BRPI1104620B1 - pharmaceutical composition for the treatment of burns and skin lesions and their preparation process - Google Patents

pharmaceutical composition for the treatment of burns and skin lesions and their preparation process Download PDF

Info

Publication number
BRPI1104620B1
BRPI1104620B1 BRPI1104620A BRPI1104620A BRPI1104620B1 BR PI1104620 B1 BRPI1104620 B1 BR PI1104620B1 BR PI1104620 A BRPI1104620 A BR PI1104620A BR PI1104620 A BRPI1104620 A BR PI1104620A BR PI1104620 B1 BRPI1104620 B1 BR PI1104620B1
Authority
BR
Brazil
Prior art keywords
weigh
pharmaceutical composition
cream
add
water
Prior art date
Application number
BRPI1104620A
Other languages
Portuguese (pt)
Inventor
Teixeira De Carvalho Lúcia
Thereza Sarto Píccolo Maria
Sarto Píccolo Mônica
Sarto Piccolo Nelson
Original Assignee
Lucia Teixeira De Carvalho
Maria Thereza Sarto Piccolo
Monica Sarto Piccolo
Sarto Piccolo Nelson
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Lucia Teixeira De Carvalho, Maria Thereza Sarto Piccolo, Monica Sarto Piccolo, Sarto Piccolo Nelson filed Critical Lucia Teixeira De Carvalho
Priority to BRPI1104620A priority Critical patent/BRPI1104620B1/en
Priority to PCT/BR2012/000331 priority patent/WO2013033797A1/en
Publication of BRPI1104620A2 publication Critical patent/BRPI1104620A2/en
Publication of BRPI1104620B1 publication Critical patent/BRPI1104620B1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/60—Salicylic acid; Derivatives thereof
    • A61K31/625—Salicylic acid; Derivatives thereof having heterocyclic substituents, e.g. 4-salicycloylmorpholine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/30—Zinc; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/38—Silver; Compounds thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/44—Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/02—Drugs for dermatological disorders for treating wounds, ulcers, burns, scars, keloids, or the like
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12—Antivirals
    • A61P31/20—Antivirals for DNA viruses
    • A61P31/22—Antivirals for DNA viruses for herpes viruses

Abstract

composição farmacêutica para tratamento de queimaduras e lesões da pele e seu processo de preparação. a presente invenção se refere a uma composição farmacêutica para o tratamento de queimaduras, escaras, úlceras varicosas e outras lesões da pele, consistindo basicamente a novidade na associação de salicilato de sódio e sais de zinco, entre estes, preferencialmente, o sulfato de zinco, em concentrações específicas, podendo ser ainda associada à sulfafdiazina de prata, sendo a base do creme constituída por álcool cetoestearílico, álcool cetoestearílico etoxilado 20 eo; lanolina, propilenoglicol parafina, vaselina sólida, de óleo mineral, metilparabeno e propilparabeno. a invenção se refere também ao processo de obtenção da composição.pharmaceutical composition for the treatment of burns and skin lesions and its preparation process. the present invention relates to a pharmaceutical composition for the treatment of burns, bedsores, varicose ulcers and other skin lesions, basically the novelty in the association of sodium salicylate and zinc salts, among them, preferably, zinc sulfate, in specific concentrations, it can also be associated with silver sulfafdiazine, the base of the cream being made up of ceto-stearyl alcohol, ethoxylated ceto-stearyl alcohol 20; lanolin, paraffin propylene glycol, solid petroleum jelly, mineral oil, methyl paraben and propyl paraben. the invention also relates to the process of obtaining the composition.

Description

Relatório Descritivo da Patente de Invenção COMPOSIÇÃO FARMACÊUTICA PARA TRATAMENTO DE QUEIMADURAS E LESÕES DA PELE E SEU PROCESSO DE PREPARAÇÃODescriptive Report of the Invention Patent PHARMACEUTICAL COMPOSITION FOR TREATING SKIN BURNS AND INJURIES AND ITS PREPARATION PROCESS

CAMPO DA INVENÇÃOFIELD OF THE INVENTION

A presente invenção se refere a uma composição farmacêutica sob a forma de cremes estáveis contendo sais de sulfato de zinco e salicilato de sódio para o tratamento de lesões de pele de causas diversas com queimaduras, escaras, piodermites, herpes zoster, e úlceras varicosas, podendo ser associada à sulfadiazina de prata.The present invention relates to a pharmaceutical composition in the form of stable creams containing salts of zinc sulfate and sodium salicylate for the treatment of skin lesions of various causes with burns, bedsores, pyoderma, herpes zoster, and varicose ulcers, which may be associated with silver sulfadiazine.

