Effects of formulation and manufacturing process on drug release from solid self-emulsifying drug delivery systems prepared by high shear mixing

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dc.creatorAraújo, Gustavo Parreira
dc.creatorMartins, Felipe Terra
dc.creatorTaveira, Stephânia Fleury
dc.creatorCunha Filho, Marcilio Sérgio Soares da
dc.creatorMarreto, Ricardo Neves
dc.date.accessioned2023-11-06T12:58:39Z
dc.date.available2023-11-06T12:58:39Z
dc.date.issued2021
dc.description.abstractThis study sought to investigate the influence of formulation and process factors of the high shear mixing (HSM) on the properties of solid self-emulsifying drug delivery systems (S-SEDDS) containing the model drug carvedilol (CAR). Firstly, liquid SEDDS (L-SEDDS) were prepared by mixing castor oil with different proportions of surfactant (Solutol or Kolliphor RH40) and cosolvent (Transcutol or PEG400). A miscible L-SEDDS with high drug solubility (124.3 mg/g) was selected and gave rise to 10% (m/m) CAR loaded-emulsion with reduced particle size. Then, a factorial experimental design involving five component’s concentration and two process factors was used to study the solidification of the selected L-SEDDS by HSM. CAR content, diffractometric profile, and in vitro dissolution were determined. Morphological and flow analyses were also performed. Porous and spherical particles with mean sizes ranging from 160 to 210 µm were obtained. Particle size was not affected by any formulation factor studied. Powder flowability, in turn, was influenced by L-SEDDS and crospovidone concentration. CAR in vitro dissolution from S-SEDDS was significantly increased compared to the drug as supplied and was equal (pH 1.2) or lower (pH 6.8) than that determined for L-SEDDS. Colloidal silicon dioxide decreased drug dissolution, whereas an increase in water-soluble diluent lactose and L-SEDDS concentration increased CAR dissolution. The proper selection of liquid and solid constituents proved to be crucial to developing an S-SEDDS by HSM. Indeed, the results obtained here using experimental design contribute to the production of S-SEDDS using an industrially viable process.
dc.identifier.citationARAÚJO, Gustavo Parreira et al. Effects of formulation and manufacturing process on drug release from solid self-emulsifying drug delivery systems prepared by high shear mixing. AAPS PharmSciTech, [s. l.], v. 22, e254, 2021. DOI: 10.1208/s12249-021-02128-1. Disponível em: https://link.springer.com/article/10.1208/s12249-021-02128-1. Acesso em: 31 out. 2023.
dc.identifier.doi10.1208/s12249-021-02128-1
dc.identifier.issne- 1530-9932
dc.identifier.urihttps://link.springer.com/article/10.1208/s12249-021-02128-1
dc.language.isoeng
dc.publisher.countryEstados unidos
dc.publisher.departmentInstituto de Química - IQ (RMG)
dc.rightsAcesso Restrito
dc.subjectHigh shear mixer
dc.subjectDissolution enhancement
dc.subjectCarvedilol
dc.subjectFactorial design
dc.subjectSelf-emulsifying drug delivery system
dc.titleEffects of formulation and manufacturing process on drug release from solid self-emulsifying drug delivery systems prepared by high shear mixing
dc.typeArtigo

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