FR2787331A1 - Tablet containing alpha-amylase, useful e.g. for assisting digestion, containing materials, especially magnesium stearate, of plant origin - Google Patents
Tablet containing alpha-amylase, useful e.g. for assisting digestion, containing materials, especially magnesium stearate, of plant origin Download PDFInfo
- Publication number
- FR2787331A1 FR2787331A1 FR9816194A FR9816194A FR2787331A1 FR 2787331 A1 FR2787331 A1 FR 2787331A1 FR 9816194 A FR9816194 A FR 9816194A FR 9816194 A FR9816194 A FR 9816194A FR 2787331 A1 FR2787331 A1 FR 2787331A1
- Authority
- FR
- France
- Prior art keywords
- magnesium stearate
- amylase
- plant origin
- useful
- mixture
- 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.)
- Granted
Links
- 102000004139 alpha-Amylases Human genes 0.000 title claims abstract description 10
- 108090000637 alpha-Amylases Proteins 0.000 title claims abstract description 10
- 229940024171 alpha-amylase Drugs 0.000 title claims abstract description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 title claims description 19
- 235000019359 magnesium stearate Nutrition 0.000 title claims description 9
- 230000029087 digestion Effects 0.000 title 1
- 239000000463 material Substances 0.000 title 1
- 239000000203 mixture Substances 0.000 claims description 29
- 238000009472 formulation Methods 0.000 claims description 12
- 235000013311 vegetables Nutrition 0.000 claims description 3
- 241001133760 Acoelorraphe Species 0.000 claims description 2
- 241000196324 Embryophyta Species 0.000 claims description 2
- 229920002472 Starch Polymers 0.000 claims description 2
- 125000002057 carboxymethyl group Chemical group [H]OC(=O)C([H])([H])[*] 0.000 claims description 2
- 239000008107 starch Substances 0.000 claims description 2
- 235000019698 starch Nutrition 0.000 claims description 2
- 239000003651 drinking water Substances 0.000 description 10
- 235000020188 drinking water Nutrition 0.000 description 10
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 8
- 238000004519 manufacturing process Methods 0.000 description 7
- 229920001800 Shellac Polymers 0.000 description 6
- 229930006000 Sucrose Natural products 0.000 description 6
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 description 6
- 239000004208 shellac Substances 0.000 description 6
- 235000013874 shellac Nutrition 0.000 description 6
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 6
- 229940113147 shellac Drugs 0.000 description 6
- 239000005720 sucrose Substances 0.000 description 6
- 239000001993 wax Substances 0.000 description 6
- 244000215068 Acacia senegal Species 0.000 description 4
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 description 4
- 108010010803 Gelatin Proteins 0.000 description 4
- 229920000084 Gum arabic Polymers 0.000 description 4
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 description 4
- 239000000205 acacia gum Substances 0.000 description 4
- 235000010489 acacia gum Nutrition 0.000 description 4
- 150000002148 esters Chemical class 0.000 description 4
- 235000019441 ethanol Nutrition 0.000 description 4
- 239000008273 gelatin Substances 0.000 description 4
- 229920000159 gelatin Polymers 0.000 description 4
- 235000019322 gelatine Nutrition 0.000 description 4
- 235000011852 gelatine desserts Nutrition 0.000 description 4
- 239000000600 sorbitol Substances 0.000 description 4
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 4
- 229920003134 Eudragit® polymer Polymers 0.000 description 3
- VVQNEPGJFQJSBK-UHFFFAOYSA-N Methyl methacrylate Chemical compound COC(=O)C(C)=C VVQNEPGJFQJSBK-UHFFFAOYSA-N 0.000 description 3
- 239000004203 carnauba wax Substances 0.000 description 3
- 235000013869 carnauba wax Nutrition 0.000 description 3
- 239000004382 Amylase Substances 0.000 description 2
- 102000013142 Amylases Human genes 0.000 description 2
- 108010065511 Amylases Proteins 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 235000019418 amylase Nutrition 0.000 description 2
- 239000008119 colloidal silica Substances 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 238000000265 homogenisation Methods 0.000 description 2
- 239000004922 lacquer Substances 0.000 description 2
- 238000005461 lubrication Methods 0.000 description 2
- 238000012216 screening Methods 0.000 description 2
- 238000007873 sieving Methods 0.000 description 2
- 239000000454 talc Substances 0.000 description 2
- 229910052623 talc Inorganic materials 0.000 description 2
- 239000002966 varnish Substances 0.000 description 2
