Quickly soluble oral film dosage containing steviosides as a unpleasant taste masking agent

Inactive Publication Date: 2012-06-21
CHA BIOTECH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0016]The proposed oral film dosage has excellent effects of masking a nasty taste and may be easily prepared by a simple process at low cost, thereby being preferably used in various applications such as an or

Problems solved by technology

Especially, since they have difficulties in swallowing typical tablets or capsules, an alternative oral dosage formulation for aged persons may be required.
However, such liquid formulation has disadvantages such as deteriorated stability and incorrect dosage.
However, a film formulation easily dissolved in an oral cavity enables a drug to be absorbed in the oral mucosa, causing a bitter or nasty taste of the drug during absorption.
However, the ion-exchange resin containe

Method used

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  • Quickly soluble oral film dosage containing steviosides as a unpleasant taste masking agent
  • Quickly soluble oral film dosage containing steviosides as a unpleasant taste masking agent
  • Quickly soluble oral film dosage containing steviosides as a unpleasant taste masking agent

Examples

Experimental program
Comparison scheme
Effect test

example 14

[0093]Ondansetron based quickly soluble film prepared according to Example 9 of the present invention was subjected to dissolution experiments at pH 1.2 in comparison with a conventional product named Zofran Zydis tablet containing ondansetron available from GlaxoSmithKline Co. (CSK) based on Notice of the Food and Drug Administration and the experimental results are shown in FIG. 1. As shown in the accompanying drawings, there was no substantial difference in elution between both of the formulations.

example 15

[0094]Ondansetron based quickly soluble film prepared according to Example 9 of the present invention was subjected to pharmacokinetic tests in comparison with a conventional product named Zofran® Zydis tablet containing ondansetron available from GlaxoSmithKline Co. (GSK). The experiments is conducted for healthy fourteen (14) adult men and women with Latin square method based on Notice of bioequivalence test standard of the Food and Drug Administration.

[0095]The experimental results are shown in Table 9 and FIG. 2. It was confirmed that the inventive film of this example has the bioequivalence as shown in Table 9 and FIG. 2.

TABLE 9Pharmacokinetic test result of ondansetron film formulationsParameterGroup 1Group 2AUCO~24(ng · hr / mL)244.78 ± 91.83 259.64 ± 87.10Cmax(ng / mL)30.93 ± 10.7133.16 ± 8.89Tmax(hr)1.86 ± 0.71 1.94 ± 0.75Note 1)Group 1 is Ondansetron film formulations (8 mg). Group 2 is Zorfran ®Zydis ODTs

example 16 to 20

[0096]As active pharmaceutical ingredients, sildenafil free base, sildenafil lactate, sildenafil citrate, granisetron, and montelukast sodium were added to prepare films having constitutional compositions shown in the following Table 10. The sensory test was randomly conducted and test results were that unpleasant aftertaste was well masked.

TABLE 10Exam-Exam-Exam-Exam-Exam-ple 15ple 16ple 17ple 18ple 19Ingredient(wt. %)(wt. %)(wt. %)(wt. %)(wt. %)Sucralose1.7221.50.5Neotame120Acesulfame0.50.510.5potassiumRebaten 97%22220.5Citric acid0.20.20.20.60.6Hydroxypropyl22232starchSpan200.10.50.10.40.4Menthol0.42.30.333Carageenan0.10.10.10.10.2Pigment0.10.10.10.10.1Polysorbate 800.40.50.30.30.3Peppermint oil0.82.70.633Pullulan62.377.555.181.578.9Microcrystalline1.41.40.71.54celluloseBeta0.7cyclodextrinLemon flavor220.81.51.5Sildenafil25free baseSildenafil4.2lactateSildenafil35citrateGranisetron1hydrochlorideMontelukast5sodiumTotal weight100.0100.0100.0100.0100.0

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Abstract

Disclosed is a quickly soluble oral film dosage for masking a nasty taste, in particular, a quickly soluble oral film dosage comprising a stevioside based sweetener and a high potency sweetener in a ratio by weight (w/w) of 1:3 to 3:1, which may efficiently mask a bitter or nasty taste of a medicine and may be quickly dissolved in a mouth without water, thereby improving an aftertaste thereof thus enhancing dosage acceptability of a patient.

Description

BACKGROUND OF THE INVENTION[0001]This application claims priority to Korean Patent Application No. 10-2009-0057276, filed on Jun. 25, 2009 and Korean Patent No. 10-2010-0057450, filed on Jun. 17, 2010, in the Korean Intellectual Property Office, the entire contents of which are hereby incorporated by reference.FIELD OF THE INVENTION[0002]The present invention relates to a quickly soluble oral film dosage for effectively masking a unpleasant taste and, more particularly, to a quickly soluble oral film dosage comprising a stevioside based sweetener and a high potency sweetener in a ratio by weight (w / w) of 1:3 to 3:1, which may efficiently mask a bitter or nasty taste of a medicine and may be quickly dissolved in a mouth without water, thereby improving an aftertaste thereof thus enhancing dosage acceptability of a patient.BACKGROUND OF THE RELATED ART[0003]A social distribution ratio of aged population has currently increased owing to an extended span of human life. Old people genera...

Claims

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Application Information

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IPC IPC(8): A61K39/00A23L27/30
CPCA61K9/0056A61K9/006A61K47/36A61K31/09A61K31/14A61K9/7007A61P1/02A61P43/00
Inventor PARK, JIN-KYUYANG, WON-SUKJUNG, KYOUNG TAE
Owner CHA BIOTECH
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