WO1997025862A1 - Composition et methode de pretraitement de l'hepatite - Google Patents

Composition et methode de pretraitement de l'hepatite Download PDF

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Publication number
WO1997025862A1
WO1997025862A1 PCT/US1997/000664 US9700664W WO9725862A1 WO 1997025862 A1 WO1997025862 A1 WO 1997025862A1 US 9700664 W US9700664 W US 9700664W WO 9725862 A1 WO9725862 A1 WO 9725862A1
Authority
WO
WIPO (PCT)
Prior art keywords
interferon
alpha
patient
hepatitis
buccal
Prior art date
Application number
PCT/US1997/000664
Other languages
English (en)
Inventor
Elliot Alpert
Original Assignee
Mcgill University
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Mcgill University filed Critical Mcgill University
Priority to AU17486/97A priority Critical patent/AU1748697A/en
Publication of WO1997025862A1 publication Critical patent/WO1997025862A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/19—Cytokines; Lymphokines; Interferons
    • A61K38/21—Interferons [IFN]
    • A61K38/212—IFN-alpha

Definitions

  • the interferon-alpha intended for sublingual/buccal administration is formulated in a saliva soluble solid dosage form which is held in the mouth to form a saliva solution of the interferon to promote contact of the interferon with the oral and pharyngeal mucosa of the patient receiving said dosage form.
  • the solid dosage form is formulated to dissolve, when held in a patient's. outh, to form a saliva solution of the dose of interferon to promote contact of the interferon with the oral pharyngeal mucosa.
  • the solid dosage form is in the form of a lozenge adapted to be dissolved upon contact with saliva in the mouth, with or without the assistance of chewing, to form a saliva solution of the interferon.
  • the lozenge is formulated to provide about 1 to about 1500 IU, more preferably about 50 to about 500 of interferon-alpha in solution upon dissolution of the dosage form in the mouth.
  • Interferon-alpha can be used to prepare an oral medicament useful for enhancing the disease remission rate in hepatitis positive patients receiving parenterally administered interferon.
  • a medicament comprises about 1 to about 1500 IU of interferon-alpha and a pharmaceutically acceptable carrier therefor.
  • the medicament is in the form of a saliva soluable dosage form which is held in the mouth of the patient to form a saliva solution of interferon.
  • the medicament is useful for treating a hepatitis positive patient prior to initiating standard parenteral interferon therapy.
  • the medicament can be administered simultaneously with standard parenteral interferon therapy.
  • Interferon can be administered in accordance with this invention in either a liquid (solution) or solid dosage form.
  • interferon can be administered dissolved in a buffered aqueous solution typically containing a stabilizing amount (1-5% by weight) of blood serums.
  • a buffered solution suitable as a carrier of interferon administered in accordance with this invention is phosphate buffered saline prepared as follows:
  • Table 6 shows ALT, AST and HCV RNA concentrations detected in patient sera at baseline, after completion of buccal therapy, after completion of injectable therapy and at the last evaluable follow-up.
  • Table 7 lists the responses seen during both treatment phases and at follow- up, and Table 8 summarizes these responses. TABLE 6. Individual and Mean ALT, AST and HCV RNA Values in 10 HCV+ Patients

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

L'invention a trait à une composition à base d'interféron-alpha présentée sous la forme d'un médicament à administrer par voie orale permettant un meilleur traitement de l'hépatite par interféron. Des patients atteints de l'hépatite, ayant été soumis à un prétraitement par voie buccale/sublinguale au moyen de faibles doses d'interféron-alpha, montrent un taux amélioré de rémission après une thérapie à l'interféron administré par voie parentérale.
PCT/US1997/000664 1996-01-19 1997-01-16 Composition et methode de pretraitement de l'hepatite WO1997025862A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU17486/97A AU1748697A (en) 1996-01-19 1997-01-16 Hepatitis pretreatment composition and method

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US1022496P 1996-01-19 1996-01-19
US60/010,224 1996-01-19

Publications (1)