TÉCNICA ANTERIORPREVIOUS TECHNIQUE

A técnica de excisão e enxertia precoce tem sido muito utilizada, visando o fechamento precoce da ferida, evitando assim complicações passíveis de ocorrer coma a ferida aberta. Entretanto, o tratamento convencional e a excisão são igualmente seguros e eficientes nas queimaduras envolvendo menos de 30 % da superfície corporal.The excision and early grafting technique has been widely used, aiming at the early closure of the wound, thus avoiding complications that may occur with the open wound. However, conventional treatment and excision are equally safe and efficient for burns involving less than 30% of the body surface.

Durante a evolução deste tipo de ferida queimada, existe sempre o risco de infecção local e sistêmica, visto que o ambiente desta ferida pode propiciar a proliferação de microorganismos aí presentes, necessitando-se, portanto, de medicamentos para tratamento local eficiente. Devido à isquemia tecidual, os antibióticos orais administrados sistematicamente não chegam de maneira eficiente à ferida, onde são mais necessários. Por isso, é necessária a terapia antibiótica tópica, para ação direta na ferida.During the evolution of this type of burned wound, there is always the risk of local and systemic infection, since the environment of this wound can promote the proliferation of microorganisms present there, therefore requiring medicines for efficient local treatment. Due to tissue ischemia, oral antibiotics administered systematically do not reach the wound efficiently, where they are most needed. Therefore, topical antibiotic therapy is required for direct action on the wound.

Vários são os agentes tópicos em uso para o tratamento da infecção da ferida queimada, sendo a mais comum a terapia tópica da sulfadiazina de prata. Tal substância combina propriedades antibacterianas do íon prata e da sulfadiazina. Possui amplo espectro de atividade sobre microorganismos Gram positivos e negativos, sendo de particular eficácia para Pseudomonas aeruginosa, possuindoThere are several topical agents in use for the treatment of burn wound infection, the most common being topical silver sulfadiazine therapy. Such a substance combines antibacterial properties of the silver ion and the sulfadiazine. It has a broad spectrum of activity on positive and negative Gram microorganisms, being particularly effective for Pseudomonas aeruginosa, having

2/5 ainda, atividade antiviral (contra herpes zoster) e antifúngica.2/5 still, antiviral (against herpes zoster) and antifungal activity.

O mecanismo de ação antimicrobiana da sulfadiazina de prata pode ser explicado pela reação do ion prata com o DNA da bactéria, atuando especificamente no processo de replicação. Algumas pesquisas sugerem uma interação do fármaco com a parede da célula bacteriana, tornando-a lábil. A sua ação é prolongada, por se tratar de um complexo que se dissocia vagarosamente, resultando em um reservatório de prata no local do ferimento. É usada veiculada em cremes ou pomadas na concentração de 1%. Não deve’ ser associada ao uso concomitante de enzimas proteoliticas de uso tópico, porque existe a possibilidade de inativação das enzimas pela prata.The mechanism of antimicrobial action of silver sulfadiazine can be explained by the reaction of the silver ion with the bacterium's DNA, acting specifically in the replication process. Some research suggests an interaction of the drug with the bacterial cell wall, making it labile. Its action is prolonged, as it is a complex that dissociates slowly, resulting in a silver reservoir at the wound site. It is used in creams or ointments at a concentration of 1%. It must not be associated with the concomitant use of proteolytic enzymes for topical use, because there is a possibility of inactivation of the enzymes by silver.

OBJETIVOS E VANTAGENS DA INVENÇÃOOBJECTIVES AND ADVANTAGES OF THE INVENTION

A presente invenção tem como objetivo proporcionar uma composição farmacêutica de uso tópico para o tratamento de queimaduras que reduza o tempo para a liberação completa da escara e para a contração e epitelização completa da ferida, e, por conseguinte, reduzir substancialmente os custos do tratamento e o sofrimento do paciente.The present invention aims to provide a pharmaceutical composition for topical use for the treatment of burns that reduces the time for the complete release of the eschar and for the complete contraction and epithelization of the wound, and, therefore, to substantially reduce the costs of treatment and the patient's suffering.

