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

Robust rapid disintegration tablet formulation

A disintegrating agent and rapid technology, which can be used in medical preparations containing active ingredients, anti-inflammatory agents, non-central analgesics, etc., can solve problems such as the stability of drugs that are unfavorable for unstable alkalinity

Inactive Publication Date: 2010-03-24
HERCULES INC
View PDF9 Cites 3 Cited by
  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

It should also be noted that calcium silicates in general are characterized by an alkaline surface pH, which may be detrimental to the stability of alkaline-labile drugs

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

Embodiment

4 Hydroiodic acid, 57% in water

Gas Chromatograph and Integrator Parameters

oven

130℃

injection port

200℃

detector current

175mA

Flow Rate: Helium

30ml / min

Detector temperature

250℃

attenuation

3

recording speed

1.0

peak width

0.04

Threshold

4

[0041] Integrator parameters are for a Hewlett Packard Model 3390A Reporting Integrator.

step

1. Dry approximately 0.5 g of sample in an oven at 105°C.

2. Set the heating module temperature to 150°C.

3. Add 0.05-0.08 grams of the cooled sample to a tared 5 ml reaction vial, recording the weight to approximately 0.0001 grams, in two or three replicates.

4. Add 2ml of hydroiodic acid with a pipette and cover the sample.

5. Add 2ml of internal standard solution with a repipet dispenser or equivalent.

6. Immediately cap the vial with the mininert valve cap and shake the vial. Monitor the block temperature...

Embodiment 1

[0052] A 500 gram batch of dry blended powder was prepared as described in Comparative Example 2, however, substituting the water insoluble T10 Pharm EC available from the Aqualon Division of Hercules Incorporated for the hydroxypropyl cellulose in the composition, compressed into 100 mg tablets:

parts by weight

Dimenhydrinate 25

T10Pharm EC 15

Granular Mannitol 54.25

Croscarmellose 5

Stearic acid 0.5

Magnesium stearate 0.25

[0053] Table 3. Breaking strength, friability and disintegration time obtained for the control formulation in Example 1. Tablets were prepared using a rotary tablet press at a compression force of 5 kN and 8 kN.

table 3

feature

[0054] Replacing hydroxypropyl cellulose with T10Pharm EC was very effective in maintaining low friability and improving tablet strength compared to the control, and was very effective in maintaining a fast disintegration time of less than 30 seconds.

Embodiment 2

[0055] A 500 g batch of dry blend powder was prepared as described in Example 1 above, however, substituting only 10% of T10Pharm EC for 15% of the water insoluble T10Pharm EC, compressed into 100 mg tablets:

parts by weight

Dimenhydrinate 25

T10Pharm EC 10

Granular Mannitol 59.25

Croscarmellose 5

Stearic acid 0.5

Magnesium stearate 0.25

[0056] Table 4. Breaking strength, friability and disintegration time obtained for the control formulation in Example 2. Tablets were prepared using a rotary tablet press at a compression force of 5 kN and 8 kN.

Table 4

feature

[0057] Lowering the EC content from 15% to 10% did not compromise the low friability of the tablets, while providing a similarly fast disintegration time to the control.

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
particle sizeaaaaaaaaaa
Login to View More

Abstract

The invention relats to a rapidly disintegrating, orally administered tablet or compressed dosage form, comprising ethylcellulose (EC) as a directly compressible binder which enhances tablet robustness as manifested by improved strength, lower friability, lower hygroscopicity and yet, hydrophobic nature notwithstanding, does not retard disintegration, but shortens disintegration time or is disintegration time neutral when co-formulated with disintegrants and other water-soluble excipients such as sugar alcohols.

Description

[0001] related application [0001] This application claims the benefit of US Provisional Patent Application Serial No. 60 / 928,125, filed May 8, 2007, which is hereby incorporated by reference in its entirety. technical field [0002] The invention provides a rapidly disintegrating low friability tablet preparation. The tablet formulation includes: an ethyl cellulose binder formulated together with typical disintegrants and other common tablet adjuvants such as fillers, tablet lubricants and glidants. Tablets produced from this formulation have been tested to have a friability of about 5% or less and are capable of disintegrating in less than about 60 seconds. Background technique [0003] Fast-disintegrating or fast-dissolving tablets or oral dosage forms designed to disintegrate rapidly in the oral cavity and deliver active ingredients are gaining attention as vehicles for administering active ingredients in nutraceuticals and pharmaceuticals, especially in children and t...

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(China)
IPC IPC(8): A61K9/00A61K31/00
CPCA61K31/00A61K9/1652A61K9/0056A61P1/04A61P1/10A61P1/12A61P25/16A61P25/20A61P25/24A61P25/28A61P29/00A61P3/10A61P31/00A61P43/00A61P9/00A61P9/06A61P9/12
Inventor T·迪里希
Owner HERCULES INC