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Mucosal delivery tablet

A technology of tablets and therapeutic agents, applied in the field of bioadhesive tablets, which can solve problems such as detachment

Inactive Publication Date: 2007-02-28
HENKEL KGAA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

In this case, regular flat or cupped tablets are prone to involuntary detachment by oral movements

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0078] [65] This example describes the co-spray drying of Amioca and CARBOPOL  Preparation of the bioadhesive composition prepared from the mixture.

[0079] [66] A mixture of 10% by weight Amioca waxy corn starch (obtained from National Starch & Chemical Company, Bridgewater, New Jersey) and 90% water was prepared as a slurry. The mixture was heated by injecting steam at a pressure of 2.75 bar in a continuous jet cooker, regulated with a jacket of cooling water, maintaining the temperature at 150°C. The final starch solids content, determined by heating a small sample at 135°C for 2 hours, was 7.74%.

[0080] [67] CARBOPOL was prepared by slowly adding CARBOPOL to deionized water with constant stirring until fully dispersed  974P (available from Noveon, Inc.) in 1% water.

[0081] [68] The solution of starch and CARBOPOL is uniformly mixed in such a ratio that a desired ratio between starch and CARBOPOL is obtained. For example, mixing 1085 g Amioca solution and 5600 g ...

Embodiment 2

[0083] [69] A series of convex (two-sided) cup-shaped tablets were prepared in reduced mass using a spray-dried blend of 85% Amioca and 15% CARBOPOL to reduce edge thickness. A standard punch with D = 0.4375" and d = 0.040" was used. The calculated edge thickness h and ratio d / h are shown in Table 7.

[0084] quality

(mg)

Measured Center Thickness (in)

t

Calculated Edge Thickness (in)

h

d / h

196

0.122

0.042 *

0.95

180

0.116

0.036

1.11

160

0.1125

0.0325

1.23

140

0.106

0.026

1.54

120

0.102

0.022

1.82

130

0.1045

0.0245

1.63

[0085] *Calculated from the measured center thickness and the d of the punch press used, as: h=t-2d or

[0086] 0.122-(2×0.040)=0.042

Embodiment 3

[0088] [70] Bioadhesive tablets with a mass of 130 mg and containing 15 mg of micronized benzocaine were prepared. The bioadhesive component was a co-spray dried mixture of jet cooked Amioca and Carbopol 974P NF. The ingredients used to prepare the tablets are shown in Table 8.

[0089] components

[0090] [71] Using a pair of standard cup punches (cup depth 0.040") at 3000 psi, a tablet size of 0.4375" diameter was produced. This produced a tablet with a thickness of about 0.1045" measured in the center and about 0.0245" at the edges. The ratio of cup depth to rim depth is 1.6.

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Abstract

Mucoadhesive tablets have a convex surface, a diameter to cup depth ratio of 4-20 and a cup depth to edge thickness ratio of greater than 0.75 swiftly adheres and conforms to the contacting tissue. The tablets are used to administer actives such as, for example, benzocaine.

Description

technical field [0001] [1] The present invention relates to a bioadhesive tablet shaped to provide improved adhesion to mucous membranes, especially oral mucous membranes. Background technique [0002] [2] Bioadhesive formulations are designed for mucoadhesion. The most commonly used bioadhesive dosage forms are pastes, ointments, lozenges, tablets, patches and gels. In the treatment of systemic diseases or diseases of the oropharynx or other parts of the body, such formulations are used to enhance the local or systemic action of the drug. [0003] [3] Bioadhesive tablets for local or total oral drug delivery are preferably placed on the gums, for example, to minimize stress from oral movement or contact with the tongue and teeth. However, there are some conditions, such as ulcers or cold sores, where the agent must be applied directly to the sore, wherever it occurs within the mouth. In this case, conventional flat or cupped tablets are prone to invol...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K47/36A61K45/00A61K31/245
CPCA61K9/006A61K9/2027A61K9/2095A61K9/2059A61P1/02A61P29/00A61K9/20
Inventor P·B·福尔曼Y·张R·普里
Owner HENKEL KGAA
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