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- 230000003501 anti-edematous effect Effects 0.000 description 1
- 230000003110 anti-inflammatory effect Effects 0.000 description 1
- 208000005881 bovine spongiform encephalopathy Diseases 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 238000000576 coating method Methods 0.000 description 1
- 230000001079 digestive effect Effects 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 239000008298 dragée Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 229940088598 enzyme Drugs 0.000 description 1
- 239000007888 film coating Substances 0.000 description 1
- 238000009501 film coating Methods 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- AJDUTMFFZHIJEM-UHFFFAOYSA-N n-(9,10-dioxoanthracen-1-yl)-4-[4-[[4-[4-[(9,10-dioxoanthracen-1-yl)carbamoyl]phenyl]phenyl]diazenyl]phenyl]benzamide Chemical compound O=C1C2=CC=CC=C2C(=O)C2=C1C=CC=C2NC(=O)C(C=C1)=CC=C1C(C=C1)=CC=C1N=NC(C=C1)=CC=C1C(C=C1)=CC=C1C(=O)NC1=CC=CC2=C1C(=O)C1=CC=CC=C1C2=O AJDUTMFFZHIJEM-UHFFFAOYSA-N 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 239000001048 orange dye Substances 0.000 description 1
- -1 orange yellow Substances 0.000 description 1
- 238000011084 recovery Methods 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 238000002560 therapeutic procedure Methods 0.000 description 1
- 239000001043 yellow dye Substances 0.000 description 1
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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- 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
-
- 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
- A61P1/14—Prodigestives, e.g. acids, enzymes, appetite stimulants, antidyspeptics, tonics, antiflatulents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
Abstract
Description
NOUVELLE FORMULATION DE COMPRIMÉSNEW TABLET FORMULATION
A BASE D'ALPHA AMYLASEBASED ON ALPHA AMYLASE
La présente invention concerne une nouvelle formulation de comprimés dont le principe The present invention relates to a new formulation of tablets, the principle of which
actif est l'alpha amylase.active is alpha amylase.
Depuis la récente apparition de l'encéphalite spongiforme bovine, il est impératif d'éviter Since the recent appearance of bovine spongiform encephalitis, it is imperative to avoid
d'utiliser, dans la fabrication des médicaments, des produits de souche animale, tels que la géla- to use, in the manufacture of medicines, animal strain products, such as gelatin
tine ou l'acide stéarique, qui sont couramment employés dans la confection de formes galéniques tine or stearic acid, which are commonly used in the manufacture of dosage forms
telles que les comprimés ou les dragées. such as tablets or dragees.
Le principe actif du médicament de l'invention à savoir, l'alpha amylase, est une enzyme The active principle of the medicament of the invention, namely, alpha amylase, is an enzyme
bien connue, couramment utilisée en thérapeutique, non seulement pour son activité dans les pro- well known, commonly used in therapy, not only for its activity in pro-
cessus digestifs, mais aussi pour ses propriétés anti-oedémateuse et anti-inflammatoire. digestive processes, but also for its anti-edematous and anti-inflammatory properties.
La demanderesse, qui a déjà mis au point dans le passé une formule comportant le même principe actif, a donc été amenée à concevoir une nouvelle formulation dans laquelle les produits d'origine animale ont été supprimés, plus précisément: - la gélatine, apparaissant au cours du procédé de fabrication au niveau de l'enrobage du noyau de l'alpha amylase, The plaintiff, who has already developed in the past a formula comprising the same active principle, was therefore led to design a new formulation in which the products of animal origin have been deleted, more precisely: - gelatin, appearing in the during the manufacturing process in the coating of the alpha amylase core,
- le stéarate de magnésium intervenant comme lubrifiant au cours du procédé de fabrica- - the magnesium stearate used as a lubricant during the manufacturing process
tion des comprimés qui a été remplacé par un stéarate de magnésium d'origine végétale. tion of the tablets which has been replaced by a magnesium stearate of vegetable origin.
Le stéarate de magnésium entrant dans la formulation de l'invention est de préférence The magnesium stearate used in the formulation of the invention is preferably
extrait du palmier.extract from the palm tree.
