WO2003097019A1 - Systeme multilamellaire pour administration d'actifs par ingestion - Google Patents
Systeme multilamellaire pour administration d'actifs par ingestion Download PDFInfo
- Publication number
- WO2003097019A1 WO2003097019A1 PCT/FR2003/001353 FR0301353W WO03097019A1 WO 2003097019 A1 WO2003097019 A1 WO 2003097019A1 FR 0301353 W FR0301353 W FR 0301353W WO 03097019 A1 WO03097019 A1 WO 03097019A1
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- WIPO (PCT)
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- different formulations
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Classifications
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- 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
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4808—Preparations in capsules, e.g. of gelatin, of chocolate characterised by the form of the capsule or the structure of the filling; Capsules containing small tablets; Capsules with outer layer for immediate drug release
-
- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
-
- 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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P9/00—Drugs for disorders of the cardiovascular system
- A61P9/12—Antihypertensives
Definitions
- Multilamellar system for administration of active ingredients by ingestion.
- the present invention relates to a multi-lamellar system for the administration of active substances (in particular drugs) by ingestion by the oral route.
- oral drug delivery systems have been described. They can be liquid preparations (syrups, drops, solutions, etc.) or solid unit preparations (tablets, capsules, soft capsules, etc.). The system chosen depends on the nature of the drug (active ingredient) to be administered and on the desired release profile for the active ingredient (fast, slow ).
- the multi-lamellar system according to the invention in addition to being new for the administration of drugs by oral ingestion, makes it possible to remedy the drawbacks of current oral forms, thanks to a unique formulation system with multiple possibilities using a method simple and efficient industrial.
- the present invention relates to a system which meets all these new requirements for sophisticated release of the active principles and overcomes all the drawbacks mentioned above because it allows:
- active agents of different natures powders in solution, powders in suspensions, hydrophilic or lipophilic liquids for example, • to administer, in an advantageous manner, active agents in large proportions, in particular liquids, or low doses, or very toxic active ingredients,
- This unique new system consists of a basic multi-lamellar system used as it is, advantageously in planar form, or, in a new and surprising way, of the superposition of one or more identical or different basic multi-lamellar systems.
- the basic multi-lamellar system comprises a polymeric support film, without active ingredient, homogeneous, on which the preparation, homogeneous (constant concentration over its entire surface), containing the active ingredient (s), is coated, by spreading , with a constant thickness over its entire surface (for example by rolling) to form the matrix layer.
- This preparation can, according to particular embodiments, consist of liquid or solid active principle (s), of excipients or additives having different physico-chemical properties: aqueous liquids, oily liquids and powders.
- s liquid or solid active principle
- the basic multi-lamellar system in addition to the matrix layer containing the active ingredient (s), may consist of several superimposed matrix layers, each homogeneous, of constant thickness over the entire surface for a given layer, coated successively, containing or not all containing active ingredients.
- the basic multi-lamellar system can be cut into units and used as it is, advantageously in planar form, thus allowing multiple possibilities of release profiles (including for example delayed, and / or prolonged, and / or pulsed release) .
- the support film is a polymer film, soluble or insoluble in digestive liquids, homogeneous, of constant thickness over its entire surface.
- polymers or copolymers obtained by reaction of the polymers mentioned in different proportions, the list of which, without being exhaustive, is indicated below, can be used (in dispersion in the appropriate solvents), alone or as a mixture to produce films which are more or less soluble or insoluble in digestive liquids.
- Films are dried using heat and / or using infrared ramps and / or using microwaves.
- the polymers or copolymers used for the support film (2) can be used (in dispersion in the appropriate solvents) as well as excipients, absorption-promoting agents, emulsifiers, agents of texture, flavorings or sweeteners, adhesives.
- excipients for the production of the matrix layer (3), the polymers or copolymers used for the support film (2) can be used (in dispersion in the appropriate solvent
- the excipients and manufacturing methods used for the matrix layer lead to gelled preparations of the solution, suspension, emulsion, pre-emulsion, micro-emulsion, pre-micro-emulsion type.
- a coating is produced so as to obtain matrix layers (3) whose thickness is constant over the entire surface of the same matrix layer.
- the coating is carried out cold or hot. If necessary, the drying of the matrix layers (3) is carried out with heat (preferably between 20 ° C and 100 ° C) and / or thanks to infrared ramps and / or thanks to the use of microwaves.
- the permutations and combinations of the ingredients of the matrix layer allow a large number of formulations with profiles to be produced. programmed and varied release specific to each active: immediate release ( ⁇ 1 hour), and / or extended release over 24 hours, and / or delayed release (with a delay of 1 to 12 hours), and / or pulsed release (several successive releases with a delay between them of 1 to 12 hours). These possibilities are increased if several matrix layers are superimposed.
