Publicado

2020-05-01

Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations)

Evaluación de propiedades fisicoquímicas y estudios de disolución sobre el control de calidad de fármacos de baja solubilidad en agua (materias primas y formulaciones farmacéuticas)

DOI:

https://doi.org/10.15446/rcciquifa.v49n2.89486

Palabras clave:

Drugs, low water solubility, physicochemical characterization, dissolution, quality control (en)
Drogas, baja solubilidad en agua, caracterización fisicoquímica, disolución, control de calidad (es)

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Autores/as

  • Matheus da Silva Ferreira Department of Exact and Earth Sciences (DCET), State University of Bahia (UNEB), Campus I, 2555 Silveira Martins Street, Cabula, 41150-000, Salvador, Bahia
  • Gilmar Antônio de Carvalho Teles Júnior Department of Life Sciences (DCV), State University of Bahia (UNEB), Campus I, 2555 Silveira Martins Street, Cabula, 41150-000, Salvador, Bahia
  • Carlos Magno Ramos Carvalho Júnior Department of Life Sciences (DCV), State University of Bahia (UNEB), Campus I, 2555 Silveira Martins Street, Cabula, 41150-000, Salvador, Bahia
  • Fernanda de Souza Dias Department of Life Sciences (DCV), State University of Bahia (UNEB), Campus I, 2555 Silveira Martins Street, Cabula, 41150-000, Salvador, Bahia
  • Wilson Saback Dias dos Santos Júnior Department of Life Sciences (DCV), State University of Bahia (UNEB), Campus I, 2555 Silveira Martins Street, Cabula, 41150-000, Salvador, Bahia
  • Marluce Oliveira da Guarda Souza Department of Exact and Earth Sciences (DCET), State University of Bahia (UNEB), Campus I, 2555 Silveira Martins Street, Cabula, 41150-000, Salvador, Bahia
  • Aníbal de Freitas Santos Júnior Department of Exact and Earth Sciences (DCET), State University of Bahia (UNEB), Campus I, 2555 Silveira Martins Street, Cabula, 41150-000, Salvador, Bahia

The purpose of this study was to evaluate physicochemical properties and dissolution studies of furosemide (FUR), hydrochlorothiazide (HCTZ) and nifedipine (NIF), low water solubility drugs, in raw materials and pharmaceutical formulations. Surface and physicochemical characterization techniques -scanning electronic microscopy (SEM), thermogravimetry (TG), X-ray diffraction (XRD) and infrared (IR) spectrometry- as well as physical and physicochemical tests on tablets and capsules were applied as supporting information on drug quality control. Simple, rapid, and efficient UV-Vis methods were developed and validated for the determination of FUR, HCTZ and NIF samples. SEM exhibited considerable differences in the crystal morphological structures. Among the drugs studied, except for furosemide, more than one polymorph was present in the samples. Drug release profiles were satisfactory for all products. FUR and HCTZ tablets exhibited similar dissolution profiles, with very rapid release to the pharmaceutical specialties (reference, similar and generic). For HCTZ tablets, the similar drug (f2= 48.74) is not equivalent to the reference drug. NIF capsules (reference and compounded) showed a release ≥80% of stated on product labels, in 10 minutes. The results obtained in this study suggest that the quality parameters and drug dissolution profiles may have been influenced by the morphology and size of the crystals, excipients, and technological processes.

El propósito de este estudio fue evaluar las propiedades fisicoquímicas y los estudios de disolución de furosemida (FUR), hidroclorotiazida (HCTZ) y nifedipina (NIF), medicamentos de baja solubilidad en agua, en materias primas y formulaciones farmacéuticas. Técnicas de caracterización fisicoquímica y de superficie: microscopía electrónica de barrido (SEM), termogravimetría (TG), difracción de rayos X (XRD) y espectrometría infrarroja (IR), así como pruebas físicas y fisicoquímicas en tabletas y cápsulas que se aplicaron como información de apoyo sobre el control de calidad. Se desarrollaron y validaron métodos simples, rápidos y eficientes de UV-Vis para la determinación de muestras de FUR, HCTZ y NIF. SEM exhibió diferencias considerables en las estructuras morfológicas de cristal. Entre las drogas estudiadas, a excepción de la furosemida, más de un polimorfo estaba presente en las muestras. Los perfiles de liberación de fármacos fueron satisfactorios para todos los productos. Las tabletas FUR y HCTZ exhibieron perfiles de disolución similares, con una liberación muy rápida a las especialidades farmacéuticas (referencia, similares y genéricas). Para las tabletas de HCTZ, el medicamento similar (f2= 48,74) no es equivalente al medicamento de referencia. Las cápsulas NIF (de referencia y compuestas) mostraron una liberación ≥80% de la indicada en las etiquetas del producto, en 10 minutos. Los resultados obtenidos en este estudio sugieren que los parámetros de calidad y los perfiles de disolución del fármaco pueden haber sido influenciados por la morfología y el tamaño de los cristales, excipientes y procesos tecnológicos.

