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Claims for Patent: 5,178,878

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Claims for Patent: 5,178,878

Title: Effervescent dosage form with microparticles
Abstract:A pharmaceutical dosage form incorporates microparticles which are susceptible to rupture upon chewing or which are adapted to provide substantially immediate release of the pharmaceutical ingredient contained in the microparticles. These microparticles are provided in a tablet with an effervescent disintegration agent. When the tablet is taken orally, the effervescent disintegration agent aids in rapid dissolution of the tablet and hence permits release of the microparticles, and swallowing of the microparticles, before the pharmaceutical ingredient is released from the microparticles. The system therefore provides particularly effective taste masking.
Inventor(s): Wehling; Fred (New Hope, MN), Schuehle; Steve (Maple Grove, MN), Madamala; Navayanarao (Plymouth, MN)
Assignee: Cima Labs, Inc. (Minneapolis, MN)
Application Number:07/869,788
Patent Claims: 1. A solid pharmaceutical dosage form adapted for direct oral administration to a human comprising: a mixture of at least one saliva activated effervescent agent and a plurality of microparticles, each said microparticle including at least one systemically distributable pharmaceutical ingredient and a protective material substantially encompassing said pharmaceutical ingredient, said microparticles having at least about 70 percent 30-minute release, said mixture being present as a tablet of a size and shape adapted for direct oral administration to a human patient, said tablet being substantially completely disintegrable so as to release said microparticles upon exposure to saliva, said at least one effervescent agent being present in an amount which is effective to aid in rapid disintegration of said tablet, without chewing, and thereby release said microparticles.

2. A solid pharmaceutical dosage form adapted for direct oral administration to a human comprising: a mixture of at least one saliva activated effervescent agent and a plurality of microparticles, each said microparticle including at least one systemically distributable pharmaceutical ingredient and a protective material substantially encompassing said pharmaceutical ingredient, said microparticles being susceptible to release of said pharmaceutical ingredient upon rupture thereof, said mixture being present as a tablet of a size and shape adapted for direct oral administration to a human patient, said tablet being substantially completely disintegrable so as to release said microparticles upon exposure to saliva, said at least one effervescent agent being present in an amount which is effective to aid in rapid disintegration of said tablet, without chewing, and thereby release said microparticles.

3. A dosage form as claimed in claim 1 wherein each said microparticle includes said pharmaceutical ingredient dispersed in a matrix of said protective material.

4. A dosage form as claimed in claim 1 wherein said microparticles have a mean diameter about 200 microns.

5. A dosage form as claimed in claim 1 wherein said microparticles consist essentially of particles between about 200 mesh and about 30 mesh.

6. A dosage form as claimed in claim 1 wherein said at least one systemically distributable pharmaceutical ingredient includes at least one psychotropic drug.

7. A dosage form as claimed in claim 2 wherein each said microparticle includes said pharmaceutical ingredient dispersed in a matrix of said protective material.

8. A dosage form as claimed in claim 2 wherein said microparticles have a mean diameter about 200 microns.

9. A dosage form as claimed in claim 2 wherein said microparticles consist essentially of particles between about 200 mesh and about 30 mesh.

10. A dosage form as claimed in claim 2 wherein said at least one systemically distributable pharmaceutical ingredient includes at least one psychotropic drug.

11. A dosage form as claimed in claim 1 wherein said microparticles are susceptible to release of said pharmaceutical ingredient upon rupture thereof.

12. A method of administering at least one systemically distributable pharmaceutical ingredient to a human patient comprising the steps of:

a) providing a tablet including a mixture of at least one saliva activated effervescent agent and microparticles incorporating said pharmaceutical ingredient and a protective material substantially encompassing said pharmaceutical ingredient, said microparticles having at least about 70 percent 30-minute release, said tablet being substantially completely disintegrable upon exposure to saliva, said at least one effervescent agent being present in an amount which is effective to aid in rapid disintegration of said tablet, without chewing; and

b) placing said tablet in the mouth of a patient so that saliva in said patient's mouth activates said effervescent agent in said tablet and said tablet substantially completely disintegrates in the patient's mouth to release said microparticles, said at least one effervescent agent promoting disintegration of said tablet and providing a distinct sensation of effervescence during said disintegration, whereby said sensation of effervescence will substantially promote secretion of saliva by the patient to thereby further promote said disintegration.

13. A method of administering at least one systemically distributable pharmaceutical ingredient to a human patient:

a) providing a tablet including a mixture of at least one saliva activated effervescent agent and microparticles incorporating said pharmaceutical ingredient and a protective material substantially encompassing said pharmaceutical ingredient, said microparticles being susceptible to release of said pharmaceutical ingredient upon rupture thereof, said tablet being substantially completely disintegrable upon exposure to saliva, said at least one effervescent agent being present in an amount which is effective to aid in rapid disintegration of said tablet, without chewing; and

b) placing said tablet in the mouth of a patient so that saliva in said patient's mouth activates said effervescent agent in said tablet and said tablet substantially completely disintegrates in the patient's mouth, said at least one effervescent agent promoting disintegration of said tablet and providing a distinct sensation of effervescence during said disintegration, whereby said sensation of effervescence will substantially promote secretion of saliva by the patient to thereby further promote said disintegration and minimize any need for chewing to promote said disintegration, said microparticles being released from said tablet upon disintegration of the tablet in said patient's mouth.
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