Formula
Rp.
Benzoylis peroxydum cum aqua 5.00 g
Acetonum / Aether 2.00 g
Propylenglycolum 5.00 g
Carbomeri mucilago 88.00 g
Ingredients in the formula
Anhydrous benzoyl peroxide- Benzoylis peroxidum- Peroxyde de benzoyle-Benzoylis peroxydum cum aqua- DibenzoylperoxidHydrous benzoyl peroxide USP contains approximately 70% benzoyl peroxide; the remaining 30% is water added to reduce flammability and shock sensitivity. The British Pharmacopoeia (BP) and European Pharmacopoeia (Ph.Eur.) state that hydrous benzoyl peroxide (benzoylis peroxidum cum aqua) should contain between 70-77% anhydrous benzoyl peroxide and not less than 20% water. Hydrous benzoyl peroxide can explode at temperatures above 60°C and ignite in the presence of reducing agents. It should be stored in its original packaging treated to minimize static electrical charges. It is used as a topical antibacterial agent at concentrations between 5-10%. It is a white granular powder with a characteristic odor, freely soluble in water and ethanol. It is used in the treatment of mild to moderate acne cases. It also has a mild keratolytic effect. Benzoyl peroxide exhibits an antibacterial effect. Its antibacterial effect is especially pronounced against the dominant microorganism found in sebaceous follicles and comedones,Propionibacterium acnes.StaphIt is also effective against Staphylococcus epidermidis. It also exhibits a drying, mildly desquamating, and keratolytic effect that helps remove excess sebum. Benzoyl peroxide is applied topically. Conductedin vitroexperiments andin vivoAnimal studies show that following topical application, a portion of benzoyl peroxide is absorbed, and after being metabolized to benzoic acid in the skin, the absorbed drug is rapidly excreted via urine. Benzoyl peroxide rapidly loses water upon exposure to air and may explode when its water content is insufficient. The hydrous form is a white, amorphous or granular powder with a characteristic odor. It is practically insoluble or very slightly soluble in water; slightly soluble in alcohol; soluble in acetone, chloroform, and ether; and soluble in methylene chloride with separation of water. CAUTION! Benzoyl peroxide is a substance capable of exploding due to grinding, severe impact, or heat. Hydrous benzoyl peroxide, which poses a lower explosion risk, can also explode at temperatures above 60°C or catch fire in the presence of reducing agents. Benzoyl peroxide should be stored at 2-8°C in containers equipped to prevent static electricity hazards and capable of releasing excess pressure. Benzoyl peroxide removed from its container but not used should not be returned to its original container; it should be disposed of by adding a 10% sodium hydroxide solution. It must be protected from light.Aetheris – Ether – Diethyl etherIt is a clear, colorless, volatile, highly flammable, and very mobile liquid with a characteristic odor. Its boiling point is 34-35°C. It is soluble in water at a ratio between 1:12 and 1:15; miscible with alcohol, chloroform, methylene chloride, petroleum ether, fixed oils, and volatile oils. Ether is the first general anesthetic agent used to prepare patients for surgical procedures. It is used as a solvent in the formula.Propylene glycol – Methylethylene glycol – Methyl glycol – Propylene glycolIt is an excipient used for various purposes in pharmaceutical preparations. It is used as a vehicle for cosmetic products. Due to its moisturizing properties, it is used instead of glycerin in topical moisturizing preparations. Propylene glycol may cause local irritation on skin and mucous membranes. It is miscible with water, acetone, alcohol, and chloroform; soluble in ether; immiscible with fixed oils, but sometimes dissolves essential oils. It should be stored in a cool place and in airtight containers. It must be protected from light and moisture.CARBOMERI MUCILAGO – HIDROFILNI GEL KARBOMERAIf we examine the vehicle / base formula included in the formulation;Carbomera 0.50 g – 1.00 g
Propylenglycolum 10.00 g
Triethanolamini solutio 10% 7.00 g – 14.00 g
(Or Natriihydroxydi solutio 10% or Trometamoli solutio 10%)
Aqua puricata a.d. 100 g
Ingredients in the base formula;
Carbopol- Polyacrylic acid- Acidum polyacrylicum- Carbopol- Polyacrylic acid-CarbomerCarbomers are synthetic, white, lightweight, acidic hygroscopic polymers with a faint characteristic odor and high molecular weight. The molecular weight of Carbomer 941 is approximately 1,000,000; it dissolves in water and, following neutralization, in glycerin and 95% ethanol. When working with these gels, care must be taken to prevent air entrapment within the product. These gels should be protected from light; their high alcohol content is sufficient to act as a preservative.
It is a white, soft, hygroscopic powder with a faint characteristic odor. Following neutralization with alkali hydroxides or alkali amines, it dissolves in water, alcohol, and glycerol. The pH of its 1% aqueous dispersion is approximately 3. Carbomer is a high-molecular-weight crosslinked synthetic acrylic acid polymer. Carbomer has a viscosity that does not disrupt optical parameters and is used to compensate for tear deficiency in dry eye syndrome (keratitis sicca), keratoconjunctivitis sicca, exophthalmos, lagophthalmos, and other pathological conditions causing insufficient or impaired lubrication of the ocular surface. Due to its high molecular weight, minimal systemic absorption ensures safe use. Carbomer should be stored in tightly closed, airtight containers.Trolamine- Trolamina- TrolaminumIt is a colorless, viscous organic compound of strong basic character. It is included in formulations as an emulsifier and surfactant. It may cause contact allergies. In addition to being used as a balancer in cosmetic products with very diverse pH values, it is particularly preferred for makeup removal in cleansing creams and cleansing milks, as well as in skin lotions, gels, shampoos, and shaving foams. A 1% solution has an approximate pH value.Preparation of the baseCarbomer is mixed with a quantity of boiled and cooled distilled water and left to swell. With the remaining water, propylene glycol and triethanolamine are added and mixed slowly to complete the dispersion.Preparation of the formulaBenzoyl peroxide (hydrous) is mixed with acetone or ether. Propylene glycol is added. Finally, the previously prepared gel is added to complete the preparation.
The formula should be stored in well-closed containers, preferably in aluminum tubes, protected from heat (25°C) and light. Apply to clean skin once or twice daily.
The formula is used for its antiseptic, exfoliant (widespread redness and scaling due to an existing skin disease, medications, malignancy, or unknown causes), and antimycotic effects.
Wishing you a good week…
Source: Farmaceutsko drustvo Srbije
Spec. Pharm. Ahmet Nezihi Pekcan
Pekcan Pharmacy – Konya
[email protected]
Tel: (332) 3520657http://www.majistralformul.com/
