WO1994021268A1 - Preparation pharmaceutique a liberation prolongee renfermant de l'aluminium - Google Patents
Preparation pharmaceutique a liberation prolongee renfermant de l'aluminium Download PDFInfo
- Publication number
- WO1994021268A1 WO1994021268A1 PCT/EP1994/000829 EP9400829W WO9421268A1 WO 1994021268 A1 WO1994021268 A1 WO 1994021268A1 EP 9400829 W EP9400829 W EP 9400829W WO 9421268 A1 WO9421268 A1 WO 9421268A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- aluminium
- compound
- phosphate
- pharmaceutical preparation
- sodium
- Prior art date
Links
Classifications
-
- 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
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2077—Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/42—Phosphorus; Compounds thereof
-
- 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
- A61K9/2009—Inorganic compounds
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
Definitions
- the invention relates to an antacid and/or adstringent and absorbent pharmaceutical preparation containing at least one aluminium compound, as well as a process for the production of such preparations.
- aluminium-based e.g. aluminium hydroxide, magnesium-aluminium-hydrate, magaldrate etc.
- oral suspension oral suspension
- Another ob- ject of the invention relates to the provision of a pharma ⁇ ceutical preparation with sustained release of the antacid and/or adstringent and absorbent compounds.
- the principle of the invention is a phosphate delivery system controlled by the swelling mechanism of the hydro- colloid.
- Fig.1 the top left rectangle symbolizes the magaldrate example.
- Excess acid (AC) in the gastric fluid is neutralized (N) by the OH ⁇ -flux.
- the resulting Al3 + - flux is bound by the phosphate P and the swelled (arrow B) hydrocolloid HY to the phosphate/hydro- colloid/aluminium system (PHAS) .
- the phosphate/ hydrocolloid system (P+HY) controls the dissolution and binding of the aluminium as shown in
- Fig.2 (left of the dotted line: stomach ST; right of the dotted line: intestines IN) partly through an oscil ⁇ lating reaction mechanism influenced by the change of the intragastric pH-value, partly by binding the aluminium to the hydrocolloid, advantageously to a crosslinked polymer.
- Fig.3 shows the principle of the aluminium capture based partly on the significant difference in the solubility of aluminium hydroxide and aluminium phosphate; partly, it is also based on the function of the hydrocolloid-phosphate system, which binds the aluminium and is activated by the swelling of the hydrocolloid.
- the described aluminium capturing system does not decrease the acid neutralization ca ⁇ pacity of the aluminium compound at the acidic pH of the stomach (ST) but inhibits the absorption of alu- minium from the stomach (ST) and the duodenum (inte ⁇ stines (IN) , see Fig.2) of higher pH.
- Table I Change of the aluminium amount excreted by the urine of 5 patients over 24 hours after administration of 750 mg magaldrate compared to the control value of the pre ⁇ vious day: ⁇ g Al/24 h eliminated by urine Subject magaldrate magaldrate with the phosphate-hydrocolloid system ace. example 3
- Difference si ⁇ nificant not si ⁇ nificant s ⁇ (S.E.M.) is the standard deviation of the mean value; the t-value is the Student-t at 5% significance level.
- the aluminium compound may be selected from a wide range of inorganic and organic salts or complex compounds, such as aluminium hydroxide, aluminium glycinate (dihydroxyaluminium aminoacetate hydrate, USP XXII p. 445) , aluminiumsodium trisilicate, aluminium hydroxycarbonate (dihydroxyaluminium sodium carbonate, USP XXII p.447) , basic aluminium carbonate gel (USP XXII p.50) , aluminium phosphate (USP XXII p.53) , aluminium magnesium silicate (B.P.), natural or synthetic aluminium- and magnesium-containing compounds, preferably aluminiummagnesium hydroxycarbonate (hydrotalcite) and aluminiummagnesium hydroxysulphate (magaldrate) .
- inorganic and organic salts or complex compounds such as aluminium hydroxide, aluminium glycinate (dihydroxyaluminium aminoacetate hydrate, USP X
- the water-swellable compounds may be selected from the group comprising cellulose glycolic acid, starch glycolic acid, polyacrylic acid, copolymers of acrylic acid-methacrylic acid, alginic acid (polymannuronic acid, USNF XVII) , poly- vinylpyrrolidone, calcium alginate (BPC) , sodium alginate (USNF XVII) , Carbopol (R) 934P (carbomer, USNF XVII) , carb- oxymethylcellulose calcium (USNF XVII) , carboxymethylcellu- lose sodium (carmellose, USP XXII) , carrageenan (USNF XVII) , croscarmellose sodium (USNF XVII,Ac-Di-Sol (R) ) , cross-linked polyvinylpyrrolidone (USNF XVII, Polyplasdone XL (R) ) , hydroxypropylmethylcellulose (US
- the phosphate compound may be selected from the group com ⁇ prising mono-, di- and tribasic calcium phosphate; mono-, di- and tribasic magnesium phosphate; mono- and dibasic sodium phosphate; mono- and dibasic potassium phosphate; mono- and dicalcium glycerophosphate.
