CS239850B1 - Hydrophobic emulsion ointment - Google Patents

Abstract

The invention relates to a hydrophobic emulsion ointment, where the optimal ratio between pentaerythritol monooleate, petrolatum and metallic soaps results in an emulsion with a high water content suitable for continuous production.

Description

239850

BACKGROUND OF THE INVENTION The present invention relates to a hydrophobic emulsion composition, in particular for protecting skin working in humid environments, heavy, construction, laundry, and the like. The hydrophobic emulsion ointment can also be used as a basis for the master-liter formula.

Hydrophobic emulsion ointments include emulsion-type interdisperse systems, wherein the aqueous phase forms the inner part and the hydrophobic phase is the continuous outer part of the emulsion. They are called water-in-oil (V / O) emulsions, where the oil phase usually forms petroleum products; petroleum jelly, liquid paraffin and / or solid, cholesterol, waxes and the like.

V / O ointments are one of the more advanced topical systems after single-phase hydrophobic ointments, so pharmacopoeia uses them even more often with an alcohol emulsion-type (O / Vj. certain heavy duty industrial and O / O type ointments, where the stability of the formulation must be greater than that of an ad hoc emulsion in a pharmacy.

Emulsifiers are also quite outdated from the above, and the preparation of those parts of high-performance industrial lines faces major difficulties. In the present time, it is inclined to the discontinuous form of manufacture, where the emulsification is carried out in a very short period of time and a large shear rate of the phases.

Emulsifiers which are common in pharmacy-small-scale practice (lanolin, cholesterol) are difficult to tolerate and, over time, there is a typical instability of V / O emulsion ointments for phase separation, especially at high water content and so on. product depreciation.

In industrial production, although it is a large-scale production, especially the working-ointment ointments, it is simple and quick to prepare stable ointments, the emulsion must be sufficiently stable to withstand the effects of the process during continuous production.

It is an object of the present invention to provide an optimal, economically advantageous and therapeutically effective emulsion ointment which satisfies all the requirements for large-scale production, comprising as few ingredients as possible.

In the preparation of the recipe, a combination of emulsifiers (V / O type) and water / oil proportions were used. As the therapeutically and economically most advantageous emulsifier, we have found pentaerythritol monooleate, which is a known emulsifier of the V / O type (H. Sucher, Pharm. Ind. 35, 85-91, 1973).

By suitable formulation of the formulation it has been achieved that the ointment prepared is stable despite its usually high water content. Prepared by the skin is non-irritating, does not form a oily skin, yet protects against dampness and hand care. These properties are proven in volunteers during clinical trials.

It is an object of the present invention to provide a V / O emulsion ointment formulation that is suitable for continuous production in industrial practice, despite the uniquely high water content. The optimum formulation was made using a V-type / Opentaerythrit monooleate type emulsifier stabilized with aluminum stearate and magnesium stearate.

The hydrophobic emulsion ointment according to the invention is characterized in that it contains from 4.0 to 16% by weight of the composition. pentaerythritol monooleate, 0.75 to 3.0 percent by weight; magnesium stearate, 0.375 to 1.50 wt. aluminum stearate, 5.0 to 50.0% by weight; white or yellow petrolatum, 3.0 to 20.0% w / w. % paraffin liquid, 9.0 to 86.825 wt. water and 0.05 to 0.5% by weight of a correcting excipient.

Preparation process

The stearate emulsifier and the oil component (petroleum jelly, paraffin liquid) are heated to a suitable temperature. The sterilized distilled water, the oil components of the recipe and the perfume are emulsified after the pump dispensers have been adjusted in the formulation to a continuous line for ointments. The emulsion ointment may be treated and homogenized on a triple tube after cooling. The following is an example of an emulsion mass without being limited to it. Example * parts of mass.

Pentaerythritol monooleate 8,00 Magnesium stearate 1,50 Aluminum stearate 0,75 Vaseline white 12,50 Liquid paraffin 7,50 Perfume 0,15 Distilled water 69,60

Claims (3)

SUBJECT A hydrophobic emulsion ointment characterized by being firmly attached to an industrial dew flange in that it contains 4.0 to 16% by weight. % pentaerythrone monooleate, 0.75 to 3.0 wt. magnesium stearate, 0.375 to 1.50. % wt. aluminum stearate, 5.0 to 50.0 wt. % white or yellow petrolatum, 3.0 to 20.0 wt. % paraffin liquid, 9.0 to 86.825 wt. % water and 0.05 to 0.5 wt. fragrance-correcting excipient. INVENTION 2. A hydrophobic emulsion ointment according to claim 1, wherein the ointment comprises magnesium stearate and aluminum stearate in a weight ratio of 2: 1. 3. A hydrophobic emulsion ointment according to items 1 and 2, characterized in that the weight ratio between pentaerythritol monooleate and hydrophobic components is 1: 2.5.