IP Library Granted Patent US 8,545,890
Granted Patent B2
US 8,545,890 · App. 12/270,905 · Granted Oct 1, 2013

Orally disintegrating tablets

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Quick Facts
Patent No.
US 8,545,890
App. No.
12/270,905
Granted
Oct 1, 2013
Kind
B2
Abstract

The present invention describes a directly compressible composite excipient prepared by coating calcium silicate with a carbohydrate. The present invention further describes the incorporation of the composite excipient into a tablet formulation. The orally disintegrating tablets are of optimal mechanical strength and disintegrate within 60 seconds in the oral cavity.

Claims (15)

1. A composite excipient consisting of calcium silicate particles substantially completely covered by and in contact with mannitol.

2. The composite of claim 1 wherein the calcium silicate comprises about 5% to about 50% of the composite by weight, and the mannitol comprises about 50% to about 95% of the composite by weight.

3. The composite excipient of claim 1 wherein the calcium silicate comprises about 25% of the composite by weight, and the mannitol comprises about 75% of the composite by weight.

4. The composite excipient of claim 1 wherein the composite excipient has an average particle size of at least about 50 micrometers.

5. A method of making the composite excipient, the method comprising:

adding mannitol to water;

heating the solution to a temperature at which mannitol is substantially dissolved to form a solution;

adding calcium silicate with stirring to the solution to form a slurry;

drying the slurry in a heated air stream to form calcium silicate that is substantially completely covered by and in contact with mannitol.

6. An orally disintegrating tablet comprising:

a. at least one pharmaceutically active ingredient or nutraceutical; and

b. a composite excipient consisting of calcium silicate particles substantially completely covered by and in contact with mannitol, whereby the calcium silicate is prevented from reacting with the active pharmaceutical ingredient.

7. The orally disintegrating tablet of claim 6 further including a salivating agent.

8. The orally disintegrating tablet of claim 6 wherein the calcium silicate comprises about 5% to about 50% of the composite excipient by weight, and the mannitol comprises about 50% to about 95% of the composite excipient by weight.

9. The orally disintegrating tablet of claim 6 wherein the composite excipient has an average particle size of at least about 50 micrometers.

Assignments (9)
SECURITY AGREEMENT (NOTES) Recorded Nov 6, 2020
From: AVANTOR FLUID HANDLING, LLC; AVANTOR PERFORMANCE MATERIALS, LLC; NUSIL TECHNOLOGY LLC; RELIABLE BIOPHARMACEUTICAL, LLC; THERAPAK, LLC
To: THE BANK OF NEW YORK MELLON TRUST COMPANY, N.A., AS NOTES COLLATERAL AGENT
Reel/Frame 054343/0414 →
RELEASE (REEL 041966 / FRAME 0247) Recorded Nov 27, 2017
From: JEFFERIES FINANCE LLC
To: NUSIL TECHNOLOGY, LLC; APPLIED SILICONE COMPANY LLC; AVANTOR PERFORMANCE MATERIALS, LLC (FORMERLY AVANTOR PERFORMANCE MATERIALS, INC.)
Reel/Frame 044810/0154 →
RELEASE (REEL 041966 / FRAME 0211) Recorded Nov 27, 2017
From: JEFFERIES FINANCE LLC
To: NUSIL TECHNOLOGY, LLC; APPLIED SILICONE COMPANY, LLC; AVANTOR PERFORMANCE MATERIALS, LLC (FORMERLY AVANTOR PERFORMANCE MATERIALS, INC.)
Reel/Frame 044810/0207 →
SECURITY INTEREST Recorded Mar 10, 2017
From: NUSIL TECHNOLOGY LLC; APPLIED SILICONE COMPANY LLC; AVANTOR PERFORMANCE MATERIALS, LLC (FORMERLY KNOWN AS AVANTOR PERFORMANCE MATERIALS, INC.)
To: JEFFERIES FINANCE LLC
Reel/Frame 041966/0247 →
SECURITY INTEREST Recorded Mar 10, 2017
From: NUSIL TECHNOLOGY LLC; APPLIED SILICONE COMPANY LLC; AVANTOR PERFORMANCE MATERIALS, LLC (FORMERLY KNOWN AS AVANTOR PERFORMANCE MATERIALS, INC.)
To: JEFFERIES FINANCE LLC
Reel/Frame 041966/0211 →
RELEASE OF SECURITY INTEREST Recorded Jun 21, 2016
From: CREDIT SUISSE, AG, CAYMAN ISLANDS BRANCH
To: AVANTOR PERFORMANCE MATERIALS, INC.
Reel/Frame 038976/0233 →
SECURITY INTEREST Recorded Oct 3, 2014
From: AVANTOR PERFORMANCE MATERIALS, INC.
To: CREDIT SUISSE AG, CAYMAN ISLANDS BRANCH
Reel/Frame 033882/0488 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 14, 2011
From: PILGAONKAR, PRATIBHA S; RUSTOMJEE, MAHARUKH T.; GANDHI, ANILKUMAR S; BAGDE, PRADNYA M.; MORVEKAR, HETAL N
To: RUBICON RESEARCH PRIVATE LIMITED
Reel/Frame 025784/0125 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 12, 2010
From: PILGAONKAR, PRATIBHA S.; RUSTOMJEE, MAHARUKH T.; GHANDI, ANILKUMAR S; BAGDE, PRADNYA M; MORVEKAR, HETAL N.
To: RUBICON RESEARCH PRIVATE LIMITED
Reel/Frame 025309/0069 →