- Auxiliary materials may be disintegrants such as starch, microcellulose, cross-linked polyvinylpyrrolidone etc.; tableting aids, such as lubricants, e.g. talc, magnesium stearate etc.; sweeteners such as saccharose, glucose, sac ⁇ charin-sodium, sodium cyclamate, aspartame etc.; flavouring agents such as lemon, orange and cassis aroma; fillers such as lactose.
- disintegrants such as starch, microcellulose, cross-linked polyvinylpyrrolidone etc.
- tableting aids such as lubricants, e.g. talc, magnesium stearate etc.
- sweeteners such as saccharose, glucose, sac ⁇ charin-sodium, sodium cyclamate, aspartame etc.
- flavouring agents such as lemon, orange and cassis aroma
- fillers such as lactose.
- 500g hydrotalcite and 70g tribasic calcium phosphate powder are homogenized.
- 90g of cross-linked polyvinylpyrrolidone are swelled with 60-75 ml water (required for wet granulation) during 2 hours and then mixed with the powder mixture and kneaded.
- the wet mass is granulated by passing it through a sieve with openings of 1.4 mm.
- the granules are dried to a moisture content of 2.5% and then regranulated through a sieve with openings of 0.8 mm.
- Example 2 The same procedure is followed as in Example 1 with the following compounds (for 1000 tablets of 0.75 g average weight each) :
- Inner phase aluminium hydroxycarbonate 600 g tribasic magnesium phosphate 34 g carboxymethylcellulose sodium of low substitution grade 10 g cross-linked carboxymethyl ⁇ cellulose sodium (Ac-Di-Sol (R) ) 10 g water 80-100 ml outer phase: potato starch (disintegrant) 50 g talc 24 g magnesium stearate 12 g
- Example 2 The same procedure is followed as in Example 1 with the following compounds (for 1000 tablets of 1.3 g average weight each) :
- Example 2 The same procedure is followed as in Example 1 with the following compounds (for 1000 tablets for 1.5 g average weight each) : Inner phase: aluminium hydroxide 375 g tribasic calcium phosphate 100 g Nymcel ZSB 1 ⁇ (R) 200 g water 80-100 ml outer phase: microcrystalline cellulose Avicel PH 102 ⁇ R > 825 g
- Example 4 The same procedure is followed as in Example 4 with the following compounds (for 1000 tablets of 1.5 g average weight each) , with the exception that double-layered tablets are formed.
- the antacid active ingredient is pressed as the first layer, onto which the second layer containing the other components and the microcrystalline cellulose is pressed:
- First layer aluminium hydroxide 375 g microcrystalline cellulose
- Example 4 The same procedure is followed as in Example 4 - with the exception that three-layered tablets are formed - with the following compounds (for 1000 tablets of 1.5 g average weight each) :
- First layer Aluminium hydroxide 375 g microcrystalline cellulose
- Example 4 The same procedure is followed as in Example 4 - with the exception that the particles of the phosphate, compound are coated by spraying on them (and afterwards drying) an isopropanolic solution of Eudragit L100-55 - with the following compounds (for 1000 tablets of 1.5 g average weight each) : Inner phase (aluminium) : aluminium hydroxide 375 g inner phase (phosphate) : tribasic calcium phosphate 100 g coating:
- Nymcel ZSB 10 ⁇ R 200 g water 80-100 ml outer phase: microcrystalline cellulose
- Example 9 The same procedure is followed and composition used as in Example 7 with the exception that the tribasic calcium phosphate is coated with a solution of 4.5 g celluloseacetatephtalate in 30 ml of acetone.
- Example 9 The same procedure is followed and composition used as in Example 7 with the exception that the tribasic calcium phosphate is coated with a solution of 4.5 g celluloseacetatephtalate in 30 ml of acetone.
