DK200101019A - Pharmaceutical composition containing brivudine for once-daily administration - Google Patents

Pharmaceutical composition containing brivudine for once-daily administration Download PDF

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Publication number
DK200101019A
DK200101019A DK200101019A DKPA200101019A DK200101019A DK 200101019 A DK200101019 A DK 200101019A DK 200101019 A DK200101019 A DK 200101019A DK PA200101019 A DKPA200101019 A DK PA200101019A DK 200101019 A DK200101019 A DK 200101019A
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Denmark
Prior art keywords
brivudine
pharmaceutical composition
once
composition containing
daily administration
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DK200101019A
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Danish (da)
Inventor
Alessandro Casini
Bettina Stubinski
Attilio Crea
Original Assignee
Berlin Chemie Ag
Menarini Recerche S P A
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Application filed by Berlin Chemie Ag, Menarini Recerche S P A filed Critical Berlin Chemie Ag
Publication of DK200101019A publication Critical patent/DK200101019A/en
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Publication of DK177084B1 publication Critical patent/DK177084B1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
    • A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
    • A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
    • A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
    • A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
    • A61K31/7072—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A61P31/22—Antivirals for DNA viruses for herpes viruses
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2013—Organic compounds, e.g. phospholipids, fats
    • A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Virology (AREA)
  • Public Health (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Communicable Diseases (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biotechnology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)

Description

PATENTKRAV 1. Farmaceutisk præparat til oral indgivelse én gang dagligt indeholdende brivudin som aktiv bestanddel sammen med farmaceutisk acceptable bærere og excipienser til behandlingen af herpes zoster-infektioner eller post-herpes neuralgi. 2. Farmaceutisk præparat ifølge krav 1, hvor mængden af aktiv bestanddel er fra 50 til 300 mg. 3. Farmaceutisk præparat ifølge krav 2, hvor mængden af aktiv bestanddel er fra 100 til 200 mg. 4. Farmaceutisk præparat ifølge krav 3, hvor mængden af aktiv bestanddel er 125 mg. 5. Farmaceutisk præparat ifølge krav 4, som er udvalgt fra gruppen bestående af: brivudin 125 mg, mikrokrystallinsk cellulose 74, mg, lactose-monohydrat 37 mg, povidon K-værdi 25 6,5 mg, magnesiumstearat 2,5 mg, rent vand indtil 245 mg samlet vægt, brivudin 125 mg, mikrokrystallinsk cellulose 74 mg, majsstivelse 37 mg, povidon K-værdi 25 6,5 mg, magnesiumstearat 2,5 mg, rent vand indtil 245 mg samlet vægt, brivudin 125 mg, mikrokrystallinsk cellulose 74 mg, lactose 37 mg, povidon K-værdi 25 6,5 mg, magnesiumstearat 2,5 mg, rent vand indtil 245 mg samlet vægt, brivudin 125 rag, mikrokrystallinsk cellulose 74 mg, majsstivelse 37 mg, copovi-don VA 64 6,5 mg, magnesiumstearat 2,5 mg, rent vand indtil 245 mg samlet vægt, brivudin 125 mg, mikrokrystallinsk cellulose 74 mg, lactose 37 mg, copovidon VA 64, 6,5 mg, collidone CL 5,0 mg, magnesiumstearat 2,5 mg, rent vand indtil 250 mg samlet vægt, brivudin 125 mg, mikrokrystallinsk cellulose/aerosil 122,5 mg, magnesiumstearat 2,5 mg, rent vand indtil 250 mg samlet vægt, brivudin 125 mg, mikrokrystallinsk cellulose/aerosil 100,5 mg, collidone CL 22,0 mg, magnesiumstearat 2,5 mg, rent vand indtil 250 mg samlet vægt, brivudin 125 mg, mikrokrystallinsk cellulose 122,5 mg, magnesiumstearat 2,5 mg, rent vand indtil 250 mg samlet vægt (øjeblikkelig frigivelse), brivudin 125 mg, mikrokrystallinsk cellulose 74,0 mg, lactose-monohydrat 32,0 mg, aerosil 5,0 mg, copovidon VA 64 6,5 mg, magnesiumstearat 2,5 mg, macro-gol 6000 1,5 mg, titandioxid 4,5 mg (coatet tablet med øjeblikkelig frigivelse). 6. Anvendelse af et farmaceutisk præparat til indgivelse én gang dagligt indeholdende 50 til 300 mg brivudin til behandlingen af herpes zoster-infektioner eller post-herpes neuralgi. 7. Anvendelse ifølge krav 6, hvor brivudin-indholdet er 125 mg. 8. Fremgangsmåde til behandling af herpes zoster-infektioner eller post-herpes neuralgi, hvor 50 til 300 mg brivudin indgives én gang dagligt. 9. Fremgangsmåde ifølge krav 8, hvor 125 mg brivudin anvendes.1. A once-daily pharmaceutical composition containing brivudine as an active ingredient together with pharmaceutically acceptable carriers and excipients for the treatment of herpes zoster infections or post-herpes neuralgia. The pharmaceutical composition of claim 1, wherein the amount of active ingredient is from 50 to 300 mg. The pharmaceutical composition of claim 2, wherein the amount of active ingredient is from 100 to 200 mg. The pharmaceutical composition of claim 3, wherein the amount of active ingredient is 125 mg. Pharmaceutical composition according to claim 4, selected from the group consisting of: brivudine 125 mg, microcrystalline cellulose 74, mg, lactose monohydrate 37 mg, povidone K value 6.5 mg, magnesium stearate 2.5 mg, pure water up to 245 mg total weight, brivudine 125 mg, microcrystalline cellulose 74 mg, corn starch 37 mg, povidone K value 25 6.5 mg, magnesium stearate 2.5 mg, pure water up to 245 mg total weight, brivudine 125 mg, microcrystalline cellulose 74 mg, lactose 37 mg, povidone K value 25 6.5 mg, magnesium stearate 2.5 mg, pure water up to 245 mg total weight, brivudine 125 rag, microcrystalline cellulose 74 mg, corn starch 37 mg, copovidone VA 64 6, 5 mg, magnesium stearate 2.5 mg, pure water up to 245 mg total weight, brivudine 125 mg, microcrystalline cellulose 74 mg, lactose 37 mg, copovidone VA 64, 6.5 mg, collidone CL 5.0 mg, magnesium stearate 2.5 mg, pure water up to 250 mg total weight, brivudine 125 mg, microcrystalline cellulose / aerosil 122.5 mg, magnesium stearate 2.5 mg, pure water up to 250 mg total weight, brivudine 125 mg, microcrystalline cellulose / aerosil 100.5 mg, collidone CL 22.0 mg, magnesium stearate 2.5 mg, clean water up to 250 mg total weight, brivudine 125 mg, microcrystalline cellulose 122, 5 mg, magnesium stearate 2.5 mg, pure water up to 250 mg total weight (immediate release), brivudine 125 mg, microcrystalline cellulose 74.0 mg, lactose monohydrate 32.0 mg, aerosil 5.0 mg, copovidone VA 64 6 , 5 mg, magnesium stearate 2.5 mg, macrogol 6000 1.5 mg, titanium dioxide 4.5 mg (immediate release coated tablet). Use of a once-daily pharmaceutical composition containing 50 to 300 mg of brivudine for the treatment of herpes zoster infections or post-herpes neuralgia. Use according to claim 6, wherein the brivudine content is 125 mg. A method of treating herpes zoster infections or post-herpes neuralgia, where 50 to 300 mg of brivudine is administered once daily. The method of claim 8, wherein 125 mg of brivudine is used.