Este objetivo é alcançado por meio do emprego em concentrações especificas de salicilato de sódio e sais de zinco, entre estes, preferencialmente, o sulfato de zinco.This objective is achieved through the use of specific concentrations of sodium salicylate and zinc salts, among them, preferably, zinc sulfate.

A presente composição possui a seguinte apresentação: creme de sulfato de zinco heptahidratado a 1% e salicilato de sódio nas concentrações de 10, 20 e 40%.The present composition has the following presentation: zinc sulfate cream 1% heptahydrate and sodium salicylate in concentrations of 10, 20 and 40%.

Os objetivos da invenção também são alcançados por uma segunda concretização da invenção que apresenta a seguinte formulação: creme de sulfato de zinco hetahidratado a 1% e sulfadiazina de prata a 1%.The objectives of the invention are also achieved by a second embodiment of the invention which features the following formulation: 1% zinc sulphate hydrate cream and 1% silver sulfadiazine.

A composição também poderá se apresentar das seguintes formas: creme de salicilato de sódio nas concentrações de 10, 20 e 40% e sulfadiazina de prata a 1%;The composition can also be presented in the following ways: sodium salicylate cream in concentrations of 10, 20 and 40% and silver sulfadiazine at 1%;

3/5 creme de salicilato de sódio nas concentrações de 10, 20 e 40%.3/5 sodium salicylate cream in concentrations of 10, 20 and 40%.

Os cremes da presente invenção têm por base principal a seguinte formulação:The creams of the present invention are mainly based on the following formulation:

PRODUTO PRODUCT QUANTIDADE* AMOUNT* ÁLCOOL CETOESTEARÍLICO CETOSTEARYL ALCOHOL 3, OKg 3, OKg ÁLCOOL CETOESTEARÍLICO ETOXILADO 20 EO ETOXYLATED CETOESTEARYL ALCOHOL 20 EO 0,70Kg 0.70Kg LANOLINA LANOLIN 0,50Kg 0.50Kg PROPILENOGLICOL PROPILENOGLICOL 0,lOKg 0, lOKg PARAFINA PARAFFIN 0,7OKg 0.7OKg VASELINA SÓLIDA SOLID VASELINE 0,7OKg 0.7OKg ÓLEO MINERAL MINERAL OIL 4,3Kg 4.3Kg METILPARABENO Methylparaben 20g 20g PROPILPARABENO PROPILPARABEN 15g 15g *Quantidade para lOKg * Quantity for lOKg

Foi demonstrado pelo estudo comparativo anexo desenvolvido pelo Dr. Nelson Sarto Piccolo, referência nacional no tratamento de queimaduras, a viabilidade e as vantagens da associação objeto da presente invenção. As queimaduras tratadas com a concretização preferida da presente invenção - pela associação de salicilato de sódio e sais de zinco - obtiveram tempo médio de liberação da escara inferior ao consumido pelas demais substâncias, reduzindo em 50% o período em relação aos demais agentes tópicos existentes no estado da técnica. O tempo de cura da ferida obteve uma redução de até 30% com a utilização do salicilato de sódio e sulfato de zinco.It was demonstrated by the attached comparative study developed by Dr. Nelson Sarto Piccolo, a national reference in the treatment of burns, the viability and the advantages of the association object of the present invention. The burns treated with the preferred embodiment of the present invention - by the association of sodium salicylate and zinc salts - obtained an average time of releasing the eschar to that consumed by the other substances, reducing the period in 50% in relation to the other topical agents existing in the state of the art. The healing time of the wound was reduced by up to 30% with the use of sodium salicylate and zinc sulfate.

