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EP0173928B1 Expired / Lapsed EP ⏱️ 0.0 years remaining

Controlled-release medical preparations

Assignee: Pfizer Health AB
•
Filing: 1985-08-23
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Granted: 1990-06-13
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Expires: 2005-08-23
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Abstract

Abstract The present invention concerns a novel pharamceutical preparation having a biphasic release pattern. The preparation comprises a tablet core containing a drug. The tablet is coated with a coating essentially consisting of a film-forming water-insoluble polymer having fine water soluble particles randomly distributed therein. The fine particles include a drug active substance, which is the same as the drug in the core. The drug active substance in the particles may also be different from the one in the tablet core.

Inventors

  • 👤 Ake Rikard Lindahl
  • 👤 Bo Magnus Ekman

Bibliographic Details

Application Number —
Jurisdiction EP
Data Source google_patents
Last Synchronized 2026-11-05 23:45
CPC Classifications
A; A61; A61K; A61K9/00; A61K9/20; A61K9/2072; A61K9/2086; A61K9/209

Claims Analysis

Total Claims: 17
Claim 1
Independent Claim 61 words
A controlled-release pharmaceutical preparation having biphasic release profile, comprising a drug tablet and a coating applied thereon, wherein the coating essentially consists of a filmforming polymer which is insoluble in water and gastro-intestinal fluids and a water-soluble pore-creating material being randomly distributed in said polymer characterized in that the pore-creating material includes a drug active substance in a therapeutically effective amount.
Claim 2
Dependent Claim 61 words
A controlled-release pharmaceutical preparation having biphasic release profile, comprising a drug tablet and a coating applied thereon, wherein the coating essentially consists of a filmforming polymer which is insoluble in water and gastro-intestinal fluids and a water-soluble pore-creating material being randomly distributed in said polymer characterized in that the pore-creating material includes a drug active substance in a therapeutically effective amount.
Claim 3
Dependent Claim 23 words
Preparation according to Claim 1 characterized in that the pore-creating material includes a drug active substance different from that in the drug core.
Claim 4
Dependent Claim 28 words
Preparation according to Claim 1 characterized in that the drug active substance in the pore-creating material is the same substance as the one present in the drug core.
Claim 5
Dependent Claim 45 words
Preparation according to any one of the preceding Claims characterized in that the pore-creating material also include a substance, which is soluble in water and gastro-intestinal fluids and therapeutically essentially inactive in the amount used, said amount being sufficient to give a preselected release profile.
Claim 6
Dependent Claim 32 words
Preparation according to Claim 2 characterized in that the drug in the core is potassium chloride and that the drug active substance included in the pore-creating material is an instant release diuretic.
Claim 7
Dependent Claim 29 words
Preparation according to Claim 3 characterized in that the drug active substance is selected from phenylpropanol amine, a penicillin, cephalosporin, a benzodiazepine, a calcium antagonist and a short-acting hypnotic.
Claim 8
Dependent Claim 24 words
Preparation according to any of the Claims 1-5 characterized in that the filmforming polymer is selected from cellulose derivatives, acrylic polymers and vinyl polymers.
Claim 9
Dependent Claim 23 words
Preparation according to any of the preceding Claims characterized in that the filmforming polymer is a terpolymer consistin of vinylchloride, vinylacetate and vinylalcohol.
Claim 10
Dependent Claim 83 words
A method of preparing the controlled-release preparation according to Claim 1 comprising the steps of dissolving the polymer in a solvent, preparing a suspension or solution of the core-creating material including the drug active substance and solution of the polymer to form a coating fluid, applying the coating fluid in the form of a solution or suspension to the drug tablet and drying the coating fluid on the tablet to provide a polymer-coated tablet having water-soluble pore-creating material randomly distributed within the coating.
Claim 11
Dependent Claim 23 words
Method according to Claim 9 characterized in that the pore-creating material includes a drug active substance different from that in the drug core.
Claim 12
Dependent Claim 28 words
Method according to Claim 9 characterized in that the drug active substance in the pore-creating material is the same substance as the one present in the drug core.
Claim 13
Dependent Claim 44 words
Method according to any of the Claims 9-11 characterized in that the pore-creating material also includes a substance that is soluble in water and gastrointestinal fluids and therapeutically essentially inactive in the amount used, said amount being sufficient to give a preselected release profile.
Claim 14
Dependent Claim 32 words
Method according to Claim 10 characterized in that the drug in the core is potassium chloride and that the drug active substance included in the pore-creating material is an instant release diuretic.
Claim 15
Dependent Claim 30 words
Method according to Claim 11 characterized in that the drug active substance is selected from phenylpropanol amine, a penicillin, cephalosporin, a benzodiazepine, a calcium antagonist and a short- circuiting hypnotic.
Claim 16
Dependent Claim 24 words
Method according to any of the Claims 10-14 characterized in that the filmforming polymer is selected from cellulose derivatives, acrylic polymers and vinyl polymers.
Claim 17
Dependent Claim 23 words
Method according to any of the Claims 10-15 characterized in that the filmforming polymer is a terpolymer consisting of vinylchloride, vinylacetate and vinylalcohol.

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