Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs.
Theophylline is an important drug for treatment of canine chronic bronchitis and bradyarrhythmias, but new products require validation since pharmacokinetics in dogs can vary by formulation. A new, 503B outsourcing facility-produced theophylline product (OFT) is available for veterinary use. Outsour...
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Public Library of Science (PLoS)
2022-01-01
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| Series: | PLoS ONE |
| Online Access: | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0262336&type=printable |
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| author | Jennifer M Reinhart Gabriela A R de Oliveira Lauren Forsythe Zhong Li |
| author_facet | Jennifer M Reinhart Gabriela A R de Oliveira Lauren Forsythe Zhong Li |
| author_sort | Jennifer M Reinhart |
| collection | DOAJ |
| description | Theophylline is an important drug for treatment of canine chronic bronchitis and bradyarrhythmias, but new products require validation since pharmacokinetics in dogs can vary by formulation. A new, 503B outsourcing facility-produced theophylline product (OFT) is available for veterinary use. Outsourcing facilities have many advantages over traditional compounding sources including current good manufacturing practice compliance. The purpose of this study was to establish the pharmacokinetics of OFT in dogs. Eight healthy dogs received 11 mg/kg intravenous aminophylline and 10 mg/kg oral OFT followed by serial blood sampling in a two-way, randomized, crossover design with 7-day washout. Plasma theophylline concentrations were quantified by liquid chromatography-mass spectrometry. Bioavailability, maximum concentration, time to maximum concentration, half-life and area under the curve were: 97 ± 10%, 7.13 ± 0.71 μg/mL, 10.50 ± 2.07 h, 9.20 ± 2.87 h, and 141 ± 37.6 μg*h/mL, respectively. Steady-state predictions supported twice daily dosing of the OFT, but specific dosage recommendations are hindered by lack of a canine-specific therapeutic range for plasma theophylline concentration. These findings suggest that the OFT is well absorbed and can likely be dosed twice daily in dogs, but future pharmacodynamic and clinical studies are needed to establish a definitive therapeutic range for theophylline in this species. |
| format | Article |
| id | doaj-art-e8070507b67441a380626659423c8017 |
| institution | DOAJ |
| issn | 1932-6203 |
| language | English |
| publishDate | 2022-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
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| spelling | doaj-art-e8070507b67441a380626659423c80172025-08-20T03:15:48ZengPublic Library of Science (PLoS)PLoS ONE1932-62032022-01-01171e026233610.1371/journal.pone.0262336Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs.Jennifer M ReinhartGabriela A R de OliveiraLauren ForsytheZhong LiTheophylline is an important drug for treatment of canine chronic bronchitis and bradyarrhythmias, but new products require validation since pharmacokinetics in dogs can vary by formulation. A new, 503B outsourcing facility-produced theophylline product (OFT) is available for veterinary use. Outsourcing facilities have many advantages over traditional compounding sources including current good manufacturing practice compliance. The purpose of this study was to establish the pharmacokinetics of OFT in dogs. Eight healthy dogs received 11 mg/kg intravenous aminophylline and 10 mg/kg oral OFT followed by serial blood sampling in a two-way, randomized, crossover design with 7-day washout. Plasma theophylline concentrations were quantified by liquid chromatography-mass spectrometry. Bioavailability, maximum concentration, time to maximum concentration, half-life and area under the curve were: 97 ± 10%, 7.13 ± 0.71 μg/mL, 10.50 ± 2.07 h, 9.20 ± 2.87 h, and 141 ± 37.6 μg*h/mL, respectively. Steady-state predictions supported twice daily dosing of the OFT, but specific dosage recommendations are hindered by lack of a canine-specific therapeutic range for plasma theophylline concentration. These findings suggest that the OFT is well absorbed and can likely be dosed twice daily in dogs, but future pharmacodynamic and clinical studies are needed to establish a definitive therapeutic range for theophylline in this species.https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0262336&type=printable |
| spellingShingle | Jennifer M Reinhart Gabriela A R de Oliveira Lauren Forsythe Zhong Li Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs. PLoS ONE |
| title | Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs. |
| title_full | Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs. |
| title_fullStr | Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs. |
| title_full_unstemmed | Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs. |
| title_short | Pharmacokinetics of a 503B outsourcing facility-produced theophylline in dogs. |
| title_sort | pharmacokinetics of a 503b outsourcing facility produced theophylline in dogs |
| url | https://journals.plos.org/plosone/article/file?id=10.1371/journal.pone.0262336&type=printable |
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