Rapidly disintegratable multiparticular tablet

• US 5,464,632 A
• Filed: 11/29/1994
• Issued: 11/07/1995
• Est. Priority Date: 07/22/1991
• Status: Expired due to Term

• Current Assignee: ETHYPHARM
• Original Assignee: Laboratories Perouse SAS (Laboratories Perouse)
• Inventors: Bruna, Etienne, Gendrot, Edouard, Cousin, Gerard
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): Benston, Jr., William E.
• Application Number:
  US08/346,324
• Time in Patent Office: 343 Days
• Field of Search: 424/458, 424/440, 424/465, 424/428, 424/441, 424/473, 424/489
• US Class Current: 424/465
• CPC Class Codes: A61K 9/0056 Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
• CPC Class Codes: A61K 9/2077 Tablets comprising drug-containing microparticles in a substantial amount of supporting matrix; Multiparticulate tablets
• CPC Class Codes: A61K 9/2081 with microcapsules or coated microparticles according to A61K9/50

Abstract

Rapidly disintegratable multiparticulate tablet the excipient mixture of which is suitable for imparting a disintegration rate such that the tablet disintegrates in the mouth in an extremely short time, notably in less than sixty seconds, characterized by the fact that the active substance is present in the form of coated microcrystals or coated or uncoated microgranules.

Claims

1. A rapidly disintegratable tablet for oral administration with or without the use of water, said tablet comprising an active substance and a mixture of excipients, wherein said active substance is multiparticulate and in the form of coated microcrystals, coated microgranules or uncoated microgranules and wherein said mixture of excipients comprises excipients which are responsible for the disintegration, said tablet being intended to be swallowed said disintegration occurring in less than sixty seconds under the action of the excipients which are responsible for the disintegration and which are selected from the group consisting at least one disintegrating agent and at least one swelling agent.

2. The tablet of claim 1, wherein the active substance is in the form of coated microcrystals and is selected from the group consisting of gastrointestinal sedatives, antacids, analgesics, anti-inflammatory agents, coronary vasodilators, peripheral and brain-vasodilators, anti-infectious agents, antibiotics, antiviral agents, antiparasitic agents, anticancerous drugs, antianxiety agents, neuroleptic drugs, agents stimulating the central nervous systems, antidepressant drugs, antihistaminic agents, antidiarrheal agents, laxatives, nutritional supplements, immunodepressant drugs, cholesterol lowering agents, hormones, enzymes, antispasmodic agents, antiangorous agents, drugs acting on the rhythm of the heart, drugs used in the treatment of arterial hypertension, anti-migraine agents, drugs acting on blood coagulability, anti-epileptic agents, myorelaxing agents, drugs used in the treatment diabetes, drugs used in the treatment of thyroidal dysfunctions, diuretical agents, anorexigenic drugs, anti-asthmatic agents, expectorants, antitussive agents, mucoregulators, decongestants, hypnotics, antinausea agents, hematopoietical agents, uricosuric agents, plant extracts and contrast mediums.

3. The tablet of claim 1, wherein the active substance is in the form of coated microgranules and is selected from the group consisting of gastrointestinal sedatives, antacids, analgesics, anti-inflammatory agents, coronary vasodilators, peripheral and brain-vasodilators, anti-infectious agents, antibiotics, antiviral agents, antiparasitic agents, anticancerous drugs, antianxiety agents, neuroleptic drugs, agents stimulating the central nervous system, anti-depressant drugs, antihistaminic agents, antidiarrheal agents, laxatives, nutritional supplements, immunodepressant drugs, cholesterol lowering agents, hormones, enzymes, anti-spasmodic agents, antiangorous agents, drugs acting on the rhythm of the heart, drugs used in the treatment of arterial hypertension, anti-migraine agents, drugs acting on blood coagulability, anti-epileptic agents, myorelaxing agents, drugs used in the treatment of diabetes, drugs used in the treatment of thyroidal dysfunctions, diuretical agents, anorexigenic drugs, anti-asthmatic agents, expectorants, antitussive agents, mucoregulators, decongestants, hypnotics, antinausea agents, hematopoietical agents, uricosuric agents, plant extracts and contrast mediums.

4. The tablet of claim 1, wherein the mixture of excipients comprises at least one disintegrating agent selected from the group consisting of carboxymethylcellulose, insoluble reticulated PVP type and at lest one swelling agent selected from the group consisting of starch, modified starch and microcrystalline cellulose.

5. The tablet of claim 1, wherein the mixture of excipients comprises at least one disintegrating agent selected from the group consisting of carboxymethylcellulose and insoluble reticulated PVP, and at least one swelling agent selected from the group consisting of starch, modified starch and microcrystalline cellulose and a direct compression sugar.

6. The tablet of claim 1, wherein the active substance is in the form of uncoated microgranules and is selected from the group consisting of gastrointestinal sedatives, antacids, analgesics, anti-inflammatory agents, coronary vasodilators, peripheral and brain-vasodilators, anti-infectious agents, antibiotics, antiviral agents, antiparasitic agents, anticancerous drugs, antianxiety agents neuroleptic drugs, agents stimulating the central nervous system anti-depressant drugs antihistaminic agents, antidiarrheal agents, laxatives, nutritional supplements, immunodepressant drugs, cholesterol lowering agents, hormones, enzymes, anti-spasmodic agents, antiangorous agents, drugs acting on the rhythm of the heart, drugs used in the treatment of arterial hypertension, anti-migraine agents, drugs acting on blood coagulability, anti-epileptic agents, myorelaxing agents, drugs used in the treatment of diabetes, drugs used in the treatment of thyroidal dysfunctions, diuretical agents, anorexigenic drugs, anti-asthmatic agents, expectorants, antitussive agents, mucoregulators, decongestants, hypnotics, anti-nausea agents, hematopoietical agents, uricosuric agents, plant extracts and contrast mediums.