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Pharmaceutical tablet

A tablet and drug technology, applied in the field of pharmaceutical dosage forms, can solve problems such as difficult guarantee and limited range of color distinction

Inactive Publication Date: 2006-08-02
PHARMACIA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

A large number of drugs are currently tableted, and many of these drugs are formulated in different dosage strengths, so a unique appearance for any new tablet becomes more important but also more difficult to guarantee
[0003] Especially the range of easily distinguishable colors available to tablet formulators is quite limited

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0104] A sublingual tablet formulation is prepared having the following composition:

[0105] Compound Z 1.11%

[0106] Avicel TM PH-101 (microcrystalline cellulose) 46.71%

[0107] Colorcon starch 1500 (pregelatinized starch) 44.00%

[0108] Croscarmellose Sodium NF 5.00%

[0109] Colloidal Silica NF 0.50%

[0110] Cinnamon flavoring 0.14%

[0111] Mint flavoring 0.04%

[0112] Dye (Cherry #1632, Crompton & Knowles) 0.50%

[0113] Magnesium Stearate 2.00%

[0114] Mix the pregelatinized starch and dye in a high shear mixer for 2 minutes, or until well combined. The following ingredients were then placed one by one on the resulting mixture in the high shear mixer: compound Z; microcrystalline cellulose; colloidal silicon dioxide; croscarmellose sodium. Mixing in the high shear mixer was continued for an additional 2 minutes. If the dye is not sufficiently dispersed into the resulting mixture, continue mixing in 1 minute increments until good dye dispersion is observ...

Embodiment 2

[0120] Sublingual tablets prepared as in Example 1 were coated with gellan gum coating according to the following procedure.

[0121] Prepare a coating solution with the following composition:

[0122] Gelling gum (Kelcogel TM ) 2.00%

[0123] Sodium citrate 0.13%

[0124] Propylene Glycol 0.40%

[0125] Lecithin 0.20%

[0126] Deionized water 97.27%

[0127] Deionized water was heated to 70 °C. Add other ingredients with stirring until all ingredients are evenly dispersed. The resulting coating solution with a solids content of 2.73% was maintained at a temperature of 70°C during stirring and subsequent spraying.

[0128] 700 g of the tablet of Example 1 were placed in a 12 inch (approximately 300 mm) coating pan and preheated to a bed temperature of 60°C. The coating solution was sprayed onto the tablets under the following conditions:

[0129] Outlet air temperature 50-60℃

[0130] Pot speed 16rpm

[0131] Air velocity 30-35cfm(0.84-0.98m 3 / minute)

[0132] At...

Embodiment 3

[0137] A sublingual tablet formulation is prepared having the following composition:

[0138] Compound Z 1.05%

[0139] Mannitol, granulated 70.00%

[0140] Sorbitol 16.57%

[0141] Hydroxypropyl cellulose, LH-11 type 7.00%

[0142] Xanthan Gum 2.50%

[0143] Colloidal Silica NF 0.50%

[0144] Cinnamon flavoring 0.14%

[0145] Mint flavoring 0.04%

[0146] Dye (Cherry #1632, Crompton & Knowles) 0.20%

[0147] Magnesium Stearate 2.00%

[0148] Mix the mannitol and dye in a high shear mixer for 2 minutes or until well combined. The following ingredients were then placed one by one on the resulting mixture in the high shear mixer: compound Z; sorbitol; hydroxypropyl cellulose; xanthan gum; colloidal silicon dioxide. Mixing in the high shear mixer was continued for an additional 2 minutes. If the dye is not sufficiently dispersed throughout the resulting mixture, continue mixing in 1 minute increments until good dye dispersion is observed. A small portion of the mixture...

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Abstract

A pharmaceutical tablet is provided comprising a core and a coating adherent thereto, wherein (a) the core comprises solid particles of a water-soluble dye distributed in a matrix, and (b) the coating comprises gellan gum. The tablet is suitable for peroral or intraoral administration, for example for delivery of a drug contained in the core of the tablet to a subject. The tablet has a speckled appearance that renders the tablet readily identifiable.

Description

technical field [0001] The present invention relates to orally administrable pharmaceutical dosage forms, especially tablets. Background technique [0002] Tablets are the most common and convenient pharmaceutical dosage form for oral administration of drugs. Easily identifiable by appearance including size, shape, surface structure, markings and color are important functional attributes of tablets. This ease of identification is important in reducing dispensing errors and enabling patients who are taking multiple medications to distinguish which medications they are taking at different times or with different frequencies. A large number of drugs are currently tableted, and many of these drugs are formulated in different dosage strengths, so it becomes more important but also more difficult to ensure that any new tablet has a unique appearance. [0003] Especially the range of easily distinguishable colors available to tablet formulators is rather limited. This problem ha...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/34F02M37/18A61K9/00A61K9/28A61K31/4745A61K45/00A61K47/36A61P15/00A61P25/00A61P25/04A61P25/34A61P27/02A61P27/06A61P29/00A61P31/04A61P43/00B60K15/077F02M37/00F02M37/02F02M37/04F02M37/08F02M37/10F02M37/22F04F5/10
CPCA61K9/006F02M37/0052B60K2015/03105A61K9/0056A61K9/286F02M2037/225F02M37/025B60K2015/03118F02M37/106B60K15/077F02M37/0094F02M37/44A61P15/00A61P25/00A61P25/04A61P25/06A61P25/34A61P27/02A61P27/06A61P29/00A61P31/00A61P31/04A61P43/00A61K9/20A61K9/28
Inventor 艾丽斯·C·马蒂诺罗伯特·M·诺亚克史蒂文·A·皮尔曼
Owner PHARMACIA CORP
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