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Ondansetron film compositions

A technology of composition and film-forming polymer, which is applied in the direction of drug combination, drug delivery, food science, etc., and can solve the problems of increasing the extra cost of active components and not being able to effectively cover up the strange smell of active components.

Inactive Publication Date: 2010-11-24
MONOSOL RX
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, all these taste-masking methods currently used not only increase the additional cost of the active ingredient, but also often cannot effectively mask the bad taste of the active ingredient

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0069] Example 1 - Bitterness of films without taste-masking components

[0070] 8 mg of the film composition mixed with ondansetron was prepared and presented to a panel of 5 persons to evaluate the bitter perception of the film composition. The film composition is given in Table 1 below:

[0071] Table 1

[0072] components

[0073] Colorant

[0074] Each rater places the film strip in his or her mouth until dissolved. Then ask the raters to evaluate the bitterness of the film strips on a scale of 1 to 5, where 1 is "no bitterness", 2 is "low bitterness", 3 is "medium bitterness", 4 is "too high bitterness", 5 is "very bitter". High bitterness". The results are shown in Table 2 below:

[0075] Table 2

[0076]

[0077] As can be seen, the strips incorporating 8 mg of ondansetron without any taste-masking component recorded an average bitterness rating of 3.10. Such a high bitterness rating falls somewhere between "medium bitterness" ...

Embodiment 2

[0078] Example 2 - Bitter Taste of Films Containing Taste-Masking Components

[0079] 8 mg of the film composition mixed with ondansetron and the taste-masking components were prepared and presented to a 5-person panel to assess the bitter perception of the film composition. Specifically, the film composition contained 8% calcium carbonate and 1% sodium bicarbonate. The film composition is given in Table 3 below:

[0080] table 3

[0081] components

[0082] ondansetron

[0083] Each rater places the film strip in his or her mouth until dissolved. Then ask the raters to evaluate the bitterness of the film strips on a scale of 1 to 5, where 1 is "no bitterness", 2 is "low bitterness", 3 is "medium bitterness", 4 is "too high bitterness", 5 is "very bitter". High bitterness". The results are shown in Table 4 below:

[0084] Table 4

[0085]

[0086] As can be seen, film strips mixed with 8 mg of ondansetron mixed with taste-masking compo...

Embodiment 3

[0087] Example 3 - Bitter Taste of Films Without Calcium Carbonate

[0088] 8 mg of film composition mixed with ondansetron and 1% sodium bicarbonate was prepared and presented to a 2-person panel to evaluate the bitter perception of the film composition. The film composition is given in Table 5 below:

[0089] table 5

[0090] components

[0091] Maltese

[0092] Each rater places the film strip in his or her mouth until dissolved. Then ask the raters to evaluate the bitterness of the film strips on a scale of 1 to 5, where 1 is "no bitterness", 2 is "low bitterness", 3 is "medium bitterness", 4 is "too high bitterness", 5 is "very bitter". High bitterness". The results are shown in Table 6 below:

[0093] Table 6

[0094]

[0095] As can be seen, the calcium carbonate-free film strips spiked with 8 mg of ondansetron recorded an average bitterness rating of 3.25. This level of bitterness rating was found to impart a bitter taste to th...

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PUM

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Abstract

The present invention relates to products and methods of making products having a taste masked active component. In particular, the present invention relates to taste-masked film dosage forms including at least one active component and a slow dissolving basic composition.

Description

technical field [0001] The present invention relates to film formulations comprising at least one active ingredient. More specifically, the present invention relates to products that acceptably taste mask the active ingredient and processes for the preparation of such products. The active ingredient may be a weak base such as ondansetron. Background technique [0002] Administration of the active ingredient, especially the pharmaceutical composition, can be accomplished in a number of different dosage forms. Since such active ingredients often have a bitter off-taste, the active ingredient can be administered by swallowing a tablet or other dosage form, which limits the time the active ingredient is present in the user's mouth. [0003] However, it may be desirable to administer the active ingredient in an orally dissolvable film dosage form, which is placed in the mouth and is capable of dissolving, thereby releasing the active ingredient. Such film dosage forms are adva...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/70A61K47/30A61K47/04A61K31/4178
CPCA61K9/006A23G4/06A61K31/4178A61P43/00
Inventor 加里·L·迈尔斯马杜苏登·哈里哈兰普拉迪普·桑格维
Owner MONOSOL RX
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