WO2000064255A1 - Pharmaceutical gel formulation - Google Patents

Abstract

The pharmaceutical formulation of the active substance concentration in the range from 0.5 % to 5 %, in the case of potent agents such as perhydrol to - 3 %, of increased viscosity and is in the form of gel.

Description

PHARMACEUTICAL GEL FORMULATION

The object of invention is the pharmaceutical gel formulation used as

a disinfecting or therapeutic agent, especially on minor skin injuries, such

as various cuts, epidermis abrasions, wounds.

Known agents of similar nature have been used for years in the liquid

form, mainly in the form of solutions or aqueous or alcoholic mixtures.

The antiseptic action of other known medicines in the form of fat- or

paraffinbased ointments or gels is indicated only as an additional side

effect apart from their specific main indication.

Products such as hydrogen peroxide solution, gentian, or iodine

tincture have been used for decades in the form of aqueous or alcoholic

solutions, as well as in the case of agents such as Rivanol in the form of

tablets designed to be dissolved in water.

The above-listed products fulfil their role but have also some disadvan¬

tages such as acting upon the surface area much larger than required for the defined type of lesion or wound, the impossibiUty of using the agent at

the suitable, pre-determined amount, and the adverse effects of their

application, disagreeable for the injured person, such as wet or soiled

clothes.

An additional, untoward effect of the use of the up-to-date agents,

especially in the case of pouring them over a large surface area, is the

possibility of irritating the skin of particularly sensitive type.

Moreover, it is not possible to use thus prepared formulation over

a prolonged period of time; particularly when the container is not closed

properly, as then the antiseptic and therapeutic properties are significant¬

ly lowered with time.

Unexpectedly it was found that such formulations in the form of gel

fulfil their previous role excellently, and make the up-to-date agents

devoid of disadvantages and difficulties associated with their use both at

large scale, i.e. in hospitals, as well as in the case of individual appUcation

by the patient.

The field of the invention consists in the fact that the defined pharmaceutical agent in the form of gel, Uke hydrogen peroxide solution,

gentian, or iodine tincture, and in particular in the form of organic or

inorganic hydrogel or polyethylene glycol gel, is of increased viscosity and after the solvent is evaporated, creates a protective coating prolonging the

action of the formulation.

The beneficial concentrations of the active substance in gel formulation

should not be outside the range of 0,5 to 5%, and in the case of very potent

agents such as perhydrol - to 3%.

The benefit of such form of the indicated pharmaceutical products is,

above all, the strictly defined local action, the possibility of precise dosing,

both with respect to the amount of the applied patented drug as well as to

the concentration, which results in the substantial increase of the

effectiveness of action.

The important benefit is the possibiUty of lowering the concentration

without impairing the effectiveness of the formulation, which is of

particular importance in terms of logistics - the reduction of volume and

basis weight of the finished product as well as considerable extending of its

vaUdity period - over three times.

The object of invention is iUustrated by the following embodiment examples:

Example 1

Hydrogen peroxide solution (hydroenum peroxydatum). The formulation

composed on the basis of gel of the organic hydrogel group, with the use of hydroxyethylceUulose 3000 polymer, 2% concentration of the active sub¬

stance - hydrogen peroxide, viscosity of 4500 cnp.

Example 2

Gentian (pyoctanium aquosa solutio) in gel. The formulation composed

on the basis of polyethylene glycol 4000 gel, 2% concentration of the active

substance - gentian violet dissolved in water, viscosity of 3000 cnp.

Example 3

Gentian (pyoctanium spiritaosa solutio) in gel. The formulation composed

on the basis of polyethylene glycol 4000 gel, 1% concentration of the active

substance - gentian violet dissolved in 70° spirit, viscosity of 4000 cnp.

Example 4

Lodine tincture (iodi spiritaosa) in gel. The formulation composed on the

basis of polyethylene glycol 4000 gel, 1,5% concentration of free iodine,

viscosity of 5000 cnp.

Example 5

The formulation containing iodine in the polymer structure with polyviny-

lpyrroUdone. The formulation composed on the basis of organic gel, 4%

concentration of the active substance - povidone. For formulations according to the invention, the laboratory tests confir¬

med the indicated benefits; moreover, an additional benefit was discovered in

the form of prolonged stabiUty of the specific patented drugs, and in

particular of hydrogen peroxide solution, in the case of which oxygen release

was not found in the prolonged storage period; in the case of all formulations

no disappearance of antiseptic properties with time was found.

Claims

PATENT CLAIMS

1. The pharmaceutical formulation in gel containing from 0,5% to 5% of

hydrogen peroxide solution as the active substance, characterised in

that it has increased viscosity within the range from 2000 to 10000 cnp.

2. The pharmaceutical formulation in gel containing from 0,5% to 2% of

gentian violet as the active substance, characterised in that it has

increased viscosity within the range from 2000 to 10000 cnp.

3. The pharmaceutical formulation in gel containing from 1 % to 3% of

free iodine as the active substance, characterised in that it has increased

viscosity within the range from 2000 to 10000 cnp.

4. The pharmaceutical formulation in gel containing from 1 % to 5% in its

structure of polyvinylpyrroUdone (pvp) as the active substance, charac¬

terised in that it has increased viscosity within the range from 2000 to

10000 cnp.