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Lamellar double hydroxides as pharmaceutical excipients: a compatibility study

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Abstract

Lamellar double hydroxides (LDH) are a class of inorganic materials widely used as pharmaceutical ingredients. However, their use as excipients and mainly as drug carriers lacks specific research in pharmaceutical technology, as there are no publications capable of defining the behavior of these materials as components of a formulation in the presence of other pharmaceutical adjuvants already consolidated. The purpose of the study was to evaluate the excipient–excipient compatibility of calcium and aluminum LDH (LDH–CaAl) against other excipients, including colloidal silicon dioxide (aerosil®), soluble starch (SS), microcrystalline cellulose 101 (MCC), magnesium stearate (MS), hydroxypropyl-beta-cyclodextrin (HPβCD), lactose monohydrate (LACM), sodium starch glycollate (SSG), PVP-K30 and talc. Initially, absorption spectroscopy in the infrared region with Fourier transform (FTIR) and thermogravimetry and differential thermal analysis (TG/DTA) was performed. When signs of possible interactions were observed, X-ray diffraction (XRD) was performed as a complementary technique. At the end of the study, the FTIR spectra and the TG curves of LDH–CaAl and each of the isolated excipients were compared with the analysis of the binary mixtures, where there is compatibility between LDH–CaAl and all excipients tested. Although the XRD has been used to assess evidence of interactions in mixtures with stearate, lactose, PVP and talc, the joint analysis of the results proved to be satisfactory. All these pioneering results suggest, therefore, the acceptability and suitability of LDH–CaAl as a potentially scalable excipient for the development of safe and rational dosage forms.

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Acknowledgements

To the Department of Science and Technology—Brazilian Ministry of Health (DECIT-MS) for fostering research and to National Council for Scientific and Technological Development—Brazilian Ministry of Science, Technology and Innovation (CNPq) for funding research grants.

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Authors and Affiliations

  1. Laboratório de Tecnologia dos Medicamentos (LTM), Departamento de Ciências Farmacêuticas, Universidade Federal de Pernambuco, Av. Prof. Arthur de Sá, s/n, Cidade Universitária, Recife, PE, 50740-521, Brazil

    Leslie Raphael de Moura Ferraz, Laysa Creusa Paes Barreto Barros Silva, Demis Ferreira de Melo, Natália Millena da Silva, Larissa Pereira Alves, Ilka do Nascimento Gomes Barbosa, Manuela Carine Cavalcante Erhardt & Pedro José Rolim Neto

  2. Núcleo de Pesquisa em Biodiversidade e Biotecnologia (Biotec), Universidade Federal do Piauí, Parnaíba, PI, 64202-020, Brazil

    Leiz Maria Costa Véras

  3. Central Analítica de Fármacos, Medicamentos e Alimentos (CAFMA), Universidade Federal do Vale do São Francisco, Av. José de Sá Maniçoba, s/n, Centro, Petrolina, PE, 56304-917, Brazil

    Larissa Araújo Rolim

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Contributions

All authors contributed to the design and development of the study. The preparation of the material, execution of the tests and analysis of the data were carried out by [LRdeMF], [LCPBBS], [IdoNGB], [MCCE] and [DFdeM]. The first draft of the manuscript was written by [LRdeMF], [NMdaS], [LPA] and [LMCV], and all authors commented on the previous versions of the manuscript. The final review was carried out by [LAR] and [PJRN]. All authors read and approved the final manuscript.

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Correspondence to Laysa Creusa Paes Barreto Barros Silva.

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de Moura Ferraz, L.R., Silva, L.C.P.B.B., de Melo, D.F. et al. Lamellar double hydroxides as pharmaceutical excipients: a compatibility study. J Therm Anal Calorim 149, 2857–2872 (2024). https://doi.org/10.1007/s10973-024-12882-6

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