- a characteristic of the invention it is possible to coat at the same time (in the same spreading phase), in parallel lines or according to a geometrical arrangement defined beforehand, a preparation, or different preparations of matrix layers (4) , (5), (6), (7), (8), (9), (10), (11) so as to form a layer which can thus contain different formulations.
- This arrangement also makes it possible to increase the number of possibilities of programmed releases and, moreover, to formulate incompatible active principles.
- the judicious choice of the support films and of the formulations of the different matrix layers in a system obtained, with or without superposition of one or of different basic systems makes it possible by simple use of the system as it is in planar form, after cutting into units, according to another characteristic of the invention, with multiple and sophisticated possibilities of release programmed specific to each active ingredient without the need to wind or fold the systems.
- the systems Before or after cutting, the systems may have undergone an operation such as folding, winding, etc., without this list of operations being limiting, so as to obtain formatting of the systems adapted to the need.
- an operation such as folding, winding, etc.
- Folding or wrapping may require the presence of adhesive on or in the upper matrix layer or on predetermined portions of the support film. According to the invention it is also possible to seal the support films, according to the state of the art, in particular hot.
- the units obtained according to the methods described in one of the preceding characteristics can be placed as such in a primary packaging, such as sachet, blister, or pill box ...
- one or more units or systems can also be associated with one or more other dosage forms and / or of powdery, liquid or semi-solid excipients (FIG. 8).
- Several units (16) different or of the same formulation can be placed with the necessary excipients in the same capsule or a soft capsule or a tablet (17) ( Figure 7), for example.
- the last two possibilities can be combined.
- the invention thus makes it possible to meet the new needs of galenics, namely, to obtain a sophisticated combination of programmed release profiles for identical or different active agents and to use various active principles.
- the dosage of the active ingredient (s) can easily be adapted by simple modification of the cutting surface when placing in units or by modification of the number of superimposed basic systems or by regrouping of several identical or different systems in another form of presentation, for example: a tablet.
- polymers or copolymers obtained by reaction of the polymers mentioned in different proportions
- the polymers or copolymers used for the support film (2) can be used (in dispersion in the appropriate solvents) as well as absorption-promoting agents, emulsifiers, texture agents, flavorings or sweeteners, adhesives; such as the following excipients, without this list being exhaustive: fatty acids and derivatives, fatty alcohols and derivatives, polyglycolized saturated or unsaturated glycerides, ⁇ -methyl-2-pyrrolidone, emulsifying agents (such as polyoxyethylene esters and esters of sorbitan, oleates, lecithins of animal or vegetable origin, polyoxyethylenated castor oil, sucro esters, fatty acid esters of polyethylene glycol, fatty acid esters of glycerol, fatty acid esters of propylene glycol, bile acids and their salts), diethylene glycol monoethyl ether, dimethylisosorbide, terpenes, phospholipids,
- anti-inflammatories and analgesics such as for example corticoids, indomethacin, ibuprofen, diclofenac, tenoxicam or piroxicam, antiseptics, vasodilators such as nitroglycerin or isosorbide dinitrate, anti-asthma, anti-bacterial, antibiotics, cardiotonic, anesthetics such as lidocaine, anti-angina, anti-arrhythmics, anti-hypertensives, anti-platelet aggregants, antitussives and expectorants than codeine, antihistamines such as chlorphenamine, dopaminergic agonists, sleep regulators such as melatonin, hemostasis promoters, hormones, anti-tumor, antimigraine, anti-parkinsonian, memory stimulants, antidepressants, an analgesics, such as for example corticoids, indomethacin, ibuprofen, diclofenac,
- Figure 1 shows in section the basic multi-lamellar system (1) by coating a matrix layer (3) on a support film (2).
- Figures 2 and 3 illustrate another characteristic of the invention, namely a coating in parallel ( Figure 2) or according to a defined geometric arrangement ( Figure 3) of different preparations of matrix layers (4), (5), (6 ), (7), (8), (9), (10), (11).
- FIG. 4 illustrates another characteristic of the invention, namely the superposition of different systems, leading to the superposition of support films (2), (15) of identical or different formulations and matrix layers of identical or different formulations (12 ), (13), (14).
- FIG. 5 illustrates another characteristic of the invention, namely the possibility of dividing the systems into units (16).
- FIGS. 6 to 8 illustrate another characteristic of the invention, namely the packaging of one or more units (16), as such in a primary packaging, for example a blister or the distribution of one or more units ( 16) in other dosage forms, for example in a tablet ( Figures 6 and 7), alone or in combination with other dosage forms ( Figure 8).
- the following EXAMPLES illustrate the invention but do not limit it in any way.
