Study of the relative bioavailability of a multisource formulation of sulfamethoxazole regarding the drug reference
OBJETIVES: To determine the relative bioavailability of an oral formulation of multisource sulfamethoxazole 200 mg / 5 ml respect to the reference formulation Oryctolagus cuniculus L (albino rabbits). MATERIAL AND METHODS: The samples studied consisted of 25 vials of suspension of sulfamethoxaz...
| Main Authors: | , , , , |
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| Format: | Article |
| Language: | Spanish |
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Universidad de San Martín de Porres
2016-03-01
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| Series: | Horizonte Médico |
| Subjects: | |
| Online Access: | http://www.medicina.usmp.edu.pe/medicina/horizonte/2016_3/Art2_Vol16_N3.pdf |
| _version_ | 1811276075801509888 |
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| author | Alvarado Yarasca Alberto Neuman Villanueva Vilchez Elena |
| author_facet | Alvarado Yarasca Alberto Neuman Villanueva Vilchez Elena |
| author_sort | Alvarado Yarasca |
| collection | DOAJ |
| description | OBJETIVES: To determine the relative bioavailability of an oral formulation of multisource sulfamethoxazole 200 mg / 5 ml respect to the reference formulation Oryctolagus cuniculus L (albino rabbits).
MATERIAL AND METHODS: The samples studied consisted of 25 vials of suspension of sulfamethoxazole / trimethoprim multisource 200 mg: 40 mg / 5 ml T1 with the letter assigned to the batch 11070674; and as a reference (R) 25 flasks Bactrim suspension of 200 mg: 40 mg / 5 ml, RJ0774 batch.The protocol consisted of a single oral dose of 100 mg / kg of sulfamethoxazole 200 mg / 5 ml of each of the formulations to 12 albino rabbits after a 12 hour fasting, through an open design in two cross periods (T / R), randomized, double-blind study with a greater range of 5 half-lives between each administration, later to determine plasma concentrations of the drug in default until 12 hours by means of a spectrophotometric method periods of time colorimetric diazotization. With the data of plasma, bioavailability curves were constructed, including the area under the curve (ABC, ABC), C and o-12ho-∞maxt were determined.
RESULTS: According to statistical analysis for bioequivalence, it was found: ABC- T1 / ABCR CI 90% from 0.873 to 1.021, o12ho-12h AUCT1 / AUCR 90% CI 0.868 to 1.032 and C T1 / C R CI 90% 0,866- 1,045.
CONCLUSIONS: The values of multisource sulfamethoxazole found are within the acceptable range of bioequivalence proposed by WHO and the FDA (0.80-1.25), demonstrating the bioequivalence of multisource T1 respect to the reference. |
| first_indexed | 2024-04-12T23:50:02Z |
| format | Article |
| id | doaj.art-398d8870bee648969a05de1119b1a0ef |
| institution | Directory Open Access Journal |
| issn | 1727-558X 2227-3530 |
| language | Spanish |
| last_indexed | 2024-04-12T23:50:02Z |
| publishDate | 2016-03-01 |
| publisher | Universidad de San Martín de Porres |
| record_format | Article |
| series | Horizonte Médico |
| spelling | doaj.art-398d8870bee648969a05de1119b1a0ef2022-12-22T03:11:44ZspaUniversidad de San Martín de PorresHorizonte Médico1727-558X2227-35302016-03-011631219Study of the relative bioavailability of a multisource formulation of sulfamethoxazole regarding the drug referenceAlvarado Yarasca0Alberto 1Neuman2Villanueva Vilchez3Elena4Ángel Salazar GranaraPineda PérezHugoCáceres AndonaireOBJETIVES: To determine the relative bioavailability of an oral formulation of multisource sulfamethoxazole 200 mg / 5 ml respect to the reference formulation Oryctolagus cuniculus L (albino rabbits). MATERIAL AND METHODS: The samples studied consisted of 25 vials of suspension of sulfamethoxazole / trimethoprim multisource 200 mg: 40 mg / 5 ml T1 with the letter assigned to the batch 11070674; and as a reference (R) 25 flasks Bactrim suspension of 200 mg: 40 mg / 5 ml, RJ0774 batch.The protocol consisted of a single oral dose of 100 mg / kg of sulfamethoxazole 200 mg / 5 ml of each of the formulations to 12 albino rabbits after a 12 hour fasting, through an open design in two cross periods (T / R), randomized, double-blind study with a greater range of 5 half-lives between each administration, later to determine plasma concentrations of the drug in default until 12 hours by means of a spectrophotometric method periods of time colorimetric diazotization. With the data of plasma, bioavailability curves were constructed, including the area under the curve (ABC, ABC), C and o-12ho-∞maxt were determined. RESULTS: According to statistical analysis for bioequivalence, it was found: ABC- T1 / ABCR CI 90% from 0.873 to 1.021, o12ho-12h AUCT1 / AUCR 90% CI 0.868 to 1.032 and C T1 / C R CI 90% 0,866- 1,045. CONCLUSIONS: The values of multisource sulfamethoxazole found are within the acceptable range of bioequivalence proposed by WHO and the FDA (0.80-1.25), demonstrating the bioequivalence of multisource T1 respect to the reference.http://www.medicina.usmp.edu.pe/medicina/horizonte/2016_3/Art2_Vol16_N3.pdfrelative bioavailabilitybioequivalencesulfamethoxazolemultisource drugdrug reference. |
| spellingShingle | Alvarado Yarasca Alberto Neuman Villanueva Vilchez Elena Study of the relative bioavailability of a multisource formulation of sulfamethoxazole regarding the drug reference Horizonte Médico relative bioavailability bioequivalence sulfamethoxazole multisource drug drug reference. |
| title | Study of the relative bioavailability of a multisource formulation of sulfamethoxazole regarding the drug reference |
| title_full | Study of the relative bioavailability of a multisource formulation of sulfamethoxazole regarding the drug reference |
| title_fullStr | Study of the relative bioavailability of a multisource formulation of sulfamethoxazole regarding the drug reference |
| title_full_unstemmed | Study of the relative bioavailability of a multisource formulation of sulfamethoxazole regarding the drug reference |
| title_short | Study of the relative bioavailability of a multisource formulation of sulfamethoxazole regarding the drug reference |
| title_sort | study of the relative bioavailability of a multisource formulation of sulfamethoxazole regarding the drug reference |
| topic | relative bioavailability bioequivalence sulfamethoxazole multisource drug drug reference. |
| url | http://www.medicina.usmp.edu.pe/medicina/horizonte/2016_3/Art2_Vol16_N3.pdf |
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