Product
Assignee4D Pharma Research Limited
InventorsChristophe CARITE, Sophie DECLOMESNIL
Life of this patent
Estimating the term…
Abstract
The invention provides an enteric dosage form comprising a live biotherapeutic product.
Claims21
-30. (canceled)
A pharmaceutical composition comprising a viable cell count from about 1×103 to about 1×1013 colony forming units per gram (CFU/g) of an anaerobic or microaerophilic bacteria strain with respect to a total weight of the pharmaceutical composition;
- and
- an amount of an antioxidant sufficient for enhancing the shelf stability of the pharmaceutical composition, wherein the antioxidant comprises cysteine or ascorbic acid,
- wherein the pharmaceutical composition is an orally administrable and enteric dosage form.
A method for preparing a pharmaceutical composition comprising an anaerobic or microaerophilic bacteria strain and one or more pharmaceutically acceptable excipients, wherein the pharmaceutical composition is an orally administrable and enteric dosage form, the method comprising:
- (i) providing the anaerobic or microaerophilic bacteria strain and one or more pharmaceutically acceptable excipients, wherein the one or more pharmaceutically acceptable excipients comprises an antioxidant in an amount sufficient for enhancing shelf stability, wherein the antioxidant is cysteine or ascorbic acid, and
- (ii-a) forming a tablet core comprising the anaerobic or microaerophilic bacteria strain and the one or more pharmaceutically acceptable excipients into a capsule and closing the capsule to provide the table core, or
- (ii-b) filing the anaerobic or microaerophilic bacteria strain and the one or more pharmaceutically acceptable excipients into a capsule and closing the capsule to provide a filled capsule, wherein the capsule is an intrinsically enteric capsule, or
- wherein the process comprises
- (iii) applying an enteric coating to the filled capsule or the table core.
Dependencies are inferred from the claim text.