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Multi-layered orally disintegrating tablet and the manufacture thereof

a tablet and orally disintegrating technology, applied in the direction of drug compositions, pharmaceutical product form changes, immunological disorders, etc., can solve the problems of complex and costly processing steps, brittleness, and softer tablets

Inactive Publication Date: 2011-12-29
JOHNSON & JOHNSON CONSUMER COPANIES
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0006]In one aspect, the present invention features a tablet containing a first layer and a second layer, wherein: (i) the first layer includes a pharmaceutically active agent and the composition of the first layer is different from the composition of the second layer; (ii) the tablet has a density less than about 0.8 g / cc; and (iii) the tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds.
[0007]In another aspect, the present invention features a process for making a tablet comprising a first layer and a second layer, the method including the steps of: (i) adding a first powder blend to a die platen, wherein the first powder blend includes a pharmaceutically active agent and a binder; (ii) adding a second powder blend to the die platen, wherein the second powder blend includes a binder and wherein the composition of the second powder blend is different from the composition of the first powder blend; (iii) compacting a first powder blend and a second powder blend in the die platen to form a tablet shape; and (iv) applying energy to the tablet shape for a sufficient period of time to activate the binders within the tablet shape to fuse the tablet shape into the tablet such that the tablet has a density less than about 0.8 g / cc and the tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds.

Problems solved by technology

The resulting tablet is softer, but also more fragile, brittle, and easily chipped and disadvantageously can involve complex and costly processing steps.
When used at low compression forces, these machines typically produce highly friable tablets, which are not sufficiently stable during packaging, shipping, and storage.

Method used

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  • Multi-layered orally disintegrating tablet and the manufacture thereof
  • Multi-layered orally disintegrating tablet and the manufacture thereof
  • Multi-layered orally disintegrating tablet and the manufacture thereof

Examples

Experimental program
Comparison scheme
Effect test

example 1

Manufacture of Powder Blend Containing Loratadine

[0154]The loratadine powder blend for an orally disintegrating tablet, containing the ingredients of Table 1, is manufactured as follows:

TABLE 1Loratadine Powder Blend FormulationIngredientG / BatchMg / TabletDextrose Monohydrate45.18120.0Loratadine3.76510.0Polyethylene Glycol 4000124.47565.0Maltodextrin215.06240.0Red Colorant0.0280.075Simethicone DC10035.64815.0Sucralose USP1.133.0Polyethylene Oxide1.8835.0Mint Flavor2.8247.5Total100265.5751Commercially available from Clariant PF in Rothausstr, Switzerland2Commercially available from National Starch in Bridgewater, NJ3Commercially available from SPI Pharma in Wilmington, DE

[0155]First, the sucralose, colorant, and flavor were placed together into a 500 cc sealable plastic bottle. The mixture was then blended end-over-end manually for approximately 2 minutes. The resulting mixture, the dextrose monohydrate, loratadine, and the polyethylene oxide were then added to another 500 cc sealable ...

example 2

Manufacture of Orally Disintegrating Tablet Containing Loratadine

[0156]A portion of the powder blend from Example 1 was placed into a ½ inch diameter forming cavity of an electrically insulative Teflon die platen. The powder blend was then tamped between an upper and lower flat-faced metal forming tools into a shape conformal to the surface of the forming tools. The tamping pressure was typically between 10 and approximately 50 psi of pressure. The forming tools, die platen and tablet shape were then placed between the upper RF electrode and lower RF electrode powered by an RF heating unit using a COSMOS Model C10X16G4 (Cosmos Electronic Machine Corporation, Farmingdale, N.Y.) RF generator having an output of 4 KW of power, frequency of 27 MHz, and the vacuum capacitor is set at 140. The forming tools are heated with reciculating water at a temperature of 57° C. The upper RF electrode was brought into contact with the upper forming tool and the lower RF electrode is brought into con...

example 3

Manufacture of Orally Disintegrating Tablet Containing Diphenhydramine

[0157]The diphenhydramine powder blend for an orally disintegrating tablet, containing the ingredients of Table 2, was manufactured as follows. The sucralose, yellow colorant, flavors, polyethylene glycol and maltodextrin from the formula in Table 2 were passed through a 20 mesh screen. The sieved materials were placed into a 500 cc plastic bottle and blended end over end with the remaining materials in Table 2. The powder blend was placed into the forming cavity, tamped, and activated with RF energy as described in Example 2 for approximately 2 to 5 seconds to form the orally disintegrating tablet and subsequently removed from the die platen.

TABLE 2Powder Blend Formulation Containing Diphenhydramine (DPH)IngredientG / BatchMg / TabletDextrose Monohydrate304.11219.0Diphenhydramine (Coated)349.5735.70Polyethylene Glycol 8000144.1631.80Maltodextrin288.4663.70Yellow Colorant0.780.56Orange Flavor1.651.19Vanilla Flavor2.21...

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Abstract

The present invention features a tablet containing a first layer and a second layer, wherein: (i) the first layer includes a pharmaceutically active agent and the composition of the first layer is different from the composition of the second layer; (ii) the tablet has a density less than about 0.8 g / cc; and (iii) the tablet disintegrates in the mouth when placed on the tongue in less than about 30 seconds.

Description

CROSS REFERENCE TO RELATED APPLICATIONS[0001]This application claims priority of the benefits of the filing of U.S. Provisional Application Ser. No. 61 / 245,315, filed Sep. 24, 2009, U.S. Provisional Application Ser. No. 61 / 255,582, filed Oct. 28, 2009, U.S. Provisional Application Ser. No. 61 / 314,629, filed Mar. 17, 2010, U.S. Provisional Application Ser. No. 61 / 358,167, filed Jun. 24, 2010, U.S. patent application Ser. No. 12 / 887,544, filed to Sep. 22, 2010, and U.S. patent application Ser. No. 12 / 887,552, filed Sep. 22, 2010. The complete disclosures of the aforementioned related U.S. patent applications are hereby incorporated herein by reference for all purposes.BACKGROUND OF THE INVENTION[0002]Pharmaceuticals intended for oral administration are typically provided in tablet form. Tablets are swallowed whole, chewed in the mouth, or disintegrated in the oral cavity. Soft tablets that either are chewed or dissolve in the mouth are often employed in the administration of pharmaceu...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/20A61K31/167B29C35/08A61P29/00A61P37/08B29C43/20A61K31/4545A61K31/138
CPCA61K9/0056B30B15/34A61K9/146A61K9/2018A61K9/2031A61K9/2086A61K31/138A61K31/167A61K31/4545B29C43/006B29C2043/3628B30B11/027B30B11/085B30B11/10A61K9/145A61P29/00A61P37/08A61J3/10A61K9/2036A61K9/205A61K9/2095B29C43/146
Inventor LUBER, JOSEPH R.BUNICK, FRANK J.SOWDEN, HARRY S.KRIKSUNOV, LEO B.SZYMCZAK, CHRISTOPHER E.
Owner JOHNSON & JOHNSON CONSUMER COPANIES
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