Pharmaceutical compositions for transmucosal delivery

A composition and drug technology, which can be applied in the directions of drug delivery, active ingredients of hydroxyl compounds, non-active ingredients of polymer compounds, etc., and can solve the problems of not being able to take effect quickly

Inactive Publication Date: 2018-10-23
SOLUBEST
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] (viii) The mucoadhesive nature of the formulation can delay drug release and absorption, thus not allowing rapid onset of action

Method used

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  • Pharmaceutical compositions for transmucosal delivery
  • Pharmaceutical compositions for transmucosal delivery
  • Pharmaceutical compositions for transmucosal delivery

Examples

Experimental program
Comparison scheme
Effect test

Embodiment approach

[0074] In another exemplary embodiment, the pharmaceutical composition of the present application is selected from:

[0075] 1) Sumatriptan, Poloxamer 407, NaCMC and mannitol;

[0076] 2) Sumatriptan, Poloxamer 407, NaCMC, Mannitol and KH 2 PO 4 ;

[0077] 3) Sumatriptan, Poloxamer 407, NaCMC, soluble starch and mannitol;

[0078] 4) Sumatriptan, Poloxamer 407, NaCMC, Soluble Starch, Mannitol, Steviolbioside and KH 2 PO 4 ;

[0079] 5) Cannabis resin, poloxamer 407, NaCMC and mannitol;

[0080] 6) Aprepitant, Poloxamer 407, NaCMC and mannitol;

[0081] 7) THC, D-alpha-tocopherol, polyethylene glycol, poloxamer 407, NaCMC, soluble starch, and steviolbioside; and

[0082] 8) Prednisolone, Poloxamer 407, NaCMC, and Mannitol; and

[0083] 9) Insulin, EDTA, Poloxamer 407 and NaCMC.

[0084] In another aspect, the application provides a method of preparing the composition of the embodiment, comprising the steps of:

[0085] 1) dissolving two or more polymers, fast dissolv...

example 1

[0160] Example 1: Formulation of sumatriptan with Poloxamer 407 and NaCMC

[0161] Drug solution: sumatriptan (1.0 g) was dissolved in a mixture of 17 g of n-propanol and 8 g of acetone at 25° C. under stirring at 300 rpm.

[0162] Polymer solution: Poloxamer 407 (2.0 g), NaCMC (1.0 g) and mannitol (0.5 g) were dissolved in 50 ml of water at 57°C with stirring at 300 rpm.

[0163] The drug solution was added to the polymer solution at a feed rate of 2 ml / min with stirring at 300 rpm at 55°C. The obtained clear and uniform hot (50-55° C.) solution was spray-dried using a Buchi mini-spray dryer with an inlet air temperature of 105° C. and an outlet air temperature of 62° C. to obtain a powder.

example 2

[0164] Example 2: Formulation of sumatriptan with Poloxamer 407, NaCMC and modified starch

[0165] Drug solution: sumatriptan (1.0 g) was dissolved in a mixture of 17 g of n-propanol and 8 g of acetone at 25° C. under stirring at 300 rpm.

[0166] Polymer solution: Poloxamer 407 (2.0 g), NaCMC (0.5 g), modified starch (0.5 g) and mannitol (0.5 g) were dissolved in 50 ml of water at 57° C. under stirring at 300 rpm.

[0167] The drug solution was added to the polymer solution at a feed rate of 2 ml / min with stirring at 300 rpm at 55°C. The obtained clear and uniform hot (50-55° C.) solution was spray-dried using a Buchi mini-spray dryer with an inlet air temperature of 105° C. and an outlet air temperature of 62° C. to obtain a powder.

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Abstract

The present application relates to a pharmaceutical composition for transmucosal administration of an active lipophilic compound through the oral mucosa comprising a lipophilic active compound, a polymeric matrix formed by two or more water-soluble polymers and a rapid dissolution agent. At least one of the water-soluble polymers is an amphiphilic polymer and at least one is either a hydrophilic polymer or an amphiphilic polymer with a hydrophobic-hydrophilic balance different from the first amphiphilic polymer. In addition, the polymeric matrix is not crosslinked and no covalent interaction occurs between the two or more polymers and between the polymers and the lipophilic active compound, which is interwoven with the aforesaid polymeric matrix.

Description

technical field [0001] The present invention relates to oral administration, in particular to a compound drug administered through oral mucosa. Background technique [0002] Modern therapeutics includes consideration of the route of administration and the use of drug delivery to assess efficacy. Of the two main classes of drug delivery (ie, topical versus systemic), systemic methods are less invasive and easier to administer and are therefore preferred. Systemic administration allows pharmaceutical compounds to enter the circulatory system directly to affect the entire body. In sharp contrast to it is topical medication, which generally only acts on the local area. [0003] Two commonly used systemic administration methods are: injection administration (including: intravenous and intraperitoneal injection, infusion) and enteral administration (including: oral administration and gastrointestinal administration). .Transmucosal administration, especially oral mucosal adminis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K47/30A61K47/10A61K47/36A61K47/42A61K9/20
CPCA61K31/5377A61K9/006A61K9/1611A61K9/1641A61K9/1652A61K9/2009A61K9/2018A61K9/2031A61K9/2054A61K9/2059A61K31/352A61K31/4045A61K31/573A61K38/28A61K9/1623A61K9/1635A61K31/05
Inventor 加利亚·特姆金-卡拉兹萨拜娜·格洛茨曼帕维尔·卡兹丹
Owner SOLUBEST
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