim.…”

Section: Introductionmentioning

confidence: 99%

Thermal decomposition of some chemotherapic substances

Fernandes¹,

Filho²,

Mendes³

et al. 1999

J. Braz. Chem. Soc.

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Termogravimetria, termogravimetria derivada (TG,DTG), calorimetria exploratória diferencial (DSC) e difratometria de raios X foram utilizados para estudar o trimetroprim, sulfametoxazol, ampicilina, cloridrato de tetraciclina e rifampicina. Os resultados permitiram obter informações sobre a estabilidade térmica destes compostos e a decomposição térmica em atmosfera de ar.Thermogravimetry, derivative thermogravimetry (TG, DTG), differential scanning calorimetry (DSC) and X ray diffraction powder patterns have been used to study trimethoprim, sulfamethoxazole, ampicillim, tetracycline hydrochloride and rifampim. The results revealed the extent of their thermal stability and also allowed interpretations concerning their thermal decompositions in air atmosphere.

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“…Previous studies indicated that this mass loss corresponds to one of the three furosemide degradation steps. 48 For all APIs, no water loss was observed in the usual range (room temperature to 100 ºC), 32 which can be explained by the low TGA sensitivity.…”

Section: Thermogravimetric Analysismentioning

confidence: 90%

Determination of volatiles in pharmaceutical certified reference materials

Nogueira¹,

Queiroz²,

Silva³

et al. 2012

J. Braz. Chem. Soc.

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Este trabalho compara os resultados obtidos na determinação de voláteis (água e solventes residuais) em novos materiais de referência certificados (MRC) ou candidatos a MRC dos ingredientes ativos farmacêuticos (API) captopril, metronidazol, diclofenaco sódico, diclofenaco potássico e furosemida, através do uso de diferentes técnicas: perda por dessecação (LOD), titulação coulométrica tipo Karl Fisher (KF), cromatografia gasosa (injeção por headspace estático) com detector por ionização em chama (sHS-GC-FID) e com espectrômetro de massas (sHS-GC-MS), análise termogravimétrica (TGA) e espectroscopia no infravermelho próximo (NIR) com análise estatística multivariada dos resultados. As três primeiras técnicas levaram a resultados complementares na determinação de voláteis, enquanto as outras duas mostraram pouca sensibilidade para a determinação de voláteis na faixa de concentração avaliada. A perda por dessecação foi considerada a técnica mais apropriada para determinação da fração mássica de voláteis a ser utilizada no cálculo do teor de API por balanço de massa.This work compares the results obtained for the determination of volatiles (water and residual solvents) in new certified reference materials (CRM) or candidate CRMs of the active pharmaceutical ingredients (API) captopril, metronidazole, sodium diclofenac, potassium diclofenac and furosemide, by means of different techniques: loss on drying (LOD), Karl Fischer (KF) coulometric titration, static headspace gas chromatography with flame ionization detection (sHS-GC-FID) and with mass spectrometry (sHS-GC-MS), thermogravimetric analysis (TGA) and near infrared spectroscopy (NIR) with multivariate chemometric analysis of results. The first three methods led to complementary results. The two other techniques were not sufficiently sensitive to determine volatiles in the concentration range evaluated. The loss on drying method was considered the most appropriate to determine the mass fraction of the volatiles to be used in the mass balance calculation of the API mass fraction in the pharmaceutical CRMs.Keywords: volatiles, water, residual solvents, active pharmaceutical ingredient (API), certified reference materials (CRM), analytical quality control IntroductionSeveral are the reasons for determining the mass fractions of water and residual solvents in pharmaceuticals, including their influence on the physicochemical 1-7 and microbiological stability of raw materials and finished products, their potential toxicity [1][2][3]8 and also economic aspects 9 since their presence results in analyte mass fractions smaller than 100%. Residual solvents may be introduced in active pharmaceutical ingredients (API) during their synthesis, especially if the final purification step is carried out by crystallization in different solvents, as well as during drug products formulation and manufacturing. 1,7,8 In the particular case of certified reference materials (CRM) of APIs, the determination of volatiles is essential both to demonstrate the compliance with Pharmacopeial acc...

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Thermal decomposition of some diuretic agents

Cited by 18 publications

References 3 publications

A comparative study between hot-melt extrusion and spray-drying for the manufacture of anti-hypertension compatible monolithic fixed-dose combination products

A comparative study between hot-melt extrusion and spray-drying for the manufacture of anti-hypertension compatible monolithic fixed-dose combination products

Thermal decomposition of some chemotherapic substances

Determination of volatiles in pharmaceutical certified reference materials

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