An experimental investigation of effusivity as an indicator of powder blend uniformity

Leonard, G. W.; Bertrand, François; Chaouki, Jamal; Gosselin, Patrick

doi:10.1016/j.powtec.2006.12.007

Cited by 40 publications

(16 citation statements)

References 26 publications

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“…These inadequacies refl ected problems in the ingredient mixing process and excipient and drug grain size variation, which altered the pharmacotechnics of the formulations and affected the release of the active agent of the capsules in most of the dissolution test samples. 13,15 The results suggest that the controls over the raw materials, compounding process and fi nished product quality were faulty or nonexistent in the pharmacies from which the formulations were dispensed. They also suggest that the pharmacies were not following the good practices for compounding medications for human use laid down in RDC Resolution No.…”

Section: Discussionmentioning

confidence: 99%

Avaliação da qualidade de cápsulas de sinvastatina de farmácias magistrais

Markman¹,

Rosa²,

Koschtschak³

2010

Rev. Saúde Pública

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OBJECTIVE:To validate a method for determining the simvastatin content of compounded capsules, using high performance liquid chromatography. METHODS:Eighteen samples of simvastatin 40 mg capsules from compounding pharmacies in the cities of São Paulo, Guarulhos, São Bernardo do Campo and Campinas, Southeastern Brazil, prescribed for fi ctitious patients were assessed. The analyses were based on the Brazilian Pharmacopoeia and on the high performance liquid chromatography method, optimized and validated in accordance with national and international standards for identifi cation and quantifi cation tests on compounded capsules. RESULTS:The mean weight of the capsules ranged from 70 mg to 316 mg; four samples presented weight variation outside of the specifi cation. The simvastatin content in the capsules was within the specifi cation in 11 samples. In six, the content ranged from 4% to 87% of the declared quantity, thereby not complying with the content requirements for the active agent. For one sample, no content or uniformity determinations were performed. In the content uniformity test, 15 samples presented indices of less than 85%, with relative standard deviations greater than 6%. Three pharmacies had met the specifi cation in this test. In the dissolution test, eight samples presented unsatisfactory results in the fi rst stage of the test, while the remainder presented inconclusive results. CONCLUSIONS:The method used was shown to be suitable for application to quality control, and it revealed the poor quality of the simvastatin capsules produced by some compounding pharmacies.

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Section: Discussionmentioning

confidence: 99%

Avaliação da qualidade de cápsulas de sinvastatina de farmácias magistrais

Markman¹,

Rosa²,

Koschtschak³

2010

Rev. Saúde Pública

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“…Nowadays, new chemical entities discovered are generally more targeted and potent so that the concentration of such drugs in the dosage form is very low. In certain cases, active concentrations can be lower than 1 wt.% and in case of such formulation, it becomes very tedious to achieve good blend uniformity, further emphasizing the need to strengthen the development of accurate and efficient technologies for characterizing blend homogeneity and determining optimal blending time [4].…”

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 techniques have been used to do this including near infrared spectroscopy (NIRS) (Ely et al, 2006), Raman spectroscopy (Hausman et al, 2005), thermal effusivity (Léonard et al, 2008), and laser-induced florescence spectroscopy (LIF) (Lai and Cooney, 2004;Lai et al, 2001). NIRS and Raman spectroscopy are used extensively in the pharmaceutical industry due to the range of pharmaceutically relevant materials for which they have unique spectra.…”

Section: Introductionmentioning

confidence: 99%