Método para controle da qualidade de medicamentos sólidos por difração de raios X

• Ano de defesa: 2015
• Autor(a) principal: Salvi, Simone Toledo Bonemer de [UNESP]
• Tipo de documento: Tese
• Tipo de acesso: Acesso aberto
• Idioma: por
• Instituição de defesa: Universidade Estadual Paulista (Unesp)
• Palavras-chave em Português: Raios X; Cristalografia; Polimorfismo (Cristalografia); Fármacos; Crystallography
• Link de acesso: http://hdl.handle.net/11449/136087; http://www.athena.biblioteca.unesp.br/exlibris/bd/cathedra/22-02-2016/000854529.pdf

The x-ray powder diffraction (XPPD) is an excellent technique to obtain information about the crystal solid state on active pharmaceuticals ingredients (active ingredient) and inactive (excipients). Knowing that these ingredients can exhibit the phenomenon of polymorphism, this technique is efficient to differentiate among polymorphic forms. Beyond the problem of polymorphism, also, can occur changes in the crystallinity, dimensions and crystallites forms (physical characteristics), that must be maintained as the same characteristics that were used during the development and registration of medicament, because this factors can affect the farmaco bioavailability. To adequate analysis of these solids ingredients, some methods using DRXP data are recommended: Rietveld method (RM), Le Bail method (MLB), Pawley Method (PM) and the PONKCS method (Partial Or No Known Crystal Structure) which is based on RM. The RM can be adequately applied on characterization and quantification of crystal forms in polycrystalline materials, although the crystalline structure is necessary in this method. However, for many of these ingredients, there are few crystallographic information about, and for the cases that the crystal structure are unknown or partially known, the PONKCS method can be applied. As showed in the case of the excipient α-lactose monohydrate, present in the antihypertensive hydrochlorothiazide, and quantified 70.03wt% of lactose and 29.97wt% of hydrochlorothiazide, and in the case of the magnesium stearate, quantified in 1.4wt% on atenolol tablet. The PONKCS and Le Bail methods are used for profile fitting, and for identification of peaks in partially known crystal phases, but not used for quantification. The LBM and PM were used for profile fitting in the cases that the PONKCS method were applied, and in atenolol tests. The present work aimed identify and characterize excipients and pharmacos...