Peptide YY pharmaceutical formulations, compositions, and methods
Inventors
Acosta, Andres • VASICEK, Thomas • Brown, Beth Anne-Szkudlarek
Assignees
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Publication Number
US-11911445-B2
Publication Date
2024-02-27
Expiration Date
Abstract
Pharmaceutical compositions comprising PYY (e.g., PYY(3-36) and analogs and variants thereof), satiety peptides, satiety hormones, metabolic hormones, and methods of treating metabolic diseases with such compositions are provided. Aspects include methods of increasing a feeling of fullness in patients treated with pharmaceutical compositions comprising PYY, PYY(3-36), satiety peptides, satiety hormones, metabolic hormones, and analogs, receptor antagonists and variants thereof.
Core Innovation
The invention is directed to a low-dose Peptide YY (PYY) pharmaceutical composition formulated as an oral dissolving tablet. The composition includes PYY in a dose of about 2.5 μg to about 250 μg and a pharmaceutically acceptable excipient selected from stabilizers, preservatives, antioxidants, buffers, surfactants, rheology modifiers, and mucosal permeation enhancers.
The composition is configured to provide satiation to a subject while minimizing or eliminating any substantial systemic delivery of PYY in the plasma of the subject. The disclosed composition acts locally through oral delivery, including local oral delivery to the tongue and oral mucosa, to increase fullness and reduce plasma PYY exposure relative to meal-induced levels.
The disclosure further situates the composition within metabolic disorder treatment contexts, including obesity, diabetes and elevated blood glucose, fatty liver disease, PCOS, and multiple sclerosis. It also contemplates optional additional active pharmaceutical ingredients, including GLP-1, oxyntomodulin, and cholecystokinin, and specific peptide forms such as PYY(3-36).
Claims Coverage
The partial record identifies one independent claim. Across the dependent claims shown, the inventive coverage centers on low-dose PYY in an oral dissolving tablet and on minimizing or eliminating substantial systemic delivery of PYY in plasma, with excipient selection and optional refinements to peptide form, dose point, preservative identity, mucosal permeation enhancer, and additional active pharmaceutical ingredients.
Low-dose PYY oral dissolving tablet with minimized plasma systemic delivery
A pharmaceutical composition comprising Peptide YY (PYY) in a dose of about 2.5 μg to about 250 μg, and a pharmaceutically acceptable excipient, wherein the composition provides satiation to a subject and minimizes or eliminates any substantial systemic delivery of PYY in the plasma of the subject, and wherein the composition is formulated as an oral dissolving tablet.
PYY(3-36) peptide form
The pharmaceutical composition of claim 1 whose PYY is specifically PYY(3-36).
About 2.5 μg dose
The pharmaceutical composition of claim 1 in which the dose of PYY is about 2.5 μg.
Preservative comprising specific parabens
A pharmaceutical composition of claim 1 is specified to include a preservative comprising sodium methyl paraben or sodium propyl paraben.
Mucosal permeation enhancer comprising gelatin
A pharmaceutical composition according to claim 1 further includes a mucosal permeation enhancer comprising gelatin.
Optional additional active pharmaceutical ingredients from a named set
A pharmaceutical composition of claim 1 further includes one or more selected active pharmaceutical ingredients chosen from a broad named list.
Overall, the claimed subject matter is centered on an oral dissolving tablet containing low-dose PYY, including optional specification of PYY(3-36) and a fixed about 2.5 μg dose, together with selected excipients that support satiation while minimizing or eliminating substantial systemic delivery into plasma. Dependent claims shown further refine preservative identity, specify a mucosal permeation enhancer, and optionally broaden the formulation by adding one or more additional active ingredients.
Stated Advantages
Provides satiation to a subject.
Minimizes or eliminates any substantial systemic delivery of PYY in the plasma of the subject.
Documented Applications
Treatment or use in metabolic disorders including obesity.
Treatment or use in metabolic disorders including diabetes and elevated blood glucose.
Treatment or use in metabolic disorders including fatty liver disease.
Treatment or use in metabolic disorders including PCOS.
Treatment or use in metabolic disorders including multiple sclerosis.
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