Pharmaceutical dosage form for mucosal delivery

The technology of one drug, all drugs, applied in the direction of drug combination, drug delivery, sugar-coated pills, etc., can solve the problems of not providing the route of administration or dosage form characteristics, and achieve the effect of enhancing the appearance, improving mucoadhesiveness, and improving sensory quality

Inactive Publication Date: 2005-06-15
PHARMACIA CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

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Method used

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  • Pharmaceutical dosage form for mucosal delivery
  • Pharmaceutical dosage form for mucosal delivery
  • Pharmaceutical dosage form for mucosal delivery

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0144] Tablets for sublingual administration of the following compositions are prepared:

[0145] Compound Z 1.11%

[0146] Avicel TM PH-101 (microcrystalline cellulose) 46.71%

[0147] Colorcon Starch 1500 (pregelatinized starch) 44.00%

[0148] Croscarmellose Sodium NF 5.00%

[0149] Colloidal Silica NF 0.50%

[0150] Cinnamon flavoring 0.14%

[0151] Mint flavoring 0.04%

[0152] Colorant (Cherry #1632, Crompton & Knowles) 0.50%

[0153] Magnesium Stearate 2.00%

[0154] Place the pregelatinized starch and colorant in a high shear mixer and mix for 2 minutes or until well combined. Then, the following components were added in portions to the mixture prepared in the high-shear mixer: compound Z; microcrystalline cellulose, colloidal silicon dioxide, and croscarmellose sodium. Mixing was continued for an additional 2 minutes in the high shear mixer. If the colorant is not sufficiently dispersed throughout the mixture, continue mixing for another 1 minute until a go...

Embodiment 2

[0160] The sublingual tablets prepared in Example 1 were coated with gellan gum according to the method described below.

[0161] A coating solution of the following composition was prepared:

[0162] Gellan gum (Kelcogel TM ) 2.00%

[0163] Sodium citrate 0.13%

[0164] Propylene Glycol 0.40%

[0165] Lecithin 0.20%

[0166] Deionized water 97.27%

[0167] Deionized water was heated to 70 °C. Add the other ingredients, stirring as you add until all ingredients are evenly dispersed. The resulting coating solution containing 2.73% solids was maintained at 70°C during stirring and subsequent spraying steps.

[0168] Put the tablet of Example 1, 700 g in total, into a 12-inch (about 300 mm) coating pan, and preheat to a tablet bed temperature of 60° C. The coating solution is sprayed onto the tablet under the following conditions:

[0169] Outlet air temperature 50-60°C

[0170] The rotation speed of the pot is 16rpm

[0171] Air flow 30-35cfm(0.84-0.98m 3 / minute)

...

Embodiment 3

[0176] Sublingual tablets of the following compositions are prepared:

[0177] Compound Z 1.05%

[0178] Mannitol Granules 70.00%

[0179] Sorbitol 16.57%

[0180] Hypromellose, LH-11 type 7.00%

[0181] Xanthan Gum 2.50%

[0182] Colloidal Silica NF 0.50%

[0183] Cinnamon flavoring 0.14%

[0184] Mint flavoring 0.04%

[0185] Colorant (Cherry #1632, Crompton & Knowles) 0.20%

[0186] Magnesium Stearate 2.00%

[0187] The mannitol and colorant were placed in a high shear mixer and mixed for 2 minutes or until uniformly mixed. Then, the following components were added in portions to the resulting mixture in the high shear mixer: compound Z, sorbitol, hypromellose, xanthan gum, colloidal silicon dioxide. Mixing was continued for an additional 2 minutes in the high shear mixer. If the colorant is not sufficiently dispersed throughout the mixture, continue mixing for another 1 minute until a good dispersion of the colorant is observed. A small portion of the mixture is...

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Abstract

The present invention provides a pharmaceutical tablet comprising an orally disintegrating tablet core and an excipient coating adhered thereto, wherein the coating comprises gellan gum. The tablet is suitable for oral administration, for example, the drug contained in the core of the tablet is at least partially absorbed through the oral mucosa of the patient and delivered to the patient.

Description

field of invention [0001] The present invention relates to pharmaceutical compositions suitable for intraoral administration to allow transmucosal delivery of drugs. Background of the invention [0002] Pharmaceutical dosage forms are known which are suitable for placement in the oral cavity of a patient, for example sublingually or buccally, where placement of such formulations enables absorption of the drug into the bloodstream of the patient through the oral mucosa. See, for example, Rathbone, ed. (1996) Oral Mucosal Drug Delivery, Marcel Dekker; especially the article "Mucoadhesive hydrogels for buccal delivery," by Kellaway and Warren therein, pp. 221-239, and the article "Systemic oral mucosal drug delivery" by Rathbone et al. and delivery systems, "pp. 241-284. [0003] It is often desired that such oral dosage forms, especially those intended for sublingual administration, release the drug rapidly after administration so that the therapeutic ...

Claims

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Application Information

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IPC IPC(8): A61K9/36A61K9/00A61K9/28A61K9/34A61K31/4745A61K47/36A61P15/10
CPCA61K9/0056A61K9/006A61K9/286A61P15/10A61K9/28A61K31/195
Inventor A·C·马蒂诺S·A·皮尔曼R·M·诺克N·布里藤
Owner PHARMACIA CORP
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