Anhydrous multiphase gel system

A system, gel technology, applied in the directions of gel preparation, microcapsule preparation, liposome delivery, etc., to achieve the effect of large solvent storage

Inactive Publication Date: 2009-08-19
INTENDIS GMBH
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0016] In addition to carrier penetration, enhanced hydration of the stratum corneum under occlusive conditions should also be considered, and as stated above, hydrocarbon ointments known in the prior art show strong occlusive properties

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1-5

[0086] Table 1 below shows an exemplary formulation for an anhydrous heterogeneous gel system of the invention based on a semi-solid lipid formulation having a gelling mixture consisting of propylene carbonate and propylene glycol or ethanol (summed to be 100g). Table 1 shows compositions of the invention according to Examples 1-5. The first column describes the ingredients used in the preparation. The second column gives the range (wt %) of each ingredient that may be present in the final formulation. Columns 3-7 describe the selected formulations (amount data are in wt %, respectively). In examples 3 and 4 (in columns 5 and 6) the composition according to the invention comprises Ascrolimus as active substance.

[0087] Table 1 thus shows that the amounts of the individual ingredients can be varied within wide ranges in order to obtain compositions according to the invention with advantageous properties.

[0088]The formulation of even very poorly soluble active substance...

Embodiment 6

[0092] General preparation technique of EDRS

[0093] The process depicted below figure 1 A general preparation technique for the EDR system of the present invention is shown. Depending on the desired purpose, the active substance to be introduced into the system can be introduced into the lipid phase or into the polymer phase, or even into both phases. The temperature at which the individual preparation steps are carried out can also have an influence. The lipid must almost always be molten, whereas the polymer phase is already sufficiently liquid under the particular conditions of the composition that additional liquefaction, for example by heating, can be dispensed with. When combining the individual phases, the size distribution of the vesicles (Vesikel) can be influenced in a desired manner. Upon subsequent cooling of the mixture, the vesicles were fixed under gel formation. The individual preparation steps are well within the knowledge of those skilled in the art, p...

Embodiment 7

[0095] Application studies on human skin

[0096] A compatibility study of the composition of the invention compared to two formulations according to the prior art is described below. A composition for topical treatment of atopic dermatitis is applied to a single target lesion for a period of one week. A series of trials were conducted in the form of a double-blind, randomized, single-center crossover study with two time periods.

[0097] 18 subjects (aged 19-41 years, Caucasian, with at least two 4cm 2 women and men with large lesions) participated in the study until the end; no statistical distribution was done. Subjects received two different treatments each on a different injury over two consecutive weeks. A single subject omits only a single administration.

[0098] Three preparations are used:

[0099] Carrier A: Greasy ointment (prior art)

[0100] Carrier B: Anhydrous heterogeneous gel system (EDRS) of the present invention

[0101] Carrier C: water-in-oil formu...

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PUM

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Abstract

The invention relates to an anhydrous multiphase gel system consisting of an outer lipid matrix and of an inner phase gelled by means of polymer, obtained by: a) melting the lipid phase while forming a liquid lipid phase; b) mixing and homogenizing polymers or polymer blends that are capable of swelling while forming a polymer phase to be dispersed; combining the polymer phase with the liquid lipid phase and homogenizing the phases, and; d) cold stirring the phase mixture until forming a solid gel-like mixed structure of the entire system. The anhydrous multiphase gel system is particularly suited for accommodating poorly soluble active substances in high concentrations and for topical and transdermal applications. The described system is characterized as an EDRS Entrapped Drug Reservoir System .

Description

technical field [0001] The present invention relates to topically administrable compositions in the form of anhydrous multiphase gel systems. Background technique [0002] A wide variety of topically administrable compositions are known in the art. Two typical products of such transdermally administrable systems are creams and ointments. [0003] A cream is an emulsion comprising a dispersed phase and a dispersing agent. A distinction is basically made here between water-in-oil and oil-in-water emulsions, depending on which type of emulsifier is used. In each case, however, aqueous systems are involved. [0004] Many users of creams find it particularly advantageous the ease of distribution of these creams and the fact that the creams do not feel sticky and greasy on the skin. [0005] A disadvantage of creams, however, is that they have only low occlusion. Hydration of the stratum corneum of the skin is achieved by occlusion, and the stratum corneum can absorb 3-5 time...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/127B01J13/04A61K8/14
CPCA61K2800/31A61K47/44A61K9/0014A61K8/14B01J13/0052A61K9/06A61K2800/75A61K31/439A61Q19/00A61K8/042A61K47/34A61P17/00A61P17/02A61K31/436
Inventor P·弗兰克
Owner INTENDIS GMBH
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