Desarrollo y caracterización de formulaciones farmacéuticas adaptadas para pediatría: medicamentos antituberculosos

Abstract

The use of individualized medicines for pediatrics are a useful alternative if there is no correct market dosage for this segment of population. However, a thorough investigation must be carried out in order to ensure quality testing, content uniformity, physical (homogeneity after shaking, in the case of liquid dosage forms), chemical, and microbiological stability. The quality of individualized medicines, used daily in pharmacy services (hospitals and community pharmacies), have been tested. Individualized medicine of Flecainide, Dexamethasone, Furosemide and Acetazolamide have been selected based on their demand, problems that arose during elaboration and the excipients used. In all cases, a new standard operative procedure, which ensures the quality of the individualized medicine, was developed for each active pharmaceutical ingredient studied and disseminated in the different services. The data obtained from the validation of the formulations previously mentioned, was used to elaborate a high-demanding strategy to ensure the highest quality standards of oral liquid individualized medicines for pediatric use. This included a first part related to the validation of the analytical method used, and a second part focused on the critical quality attributes that should be checked, some of them recommended by Pharmacopoeia. Active pharmaceutical ingredients used for the treatment of Tuberculosis were selected to develop medicines appropriate for children. Hence, a high-quality, child-friendly, fixed dose combination water- dispersible tablet of Isoniazid, Rifampicin and Pyrazinamide was developed according to international recommendations in terms of excipients for pediatrics and meeting pharmacopoeia requirements. In addition, its production has been optimized to be elaborated at maximum press speed while maintaining quality requirements.