Press coated, pulsatile drug delivery system suitable for oral administration
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61K-009/24
A61K-009/20
A61K-009/22
A61K-009/28
A61K-009/30
출원번호
US-0122410
(2002-04-16)
발명자
/ 주소
Ting, Richard
Hsiao, Charles
출원인 / 주소
Impax Pharmaceuticals, Inc.
대리인 / 주소
Fleshner & Kim, LLP
인용정보
피인용 횟수 :
85인용 특허 :
19
초록▼
A press-coated tablet suitable for oral administration, comprising an immediate-release compartment comprising a compressed blend of an active agent. The immediate-release compartment has a dissolution profile in which 10-75% of the active agent is dissolved within one hour and not less than 90% of
A press-coated tablet suitable for oral administration, comprising an immediate-release compartment comprising a compressed blend of an active agent. The immediate-release compartment has a dissolution profile in which 10-75% of the active agent is dissolved within one hour and not less than 90% of the active agent is dissolved within 6 hours. The tablet further comprises an extended-release compartment with a dissolution profile in which 5-40% of the active agent is dissolved within one hour, 20-75% within three hours, 40-95% of the active agent within 6 hours, and not less than 60% of the active agent is dissolved within 8 hours. Additionally, the press-coated extended-release compartment substantially envelops the immediate-release compartment, and comprises a compressed blend of the active agent, a hydrophilic polymer and hydrophobic material. The tablet exhibits a first order release of the active agent interrupted by a pulsed delivery of the active agent.
대표청구항▼
A press-coated tablet suitable for oral administration, comprising an immediate-release compartment comprising a compressed blend of an active agent. The immediate-release compartment has a dissolution profile in which 10-75% of the active agent is dissolved within one hour and not less than 90% of
A press-coated tablet suitable for oral administration, comprising an immediate-release compartment comprising a compressed blend of an active agent. The immediate-release compartment has a dissolution profile in which 10-75% of the active agent is dissolved within one hour and not less than 90% of the active agent is dissolved within 6 hours. The tablet further comprises an extended-release compartment with a dissolution profile in which 5-40% of the active agent is dissolved within one hour, 20-75% within three hours, 40-95% of the active agent within 6 hours, and not less than 60% of the active agent is dissolved within 8 hours. Additionally, the press-coated extended-release compartment substantially envelops the immediate-release compartment, and comprises a compressed blend of the active agent, a hydrophilic polymer and hydrophobic material. The tablet exhibits a first order release of the active agent interrupted by a pulsed delivery of the active agent. r compartment of said cell or cells.3. A method of delivering a nuclear protein or nuclear peptide to the nuclear compartment of a cell or cells, said method comprising: covalently joining said nuclear protein or nuclear peptide with Hsp70, or a fragment of Hsp70 capable of intracellular and intranuclear transport, to form an Hsp70 complex, and exogenously providing said complex to said cell or cells so that said complex is transported into the nuclear compartment of said cell or cells. 4. The method of claim 3 wherein said Hsp70 complex is a fusion protein and said Hsp70 or fragment of Hsp70 comprises an amino acid sequence as shown in SEQ ID NO:2.5. The method of claim 3 wherein said Hsp70 complex is a fusion protein and said Hsp70 or fragment of Hsp70 comprises an amino acid sequence as shown in SEQ ID NO:3.6. The method of claim 5 wherein said nuclear protein or nuclear peptide comprises residues 37-409 of the p50 subunit of the transcription factor NF-&kgr;B as shown in SEQ ID NO:1.7. A pharmaceutical composition comprising an Hsp70 complex, said Hsp70 complex comprising a first portion and a second portion covalently joined, said first portion comprising Hsp70 protein, or a fragment thereof capable of intracellular and intranuclear transport; and said second portion comprising a nuclear protein or nuclear peptide. 