Method for improving the bioavailability of orally delivered therapeutics
OwnerStephen Turner, Jyo Ravishankar +1inventors
InventorsStephen Turner, Jyo Ravishankar, Reza Fassihi
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Abstract
The disclosed invention is a method and composition for improving the bioavailability of a pharmaceutically active ingredient comprising an oral dosage form consisting essentially of a granulation of active ingredient, amino acid, and hydrophilic polymer, wherein the granulation is dispersed in an immediate release or extended release excipient.
Claims40
A method for improving bioavailability of a pharmaceutically active ingredient comprising orally administering to a subject in need of said active ingredient a dosage form consisting essentially of
- a. a granulation comprising granules of a low solubility or low permeability active ingredient, at least one amino acid, and at least one intra-granular hydrophilic polymer;
- b. one or more formulation excipients in which a therapeutic amount of said granulation is substantially uniformly dispersed, said excipient comprising:
- i. an immediate release excipient selected from the group consisting of microcrystalline cellulose, sodium carboxymethyl cellulose, sodium starch glycolate, corn starch and combinations of such excipients when said dosage form is an immediate release dosage form, or
- ii. a sustained release excipient comprising a polymer having a viscosity higher than the viscosity of the said intra-granular polymer;
- c. said composition being in the form of a capsule or compressed tablet.
The method of clam 1, wherein said active ingredient is atenolol.
A composition comprising an oral solid dosage form which provides improved bioavailability for an orally administered low solubility or low permeability pharmaceutically active ingredient, said dosage form consisting essentially of
- d. a granulation comprising granules of a low solubility or low permeability active ingredient, at least one amino acid, and at least one intra-granular hydrophilic polymer;
- e. one or more formulation excipients in which a therapeutic amount of said granulation is substantially uniformly dispersed, said excipient comprising
- i. an immediate release excipient selected from the group consisting of microcrystalline cellulose, sodium carboxymethyl cellulose, sodium starch glycolate, corn starch and combinations of such excipients when said dosage form is an immediate release dosage form, or
- ii. a sustained release excipient comprising a polymer having a viscosity higher than the viscosity of the said intra-granular polymer;
- f. said composition being in the form of a capsule or a compressed tablet.
Dependencies are inferred from the claim text.