- Step 1 dissolve 10 g of nifedipine in 200 g of polyoxyethylene glycol 400 and then gel by adding 15 g of AEROSIL 200
- Step 2 coat the mixture prepared in step 1 on a support film (2) consisting of hydoxypropylcellulose, hydroxypropylmethylcellulose and polyethylene glycol 400 in the proportions 60/30/10.
- the coated mass (3) is 15 mg / cm 2 of support film (2).
- Step 3 roll up and cut the system so that it contains 10 mg of nifedipine per unit and divide the units into size 0 capsules with 50 mg of lactose and 0.5 mg of magnesium stearate.
- Step 1 dissolve 5 g of indomethacin and 0.5 g of Carbomer 1342 (supplied by
- Step 2 coat the mixture prepared in step 1 on a support film (2) consisting of hydoxypropylcellulose, hydroxypropylmethylcellulose and polyethylene glycol 400 in the proportions 60/30/10.
- the coated mass (3) is 15 mg cm 2 of support film (2).
- Step 3 roll up and cut the coated system so that it contains 20 mg of indomethacin per unit and divide the units into size 0 capsules with 50 mg of lactose and 0.5 mg of magnesium stearate.
- Step 1 disperse 20 g of nifedipine in 200 g of polyoxyethylene glycol 400 and then gel by adding 15 g of AEROSIL 200.
- Step 2 coat the mixture prepared in step 1 on a support film (2) consisting of ethylcellulose and polyethylene glycol 400 in the proportions 90/10.
- the coated mass (3) is 15 mg / cm 2 of film support (2).
- Step 3 roll up and cut the system so that it contains 20 mg of nifedipine per unit and divide the units into size 0 capsules with 50 mg of lactose and 0.5 mg of magnesium stearate.
- Step 1 dissolve 2 g of lysine acetylsalicylate (expressed in acid equivalent) in a solution consisting of 12 g of PNP 29/32, 1 g of Carbopol 974, 0.15 g of glycerol, 20 ml of water and 13 ml of ethanol.
- Step 2 coat the mixture prepared in step 1 on a support film (2) consisting of
- PNP K29 / 32 supplemented with 6% (m / m) of Carbopol 974 and 1% (m / m) of glycerol.
- the coated mass (3) is 30 mg / cm 2 of support film (2).
- the support film is, before coating the mixture prepared in step 1, made adhesive with Durotak 387-2516.
- Step 3 dry under hot air at 50 ° C until a dry film is obtained and cut the system into 2 X 2 cm squares.
- Step 4 study the dissolution of acetylsalicylic acid in the pallet apparatus No. 1 of the European Pharmacopoeia, in water at 37 ° C, with UN detection at 265 nm. We observe a kinetics of order 1 dissolution with 50% dissolution of the active ingredient at 30 minutes and 100% in 2 hours.
- Step 1 dissolve 2 g of lysine acetylsalicylate (expressed in acid equivalent) in a solution consisting of 12 g of PNP K29 / 32, 1 g of Carbopol 974, 0.15 g of glycerol, 20 ml of water and 13 ml of ethanol.
- Step 2 coat the mixture prepared in step 1 on a support film (2) consisting of ethylcellulose, hydroxyethylcellulose and glycerol in the proportions 45/45/10.
- the coated mass (3) is 30 mg / cm 2 of support film (2).
- the support film is, before coating the mixture prepared in step 1, made adhesive with Durotak 387-2516.
- Step 3 dry under hot air at 50 ° C until a dry film is obtained and cut the system into 2 X 2 cm squares.
- Step 4 study the dissolution of acetylsalicylic acid in the pallet apparatus No. 1 of the European Pharmacopoeia, in water at 37 ° C, with UN detection at 265 nm.
- a kinetics of order 0 dissolution linear as a function of time
- 50% dissolution of the active ingredient at 1 h 30 minutes and 100% in 4 hours.
- the multi-lamellar system according to the invention is particularly intended for the formulation of new drugs for the pharmaceutical industry.
