Claims for Patent: 8,709,996

Summary for Patent: 8,709,996

Title:	Pharmaceutical treatment process using chitosan or derivative thereof
Abstract:	The present invention provides a solid composition for oral administration comprising: (i) a drug compound; (ii) chitosan or a derivative thereof or a salt of chitosan or salt of a derivative of chitosan; and (iii) an organic acid. Preferably the drug compound is a polar molecule having a molecular weight of 1 KDa or less, a peptide, a protein or a polysaccharide. The compositions of the invention provide enhance absorption of the drug compound.
Inventor(s):	Leane; Michael (Merseyside, GB), Smith; Alan (Nottingham, GB), Illum; Lisbeth (Nottingham, GB)
Assignee:	Archimedes Development Limited (Nottingham, GB)
Application Number:	12/766,487
Patent Claims:	1. A process for enhancing absorption of a drug compound by a mammalian patient to which the drug compound is orally administered, wherein the process comprises orally administering to the patient a solid composition comprising a solid mixture comprising the drug compound that is a polar molecule having a molecular weight of 1 KDa or less, a peptide, a protein or a polysaccharide, and chitosan or a derivative thereof or a salt of chitosan or a salt of a derivative of chitosan, and an organic acid, wherein at least a part of the acid is in the form of an agglomerate, and wherein the acid and the chitosan or a derivative thereof or a salt of chitosan or a salt of a derivative of chitosan are present in a weight ratio of from 10:1 to 1:1, whereby absorption of the drug compound is enhanced within the gastrointestinal tract of the mammalian patient. 2. A process according to claim 1, wherein the acid is lactic, glutamic, succinic, tartaric, citric, fumaric or propionic acid. 3. A process according to claim 2, wherein the acid is succinic acid. 4. A process according to claim 1, wherein the acid agglomerate is in the form of a granule, a pellet, a tablet or an acid particle engineered to a specific size. 5. A process according to claim 1, wherein the acid agglomerate is coated with a material which modifies its dissolution properties. 6. A process according to claim 1, wherein chitosan is present in the form of chitosan base. 7. A process according to claim 1, wherein the drug compound is a bisphosphonate, a nucleoside analogue antiviral drug, or an oligonucleotide. 8. A process according to claim 7, wherein the bisphosphonate is clodronate, alendronate, etidronate, pamidronate or residronate. 9. A process according to claim 7, wherein the nucleoside analogue antiviral drug is aciclovir. 10. A process according to claim 1, wherein the peptide is octreotide, insulin, glucagon, a calcitonin, parathyroid hormone or a derivative thereof, ADH (vasopressin) or an analogue thereof or a GnRH agonist. 11. A process according to claim 1, wherein the protein is a growth hormone, an interferon, erythropoetin, an interleukin, GM-CSF or G-CSF. 12. A process according to claim 1, wherein the polysaccharide is heparin or a low molecular weight heparin. 13. A process according to claim 1, wherein the acid and the chitosan or a derivative thereof or a salt of chitosan or a salt of a derivative of chitosan are present in a weight ratio of from 6:1 to 1:1. 14. A process according to claim 1, wherein the composition is coated with a material that prevents the drug compound and chitosan or a derivative thereof or a salt of chitosan or a salt of a derivative of chitosan from being released, after administration, until the composition reaches the target site of drug absorption. 15. A process according to claim 1, wherein the composition is in the form of a compressed tablet, a moulded tablet, a hard shell capsule or a soft shell capsule. 16. A process according to claim 1, wherein at least 80% of the acid is present in the form of an agglomerate. 17. A process according to claim 16, wherein at least 85% of the acid is present in the form of an agglomerate. 18. A process according to claim 17, wherein at least 90% of the acid is present in the form of an agglomerate. 19. A process according to claim 1, wherein the average particle size of the acid agglomerate, as measured by sieve analysis, is from 0.1 mm to 5 mm. 20. A process according to claim 19, wherein the average particle size of the acid agglomerate, as measured by sieve analysis, is from 0.15 mm to 3 mm. 21. A process according to claim 20, wherein the average particle size of the acid agglomerate, as measured by sieve analysis, is from 0.2 mm to 2 mm.

Details for Patent 8,709,996

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Nps Pharmaceuticals, Inc.	NATPARA	parathyroid hormone	For Injection	125511	01/23/2015		2023-05-13