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 |
| Published: |
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 |
| Summary: | 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. |
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| ISSN: | 1727-558X 2227-3530 |