Les autres caractéristiques de la nouvelle formulation sont: - ajout d'un facilitateur de délitement, - suppression de l'Eudragit, The other features of the new formulation are: - addition of a disintegration facilitator, - removal of Eudragit,
- suppression du colorant jaune orangé. - removal of the yellow-orange dye.
L'adjuvant au délitement est du carboxy-méthyl amidon dont la quantité est de préférence The disintegration aid is carboxy-methyl starch, the amount of which is preferably
de 0,2 g par comprimé. Les nouveaux comprimés possèdent ainsi l'avantage important, par rap- 0.2 g per tablet. The new tablets thus have the important advantage, compared to
port à ceux de la formule précédente, de présenter un délitement beaucoup plus régulier dans le temps, libérant ainsi l'alpha amylase de manière plus conforme à une utilisation rationnelle par port to those of the previous formula, to present a much more regular disintegration in time, thus releasing alpha amylase in a manner more consistent with rational use by
l'organisme et produisant en conséquence une meilleure activité thérapeutique. the organism and consequently producing better therapeutic activity.
Les deux formulations ainsi que les modes de fabrication ci-après sont donnés à titre de The two formulations and the manufacturing methods below are given as
simple illustration de l'invention.simple illustration of the invention.
I. Ancienne formulation.I. Old formulation.
1. Formule.1. Formula.
Alpha amylase (2 142 U, pharmacopée européenne), stéarate de magnésium, sor- Alpha amylase (2,142 U, European Pharmacopoeia), magnesium stearate, so-
bitol, gomme laque, Eudragit, talc, gélatine, saccharose, gomme arabique, oxyde de titane, jaune orangé, cire de carnauba, cire ester E. bitol, shellac, Eudragit, talc, gelatin, sucrose, gum arabic, titanium oxide, orange yellow, carnauba wax, E ester wax
2. Mode de fabrication conforme au tableau suivant. 2. Manufacturing method according to the following table.
|Amylase| SorbitolI 1Tamisage| Prémélange Sorbitol I Tamisage Mélange I Stéarate de Magnésium Tamisae Mélange Lubrification I Compression |Alcool éthylique Gomme laque / Mélange Vernis gomme laque Eau potable filtrée Saccharose | Mélange Eudragit Alcool éthylique dénaturé Montage en blanc Mélange I Pelliculage Gomme arabique Eau potable filtrée Mélange Montage en Blanc Gélatine Eau potable filtrée Mélange Eau potable filtrée Saccharose Mélange Eau potable filtrée Colorant jaune orangé S Oxyde de titane | Homogénéisation Couleur |Cire de carnauba| Cire ester E |Mélange Cirage l | Amylase | SorbitolI 1 Screening | Sorbitol Premix I Sieving Mixture I Magnesium Stearate Tamisae Mixture Lubrication I Compression Ethyl Alcohol Shellac / Lacquer Shellac Varnish Filtered Drinking Water Sucrose | Eudragit mixture Denatured ethyl alcohol White assembly Mixture I Film coating Gum arabic Filtered drinking water White assembly mixture Gelatin Filtered drinking water Mixture Filtered drinking water Sucrose Mixture Filtered drinking water Orange yellow dye S Titanium oxide | Color Homogenization | Carnauba Wax | Ester wax E | Wax mixture l
II. Nouvelle formulation.II. New formulation.
1. Formule.1. Formula.
Alpha amylase (2 142 U, pharmacopée européenne), actisol, stéarate de magné- sium d'origine végétale, sorbitol, gomme laque, saccharose, gomme arabique, talc, silice colloï- Alpha amylase (2,142 U, European pharmacopoeia), actisol, magnesium stearate of plant origin, sorbitol, shellac, sucrose, gum arabic, talc, colloidal silica
dale, oxyde de titane, cire ester E, cire de camrnauba, opalux. 2. Mode de fabrication conforme au tableau suivant. dale, titanium oxide, ester wax E, camrnauba wax, opalux. 2. Manufacturing method according to the following table.