8. The pharmaceutical composition of claim 7 wherein said nuclear protein or nuclear peptide comprises the p50 subunit of the transcription factor NF-&kgr;B.9. The pharmaceutical composition of claim 7 wherein said Hsp70 complex is a fusion protein.10. The method of claim 4, wherein said Hsp70 or fragment of Hsp70 is the fragment of Hsp70 consisting of the amino acid sequence shown in SEQ ID NO:2.11. The method of claim 5, wherein said Hsp70 or fragment of Hsp70 is the fragment of Hsp70 consisting of the amino acid sequence shown in SEQ ID NO:3.12. The pharmaceutical composition of claim 9 further comprising at least one additional active compound selected from the group consisting of: an immunosuppressant, an anti-cancer agent, an anti-viral agent, an anti-inflammatory agent, an anti-fungal agent, an antibiotic, or an anti-vascular hyperproliferation compound.13. The pharmaceutical composition of claim 9 wherein said Hsp70 or fragment of Hsp70 comprises an amino acid sequence as shown in SEQ ID NO:2.14. The pharmaceutical composition of claim 9 wherein said Hsp70 or fragment of Hsp70 comprises an amino acid sequence as shown in SEQ ID NO:3.15. The pharmaceutical composition of claim 13 or14 wherein Hsp70 or fragment of Hsp70 is C-terminal to said nuclear protein or nuclear peptide.16. The pharmaceutical composition of claim 7 wherein said nuclear protein or nuclear peptide comprises residues 37-409 of the p50 subunit of the transcription factor NF-&kgr;B as shown in SEQ ID NO:1.17. A method of delivering a compound into a cell or cells, said method comprising: associating said compound with Hsp70, or a fragment of Hsp70 capable of intracellular and intranuclear transport, to form an Hsp70 complex; and providing said Hsp70 complex to said cell or cells or to the environment surrounding said cell or cells so that said Hsp70 complex is imported into said cell or cells; wherein said compound comprises residues 37-409 of the p50 subunit of the transcription factor NF-&kgr;B as shown in SEQ ID NO:1. 18. The method of claim 1, wherein said nuclear protein or nuclear peptide is covalently joined to a fragment of Hsp70 capable of intracellular and intranuclear transport.19. The method of claim 1, wherein said Hsp70 or fragment of Hsp70 is of human origin.20. The method of claim 1, wherein said nuclear protein or nuclear peptide is capable of modulating gene expression in said nuclear compartment.21. The method of claim 20, wherein said modulation of gene expression provides immunosuppressive or immunostimulatory control.22. The method of claim 20, wherein said nuclear protein or nuclear peptide is a transcription factor.23. The method of claim 22, wherein said transcription factor is a regulator of inflammatory responses.24. A pharmaceutical composition comprising an Hsp70 complex, said Hsp70 complex comprising a first portion and a second portion covalently joined, said first portion comprising Hsp70 of human origin, or a fragment of Hsp70 of human origin capable of intracellular and intranuclear transport, and said second portion comprising a nuclear protein or nuclear peptide. 25. The pharmaceutical composition of claim 7, wherein said nuclear protein or nuclear peptide is capable of modulating gene expression in said nuclear compartment.26. The pharmaceutical composition of claim 25, wherein said modulation of gene expression provides immunosuppressive or immunostimulatory control.27. The pharmaceutical composition of claim 25, wherein said nuclear protein or nuclear peptide is a transcription factor.28. The pharmaceutical composition of claim 27, wherein said transcription factor is a regulator of inflammatory responses.29. The pharmaceutical composition of claim 9, wherein said first portion consists of an amino acid sequence as shown in SEQ ID NO:2 or SEQ ID NO:3.30. The pharmaceutical composition of claim 9, wherein said first portion consists of a fragment of Hsp70 protein capable of intracellular and intranuclear transport.31. The pharmaceutical composition of claim 14, wherein said nuclear protein or nuclear peptide is a transcription factor.32. A method of treating a disease in a patient comprising administering to said patient a therapeutically effective amount of a pharmaceutical composition according to claim 7,9,12,13,14,16,25,27 or31.33. The method of claim 32, wherein the pharmaceutical composition is according toclaim 31 and the patient is human.34. A method of treating a disease in a patient comprising administering to said patient a therapeutically effective amount of a pharmaceutical composition according to claim 7,9,12,13,14,16,17,25,27,29 or30 wherein said disease is transplant rejection, an autoimmune disease, an inflammatory disease, cancer, a viral replication disease, or a vascular disease.35. The method of claim 34 wherein said disease is transplant rejection, an autoimmune disease, an inflammatory disease or a vascular disease.
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