Fig. 1: Risikoforhold* og en-sidet nedre 95 %-konfidensintervalFIG. 1: Risk ratio * and one-sided lower 95% confidence interval

Sammenligning mellem 1 x 125 mg brivudin og 5 x 800 mg acyclovir (per protokolpopulation)Comparison between 1 x 125 mg brivudine and 5 x 800 mg acyclovir (per protocol population)

Figure DK200101019AD00061

* Risikoforhold beregnet ud fra Cox-regression med covarianter. Et risikoforhold større end 1 indikerer ♦ risikoforhold bedre behandlingseffekt af brivudin i forhold til | acyclovir | I lavere X Nedre grænse af det ensidede 95%-konfidens-interval - 95% Cl over 0,8-linien (stiplet linie) viser ikke-mindre-værdighed og over 1,O-linien (fuldt optrukne linie) viser overlegenhed af 1 x 125 mg brivudin i forhold til 5 x 800 mg acyclovir.* Risk ratios calculated from Cox regression with covariates. A risk ratio greater than 1 indicates ♦ risk ratio better treatment effect of brivudine compared to | acyclovir | In the lower X Lower limit of the one-sided 95% confidence interval - 95% CI above the 0.8 line (dashed line) shows non-dignity and above the 1, O line (fully drawn line) shows superiority of 1 x 125 mg brivudine versus 5 x 800 mg acyclovir.