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- Health & Medical Sciences (AREA)
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- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
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Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
AU2003269632A AU2003269632A1 (en) | 2002-05-15 | 2003-04-29 | Multilamellar system for the administration of active agents by means of ingestion |
US10/512,175 US20050175699A1 (en) | 2002-05-15 | 2003-04-29 | Multilamellar system for the administration of active agents by means of ingestion |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR02/05944 | 2002-05-15 | ||
FR0205944A FR2839645B1 (fr) | 2002-05-15 | 2002-05-15 | Systeme multilamellaire pour l'administration de substances actives (en particulier des medicaments) par ingestion par la voie orale |
Publications (1)
Publication Number | Publication Date |
---|---|
WO2003097019A1 true WO2003097019A1 (fr) | 2003-11-27 |
Family
ID=29286490
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/FR2003/001353 WO2003097019A1 (fr) | 2002-05-15 | 2003-04-29 | Systeme multilamellaire pour administration d'actifs par ingestion |
Country Status (4)
Country | Link |
---|---|
US (1) | US20050175699A1 (fr) |
AU (1) | AU2003269632A1 (fr) |
FR (1) | FR2839645B1 (fr) |
WO (1) | WO2003097019A1 (fr) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100369607C (zh) * | 2005-12-02 | 2008-02-20 | 深圳致君制药有限公司 | 含可待因和氯苯那敏的口服液体缓释制剂及其制备方法 |
Families Citing this family (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2013056213A1 (fr) * | 2011-10-14 | 2013-04-18 | Purdue Research Foundation | Unité à multiples feuilles pouvant être ingérée à fonctions et combinaisons prédéterminées |
WO2014039951A1 (fr) * | 2012-09-10 | 2014-03-13 | Novartis Ag | Compositions pharmaceutiques entérales |
DE102014119576A1 (de) | 2014-12-23 | 2016-06-23 | Ernst-Moritz-Arndt-Universität Greifswald | Pharmazeutische Arzneimittelform zur Applikation auf Schleimhäuten |
Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3625214A (en) * | 1970-05-18 | 1971-12-07 | Alza Corp | Drug-delivery device |
EP0872234A2 (fr) * | 1997-04-16 | 1998-10-21 | Röhm Gmbh | Forme medicale laminaire |
WO2001022947A2 (fr) * | 1999-09-30 | 2001-04-05 | Lts Lohmann Therapie-Systeme Ag | Preparation contenant des principes actifs et/ou des excipients, permettant leur liberation controlee, utilisation et production de ladite preparation |
Family Cites Families (10)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US2928770A (en) * | 1958-11-28 | 1960-03-15 | Frank M Bardani | Sustained action pill |
US4217898A (en) * | 1978-10-23 | 1980-08-19 | Alza Corporation | System with microporous reservoir having surface for diffusional delivery of agent |
DE2966275D1 (en) * | 1978-11-07 | 1983-11-10 | Beecham Group Plc | Device for oral administration to a ruminant animal |
US4681583A (en) * | 1982-12-20 | 1987-07-21 | Alza Corporation | System for dispersing drug in biological environment |
EP0300286A3 (fr) * | 1987-07-22 | 1989-06-07 | Firmenich Sa | Feuille sandwich en couches multiples et emballage faisant usage de ladite feuille |
US5326568A (en) * | 1991-05-03 | 1994-07-05 | Giampapa Vincent C | Method of tissue-specific delivery |
US5853755A (en) * | 1993-07-28 | 1998-12-29 | Pharmaderm Laboratories Ltd. | Biphasic multilamellar lipid vesicles |
DE4341442C2 (de) * | 1993-12-04 | 1998-11-05 | Lohmann Therapie Syst Lts | Vorrichtung zur kontrollierten Freisetzung von Wirkstoffen sowie ihre Verwendung |
US5447729A (en) * | 1994-04-07 | 1995-09-05 | Pharmavene, Inc. | Multilamellar drug delivery systems |
US20030194428A1 (en) * | 2002-04-10 | 2003-10-16 | Miller Frederick H. | Process for encapsulating multi-phase, multi-compartment capsules |
-
2002
- 2002-05-15 FR FR0205944A patent/FR2839645B1/fr not_active Expired - Fee Related
-
2003
- 2003-04-29 AU AU2003269632A patent/AU2003269632A1/en not_active Abandoned
- 2003-04-29 US US10/512,175 patent/US20050175699A1/en not_active Abandoned
- 2003-04-29 WO PCT/FR2003/001353 patent/WO2003097019A1/fr not_active Application Discontinuation
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3625214A (en) * | 1970-05-18 | 1971-12-07 | Alza Corp | Drug-delivery device |
EP0872234A2 (fr) * | 1997-04-16 | 1998-10-21 | Röhm Gmbh | Forme medicale laminaire |
WO2001022947A2 (fr) * | 1999-09-30 | 2001-04-05 | Lts Lohmann Therapie-Systeme Ag | Preparation contenant des principes actifs et/ou des excipients, permettant leur liberation controlee, utilisation et production de ladite preparation |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN100369607C (zh) * | 2005-12-02 | 2008-02-20 | 深圳致君制药有限公司 | 含可待因和氯苯那敏的口服液体缓释制剂及其制备方法 |
Also Published As
Publication number | Publication date |
---|---|
FR2839645A1 (fr) | 2003-11-21 |
AU2003269632A1 (en) | 2003-12-02 |
US20050175699A1 (en) | 2005-08-11 |
FR2839645B1 (fr) | 2005-08-05 |
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