Pharmaceutical composition
OwnerMoise Azria, Simon David Bateman +3inventors
InventorsMoise Azria, Simon David Bateman, Anasuya Ashok Ghosh, Shoufeng Li, Alan Edward Royce
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Abstract
The present invention provides oral pharmaceutical compositions that enable the successful delivery of drugs in a pharmaceutically effective amount, particularly poly(amino acids) such as peptides, peptidomimetics and proteins, e.g. hormones to a subject via oral administration to accomplish the desired therapeutic effect. The oral pharmaceutical composition comprising a poly(amino acid) as the active ingredient, e.g. a peptide or protein, shows a rapid disintegration and/or dissolution such that the active ingredient is able to attain a therapeutic effect.
Claims40
An oral pharmaceutical composition in the solid phase comprising:
- iv. a poly(amino acid);
- v. a delivery agent;
- and, optionally,
- vi. a diluent;
- wherein the composition has a disintegration time of no more than 10 minutes and a dissolution of >80% at 20 minutes.
An oral pharmaceutical composition in the solid phase comprising:
- vii. a poly(amino acid);
- viii. a delivery agent;
- and, optionally,
- ix. a diluent;
- wherein the composition has a disintegration time of no more than 6 minutes and a dissolution of >90% at 20 minutes.
A method of manufacturing an oral pharmaceutical composition comprising the steps
- xviii. Blending a poly(amino acid), a carrier and a disintegrant to make a first blend;
- xix. optionally blending a dry binder to the first blend to make a second blend;
- xx. optionally blending a stabilizer to the second blend to make a third blend;
- and
- xxi. compressing the third blend into a tablet having a hardness of 5 Kp to 20 Kp.
A method of pre-determining peak plasma concentration (Cmax) of an active ingredient in a patient to be treated with an oral pharmaceutical composition comprising said active ingredient and a delivery agent which method comprises adjusting the disintegration time of the pharmaceutical composition and/or the dissolution time of the active ingredient such as to provide a favorable microenvironment in the gastro intestinal tract for the dissolution of the active ingredient in the intestine in order to optimize absorption of the active ingredient and to achieve a therapeutically effective peak plasma concentration of the active ingredient in the blood plasma.
39-43. (canceled)
Dependencies are inferred from the claim text.