Recomendaciones para la elaboración y administración de fármacos antituberculosos en niños. Segunda fase del Proyecto Magistral de la Red Española de Estudio de la Tuberculosis Pediátrica (pTBred)

Pérez, Roi Piñeiro; Santiago-García, Begoña; Marrodán, Belén Rodríguez; Baquero-Artigao, Fernando; Fernández-Llamazares, Cecilia M.; Genestar, Joan Vinent; Durán, D. Gómez-Pastrana; Peña, M.J. Mellado

doi:10.1016/j.anpedi.2016.06.012

Cited by 13 publications

(3 citation statements)

References 7 publications

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“…Some national guidelines ( e.g. Spain [ 20 ], Ireland [ 21 ] and Germany [ 22 ]) even envisage ad hoc paediatric preparations from adult formulations approved in those countries.…”

Section: Resultsmentioning

confidence: 99%

Tuberculosis medicines for children in Europe: an unmet medical need

et al. 2023

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The availability of first-line medicines for the treatment of drug susceptible tuberculosis (DS-TB) is inconsistent across European countries. This is particularly worrisome for child-friendly medicines. There were reported examples of physicians being forced to adapt and/or combine formulations intended for adults to treat children with TB. Reduced compliance, unknown effects on treatment outcomes and unpredictable toxicity are potential consequences of resorting to these sub-optimal treatment options. Furthermore, the use of these alternatives may increase the risk of drug resistant TB. This study analyzed the availability and use of TB medicines in the European Union (EU)/ European Economic Area (EEA), with a particular focus on child-friendly formulations. We sought to carry out a full review of the situation by means of a survey involving the EU regulatory network. Countries were asked to confirm marketing status of anti DS-TB medicines, ways used to overcome their absence in their territory and the general difficulties they face to treat children with TB. Results confirmed that rifampicin suspension is the only child-friendly formulation available in Europe, approved in just ten Member States. Overall, 24 countries out of 30 considered the lack of adequate DS-TB medicines an unmet medical need. To overcome this, countries confirmed that they resort to importation or use adapted formulations. The joint forces of European institutions and pharmaceutical industry are crucial for the development of pediatric formulations and contribute to better compliance and health outcomes.

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“…Some national guidelines ( e.g. Spain [ 20 ], Ireland [ 21 ] and Germany [ 22 ]) even envisage ad hoc paediatric preparations from adult formulations approved in those countries.…”

Section: Resultsmentioning

confidence: 99%

Tuberculosis medicines for children in Europe: an unmet medical need

et al. 2023

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“…In the case of adults, a fixed-dose combination (FDC) of these three active pharmaceutical ingredients (APIs) is marketed as a sugar-coated tablet [2]. The combination of these three antiTBs in a solid oral tablet as FDC has many advantages over their individual administration, Pharmaceutics 2020, 12, 195 2 of 13 e.g., it improves adherence to treatment and reduces dosage errors [3]. A FDC for paediatrics has recently been approved by WHO/SRA/ERP as a dispersible (non-coated) tablet with a strawberry flavour at 50, 150, and 75 mg for INH, PZA, and RFP, respectively [4].…”

Section: Introductionmentioning

confidence: 99%

“…These tablets were developed in cooperation with TB Alliance and MacLeods [5] who have incorporated these APIs with the correct paediatric doses revised by WHO in 2010 [6]. However, this FDC has certain disadvantages: the doses are established according to a very wide weight range [3], tablets incorporate excipients that are not suitable for paediatrics (aspartame, microcrystalline cellulose), and quality problems as the poor bioavailability of RFP. The main reason hypothesized in the literature regarding this last question is the interaction between INH and RFP to yield isonicotinyl hydrazine (HYD) [7,8].…”

Section: Introductionmentioning

confidence: 99%

Stability Study of Isoniazid and Rifampicin Oral Solutions Using Hydroxypropyl-Β-Cyclodextrin to Treat Tuberculosis in Paediatrics

et al. 2020

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(1) Background: First-line antituberculosis treatment in paediatrics entails the administration of Isoniazid, Pyrazinamide, and Rifampicin. This study examines the possibility of developing a combined dose liquid formulation for oral use that would facilitate dose adjustment and adherence to treatment for younger children. (2) Methods: The active pharmaceutical ingredients stability under in vitro paediatric digestive pH conditions have been checked. The samples were studied as individual or fixed combined paediatric dosages to determine the pH of maximum stability. The use of hydroxypropyl-β-cyclodextrin to improve Rifampicin solubility and the use of ascorbic acid to increase the stability of the formulation have been studied. (3) Results: Maximum stability of combined doses was determined at pH 7.4, and maximum complexation at pH 8.0. Taking this into account, formulations presented the minimum dose of two active pharmaceutical ingredients dissolved. The addition of ascorbic acid at 0.1% w/v enables the detection of a higher remaining quantity of both drugs after three days of storage at 5 °C. (4) Conclusions: a formulation which combines the minimum paediatric dosages dissolved recommended by WHO for Isoniazid and Rifampicin has been developed. Future assays are needed to prolong the stability of the formulation with the aim of incorporating Pyrazinamide to the solution.

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Tuberculosis in children. Challenges and opportunities

Caminero

Scardigli²

2016

Anales de Pediatría (English Edition)

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Recomendaciones para la elaboración y administración de fármacos antituberculosos en niños. Segunda fase del Proyecto Magistral de la Red Española de Estudio de la Tuberculosis Pediátrica (pTBred)

Cited by 13 publications

References 7 publications

Tuberculosis medicines for children in Europe: an unmet medical need

Tuberculosis medicines for children in Europe: an unmet medical need

Stability Study of Isoniazid and Rifampicin Oral Solutions Using Hydroxypropyl-Β-Cyclodextrin to Treat Tuberculosis in Paediatrics

Tuberculosis in children. Challenges and opportunities

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