Os objetivos da invenção também são alcançados por um processo de preparação dos cremes compreendendo as seguintes etapas:The objectives of the invention are also achieved by a process of preparing the creams comprising the following steps:

Pesar 30% da base de creme e 0,5 de álcool cetoestearílico, 0,2% de metilparabeno e 0,15 % de propilparabeno e fundir em banho-maria;Weigh 30% of the cream base and 0.5 of ceto-stearyl alcohol, 0.2% of methylparaben and 0.15% of propylparaben and melt in a water bath;

- Pesar a água deionizada e aquecer a 60°C;- Weigh the deionized water and heat to 60 ° C;

- Pesar o sulfato de zinco e dissolvê-lo em pequena parte da água quente;- Weigh the zinc sulfate and dissolve it in a small part of the hot water;

4/54/5

Pesar o salicilato de sódio na concentração desejada e dissolvê-lo em toda água quente restante;Weigh the sodium salicylate in the desired concentration and dissolve it in any remaining hot water;

- Juntar 4 em 1, com agitação constante;- Add 4 in 1, with constant agitation;

- Juntar 3em 5, agitando até dar consistência;- Add 3 in 5, stirring until consistency;

- Envasar.- Filling.

Na segunda modalidade da invenção, o processo assim se apresenta:In the second embodiment of the invention, the process is as follows:

- Pesar 20% da base de creme descrita na tabela, acrescentar os conservantes metilparabeno a 0,2% e propilparabeno a 0,15 % e fundir em banho-maria;- Weigh 20% of the cream base described in the table, add the preservatives methylparaben 0.2% and propylparaben 0.15% and melt in a water bath;

- Pesar a água deionizada e aquecer a 60°C, separando uma pequena parte para dissolução dos sais de princípios ativos;- Weigh the deionized water and heat to 60 ° C, separating a small part to dissolve the salts of active ingredients;

- Pesar a sulfadiazina de prata a 1% e solubilizá-la em água;- Weigh the silver sulfadiazine at 1% and solubilize it in water;

- Misturar 1, 2 e 3;- Mix 1, 2 and 3;

- Pesar o sulfato de zinco, (se monihidratado, usar a 0,06%; se heptahidratado, usar 1%) e dissolvê-lo em água;- Weigh the zinc sulfate, (if monohydrate, use at 0.06%; if heptahydrate, use 1%) and dissolve it in water;

- Acrescentar 5 e misturar até dar consistência;- Add 5 and mix until consistent;

- Envasar.- Filling.

• Ou ainda em outra concretização da invenção:• Or in yet another embodiment of the invention:

Pesar 30% da base de creme e 0,5 de álcool cetoestearílico, 0,2% de metilparabeno e 0,15 % de propilparabeno. Fundir em banho-maria;Weigh 30% of the cream base and 0.5 of ceto-stearyl alcohol, 0.2% of methylparaben and 0.15% of propylparaben. Cast in a water bath;

- Pesar a água deionizada e aquecer a 60°C, separar uma pequena porção para dissolução da sulfadiazina de prata;- Weigh the deionized water and heat to 60 ° C, separate a small portion to dissolve the silver sulfadiazine;

Pesar a sulfadiazina de prata a 1% água;Weigh silver sulfadiazine to 1% water;

Pesar o salicilato de sódio e dissolvê-la na na concentração desejada e acrescentá-lo em toda água aquecida, agitando até a completa dissolução do sal;Weigh the sodium salicylate and dissolve it in the desired concentration and add it to all heated water, stirring until the salt is completely dissolved;

- Acrescentar 1 em 4;- Add 1 in 4;

- Acrescentar 3 em 5 e misturar até dar consistência;- Add 3 in 5 and mix until consistent;

5/55/5

- Envasar.- Filling.

Testes de estabilidade foram realizados com até cinco anos das formulações deixadas em temperatura ambiente normais em climas de frio e calor e a conclusão é que os 5 medicamentos contendo sais de sulfadiazina de prata e sulfato de zinco são altamente estáveis, permanecendo até esta data sem alterações. Os cremes contendo sais de salicilato de sódio, por estarem em altas concentrações, são mais susceptíveis às alterações de estabilidade, como 10 oxidações, contudo se mantiveram estáveis até dois anos ou mais nos testes a que foram submetidos. Análises microbiológicas foram realizadas em amostras aleatórias e não apresentaram crescimento de microorganismos.Stability tests were carried out with up to five years of the formulations left at normal room temperature in cold and hot climates and the conclusion is that the 5 drugs containing salts of silver sulfadiazine and zinc sulfate are highly stable, remaining until this date without changes . Creams containing sodium salicylate salts, as they are in high concentrations, are more susceptible to changes in stability, such as 10 oxidations, however they remained stable for up to two years or more in the tests they were subjected to. Microbiological analyzes were performed on random samples and showed no growth of microorganisms.

