Formulation, Development and Scale-Up of Fixed-Dose Combination Tablets Containing Zidovudine, Lamivudine and Nevirapine.

Autor:	Lavra ZMM; Secretariat of Science, Technology and Strategic Inputs - Ministry of Health, Brasilia, DF, Brazil., de Medeiros FPM; Faculdade Pernambucana de Saude, Recife-PE, Brazil., da Silva RMF; Laboratorio de Tecnologia dos Medicamentos, Department of Pharmaceutical Sciences, Federal University of Pernambuco, Recife-PE, Brazil., Rosa TA; Laboratorio de Tecnologia dos Medicamentos, Department of Pharmaceutical Sciences, Federal University of Pernambuco, Recife-PE, Brazil., Wanderley Sales VA; Laboratorio de Tecnologia dos Medicamentos, Department of Pharmaceutical Sciences, Federal University of Pernambuco, Recife-PE, Brazil., Barros Silva LCPB; Laboratorio de Tecnologia dos Medicamentos, Department of Pharmaceutical Sciences, Federal University of Pernambuco, Recife-PE, Brazil., de Sousa ALMD; Laboratorio de Tecnologia dos Medicamentos, Department of Pharmaceutical Sciences, Federal University of Pernambuco, Recife-PE, Brazil., de Lima LG; Pharmaceutical Laboratory of Pernambuco (LAFEPE), Recife-PE, Brazil., Rolim LA; Pharmacy Collegiate, Federal University of Vale do Sao Francisco, Petrolina-PE, Brazil., Neto PJR; Laboratorio de Tecnologia dos Medicamentos, Department of Pharmaceutical Sciences, Federal University of Pernambuco, Recife-PE, Brazil.
Jazyk:	angličtina
Zdroj:	Current HIV research [Curr HIV Res] 2019; Vol. 17 (5), pp. 360-367.
DOI:	10.2174/1570162X17666190927162155
Abstrakt:	Background: The development of antiretroviral associations in a single dosage form aims to ensure improved efficacy, low costs and better adherence to treatment. Objective: This work performed the pharmacotechnical development, coating, and stability studies of fixed-dose combination tablets of zidovudine, lamivudine and nevirapine (300 + 200 + 150 mg, respectively). Methods: Qualitative and quantitative planning of diluents (101 and 250 microcrystalline cellulose, spray-dried monohydrate lactose and corn starch) and coating polymers (Opadry white II HP® and Instacoat Aqua Moistshield II®) were analyzed, and direct compression (DC) and wet granulation (WG) methods were tested aiming the development of the pharmaceutical form. Quality control was carried out according to the specifications set by official compendia. The chosen formulation was scaled-up and the industrial batches were submitted to accelerated and long-term stability studies. Results: The batches obtained by WG met the requirements, using 101 microcrystalline cellulose, corn starch and Opadry white II HP® as excipients. The DC trial was not possible due to the need of a greater ratio of excipients to improve formulation properties. Conclusion: Thus, this study brings a new therapeutic alternative for HIV treatment, contributing to the development of another possibility to simplify drug administration. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)
Databáze:	MEDLINE
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