- 1000 ml of an antacid suspension are prepared, having the following composition: magaldrate 200 g cross-linked carboxymethylcellulose sodium (Ac-Di-Sol (R) ) 50 g tribasic calcium phosphate 75 g tribasic magnesium phosphate 75 g hydroxy-propylmethylcellulose 4000 12 g methylparaben 10 g alcohol 10 g water, deionized to 1000 ml
- Example 10 Example 9 is repeated except that the composition differs as follows: aluminium hydroxide 100 g alginic acid 140 g monobasic sodium phosphate 140 g hydroxy-propylmethylcellulose 4000 12 g propylparaben 2.5 g methylparaben 2.5 g alcohol 10 g water, deionized to 1000 ml The alginic acid is first swelled in the acidic hydroxy- propylmethylcellulose solution containing monobasic sodium phosphate to produce the limited swelling form of the hydrocolloid.
- aluminium hydroxide 100 g alginic acid 140 g monobasic sodium phosphate 140 g hydroxy-propylmethylcellulose 4000 12 g propylparaben 2.5 g methylparaben 2.5 g alcohol 10 g water, deionized to 1000 ml
- the alginic acid is first swelled in the acidic hydroxy- propylmethylcellulose solution containing monobasic sodium phosphate to produce the limited swelling form of the hydrocolloid
- aluminium hydroxide 250 g monobasic sodium phosphate 100 g alginic acid 100 g are mixed and granulated in the dry state or by adding water and drying; then, 0.5 g Aerosil R972 (R) lubricant is mixed with the dry granules. A 0.40-0.45 g portion of the mixture is filled into a hard gelatine capsule.
- Example 12 A tablet preparation with antacid and adstringent effect is formulated with the following composition for 1000 tablets: aluminium hydroxide 500 g aluminium glycinate 500 g cellulose glycolic acid 250 g Carbopol 934p (R) 25 g tribasic magnesium phosphate 100 g magnesium stearate 23 g
- the process is completed in the usual way: the cellulose glycolic acid is swelled in the Carbopol 934p (R *> solution. This liquid is used for the wet granulation of the powder mixture.
- the tablet preparation is formed as described in Example 1.
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU64269/94A AU6426994A (en) | 1993-03-16 | 1994-03-16 | Aluminium containing pharmaceutical preparation with controlled release |
PL94310821A PL310821A1 (en) | 1993-03-16 | 1994-03-16 | Aluminium containing pharmaceutical preparation of controllable active substance release |
JP6520643A JPH08507775A (ja) | 1993-03-16 | 1994-03-16 | 放出制御性のアルミニウム含有医薬製剤 |
EP94911900A EP0689445A1 (fr) | 1993-03-16 | 1994-03-16 | Preparation pharmaceutique a liberation prolongee renfermant de l'aluminium |
CA002158437A CA2158437A1 (fr) | 1993-03-16 | 1994-03-16 | Preparation pharmaceutique contenant de l'aluminium, a liberation controlee |
FI954348A FI954348A (fi) | 1993-03-16 | 1995-09-15 | Säädetysti vapauttava alumiinia sisältävä farmaseuttinen valmiste |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
HU9300744A HUT70038A (en) | 1992-03-16 | 1993-03-16 | 2-oxoquinolines, pharmaceutical compositions containing them, and the process for preparing thereof |
HU7404/93 | 1993-03-18 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1994021268A1 true WO1994021268A1 (fr) | 1994-09-29 |
Family
ID=10983353
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/EP1994/000829 WO1994021268A1 (fr) | 1993-03-16 | 1994-03-16 | Preparation pharmaceutique a liberation prolongee renfermant de l'aluminium |
Country Status (7)
Country | Link |
---|---|
EP (1) | EP0689445A1 (fr) |
JP (1) | JPH08507775A (fr) |
AU (1) | AU6426994A (fr) |
CA (1) | CA2158437A1 (fr) |
FI (1) | FI954348A (fr) |
PL (1) | PL310821A1 (fr) |
WO (1) | WO1994021268A1 (fr) |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0692255A3 (fr) * | 1994-07-13 | 1997-07-23 | Bayer Ag | Préparation antiacide à profil de sécurité amélioré |
EP1488812A1 (fr) * | 2002-03-04 | 2004-12-22 | Medrx Co. Ltd. | Matrice liquide a transfert de phase in vivo, et preparations liquides orales |