Claims (8)

REIVINDICAÇÕES 1. Composição farmacêutica CARACTERIZADA por compreender um creme de sulfato de zinco heptahidratado a 1% e salicilato de sódio nas concentrações de 10, 20 e 40%.1. Pharmaceutical composition FEATURED for comprising a zinc sulphate cream 1% heptahydrate and sodium salicylate in concentrations of 10, 20 and 40%. 2. Composição farmacêutica CARACTERIZADA por compreender um creme de sulfato de zinco hetahidratado a 1% e sulfadiazina de prata a 1%.2. Pharmaceutical composition FEATURED for comprising a 1% zinc sulphate cream with 1% silver sulfadiazine. 3. Composição farmacêutica CARACTERIZADA por compreender um creme de salicilato de sódio nas concentrações de 10, 20 e 40% e sulfadiazina de prata a 1%.3. Pharmaceutical composition FEATURED for comprising a sodium salicylate cream in concentrations of 10, 20 and 40% and silver sulfadiazine at 1%. 4. Composição farmacêutica CARACTERIZADA por compreender um creme de salicilato de sódio nas concentrações de 10, 20 e 40%.4. Pharmaceutical composition CHARACTERIZED for comprising a sodium salicylate cream in concentrations of 10, 20 and 40%. 5. Composição farmacêutica de acordo com as reivindicações 1, 2, 3 e 4, CARACTERIZADA pela base do creme ser constituída por 3,0kg de álcool cetoestearilico; 0,70kg de álcool cetoestearilico etoxilado 20 eo; 0,50kg de lanolina; 0,10kg de propilenoglicol; 0,70kg de parafina; 0,70kg de vaselina sólida; 4,3kg de óleo mineral; 20g de metilparabeno; 15g propilparabeno; para uma quantidade de 10kg.Pharmaceutical composition according to claims 1, 2, 3 and 4, CHARACTERIZED by the fact that the base of the cream consists of 3.0 kg of ceto-stearyl alcohol; 0.70kg of ethoxylated ceto-stearyl alcohol 20 oil; 0.50kg of lanolin; 0.10 kg of propylene glycol; 0.70kg of paraffin; 0.70kg of solid petroleum jelly; 4.3 kg of mineral oil; 20g of methylparaben; 15g propylparaben; for a quantity of 10kg. 6. Processo de preparação de composição farmacêutica conforme definido nas reivindicações 1 e 5, CARACTERIZADO por compreender as seguintes etapas:6. Pharmaceutical composition preparation process as defined in claims 1 and 5, CHARACTERIZED by comprising the following steps: Pesar 30% da base de creme e 0,5 de álcool cetoestearilico, 0,2% de metilparabeno e 0,2 % de propilparabeno e fundir em banho-maria;Weigh 30% of the cream base and 0.5 of ceto-stearyl alcohol, 0.2% of methylparaben and 0.2% of propylparaben and melt in a water bath; - Pesar a água deionizada e aquecer a 60°C;- Weigh the deionized water and heat to 60 ° C; - Pesar o sulfato de zinco e dissolvê-lo em pequena parte da água quente;- Weigh the zinc sulfate and dissolve it in a small part of the hot water; Pesar o salicilato de sódio na concentração desejada e dissolvê-lo em toda água quente restante;Weigh the sodium salicylate in the desired concentration and dissolve it in any remaining hot water; - Juntar 4 em 1, com agitação constante;- Add 4 in 1, with constant agitation; - Juntar 3em 5, agitando até dar consistência;- Add 3 in 5, stirring until consistency; 2/22/2 - Envasar.- Filling. 7. Processo de preparação de composição farmacêutica conforme definido nas reivindicações 2 e 5, CARACTERIZADO por compreender as seguintes etapas:7. Pharmaceutical composition preparation process as defined in claims 2 and 5, characterized by comprising the following steps: Pesar 20% da base de creme, acrescentar os conservantes metilparabeno a 0,2% e propilparabeno a 0,15 % e fundir em banho-maria;Weigh 20% of the cream base, add the preservatives 0.2% methylparaben and 0.15% propylparaben and melt in a water bath; - Pesar a água deionizada e aquecer a 60°C, separando uma pequena parte para dissolução dos sais de princípios ativos;- Weigh the deionized water and heat to 60 ° C, separating a small part to dissolve the salts of active ingredients; ' - ’Pesar a sulfadiazina de prata a 1% e solubilizá-la em água;'- ’Weigh the 1% silver sulfadiazine and solubilize it in water; - Misturar 1, 2 e 3;- Mix 1, 2 and 3; - Pesar o sulfato de zinco, (se monihidratado, usar a 0,06%; se heptahidratado, usar 1%) e dissolvê-lo em água;- Weigh the zinc sulfate, (if monohydrate, use at 0.06%; if heptahydrate, use 1%) and dissolve it in water; - Acrescentar 5 e misturar até dar consistência;- Add 5 and mix until consistent; - Envasar.- Filling. 8. Processo de preparação de composição farmacêutica conforme definido nas reivindicações 3 e 5, CARACTERIZADO por compreenderas seguintes etapas:8. Pharmaceutical composition preparation process as defined in claims 3 and 5, CHARACTERIZED by comprising the following steps: Pesar To weight 30% da base de creme e 30% of the cream base and 0,5 de 0.5 of álcool alcohol cetoestearílico, keto-stearyl, 0,2% de metilparabeno 0.2% methylparaben e 0,15 and 0.15 % de % in propilparabeno. propylparaben. Fundir em banho-maria; Cast in a water bath; - Pesar a - Weigh the água deionizada e aquecer deionized water and heat a 60°C, at 60 ° C, separar to separate
uma pequena porção para dissolução da sulfadiazina de prata;a small portion for dissolving silver sulfadiazine; - Pesar a sulfadiazina de prata a 1% e dissolvê-la na água;- Weigh 1% silver sulfadiazine and dissolve it in water; Pesar o salicilato de sódio na concentração desejada e acrescentá-lo em toda água aquecida, agitando até a completa dissolução do sal;Weigh the sodium salicylate in the desired concentration and add it to all the heated water, stirring until the complete dissolution of the salt; . - Acrescentar 1 em 4;. - Add 1 in 4; - Acrescentar 3 em 5 e misturar até dar consistência;- Add 3 in 5 and mix until consistent; - Envasar.- Filling.
BRPI1104620A 2011-09-09 2011-09-09 pharmaceutical composition for the treatment of burns and skin lesions and their preparation process BRPI1104620B1 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
BRPI1104620A BRPI1104620B1 (en) 2011-09-09 2011-09-09 pharmaceutical composition for the treatment of burns and skin lesions and their preparation process
PCT/BR2012/000331 WO2013033797A1 (en) 2011-09-09 2012-09-05 Pharmaceutical composition for treatment of burns and injuries of the skin and its preparation process

