KR890001590A - Formulations Suitable for Stabilization of α-Interferon - Google Patents

Abstract

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Description

Formulations Suitable for Stabilization of α-Interferon

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1 to 3 are diagrams showing the stability of α ₂ -IFN hydrogel according to gelatin addition yum.

Claims (20)

Carriers and stabilizers, cellulose derivatives, polyvinyl alcohols, polyvinylpyrrolidone or polyacrylic acid polymers, or mixtures thereof, respectively as excipients in the pharmaceutical agent; And a topical administration agent for stabilizing α-interferon contained in a medicament comprising an acid or alkali-degraded gelatin, further comprising an antiadhesive and, if appropriate, other conventional adjuvants. The pharmaceutical composition of claim 1, wherein the medicament contains a hydrogel, and as an excipient, respectively, a carrier and a stabilizer, that is, a cellulose derivative, a polyvinyl alcohol, a polyvinylpyrrolidone or a polyacrylic acid polymer or a mixture thereof; And an acid or alkali-degraded gelatin, further comprising an antiadhesive agent and, optionally, other conventional adjuvants, for topical administration. 3. A medicament according to claim 2, wherein the medicament contains, as an excipient, a carrier and a stabilizer, ie hydroxyethyl cellulose and gelatin, in amounts of 0.1 to 2.0% by weight, respectively, based on the final product. 3. A medicament according to claim 2, wherein the medicament contains a carrier and a stabilizer as an excipient, ie hydroxyethyl cellulose and gelatin, and the amount of gelatin is 0.1 to 10% by weight based on the final product. The agent according to claim 3 or 4, wherein the gelatin is Bloom 160 to 200 and the degree of substitution of hydroxyethyl cellulose is 2.5. 6. A medicament according to any one of claims 1 to 5, wherein the anti-sticking agent consists of anionic, cationic, or neutral surfactants, preferably polyethoxylated sorbitan esters. The agent according to claim 6, wherein the anti-sticking agent is polysorbate 20, 60 or 80 or a mixture thereof. 8. A medicament according to any one of claims 1 to 7, wherein the a-interferon contained in the medicament is obtained from a cell culture transformed with a DNA sequence encoded for human a-interferon. The agent according to claim 8, wherein the α-interferon contained in the agent is obtained from transformed cells of E. coli. 10. The agent according to claim 9, wherein the intrinsic activity of the α-interferon contained in the agent is 1 × 10 ⁵ to 1 × 10 ¹⁰ IU per 100 g of the final product. 11. A medicament according to any one of claims 1 to 10, which contains as an adjuvant to the medicament a buffer, a moisturizer and a skin toxic preservative, a penetration enhancer and a vehicle that can be miscible with α-interferon. The agent according to claim 11, wherein the buffer system is sodium phosphate buffer, potassium hydrogen phosphate / sodium dihydrogen phosphate buffer, citric acid / phosphate buffer, potassium-sodium-glutamate-phosphate buffer, succinate buffer or a mixture thereof. 13. The agent according to claim 12, wherein the pH of the specific buffer solution is 6.0 to 7.4. 12. A medicament according to claim 11, which contains glycerol, 1, 2-propylene glycol, sorbitol, butylene glycol, polyols (e.g. polyethylene glycol 400) or mixtures thereof as moisturizers. 12. The method of claim 11, characterized in that it contains P-hydroxybenzonic acid, ester, sorbic acid, benzoic acid, chlorhexidine digluconate, benzalkonium chloride, hexadecyltrimethylammonium bromide or mixtures thereof as a non-toxic preservative to the skin. Medicine to do. 12. A medicament according to claim 11, wherein the penetration promoter that can be miscible with the α-interferon is up to 50% by weight of dimethylsulfoxide. 12. A medicament according to claim 11, wherein the vehicle used for the gel is water. Herpes labialis, Herpes genitalis including papilloma infection, pancreas and herpes zoster infections and are used as transdermal, nasal, intraocular and intravaginal virus inhibitors for similar cancers and cancers Use of a medicament according to claims 1 to 17, characterized in that it is also used for topical treatment. 0.1 to 2.0% by weight of gelatin, based on the final product, was dissolved in water at 80 DEG C or lower, and an anti-sticking agent was added to this solution; Optionally, preservatives, humectants, salts, buffers and penetration promoters are introduced into the solution; To 80 ° C. or lower, hydroxyethyl cellulose, carboxymethyl cellulose, methyl cellulose, hydroxypropylmethyl cellulose, polyvinyl alcohol, polyvinylpyrrolidone, polyacrylic acid or a mixture thereof is 0.1 to 2.0 based on the final product. In an amount of wt%, provided that the polyvinyl alcohol or polyvinylpyrrolidone is introduced in an amount of 15 wt% or less; The amount of 1 × 10 ⁵ to 1 × 10 ¹⁰ IU of α-interferon per 100 g of the final product is homogeneously dispersed in the solution, and the mixture is filled into a sterile container to stabilize the α-interferon contained in the drug. Method for preparing a topical medicament. 0.1-2.0% by weight of hydroxyethyl cellulose is dissolved in a water / glycerol mixture at a temperature of 60 ° C or less with 10% by weight or less of gelatin; Carefully stir the α-IFN solution containing polysorbate and hydrochloric acid at a temperature of 40 to 50 ° C .; A method for preparing a medicament for vaginal administration, characterized in that the solution is immediately poured into a suitable mold. ※ Note: The disclosure is based on the initial application.