Publication Number Publication Date
WO1997025862A1 true WO1997025862A1 (fr) 1997-07-24

Family

ID=21744627

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1997/000664 WO1997025862A1 (fr) 1996-01-19 1997-01-16 Composition et methode de pretraitement de l'hepatite

Country Status (2)

Country Link
AU (1) AU1748697A (fr)
WO (1) WO1997025862A1 (fr)

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR2769505A1 (fr) * 1997-10-10 1999-04-16 Michael Gerard Tovey Compositions de cytokines a administrer a la muqueuse buccale, et leurs utilisations
WO2000032223A2 (fr) * 1998-12-02 2000-06-08 Pharma Pacific Pty. Ltd. Traitement therapeutique a l'aide de medicaments immunogenes
US6660258B1 (en) 1997-05-09 2003-12-09 Pharma Pacific Pty Ltd Oromucosal cytokine compositions and uses thereof
WO2004000266A1 (fr) * 2002-06-20 2003-12-31 Yuriy Vasilievich Tyagotin Methode d'administration d'interferon par voie orale transmucosale
US7457765B2 (en) 2000-06-02 2008-11-25 Drason Consulting Services, Llc Method and system for scheduling employees in a patient care environment
US7587329B2 (en) 2000-06-02 2009-09-08 Drason Consulting Services, Llc Method and system for optimizing employee scheduling in a patient care environment

Non-Patent Citations (4)

* Cited by examiner, † Cited by third party
Title
ARCHIVUM IMMUNOLOGIAE ET THERAPIAE EXPERIMENTALIS, 1993, Vol. 41, ZIELINSKA et al., "Treatment of Six Patients with Chronic Active HCV Hepatitis, with Low Dose Natural Human Interferon Alpha Administered Orally", pages 253-257. *
BRITISH MEDICAL JOURNAL, 20 February 1993, Vol. 306, LAU, JOHNSON Y.N., "Managing Chronic Hepatitis C Virus Infection", pages 469-470. *
J. INTERFERON CYTOKINE RES., Vol. 15, Suppl. 1, 1995, the Abstract No. S206, SMIATACZ et al., "Comparison of Low Dose Natural Human Interferon Alpha Administered Orally with Mega Doses Used Parenterally in Treatment of Chronic HBV and HCV Hepatitis"; & ANNUAL MEETING OF THE INTERNATIONAL SOCIETY FOR INTERFERON AND *
THE LANCET, 27 November 1993, Vol. 342, WRIGHT, et al., "Clinical Aspects of Hepatitis B Virus Infection", pages 1340-1344. *

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6660258B1 (en) 1997-05-09 2003-12-09 Pharma Pacific Pty Ltd Oromucosal cytokine compositions and uses thereof
FR2769505A1 (fr) * 1997-10-10 1999-04-16 Michael Gerard Tovey Compositions de cytokines a administrer a la muqueuse buccale, et leurs utilisations
WO1999018992A1 (fr) * 1997-10-10 1999-04-22 Pharma Pacific Pty. Ltd. Compositions a base de cytokine pour les muqueuses buccales et utilisation de ces compositions
WO2000032223A2 (fr) * 1998-12-02 2000-06-08 Pharma Pacific Pty. Ltd. Traitement therapeutique a l'aide de medicaments immunogenes
WO2000032223A3 (fr) * 1998-12-02 2000-10-19 Pharma Pacific Pty Ltd Traitement therapeutique a l'aide de medicaments immunogenes
US7457765B2 (en) 2000-06-02 2008-11-25 Drason Consulting Services, Llc Method and system for scheduling employees in a patient care environment
US7587329B2 (en) 2000-06-02 2009-09-08 Drason Consulting Services, Llc Method and system for optimizing employee scheduling in a patient care environment
WO2004000266A1 (fr) * 2002-06-20 2003-12-31 Yuriy Vasilievich Tyagotin Methode d'administration d'interferon par voie orale transmucosale

Also Published As

Publication number Publication date
AU1748697A (en) 1997-08-11

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