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WO1994021268A1 - Preparation pharmaceutique a liberation prolongee renfermant de l'aluminium - Google Patents

Preparation pharmaceutique a liberation prolongee renfermant de l'aluminium Download PDF

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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
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/EP1994/000829
Other languages
English (en)
Inventor
István RÁCZ
János PLACHY
István ANTAL
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Synepos AG
Original Assignee
Synepos AG
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
Priority claimed from HU9300744A external-priority patent/HUT70038A/hu
Application filed by Synepos AG filed Critical Synepos AG
Priority to PL94310821A priority Critical patent/PL310821A1/xx
Priority to AU64269/94A priority patent/AU6426994A/en
Priority to FI954348A priority patent/FI954348A7/fi
Priority to CA002158437A priority patent/CA2158437A1/fr
Priority to EP94911900A priority patent/EP0689445A1/fr
Priority to JP6520643A priority patent/JPH08507775A/ja
Publication of WO1994021268A1 publication Critical patent/WO1994021268A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

Préparation pharmaceutique renfermant au moins un composé d'aluminium et présentant une activité antiacide et/ou astringente et adsorbante. Le procédé de fabrication de cette préparation consiste à traiter de 2 à 300 parties en poids d'un composé gonflant au contact de l'eau et présentant une faible aptitude au gonflement, avec 2 à 50 parties en poids d'eau, puis à le mélanger à une poudre comportant au moins un élément sélectionné dans le groupe constitué de 100 parties en poids dudit composé d'aluminium, de 2 à 150 parties en poids d'au moins un composé de phosphate, et d'au moins une matière auxiliaire. Ensuite, on peut granuler et sécher le mélange, et le transformer en comprimés ou l'utiliser pour remplir des capsules. On peut également le mettre en suspension.
PCT/EP1994/000829 1993-03-16 1994-03-16 Preparation pharmaceutique a liberation prolongee renfermant de l'aluminium Ceased WO1994021268A1 (fr)

Priority Applications (6)

Application Number Priority Date Filing Date Title
PL94310821A PL310821A1 (en) 1993-03-16 1994-03-16 Aluminium containing pharmaceutical preparation of controllable active substance release
AU64269/94A AU6426994A (en) 1993-03-16 1994-03-16 Aluminium containing pharmaceutical preparation with controlled release
FI954348A FI954348A7 (fi) 1993-03-16 1994-03-16 Säädetysti vapauttava alumiinia sisältävä farmaseuttinen valmiste
CA002158437A CA2158437A1 (fr) 1993-03-16 1994-03-16 Preparation pharmaceutique contenant de l'aluminium, a liberation controlee
EP94911900A EP0689445A1 (fr) 1993-03-16 1994-03-16 Preparation pharmaceutique a liberation prolongee renfermant de l'aluminium
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

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

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ID=10983353

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP1994/000829 Ceased 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) FI954348A7 (fr)
PL (1) PL310821A1 (fr)
WO (1) WO1994021268A1 (fr)

Cited By (3)

* Cited by examiner, † Cited by third party
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
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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP6466906B2 (ja) 2013-03-15 2019-02-06 マリンクロット ホスピタル プロダクツ アイピー リミテッド パルス的および連続的流れ制御による治療用ガス送達装置

Citations (7)

* Cited by examiner, † Cited by third party
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

Patent Citations (7)

* Cited by examiner, † Cited by third party
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 (3)

* Cited by examiner, † Cited by third party
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
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
FI954348A0 (fi) 1995-09-15
FI954348L (fi) 1995-11-15
FI954348A7 (fi) 1995-11-15
JPH08507775A (ja) 1996-08-20
PL310821A1 (en) 1996-01-08
AU6426994A (en) 1994-10-11
EP0689445A1 (fr) 1996-01-03
CA2158437A1 (fr) 1994-09-29

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