Fig 2: Risikoforhold* og en-sidet nedre 95%-konfidensintervalFigure 2: Risk ratios * and one-sided lower 95% confidence interval

Sammenligning mellem 1 x 125 mg brivudin og 5 x 800 mg acyclovir (per protokol-population)Comparison between 1 x 125 mg brivudine and 5 x 800 mg acyclovir (per protocol population)

Figure DK200101019AD00071

* Risikoforhold beregnet ud fra Cox-regression med covarianter. Et risikoforhold større end 1 indikerer ♦ risikoforhold bedre behandlingseffekt af brivudin i forhold til | acyclovir | I lavere X Nedre grænse af det ensidede 95 %-konfidens-interval - 95% Cl over 0,8-linien (stiplet linie) viser ikke-mindre-værdighed og over 1,O-linien (fuldt optrukne linie) viser overlegenhed af 1 x 125 mg brivudin i forhold til 5 x 800 mg acyclovir.* Risk ratios calculated from Cox regression with covariates. A risk ratio greater than 1 indicates ♦ risk ratio better treatment effect of brivudine compared to | acyclovir | In the lower X Lower limit of the one-sided 95% confidence interval - 95% CI above the 0.8 line (dashed line) shows non-dignity and above the 1, O line (fully drawn line) shows superiority of 1 x 125 mg brivudine versus 5 x 800 mg acyclovir.

DKPA200101019A 2001-01-03 2001-06-29 Pharmaceutical composition containing brivudine for once-daily administration DK177084B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMI20010009 2001-01-03
IT2001MI000009A ITMI20010009A1 (en) 2001-01-03 2001-01-03 PHARMACEUTICAL COMPOSITIONS CONTAINING BRIVUDINA FOR SINGLE DAILY ADMINISTRATION

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DK200101019A true DK200101019A (en) 2002-07-04
DK177084B1 DK177084B1 (en) 2011-07-11

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Country Status (20)

Country Link
AT (1) AT6141U1 (en)
BE (1) BE1014522A5 (en)
CH (1) CH695662A5 (en)
CZ (1) CZ20012464A3 (en)
DK (1) DK177084B1 (en)
ES (1) ES2192456B1 (en)
FI (1) FI20011446A (en)
FR (1) FR2818907B1 (en)
GB (1) GB2370771A (en)
GR (1) GR1004012B (en)
HR (1) HRPK20010345B3 (en)
HU (1) HUP0102816A3 (en)
IE (1) IE20010413A1 (en)
IT (1) ITMI20010009A1 (en)
NL (1) NL1018431C2 (en)
PL (1) PL348480A1 (en)
PT (1) PT102642B (en)
SE (1) SE0102309L (en)
SK (1) SK287043B6 (en)
UA (1) UA76402C2 (en)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2239527B1 (en) * 2004-03-01 2006-11-16 M. Cruz Fernandez Gonzalez PHARMACOLOGICAL COMPOSITION OF TOPICAL USE FOR THE TREATMENT OF HERPES ZOSTER.
CN113712928A (en) * 2021-09-29 2021-11-30 重庆市力扬医药开发有限公司 Brivudine drug absorbed through oral mucosa

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0104857A1 (en) * 1982-09-28 1984-04-04 Beecham Group Plc Deoxyuridine compounds, methods for preparing them and their use in medicine
IT1170232B (en) * 1983-10-31 1987-06-03 Anna Gioia Stendardi THERAPEUTIC COMPOSITIONS WITH ANTI-VIRAL ACTIVITY
US5446031A (en) * 1991-04-24 1995-08-29 Yamasa Shuyu Kabushiki Kaisha 1-β-D-arabinofuranosyl-(E)-5-(2-halogenovinyl)uracil derivatives
DK0874631T3 (en) * 1996-01-19 2004-03-22 Glaxo Group Ltd Use of valaciclovir for the manufacture of a medicament for the treatment of genital herpes in a single daily application

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HRPK20010345B3 (en) 2005-02-28
GB0110682D0 (en) 2001-06-20
ITMI20010009A0 (en) 2001-01-03
FR2818907B1 (en) 2006-05-26
DK177084B1 (en) 2011-07-11
BE1014522A5 (en) 2003-12-02
FR2818907A1 (en) 2002-07-05
CZ20012464A3 (en) 2002-08-14
SK287043B6 (en) 2009-10-07
GR20010100322A (en) 2002-10-08
PT102642A (en) 2002-07-31
IE20010413A1 (en) 2003-04-16
SK9572001A3 (en) 2003-03-04
HUP0102816A3 (en) 2005-01-28
PT102642B (en) 2003-06-30
NL1018431C2 (en) 2002-07-05
ES2192456B1 (en) 2005-02-01
GR1004012B (en) 2002-11-01
ES2192456A1 (en) 2003-10-01
GB2370771A (en) 2002-07-10
AT6141U1 (en) 2003-05-26
PL348480A1 (en) 2002-07-15
HU0102816D0 (en) 2001-09-28
FI20011446A (en) 2002-07-04
HRP20010345A2 (en) 2003-08-31
CH695662A5 (en) 2006-07-31
ITMI20010009A1 (en) 2002-07-03
FI20011446A0 (en) 2001-07-03
UA76402C2 (en) 2006-08-15
SE0102309D0 (en) 2001-06-28
SE0102309L (en) 2002-07-04
HUP0102816A2 (en) 2002-10-28

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Expiry date: 20210629