Multiple unit effervescent dosage form

• US 6,284,271 B1
• Filed: 08/28/1998
• Issued: 09/04/2001
• Est. Priority Date: 07/01/1997
• Status: Expired due to Fees

• Current Assignee: Astrazeneca AB (Astrazeneca PLC)
• Original Assignee: Astrazeneca AB (Astrazeneca PLC)
• Inventors: Thune, Mikael, Lundberg, Per Johan
• Primary Examiner(s): Page, Thurman K.
• Assistant Examiner(s): FUBARA, BLESSING M
• Application Number:
  US09/125,933
• Time in Patent Office: 1,103 Days
• Field of Search: 424/451, 424/466, 424/452, 424/494, 424/497
• US Class Current: 424/466
• CPC Class Codes: A61K 31/138 Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377
• CPC Class Codes: A61K 31/4439 containing a five-membered ring with nitrogen as a ring hetero atom, e.g. omeprazole nicotine A61K31/465
• CPC Class Codes: A61K 31/635 having a heterocyclic ring, e.g. sulfadiazine
• CPC Class Codes: A61K 9/0007 Effervescent A61K9/0065 takes precedence
• CPC Class Codes: A61K 9/0065 Forms with gastric retention, e.g. floating on gastric juice, adhering to gastric mucosa, expanding to prevent passage through the pylorus
• CPC Class Codes: A61K 9/5078 with drug-free core
• CPC Class Codes: A61P 1/04 for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
• CPC Class Codes: A61P 7/10 Antioedematous agents; Diuretics
• CPC Class Codes: A61P 9/12 Antihypertensives

Abstract

The present invention is related to an effervescent pharmaceutical preparation comprising effervescent excipients and a plurality of individual units comprising a pharmaceutically active compound and optional excipients wherein the units (1) are provided with a floating generating system. The floating generating systems comprises at least two coating layers, one of which is a gas generating layer (2) and the other layer is a barrier layer (3) enclosing the generated gas. Furthermore the invention is related to a process for the manufacture of the dosage forms, and their use in medicine.

Claims

1. An effervescent dosage form comprising, as a first component, effervescent excipients and as a separate second component, a plurality of individual units comprising a pharmaceutically active compound selected from the group consisting of a proton pump inhibitor and a beta blocking agent and optionally pharmaceutically acceptable excipients wherein each unit is provided with a floating generating system comprising at least two coating layers, one of which is a gas generating layer and the other layer is a barrier layer enclosing the generated gas, and wherein the first component is separated from the second component by the layers of the floating generating system.

2. The effervescent dosage form according to claim 1, wherein the gas generating layer is applied under the barrier layer.

3. The effervescent dosage form according to claim 1, wherein the gas generating layer comprises a water soluble binding agent and a carbon dioxide generating compound.

4. The effervescent dosage form according to claim 3, wherein the carbon dioxide generating compound is a carbonate or a bicarbonate.

5. The effervescent dosage form according to claim 1, wherein the gas generating layer comprises a water soluble binding agent and an oxygen generating compound.

6. The effervescent dosage form according to claim 1, wherein the barrier layer comprises a non-water soluble polymer and optionally a water soluble pore forming substance.

7. The effervescent dosage form according to claim 1, wherein the individual units comprises a separating layer applied under the gas generating layer separating the unit from the floating generating system.

8. The effervescent dosage form according to claim 1, wherein the proton pump inhibitor is selected from the group consisting of omeprazole, a pharmaceutically acceptable salt of omeprazole, the single enantiomers of omeprazole, and an alkaline salt of the single enantiomers of omeprazole.

9. The effervescent dosage form according to claim 1, wherein the beta blocking agent is metoprolol or a pharmaceutically acceptable salt thereof.

10. The effervescent dosage form according to claim 1, wherein the dosage form is an effervescent tablet comprising a plurality of individual coated units.