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Cómo citar

APA

da Silva Ferreira, M., de Carvalho Teles Júnior, G. A., Ramos Carvalho Júnior, C. M., de Souza Dias, F., Dias dos Santos Júnior, W. S., Oliveira da Guarda Souza, M. y de Freitas Santos Júnior, A. (2020). Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations). Revista Colombiana de Ciencias Químico-Farmacéuticas, 49(2). https://doi.org/10.15446/rcciquifa.v49n2.89486

ACM

[1]
da Silva Ferreira, M., de Carvalho Teles Júnior, G.A., Ramos Carvalho Júnior, C.M., de Souza Dias, F., Dias dos Santos Júnior, W.S., Oliveira da Guarda Souza, M. y de Freitas Santos Júnior, A. 2020. Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations). Revista Colombiana de Ciencias Químico-Farmacéuticas. 49, 2 (may 2020). DOI:https://doi.org/10.15446/rcciquifa.v49n2.89486.

ACS

(1)
da Silva Ferreira, M.; de Carvalho Teles Júnior, G. A.; Ramos Carvalho Júnior, C. M.; de Souza Dias, F.; Dias dos Santos Júnior, W. S.; Oliveira da Guarda Souza, M.; de Freitas Santos Júnior, A. Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations). Rev. Colomb. Cienc. Quím. Farm. 2020, 49.

ABNT

DA SILVA FERREIRA, M.; DE CARVALHO TELES JÚNIOR, G. A.; RAMOS CARVALHO JÚNIOR, C. M.; DE SOUZA DIAS, F.; DIAS DOS SANTOS JÚNIOR, W. S.; OLIVEIRA DA GUARDA SOUZA, M.; DE FREITAS SANTOS JÚNIOR, A. Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations). Revista Colombiana de Ciencias Químico-Farmacéuticas, [S. l.], v. 49, n. 2, 2020. DOI: 10.15446/rcciquifa.v49n2.89486. Disponível em: https://revistas.unal.edu.co/index.php/rccquifa/article/view/89486. Acesso em: 14 ago. 2024.

Chicago

da Silva Ferreira, Matheus, Gilmar Antônio de Carvalho Teles Júnior, Carlos Magno Ramos Carvalho Júnior, Fernanda de Souza Dias, Wilson Saback Dias dos Santos Júnior, Marluce Oliveira da Guarda Souza, y Aníbal de Freitas Santos Júnior. 2020. «Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations)». Revista Colombiana De Ciencias Químico-Farmacéuticas 49 (2). https://doi.org/10.15446/rcciquifa.v49n2.89486.

Harvard

da Silva Ferreira, M., de Carvalho Teles Júnior, G. A., Ramos Carvalho Júnior, C. M., de Souza Dias, F., Dias dos Santos Júnior, W. S., Oliveira da Guarda Souza, M. y de Freitas Santos Júnior, A. (2020) «Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations)», Revista Colombiana de Ciencias Químico-Farmacéuticas, 49(2). doi: 10.15446/rcciquifa.v49n2.89486.

IEEE

[1]
M. da Silva Ferreira, «Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations)», Rev. Colomb. Cienc. Quím. Farm., vol. 49, n.º 2, may 2020.

MLA

da Silva Ferreira, M., G. A. de Carvalho Teles Júnior, C. M. Ramos Carvalho Júnior, F. de Souza Dias, W. S. Dias dos Santos Júnior, M. Oliveira da Guarda Souza, y A. de Freitas Santos Júnior. «Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations)». Revista Colombiana de Ciencias Químico-Farmacéuticas, vol. 49, n.º 2, mayo de 2020, doi:10.15446/rcciquifa.v49n2.89486.

Turabian

da Silva Ferreira, Matheus, Gilmar Antônio de Carvalho Teles Júnior, Carlos Magno Ramos Carvalho Júnior, Fernanda de Souza Dias, Wilson Saback Dias dos Santos Júnior, Marluce Oliveira da Guarda Souza, y Aníbal de Freitas Santos Júnior. «Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations)». Revista Colombiana de Ciencias Químico-Farmacéuticas 49, no. 2 (mayo 1, 2020). Accedido agosto 14, 2024. https://revistas.unal.edu.co/index.php/rccquifa/article/view/89486.

Vancouver

1.
da Silva Ferreira M, de Carvalho Teles Júnior GA, Ramos Carvalho Júnior CM, de Souza Dias F, Dias dos Santos Júnior WS, Oliveira da Guarda Souza M, de Freitas Santos Júnior A. Evaluation of physicochemical properties and dissolution studies on quality control of low water solubility drugs (raw materials and pharmaceutical formulations). Rev. Colomb. Cienc. Quím. Farm. [Internet]. 1 de mayo de 2020 [citado 14 de agosto de 2024];49(2). Disponible en: https://revistas.unal.edu.co/index.php/rccquifa/article/view/89486

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