Unlock instant, AI-driven research and patent intelligence for your innovation.

Rapidly disintegrating methylcellulose tablets

a technology of methylcellulose and compressed methylcellulose, which is applied in the field of improving the process of preparing compressed methylcellulose containing tablets, can solve the problems of unpalatable dosage forms, unsatisfactory consumer acceptance of dosage forms, and viscosity of suspensions, and achieves the effect of convenient dispersibility

Inactive Publication Date: 2005-04-28
SMITHKLINE BECKMAN CORP
View PDF37 Cites 16 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"The present invention is about a better way to make methylcellulose tablets that can be easily dissolved and meet certain standards for disintegration. The methylcellulose is compressed into tablets that contain a specific amount of calcium salt. These tablets should quickly break down in certain conditions, such as acid and water."

Problems solved by technology

However, these suspensions are viscous, semi-gelatinous, and visually unappealing to the consumer.
Another disadvantage is the unpalatability of the suspensions due to the slimy mouth feel and extreme sweetness of such suspensions.
Hence, these dosage forms have not gained significant consumer acceptance.
Additionally, administration of bulk powders has caused cramping, nausea, and vomiting in some patients.
Therefore, bulk powders are not the preferred dosage form for cellulose ethers.
The pitfall with these compositions is that they contain about 400 calories of nutritive value per dose, primarily due to the high sugar content.
This high caloric value is not acceptable to the average consumers or to users suffering from blood sugar disorders, including diabetics.

Method used

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
View more

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0068]

TABLE ISwallowable Methylcellulose TabletsFormulaIngredientg / tablet(% w / w)Phase AMethocel A4M0.500067.27Dibasic Calcium phosphate, dihydrate0.03704.98Sodium lauryl sulfate0.00150.20Dye / Colouring agent0.00100.13Povidone 29K / 320.04806.46DI waterq.s.q.s.Phase BPhase A0.587579.04Sodium lauryl sulfate0.00150.20Sodium starch glycolate0.02603.50Dibasic Calcium phosphate, dihydrate0.124516.75Magnesium stearate0.00380.51TOTAL0.7433100.00

[0069] The process of preparing the rapidly disintegrating tablet of methylcellulose is carried out using specified quantities of ingredients, such as those mentioned in TABLE I above, using the following steps:

1. Preparation of Povidone K29 / 32 (PVP) Solution

[0070] The specified amount of PVP was weighed and added to the weighed quantity of water and stirred till all the PVP was dissolved completely.

2. Preparation of Phase A

[0071] Accurately weighed amounts of Methocel A4M, calcium phosphate, dibasic dihydrate, sodium lauryl sulfate, and colouring...

example 2

[0077] A formulation containing both Avicel PH 101® and Explotab®, intra and extragranularly as shown in TABLE II below, exhibited an average disintegration time of less than 1 minute in 0.1N HCl at 37± 0.5° C. using the automated disintegration apparatus.

TABLE IISwallowable Methylcellulose TabletsFormulaIngredientg / tablet(% w / w)Phase AMethocel A4M0.500060.31Avicel PH 101 ®0.03704.46Sodium lauryl sulfate0.00150.18Povidone 29K / 320.03704.46Explotab ®0.03003.62DI waterq.s.q.s.Phase BPhase A0.605573.03Sodium lauryl sulfate0.00170.21Sodium starch glycolate0.02533.05Avicel PH 101 ®0.188022.67Magnesium stearate0.00861.04TOTAL0.8291100.00

example 3

[0078] A formulation containing Avicel PH101® intragranularly, extragranular Avicel PH 102® and Explotab®, intra and extragranularly, as shown below in TABLE III exhibited an average disintegration time of less than 3 minutes in 0.1N HCl at 37±0.5° C. using the automated disintegration apparatus.

TABLE IIISwallowable Methylcellulose TabletsFormulaIngredientg / tablet(% w / w)Phase AMethocel A4M0.500059.24Avicel PH 101 ®0.03704.38Sodium lauryl sulfate0.00150.18Povidone 29K / 320.03704.38Explotab ®0.03003.56Dye / colouring agent0.00400.47DI waterq.s.q.s.Phase BPhase A0.609572.21Sodium lauryl sulfate0.00150.18Sodium starch glycolate0.02202.61Avicel PH 102 ®0.203524.11Magnesium stearate0.00750.89TOTAL0.8440100.00

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

PUM

PropertyMeasurementUnit
viscosityaaaaaaaaaa
viscosityaaaaaaaaaa
viscosityaaaaaaaaaa
Login to View More

Abstract

The present invention relates to a single-dose laxative tablet having an intragranular methylcellulose, an intragranular disintegrating agent, and a diluent. The methylcellulose is present in an amount between about 500 mg and 1000 mg and a viscosity of >1000 centipoise. There is also a plurality of tablets for oral administration. There is also a process for treating constipation in a human.

Description

FIELD OF THE INVENTION [0001] The present invention relates to an improved process for preparing compressed methylcellulose containing tablets which meet USP disintegration standards. BACKGROUND OF THE INVENTION [0002] The history of cellulose ethers, such as methylcellulose and carboxymethylcellulose suggests that these agents are effective as bulk laxatives. Their mechanism of action involves increasing both the water content of, and the bulk content of the stool, as well as lubricating the stool; thereby relieving constipation. [0003] Cellulose ethers have been administered as bulk laxatives in dosage forms comprising of tablets, suspensions, and bulk powders; the latter as sugar-free or in compositions containing high amounts of sugar. [0004] Cellulose ethers administered as suspensions in water may contain high concentrations of sucrose or other sugars and flavors. In such formulations, the sugar competes with the cellulose ether for available water, thereby preventing the cell...

Claims

the structure of the environmentally friendly knitted fabric provided by the present invention; figure 2 Flow chart of the yarn wrapping machine for environmentally friendly knitted fabrics and storage devices; image 3 Is the parameter map of the yarn covering machine
Login to View More

Application Information

Patent Timeline
no application Login to View More
Patent Type & Authority Applications(United States)
IPC IPC(8): A61K9/00A61K9/20A61K31/716A61K31/717A61K47/02A61K47/38
CPCA61K9/0056A61K9/2009A61K9/2054A61K31/717A61K9/2077A61K31/716A61K9/2059A61P1/10A61K9/20
Inventor DAGGY, BRUCEMEHTA, NARESH I.NAYAK, PRIYASHRI
Owner SMITHKLINE BECKMAN CORP