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
BRPI1104620A BRPI1104620B1 (en) 2011-09-09 2011-09-09 pharmaceutical composition for the treatment of burns and skin lesions and their preparation process

Publications (2)

Publication Number Publication Date
BRPI1104620A2 BRPI1104620A2 (en) 2013-08-13
BRPI1104620B1 true BRPI1104620B1 (en) 2020-04-07

Family

ID=47831381

Family Applications (1)

Application Number Title Priority Date Filing Date
BRPI1104620A BRPI1104620B1 (en) 2011-09-09 2011-09-09 pharmaceutical composition for the treatment of burns and skin lesions and their preparation process

Country Status (2)

Country Link
BR (1) BRPI1104620B1 (en)
WO (1) WO2013033797A1 (en)

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
PH10639A (en) * 1967-07-17 1977-07-22 Research Corp Method of treatment and composition containing silver sulfadiazine
US3761590A (en) * 1970-05-18 1973-09-25 Research Corp Silver sulfadiazine used in the treatment of burns
DE3828044A1 (en) * 1988-01-29 1989-08-10 Minninger Konrad SILVER-SULFADIAZIN-CONTAINING MEANS FOR THE LOCAL EXTERNAL THERAPY OF HERPES LABIALIS, HERPES GENITALIS, HERPES CORPORIS, ZOSTERS (HERPES ZOSTER, WINCH POAKS AND EKZEMA HERPETICATUM AND BURNS 11TH AND 111TH DEGREES IN THE FIELD OF HUMAN MEDICINE

