Oral dosage form

a technology of oral cavity and active substance, applied in the direction of instruments, using mechanical means, unknown materials, etc., can solve the problems of substantial swathing of edible cosmetics and foodstuffs, challenging the gi tract to achieve therapeutic levels, and affecting the effect of gi tract health

Inactive Publication Date: 2017-03-16
SYMRISE GMBH & CO KG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0022]More preferably, the solid active agents used in the present invention are beneficial microorganisms (probiotics) and their derivatives. It should be noted that this is the first time to realize the adhesion of probiotics to the oral mucosa with the help of mucoadhesive polymers.

Problems solved by technology

However, poor solubility, stability, and bio-availability of many active substances make achieving therapeutic levels via the GI tract challenging.
It is obvious that the key problem of administration via buccal and / or sublingual dosage forms is that physiologically and pharmacologically active substances, edible cosmetics as well as foodstuffs, especially those that cannot rapidly interact with the oral mucosa may be washed away in substantial proportion because of the continuous secretion of saliva in the oral cavity.
Since the quality and content of probiotics have not been regulated, it is difficult to accurately assess their efficacy and safety.
However because of the particular temperature / humidity sensitivity of probiotics and the efficacy depending on their physiology, activity and viability, the production of live bacteria requires expertise and stringent quality controls throughout the process.

Method used

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  • Oral dosage form
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Examples

Experimental program
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Effect test

example 1

[0123]Preparation of a mucoadhesive orodispersible tablet comprising mucoadhesive (Metolose 65SH50) probiotic (Lactobacillus plantarum 299V) granules.

[0124]Preparation of mucoadhesive probiotic granules. Firstly Lactobacillus plantarum 299v (LP299V®) was sieved to remove the particles with a diameter >200 μm. Then the sieved LP299V® and Metolose 65SH50 were added in a Turbula-Mixer and mixed at 30 r / min with the addition of desiccant bags for 5 min to obtain a dry homogeneous mixture, which was subsequently transferred into a Somakon Labmixer and tempered to 20° C. under flow of dry nitrogen. 5 ml Eudragit L isopropanol solution (12.5%) was added into the mixture under stirring at 280 r / min and then the wetted mixture was stirred for 1 min using the scrapper as well before the rest Eudragit L isopropanol solution was added under stirring at 330 r / min. After stirring at 370 r / min for 2 min with the scrapper the wetted granules formed and were sieved through a 710 μm sieve, then put i...

example 2

[0127]Preparation of a mucoadhesive orodispersible tablet comprising mucoadhesive (Metolose 65SH50) probiotic (Lactobacillus paracasei 8700:2) granules.

[0128]The preparation steps were the same as that of Example 1, but without sieving of the bacterial powder prior to granulation. The amount of each material is listed in Table 2.

TABLE 2Composition of tabletCompoundAmount (mg)Lactobacillus plantarum 299V35Matolose 65 SH 5010the mixture of Syloid ®244 FP and AL-1FP silicas (1:1)20Flavour Optamint ® Lemon-Lime1Pruv ®1Avicel ®PH 11290Pearlitol ® 100 SD31.5Kollidon ®CL-SF10

[0129]In Example 2 a mucoadhesive orodispersible tablet Ex2 was obtained and the characterization data of the tablet were concluded in Table 4.

example 3

[0131]Preparation of a mucoadhesive orodispersible tablet comprising mucoadhesive (Chitosan food grade) probiotic (Lactobacillus paracasei 8700:2) granules.

[0132]The preparation steps were the same as that of Example 1, but without sieving of the bacterial powder prior to granulation. The amount of each material is listed in Table 3.

TABLE 3Composition of tabletCompoundAmount (mg)Lactobacillus plantarum 299V35Chitosan food grade26the mixture of Syloid ®244 FP and AL-1FP Silicas (1:1)20Flavour Optamint ® Lemon-Lime1Pruv ®1Avicel ®PH 11273.7Pearlitol ® 100 SD31.5Kollidon ®CL-SF10

[0133]In Example 3 a mucoadhesive orodispersible tablet Ex3 was obtained and the characterization data of the tablet were concluded in Table 4.

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Abstract

The present invention is in the field of delivering an active substance to the oral cavity and relates to mucoadhesive active composition and corresponding mucoadhesive dosage form, which can deliver an active substance within the oral cavity, especially an orodispersible tablet for delivering probiotic substance. The present invention also relates to a method of producing the said composition and a method of processing the composition into a mucoadhesive dosage form, especially an orodispersible tablet. The present invention moreover relates to a system and a method for testing the mucoadhesion of a dosage form.

Description

FIELD OF INVENTION[0001]The present invention is in the field of delivering an active substance to the oral cavity and relates to mucoadhesive active composition and corresponding mucoadhesive dosage form, which can deliver an active substance within the oral cavity, especially an orodispersible tablet for delivering probiotic substance. The present invention also relates to a method of producing the said composition and a method of processing the composition into a mucoadhesive dosage form, especially an orodispersible tablet. The present invention moreover relates to a system and a method for testing the mucoadhesion of a dosage form.STATE OF THE ART[0002]Oral delivery is the method of swallowing an active substance with the intention of releasing it into the gastrointestinal (GI) tract of humans and animals. The GI tract comprises mainly the stomach, small bowl and large bowel. In the pharmaceutical / health care industry oral delivery is the most commonly used method and a highly ...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K35/747A61K9/00G01N33/50A61K9/20
CPCA61K35/747A61K9/2054A61K9/2095A61K9/006A61K9/2027A61K9/2009A61K2035/115A61K9/2018A61K9/2068A61K9/2059A61K9/2045G01N33/5088A61K9/2013A61K9/0056A61K9/1635A61K9/1652A61K35/741G01N19/04A61K9/19A61K9/205A61K9/2063A61K2300/00A61K47/32A61K47/38
Inventor DANIELS, ROLFHOFFMANN, ANJAGOTZ, MARCUS RUDOLFFISCHER, JORG THILOHOLMGREN, KERSTIN
Owner SYMRISE GMBH & CO KG
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