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Publication Number
US-11045450-B2
Publication Date
2021-06-29
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 provides a pharmaceutical combination therapy for gastrointestinal conditions. The therapy uses a proton pump inhibitor in combination with an antiparasitic drug, including omeprazole and fenbendazole, together with a blended mixture including dextrose anhydrous powder. The disclosed combination therapy is described as having synergistic/additive effects, including reducing gastrointestinal/ulcer recovery time and allowing reduced drug doses and/or reduced drug burden.
The disclosed compositions are formulated for oral administration as an oral non-solid/non-solid-for-oral formulation. The forms include liquid, paste, suspension, semi-solid, and granules, including granules provided as a scoop, with scoop amount constraints such as 30, 60, and 100 scoops. The disclosed formulation component includes excipients/buffers such as carboxymethylcellulose, sodium sulfite, sodium bicarbonate, and polyethylene glycol, with maintenance of an alkaline pH, including alkaline pH greater than 8.
The document further describes delivery of the oral formulation using an oral syringe and/or a dial-a-dose oral syringe. The disclosed formulations and preparation examples include scoop/granule and suspension/paste compositions with pH targets and example ingredient/excipient selections. The document includes multiple in vivo treatment/prevention examples in horses and a camel, reporting rapid ulcer improvement and improved clinical healing grades based on ulcer grading.
Claims Coverage
The partial claim set contains three independent claims. Across these independent claims, the inventive coverage centers on orally administrable compositions as blended mixtures comprising specific combinations of omeprazole or fenbendazole with carboxymethylcellulose and dextrose anhydrous powder, and fixed component-concentration limitations (“about 22% w/v omeprazole” in one claim and “about 30% w/v fenbendazole” in another).
Omeprazole plus fenbendazole blended mixture with dextrose anhydrous powder
A composition including a blended mixture including about 22% w/v omeprazole, about 30% w/v fenbendazole, and dextrose anhydrous powder.
Oral omeprazole plus fenbendazole blended mixture with carboxymethylcellulose
A composition including a blended mixture including fenbendazole, carboxymethylcellulose, about 22% w/v omeprazole, and dextrose anhydrous powder, wherein the composition is formulated for oral administration.
Oral omeprazole plus fenbendazole blended mixture with carboxymethylcellulose at about 30% w/v fenbendazole
A composition including a blended mixture including omeprazole, carboxymethylcellulose, about 30% w/v fenbendazole, and dextrose anhydrous powder, wherein the composition is formulated for oral administration.
Across the independent claims, the core coverage is directed to orally administrable compositions formulated as blended mixtures that combine omeprazole and fenbendazole with carboxymethylcellulose and dextrose anhydrous powder. The independent claims specify either about 22% w/v omeprazole or about 30% w/v fenbendazole, and dependents further refine the compositions by adding additional excipients such as sodium bicarbonate, sodium sulfite, a flavoring agent, and a wetting agent, and (in the first independent claim family) specifying granules as a scoop with scoop amounts of 30, 60, or 100.
Stated Advantages
Reducing gastrointestinal/ulcer recovery time.
Allowing reduced drug doses and/or reduced drug burden.
Reducing gastrointestinal/ulcer recovery time with synergistic/additive effects.
Documented Applications
In vivo treatment and prevention examples of gastrointestinal ulcers in horses, including rapid ulcer improvement and improved clinical healing grades.
In vivo treatment and prevention examples of gastrointestinal ulcers in a camel, including rapid ulcer improvement and improved clinical healing grades.
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