Impact of storage conditions on a new child-friendly dispersible tablet for treating Tuberculosis in pediatrics.

Suárez-González, Javier; Santoveña, Ana; Soriano, Mabel; Fariña, José B.

doi:10.34172/ps.2021.46

Cited by 2 publications

(2 citation statements)

References 1 publication

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“…Previously, the methods to detect and quantify rifampicin, isoniazid, pyrazinamide and hydrazine were successfully validated, being linear, precises and accurate as can be found in previously published studies [19,20].…”

Section: Analytical Methods Validationmentioning

confidence: 90%

“…Levofloxacin method was adapted for UPLC from a previously published article developed for High Performance Liquid Chromatography [18]. Rifampicin, isoniazid, pyrazinamide and hydrazine methods were previously validated and published by the investigation group [19,20]. For the analysis of these products a reversed phase C18 column (X-Select1 CSH C18 [2.1 × 75 mm; 2.5 μm] (Waters, USA)) was used as stationary phase.…”

Section: Analytical Methods Validationmentioning

confidence: 99%

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A pharmaceutical monitoring system to assess the quality of antituberculosis drug products used in Mauritania

et al. 2023

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The quality of drug products may be affected from manufacture to dispensing, particularly at high temperature and humidity as in Mauritania. This country is not included in the World Health Organization reports on poor quality products due to the lack of a qualified laboratory and monitoring system. Ensuring the quality of medicine is even more relevant in the case of diseases such as Tuberculosis, due to its high prevalence, complex treatment and continuous bacterial resistance. The aim was to develop a monitoring system to assess the quality of antituberculosis drugs products, by the substandard detection based on European and United States Pharmacopeial recommendations regarding quality control. In addition to studying the influence of accelerated storage conditions (40 ± 2°C/75 ± 5% relative humidity) on their qualities and comparing the dissolution profiles to contrast the quality. 18 antituberculosis drug products were taken from Europe and Mauritania, and quality was studied through visual inspection and according to the compliance of the mass uniformity, uniformity of dosage units, dissolution, disintegration and friability pharmacopeial tests. Furthermore, a dissolution profile comparison was carried out to examine quality. A stability study was conducted to assess the influence of climatic conditions on the content and the dissolved amount of the active pharmaceutical ingredients, which were determined by an ultra-performance liquid chromatography system. As result, 69.3% of 13 Mauritanian formulations had a substandard quality mainly due to non-compliance with the test for friability or content uniformity of these medicines. All European drug products complied with pharmacopeia specifications. In addition, storage conditions affected the dissolution rate of ethambutol and the uniformity of the 4 antituberculosis combination drug products.

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Section: Analytical Methods Validationmentioning

confidence: 90%

Section: Analytical Methods Validationmentioning

confidence: 99%

A pharmaceutical monitoring system to assess the quality of antituberculosis drug products used in Mauritania

et al. 2023

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Development and Optimization of a New UPLC-UV/MS Method through DoE and MLR for Detecting Substandard Drug Products to Treat Tuberculosis

et al. 2022

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Drug products used for treating tuberculosis are one of the most widely reported medicines to be classified as falsified or substandard in low- and middle-income countries, representing a major hazard to health. The aim of this study was, firstly, to develop an ultra-performance liquid chromatography (UPLC) method which is able to analyze fixed combination tablets with up to four active pharmaceutical ingredients, including isoniazid, pyrazinamide, rifampicin, and ethambutol. Secondly, we aimed to optimize it through the design of experiments and multi-linear regression based on a central composite design and to validate it according to the guidelines of the International Conference on Harmonization. The application of this tools enabled the identification of the influential factors (flow rate, formic acid, and temperature) and their effects on the studied responses (retention factor and percentage for each drug) as part of the quality by design approach. The method proved to be to be linear in the range from 5.0 to 15 µg/mL for isoniazid, pyrazinamide, and rifampicin, being precise (<1%) and accurate (97–101%). In addition, the method validated for ethambutol proved to be linear from 1.4 to 4.2 µg/mL, as well as precise (0.54%) and accurate (97.3%). The method was stability indicated for all the active pharmaceutical ingredients studied and was able to detect two substandard formulations sampled on the African market.

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Impact of storage conditions on a new child-friendly dispersible tablet for treating Tuberculosis in pediatrics.

Cited by 2 publications

References 1 publication

A pharmaceutical monitoring system to assess the quality of antituberculosis drug products used in Mauritania

A pharmaceutical monitoring system to assess the quality of antituberculosis drug products used in Mauritania

Development and Optimization of a New UPLC-UV/MS Method through DoE and MLR for Detecting Substandard Drug Products to Treat Tuberculosis

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