Amylase Sorbitol Récupérations Tamisage | Prmel lange | Sorbitol l [ Tamisage Mélange Actisol Stéarate de Magnésium (végétal) Tamisage Mélange Lubrification I Compression Alcool éthylique 5 | Gomme laque | Mélange Vernis gomme laque Eau potable filtrée |Saccharose I Mélange Alcool éthylique dénaturé Monta e en blanc | Mélange Péllicutage |Gomme arabique Eau potable filtrée Mélange Montage en blanc Silice colloïdale |Eau potable filtrée Mélange | Mélange Saccharose Eau potable filtrée | Mélange Opalux Oxyde de titane Eau potable purifiée Homogénéisation Couleur Cire de carnauba Cire ester E Mélange Cirage Amylase Sorbitol Recoveries Screening | Prmel lange | Sorbitol l [Sieving Mixture Actisol Magnesium stearate (vegetable) Sieving Mixture Lubrication I Compression Ethyl alcohol 5 | Shellac | Lacquer shellac varnish Filtered drinking water | Sucrose I Mixture Denatured ethyl alcohol Monta e en blanc | Mixture Pelicutage | Gum arabic Filtered drinking water Mixture White assembly Colloidal silica | Filtered drinking water Mixture | Sucrose Mixture Filtered drinking water | Opalux mixture Titanium oxide Purified drinking water Homogenization Color Carnauba wax Ester wax E Wax mixture
Claims (5)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR9816194A FR2787331B1 (en) | 1998-12-22 | 1998-12-22 | NEW FORMULATION OF ALPHA-AMYLASE TABLETS |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR9816194A FR2787331B1 (en) | 1998-12-22 | 1998-12-22 | NEW FORMULATION OF ALPHA-AMYLASE TABLETS |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| FR2787331A1 true FR2787331A1 (en) | 2000-06-23 |
| FR2787331B1 FR2787331B1 (en) | 2003-01-17 |
Family
ID=9534287
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FR9816194A Expired - Fee Related FR2787331B1 (en) | 1998-12-22 | 1998-12-22 | NEW FORMULATION OF ALPHA-AMYLASE TABLETS |
Country Status (1)
| Country | Link |
|---|---|
| FR (1) | FR2787331B1 (en) |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2321283A1 (en) * | 1975-05-14 | 1977-03-18 | Parcor | NEW DRUG WITH ANTIBACTERIAL ACTIVITY |
| US4740368A (en) * | 1985-12-11 | 1988-04-26 | Plevy Donald J | Amylase containing breath cleansing confection |
| JPH08259445A (en) * | 1995-01-27 | 1996-10-08 | Takeda Chem Ind Ltd | Medicinal composition for improving gastric emptying performance |
-
1998
- 1998-12-22 FR FR9816194A patent/FR2787331B1/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2321283A1 (en) * | 1975-05-14 | 1977-03-18 | Parcor | NEW DRUG WITH ANTIBACTERIAL ACTIVITY |
| US4740368A (en) * | 1985-12-11 | 1988-04-26 | Plevy Donald J | Amylase containing breath cleansing confection |
| JPH08259445A (en) * | 1995-01-27 | 1996-10-08 | Takeda Chem Ind Ltd | Medicinal composition for improving gastric emptying performance |
Non-Patent Citations (4)
| Title |
|---|
| BROCKMANN, ROLF ET AL.: "Fatty Acids" * |
| CHEMICAL ABSTRACTS, vol. 126, no. 3, 20 January 1997, Columbus, Ohio, US; abstract no. 37097, KITO, TAKESHI ET AL: "Agents for ameliorating stomach emptying capacity" XP002113772 * |
| ELDER, JOHN P.: "Thermoanalytical investigations of stearate-based tablet lubrication excipients", PROCEEDINGS OF THE 26TH CONFERENCE OF THE NORTH AMERICAN THERMAL ANALYSIS SOCIETY, 13 September 1998 (1998-09-13) - 15 September 1998 (1998-09-15), Omnipress, Madison, U.S.A., pages 522 - 526, XP002114553 * |
| GERHARTZ, W. AND YAMAMOTO, Y.S.: "Ullmann's Encyclopedia of Industrial Chemistry, Vol. A10: Ethanolamines to Fibers, 4. Synthetic Organic (5th ed.)", 1987, VCH VERLAG, WEINHEIM, DE, XP002114554 * |
Also Published As
| Publication number | Publication date |
|---|---|
| FR2787331B1 (en) | 2003-01-17 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| ST | Notification of lapse |
Effective date: 20120831 |