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Novel triptan formulations and methods for making them

A lubricant and disintegrant technology, applied in the field of orally disintegrating tablets, can solve problems such as dull gloss, unsuitable taste, and reduced actual value

Inactive Publication Date: 2009-05-13
CAPRICORN PHARMA INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, various pharmaceutical ingredients often have both unpleasant mouthfeel and unpalatable taste due to the dull, astigmatic, anhydrous and astringent properties of these substances
Therefore, the actual value of these substances will be significantly lower since patients who find them annoying will not use them as prescriptions

Method used

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  • Novel triptan formulations and methods for making them
  • Novel triptan formulations and methods for making them
  • Novel triptan formulations and methods for making them

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0086] Example 1 - Taste-masked

[0087] Table 1

[0088]

[0089] The components of Table 1 were used. Sumatriptan succinate was weighed and dissolved in purified water. Amberlite IRP 88 was weighed and added to the drug solution and mixed well for about 6 hours. The drug resin suspension is filtered and the wet cake mixture is separated and dried in a suitable drier at 50° C. for more than 8 hours until the moisture content of the mixture is reduced to about 8-12%. The drying can also be achieved by using a fluidized bed dryer for one hour.

[0090] Similarly, naratriptan, eletriptan, frovatriptan compositions were prepared.

[0091] Similarly, other resins were used to prepare taste-masked triptan compositions. Additional examples were prepared using different coating % resins. These are shown in Table Ia below.

[0092] Table Ia

[0093] Substance name

Embodiment 2

[0094] Example 2 - tableting

[0095] Table 2

[0096] Substance name dry weight% active drug Taste-masked sumatriptan succinate 54.14 excipient Microcrystalline Cellulose Powder 29.28 Lactitol powder 5.00 polyvinylpolypyrrolidone 7.00 Crosslinked Sodium Carboxymethyl Cellulose 1.00 Amberlite IRP 64 2.00 Sodium carbonate 1.00 Magnesium stearate 0.50 glycerin Appropriate amount Artificially Masked Spices Appropriate amount total 100.00

[0097] Tablet 2 was used for compression. Dispersible taste-masking agent powder and other pharmaceutically acceptable ingredients (such as flavors, sweeteners, colors, and additional disintegrants) sufficient to provide a therapeutically effective dose of 25 mg of sumatriptan are placed in a V-blender to fully Practice to obtain a homogeneously distributed mixture for compression. The unit dose is measured on an analytical balance and compressed...

Embodiment 3

[0098] Example 3 - Granulation of mixed sumatriptan

[0099] The blended sumatriptan of Example 2 was granulated using wet granulation methods known in the art. In one aspect, the solvent is an aqueous solvent. Alternatively, solvents such as isopropanol or ethanol may be used. When non-aqueous solvents are used, emulsifiers, fats, waxes, or combinations thereof may be used. These materials can be incorporated via hot melt spraying, or via solution spray granulation systems whereby the solvent is removed. Examples of emulsifiers include acetylated monoglycerides, mono and diglycerides. Waxes can include synthetic and natural waxes and combinations thereof. These microparticles are mixed with other excipients and compressed into tablets.

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PUM

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Abstract

Rapidly disintegrating oral triptan formulations having superior palatability and methods of making such are provided herein. A rapidly disintegrating oral triptan composition can comprise a triptan compound, a resin, a lubricant, a disintegrant, and a compressible material, where the triptan is admixed with the resin forming a taste-masked triptan composition, which is further admixed with the lubricant, the disintegrant, and the compressible material to form the rapidly disintegrating oral triptan composition.

Description

[0001] related application [0002] This application claims the benefit of US Provisional Patent Application Serial No. 60 / 796,789, filed May 1, 2006, the entire contents of which are hereby incorporated by reference. field of invention [0003] The present invention relates to orally disintegrating tablets and methods for their manufacture. More particularly, the present invention relates to orally disintegrating tablets consisting of rapidly dispersing triptan compositions. Background of the invention [0004] Pharmaceutical compositions can be manufactured in a variety of dosage forms depending on the desired route of administration of the therapeutic substance. Oral dosage forms, for example, include such solid compositions as tablets, emulsions and suspensions. The particular dosage form employed will depend on such factors as the solubility and chemical reactivity of the pharmaceutically active substance. In addition, dosage forms can be selected to optimize deliver...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A01N43/38A61K31/405
CPCA61K47/48184A61K9/2054A61K9/2018A61K31/787A61K9/2027A61K9/2009A61K9/0056A61K31/4184A61K47/585
Inventor S·R·彻鲁库里
Owner CAPRICORN PHARMA INC
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