Delayed Release Formulations for Oral Administration of a Polypeptide Therapeutic Agent and Methods of Using Same
AssigneeWyeth
InventorsNicholas W. Warne, Rebecca Koval, Arwinder S. Nagi, Ramarao S. Chatlapalli, Eric J. Benjamin
Life of this patent
Estimating the term…
Abstract
The invention provides compositions containing polypeptides, including therapeutic polypeptides such as interleukin-11, that are suitable for oral administration.
Claims52
A pharmaceutical composition comprising a therapeutically effective delayed release oral dosage form of a bioactive polypeptide, wherein said composition comprises
- a bioactive polypeptide, wherein said polypeptide includes one or more properties selected from the group consisting of lacking an N-linked glycosylation site, having no more than one cysteine amino acid, and having a basic pI;
- at least one binder;
- at least one plasticizer;
- at least one glidant;
- and
- a methacrylic acid copolymer.
A pharmaceutical composition comprising a therapeutically effective delayed release oral dosage form of an interleukin-11 (“IL-11”) polypeptide, wherein said composition comprises
- an IL-11 polypeptide;
- at least one binder;
- at least one plasticizer;
- at least one glidant;
- and
- a methacrylic acid copolymer.
The pharmaceutical composition of claim 9, further comprising glycine.
A pharmaceutical composition comprising a therapeutically effective delayed release oral dosage form of a bioactive polypeptide,
- wherein said bioactive polypeptide includes one or more properties selected from the group consisting of lacking an N-linked glycosylation site, having no more than one cysteine amino acid, and having a basic pI, and
- wherein said bioactive polypeptide is substantially enveloped by a first sealing coat, an enteric coating layer, and a second sealing coat, wherein said enteric coating layer is substantially disposed between said first and second sealing coat.
A pharmaceutical composition comprising a therapeutically effective delayed release oral dosage form of an Interleukin-11 (“IL-11”) polypeptide, wherein said IL-11 polypeptide is substantially enveloped by a first sealing coat, an enteric coating layer, and a second sealing coat, wherein said enteric coating layer is substantially disposed between said first and second sealing coat.
A method of treating inflammatory bowel disease in a subject, the method comprising orally administering to a subject in need thereof a therapeutically effective dose of IL-11.
Dependencies are inferred from the claim text.