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Publication Number
US-10441575-B2
Publication Date
2019-10-15
Expiration Date
Abstract
Described herein are pharmaceutical compositions including a proton pump inhibitor and an antiparasitic drug. In some embodiments, the compositions can be formulated as a non-solid for oral administration. The compositions can be used to treat gastrointestinal conditions. Methods of treatment using the compositions are also described.
Core Innovation
The invention relates to pharmaceutical combination therapy for gastrointestinal ulcer conditions using an oral paste that includes a proton pump inhibitor and an antiparasitic drug. The oral paste includes about 22% w/v omeprazole and about 30% w/v fenbendazole, together with a wetting agent formulated in a melted polyethylene glycol base agent.
The disclosed approach emphasizes synergistic/additive effects that reduce gastrointestinal recovery/incidence time and/or drug burden compared to omeprazole alone, while reducing side effects. The document describes non-solid oral formulations, including liquid or paste, suitable for oral delivery, including oral syringe administration.
The formulations can include polyethylene glycol and wetting/buffering/preservative components such as sodium sulfite, carboxymethyl cellulose, and sodium bicarbonate, with pH adjustment mentioned as sodium hydroxide. The disclosure also describes clinical healing and ulcer grade improvement in example studies in horses and a camel, including ulcer prevention and recurrence prevention examples.
Claims Coverage
The independent claim in the provided set is directed to a method of treating a gastrointestinal ulcer by administering an oral paste containing specified proportions of omeprazole and fenbendazole within a wetting-agent polyethylene glycol base formulated in a melted polyethylene glycol base agent. The dependent claims refine the independent claim by adding administration delivery, subject and severity constraints, and formulation excipients, as well as quantitative clinical outcome and time constraints.
Oral paste with omeprazole and fenbendazole in melted polyethylene glycol base with wetting agent
Administering an oral paste including about 22% w/v omeprazole, about 30% w/v fenbendazole, and a wetting agent formulated in a melted polyethylene glycol base agent to a mammal having the gastrointestinal ulcer, and treating the gastrointestinal ulcer.
Administration as oral paste by oral syringe
Administering the subject using an oral syringe.
Treatment for gastrointestinal ulcer greater than Grade 1
Treating a gastrointestinal ulcer that is greater than Grade 1.
Clinical healing with ulcer score less than 1
Providing clinical healing that results in an ulcer score of less than 1.
Treatment duration less than about 14 days
Performing the treatment in less than about 14 days.
Oral paste including sodium sulfite
Including sodium sulfite in the oral paste.
Across the independent claim and its dependents, the inventive coverage centers on oral paste treatment of a gastrointestinal ulcer using omeprazole plus fenbendazole in a melted polyethylene glycol base with a wetting agent, optionally delivered via an oral syringe and further refined by ulcer severity, quantitative healing and time thresholds, and formulation excipients such as sodium sulfite.
Stated Advantages
Reduces gastrointestinal recovery/incidence time versus omeprazole alone.
Reduces drug burden versus omeprazole alone.
Reduces side effects.
Documented Applications
Treatment of a gastrointestinal ulcer in a mammal, with example studies in horses and a camel showing clinical healing and ulcer grade improvement.
Ulcer prevention and recurrence prevention examples.
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