Also Published As

Publication number Publication date
WO2013033797A1 (en) 2013-03-14
BRPI1104620A2 (en) 2013-08-13

Similar Documents

Publication Publication Date Title
Davis et al. Wound healing. Oral and topical activity of Aloe vera
ES2664951T3 (en) Compositions comprising low viscosity glycosaminoglycans and use of said composition in chronic cystitis therapy
WO2008014685A1 (en) Formulation containing trehalose for intraarticular injection
BR122021011439B1 (en) Bisphosphocine gel formulation and uses
US20200085863A1 (en) Pharmaceutical formula for the treatment and/or prevention of arthritis and its manufacture
KR0163563B1 (en) Topical drug in combination for treatment of skin lesions
BRPI1006729B1 (en) MEDICINAL CREAM OF FUSIDIC ACID PREPARED USING SODIUM FUSIDATE AND INCORPORATED WITH A BIOPOLYMER AND ITS PREPARATION PROCESS
CN105854021A (en) External-use drug and preparation with analgesic and antibacterial effect and preparation method thereof
JP6541124B2 (en) Topical drug for diffuse neurofibroma
BRPI1104620B1 (en) pharmaceutical composition for the treatment of burns and skin lesions and their preparation process
RU2367469C2 (en) Antibacterial and necrolytic local lisoamidase pharmaceutical composition
EP1663195B1 (en) Taurine bromamine for inhibiting pathogenic bacteria and fungi growth as well as in a microbicidal composition
RU2367456C2 (en) Antibacterial and necrolytic local pharmaceutical composition
WO2007099559A2 (en) Method of preparation for novel composition of 2-{(2,6 dichlorophenyl) amino] benzeneacetic acid carboxymethyl ester or 2-[2-[2-(2,6-dichlorophenyl) amino] phenylacetoxyacetic acid and method of its use
US20150374775A1 (en) Topical nutraceutical composition
JPS62155214A (en) Antiinflammatory drug and method
RU2682454C1 (en) Ointment for treatment of thermal burns and method for treatment thereof
BRPI0902144A2 (en) process for preparing a solid oral administration pharmaceutical composition containing the active ingredients glycosamine and meloxicam and use of the association between glycosamine and meloxicam
RU2711643C1 (en) Antimicrobial and wound healing dosage form (versions) and a method for production thereof
RU2173155C1 (en) Wound-healing, anti-inflammatory and anti-infectious medicinal preparation
RU2367457C2 (en) Antibacterial and necrolytic external and local lisoamidase pharmaceutical composition
RU2560698C1 (en) Topical agent for acne
RU2164133C2 (en) Composition for wound and burn treatment
ES2402289B1 (en) PHARMACEUTICAL COMPOSITION FOR THE TREATMENT OF TENDINITIS AND / OR CALCIFIED BURSITIS.   
RU2295953C2 (en) Hydrophilic and hydrophobic compositions for treatment infectious or viral diseases and method for their using

Legal Events

Date Code Title Description
B03A Publication of a patent application or of a certificate of addition of invention [chapter 3.1 patent gazette]
B07D Technical examination (opinion) related to article 229 of industrial property law [chapter 7.4 patent gazette]
B06F Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]
B07E Notification of approval relating to section 229 industrial property law [chapter 7.5 patent gazette]
B07A Application suspended after technical examination (opinion) [chapter 7.1 patent gazette]
B09A Decision: intention to grant [chapter 9.1 patent gazette]
B16A Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]

Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 09/09/2011, OBSERVADAS AS CONDICOES LEGAIS.

B21F Lapse acc. art. 78, item iv - on non-payment of the annual fees in time

Free format text: REFERENTE A 11A ANUIDADE.

B21H Decision of lapse of a patent or of a certificate of addition of invention cancelled [chapter 21.8 patent gazette]

Free format text: ANULADA A PUBLICACAO CODIGO 21.6 NA RPI NO 2687 DE 05/07/2022 POR TER SIDO INDEVIDA.