Stability of sulfadiazine sugar-free oral suspensions for the treatment of congenital toxoplasmosis
Abstract This study aimed to develop and evaluate the stability of sulfadiazine sugar-free extemporaneous oral suspensions, focusing on treating congenital toxoplasmosis. The excipients were carefully chosen to obtain safe products for the pediatric population. Sulfadiazine suspensions (100 mg/ mL)...
| Main Authors: | , , , , , , |
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| Format: | Article |
| Language: | English |
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Universidade de São Paulo
2023-11-01
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502023000100431&tlng=en |
| _version_ | 1797635096243601408 |
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| author | Micheline Silva Dias Amanda Maccangnan Zamberlan Rebeca Lino Lourenço Emanuele Saul Saraiva Julya Sarmento Neis Luana Mota Ferreira Andréa Inês Horn Adams |
| author_facet | Micheline Silva Dias Amanda Maccangnan Zamberlan Rebeca Lino Lourenço Emanuele Saul Saraiva Julya Sarmento Neis Luana Mota Ferreira Andréa Inês Horn Adams |
| author_sort | Micheline Silva Dias |
| collection | DOAJ |
| description | Abstract This study aimed to develop and evaluate the stability of sulfadiazine sugar-free extemporaneous oral suspensions, focusing on treating congenital toxoplasmosis. The excipients were carefully chosen to obtain safe products for the pediatric population. Sulfadiazine suspensions (100 mg/ mL) were prepared from the raw material or tablets, stored in amber glass bottles at 5±3ºC, and evaluated at 0, 14, and 30 days. An ultra-performance liquid chromatographic method was developed and validated to assay the drug. The particle size ranged from 29.3 to 50.6 µm, with some variation over the study; pH values around 7.0 and non-Newtonian behavior were observed without modification in the period. Formulations showed a fast dissolution rate (>80% in 15 minutes) without variation over the study. The drug assay was about 100% of the label claimed throughout the study, demonstrating the chemical stability and the preparations’ dose homogeneity. The microbiological investigation indicated that both preparations met the requirements for the microbial count and absence of pathogens. In conclusion, the developed formulations can be used for 30 days when stored under refrigeration. The oral suspensions produced are easy to prepare and contain safe components, providing an alternative for congenital toxoplasmosis treatment in children. |
| first_indexed | 2024-03-11T12:16:30Z |
| format | Article |
| id | doaj.art-315a99b8f52e46bc9c45f2f9f97898df |
| institution | Directory Open Access Journal |
| issn | 2175-9790 |
| language | English |
| last_indexed | 2024-03-11T12:16:30Z |
| publishDate | 2023-11-01 |
| publisher | Universidade de São Paulo |
| record_format | Article |
| series | Brazilian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-315a99b8f52e46bc9c45f2f9f97898df2023-11-07T07:45:41ZengUniversidade de São PauloBrazilian Journal of Pharmaceutical Sciences2175-97902023-11-015910.1590/s2175-97902023e23359Stability of sulfadiazine sugar-free oral suspensions for the treatment of congenital toxoplasmosisMicheline Silva DiasAmanda Maccangnan ZamberlanRebeca Lino LourençoEmanuele Saul SaraivaJulya Sarmento NeisLuana Mota FerreiraAndréa Inês Horn Adamshttps://orcid.org/0000-0002-8413-3710Abstract This study aimed to develop and evaluate the stability of sulfadiazine sugar-free extemporaneous oral suspensions, focusing on treating congenital toxoplasmosis. The excipients were carefully chosen to obtain safe products for the pediatric population. Sulfadiazine suspensions (100 mg/ mL) were prepared from the raw material or tablets, stored in amber glass bottles at 5±3ºC, and evaluated at 0, 14, and 30 days. An ultra-performance liquid chromatographic method was developed and validated to assay the drug. The particle size ranged from 29.3 to 50.6 µm, with some variation over the study; pH values around 7.0 and non-Newtonian behavior were observed without modification in the period. Formulations showed a fast dissolution rate (>80% in 15 minutes) without variation over the study. The drug assay was about 100% of the label claimed throughout the study, demonstrating the chemical stability and the preparations’ dose homogeneity. The microbiological investigation indicated that both preparations met the requirements for the microbial count and absence of pathogens. In conclusion, the developed formulations can be used for 30 days when stored under refrigeration. The oral suspensions produced are easy to prepare and contain safe components, providing an alternative for congenital toxoplasmosis treatment in children.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502023000100431&tlng=enPediatric formulationSulfadiazineSuspensionCongenital toxoplasmosisExtemporaneous suspensions |
| spellingShingle | Micheline Silva Dias Amanda Maccangnan Zamberlan Rebeca Lino Lourenço Emanuele Saul Saraiva Julya Sarmento Neis Luana Mota Ferreira Andréa Inês Horn Adams Stability of sulfadiazine sugar-free oral suspensions for the treatment of congenital toxoplasmosis Brazilian Journal of Pharmaceutical Sciences Pediatric formulation Sulfadiazine Suspension Congenital toxoplasmosis Extemporaneous suspensions |
| title | Stability of sulfadiazine sugar-free oral suspensions for the treatment of congenital toxoplasmosis |
| title_full | Stability of sulfadiazine sugar-free oral suspensions for the treatment of congenital toxoplasmosis |
| title_fullStr | Stability of sulfadiazine sugar-free oral suspensions for the treatment of congenital toxoplasmosis |
| title_full_unstemmed | Stability of sulfadiazine sugar-free oral suspensions for the treatment of congenital toxoplasmosis |
| title_short | Stability of sulfadiazine sugar-free oral suspensions for the treatment of congenital toxoplasmosis |
| title_sort | stability of sulfadiazine sugar free oral suspensions for the treatment of congenital toxoplasmosis |
| topic | Pediatric formulation Sulfadiazine Suspension Congenital toxoplasmosis Extemporaneous suspensions |
| url | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502023000100431&tlng=en |
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