CN114917198A (zh) * | 2022-06-22 | 2022-08-19 | 海南妙音春制药有限公司 | 一种铝碳酸镁咀嚼片及其制备方法 |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU2014227790B2 (en) | 2013-03-15 | 2019-03-14 | Mallinckrodt Hospital Products IP Limited | Therapeutic gas delivery device with pulsed and continuous flow control |
Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3579634A (en) * | 1968-04-18 | 1971-05-18 | Garland Richard Brown | Novel antacid compositions and methods for their administration |
US3591680A (en) * | 1969-11-17 | 1971-07-06 | Smith Kline French Lab | Concentrated antacid compositions and method of producing antacid activity |
DE2201752A1 (de) * | 1971-09-23 | 1973-03-29 | Biotherax Lab | Stabiles gel auf der basis von aluminiumphosphat und verfahren zur herstellung desselben |
EP0003589A2 (fr) * | 1978-02-06 | 1979-08-22 | The Wellcome Foundation Limited | Formule pour comprimés d'antiacide |
FR2512344A1 (fr) * | 1981-09-08 | 1983-03-11 | Af Aplicaciones Far Lab | Procede de fabrication d'une suspension stable d'hydroxyde d'alumine et/ou d'hydroxyde de magnesie comme agent actif des antacida |
WO1988000051A1 (fr) * | 1986-06-24 | 1988-01-14 | Racz Istvan | Procede pour la production de preparations pharmaceutiques ayant une capacite elevee de liaison de l'acide gastrique, un effet retarde et une biodisponibilite accrue |
EP0484106A1 (fr) * | 1990-11-01 | 1992-05-06 | Merck & Co. Inc. | Compositions à libération contrôlée |
-
1994
- 1994-03-16 EP EP94911900A patent/EP0689445A1/fr not_active Withdrawn
- 1994-03-16 JP JP6520643A patent/JPH08507775A/ja active Pending
- 1994-03-16 AU AU64269/94A patent/AU6426994A/en not_active Abandoned
- 1994-03-16 WO PCT/EP1994/000829 patent/WO1994021268A1/fr not_active Application Discontinuation
- 1994-03-16 CA CA002158437A patent/CA2158437A1/fr not_active Abandoned
- 1994-03-16 PL PL94310821A patent/PL310821A1/xx unknown
-
1995
- 1995-09-15 FI FI954348A patent/FI954348A/fi not_active Application Discontinuation
Patent Citations (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3579634A (en) * | 1968-04-18 | 1971-05-18 | Garland Richard Brown | Novel antacid compositions and methods for their administration |
US3591680A (en) * | 1969-11-17 | 1971-07-06 | Smith Kline French Lab | Concentrated antacid compositions and method of producing antacid activity |
DE2201752A1 (de) * | 1971-09-23 | 1973-03-29 | Biotherax Lab | Stabiles gel auf der basis von aluminiumphosphat und verfahren zur herstellung desselben |
EP0003589A2 (fr) * | 1978-02-06 | 1979-08-22 | The Wellcome Foundation Limited | Formule pour comprimés d'antiacide |
FR2512344A1 (fr) * | 1981-09-08 | 1983-03-11 | Af Aplicaciones Far Lab | Procede de fabrication d'une suspension stable d'hydroxyde d'alumine et/ou d'hydroxyde de magnesie comme agent actif des antacida |
WO1988000051A1 (fr) * | 1986-06-24 | 1988-01-14 | Racz Istvan | Procede pour la production de preparations pharmaceutiques ayant une capacite elevee de liaison de l'acide gastrique, un effet retarde et une biodisponibilite accrue |
EP0484106A1 (fr) * | 1990-11-01 | 1992-05-06 | Merck & Co. Inc. | Compositions à libération contrôlée |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP0692255A3 (fr) * | 1994-07-13 | 1997-07-23 | Bayer Ag | Préparation antiacide à profil de sécurité amélioré |
EP1488812A1 (fr) * | 2002-03-04 | 2004-12-22 | Medrx Co. Ltd. | Matrice liquide a transfert de phase in vivo, et preparations liquides orales |
EP1488812A4 (fr) * | 2002-03-04 | 2006-05-03 | Medrx Co Ltd | Matrice liquide a transfert de phase in vivo, et preparations liquides orales |
CN114917198A (zh) * | 2022-06-22 | 2022-08-19 | 海南妙音春制药有限公司 | 一种铝碳酸镁咀嚼片及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
CA2158437A1 (fr) | 1994-09-29 |
FI954348A0 (fi) | 1995-09-15 |
EP0689445A1 (fr) | 1996-01-03 |
JPH08507775A (ja) | 1996-08-20 |
FI954348A (fi) | 1995-11-15 |
PL310821A1 (en) | 1996-01-08 |
AU6426994A (en) | 1994-10-11 |
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