Antiseptic / Antipruritic phenolated petrolatum ointmentDear colleagues, this week we will examine a formula with antiseptic properties that is effective in the treatment of itching.Formula;
Rp.
Phenolum 2 g
Glycerolum 2 g
Vaselinum 96 g
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Ingredients in the formula;
Phenic acid- Phenyl alcohol- Carbolic acid- Acid carbolique- Phenolum [Ph. Eur. 3];Phenol occurs as colorless, faint pink, or pale yellow, hygroscopic, needle-like crystals or crystalline masses with a characteristic odor that darken on standing. The United States Pharmacopeia (USP) permits the addition of a suitable stabilizing agent. Its freezing point is approximately 39.5°C. According to the British Pharmacopoeia (BP): Soluble in water; freely soluble in alcohol, dichloromethane, and glycerol. According to the United States Pharmacopeia (USP): Soluble 1 in 15 of water, 1 in 70 of liquid paraffin; freely soluble in alcohol, chloroform, ether, glycerol, and volatile oils. A solution of 1 g of phenol in water is clear and neutral or acidic to litmus. It is incompatible with alkaline salts and nonionic surfactants. Oily phenol injection (BP 1993) and phenol-glycerol injection can be sterilized by heating at 170°C for 1 hour. Phenol should not be added as a preservative to lyophilized preparations.
Phenol is one of the oldest antiseptic-disinfectants. Nowadays, it is rarely used as an antiseptic. It also exhibits local anesthetic and analgesic effects. It is incorporated into the formulation of preparations used as topical analgesics for toothache. In combination with benzocaine and ethanol, it is applied topically for toothache, aphthous ulcer (not found safe alone in the treatment of aphthous ulcers), herpes labialis, minor dental surgical procedures, and minor abrasions and irritations caused by dentures and fillings on the mouth and gums. Its 0.5%–1% solutions are used as an antipruritic against itching. Camphorated phenol is a local anesthetic preparation containing phenol, camphor, and liquid paraffin, and is used for toothache. Phenol, in combination with camphor, is effective against mild pain and itching associated with insect bites, minor burns including sunburn, minor skin abrasions, and other skin irritations. Low-concentration solutions are also used for topical disinfection. A 5% solution has been used for the disinfection of body secretions. Oily phenol solutions (Oily Phenol Injection, BP 1993) are used as an analgesic sclerosing agent for the treatment of internal hemorrhoids. For this purpose, it is injected into the submucosal tissue around internal hemorrhoids. Its aqueous solutions are utilized as sclerosing agents in the treatment of hydrocele. Phenol has been used as a neurolytic agent in 3%–4% solutions.
CAUTION! Phenol is a severely corrosive poison internally. It should never be ingested. It can be absorbed through the skin or mucous membranes and cause systemic toxicity. In this regard, appropriate precautions must be taken to prevent its absorption. Absorption of phenol vapors through the skin and lungs can also cause systemic toxicity.
It exhibits antiseptic and disinfectant activity against Gram-positive and Gram-negative bacteria, mycobacteria, and certain fungi. Its action against spores is very slow and inadequate. It is also effective against certain viruses. Its activity increases in acidic solutions. Aqueous solutions up to 1% concentration are bacteriostatic, while more concentrated solutions exhibit bactericidal effects. Phenol exerts its effect by increasing the permeability of the cytoplasmic membrane of bacteria and fungi.
Phenol is applied topically only. It is absorbed from the gastrointestinal tract, skin, and mucous membranes. It is metabolized to phenyl glucuronide and phenyl sulfate. In small amounts, it is oxidized to catechol and quinol. Most of the formed quinol is in conjugated form. Its metabolites are eliminated in the urine. Due to the oxidation of quinones, it may impart a light green color to the urine.Glycerin 98%- Glycerol [ASK; BP; DCF; FP; INN; P.Cx.79; Ph.Eur.]- Glycerol [ASK; BP; DCF; FP; INN; P.Cx.79; Ph.Eur.]- Wasserfreies Glycerol;Glycerin is an excipient widely used for various purposes in pharmaceutical formulations and cosmetic products. It is used in oral, otic, ophthalmic, topical, and parenteral pharmaceutical formulations. While it is used for its moisturizing and emollient effects in topical pharmaceutical formulations, it is mostly useful as a solvent in parenteral formulations. In oral formulations, it is used as an antimicrobial preservative, sweetener, and viscosity-increasing agent. It is a plasticizer for gelatin in soft gelatin capsules. It is also included in the composition of gelatin suppositories. Glycerin is a clear, colorless, sweet, hygroscopic, viscous liquid. It is miscible with water and alcohol; sparingly soluble in acetone; practically insoluble in chloroform, ether, fixed oils, and volatile oils. Its aqueous solutions give a neutral reaction to litmus. According to the United States Pharmacopeia (USP), the pH of Glycerin Oral Solution, USP is between 5.5 and 7.5.
Glycerin acquires explosive properties when combined with strong oxidizing agents such as potassium permanganate. Such mixtures must be strictly avoided. In the presence of light, it turns black when it comes into contact with zinc oxide or basic bismuth nitrate. When iron-contaminated glycerin is used, mixtures containing phenol, salicylate, and tannin darken in color. It complexes with boric acid to form glyceroboric acid. The acidity of this compound is higher than that of boric acid.White petrolatum- White vaseline- Officinal vaseline- Paraffin, soft, white [BP; P.Cx.79]- Petrolatum, white [NF; USP]- Vaselin, weisses [PH; Ph.Eur.];Petrolatum (Vaseline) is used for the treatment of skin irritations and skin care. Specially processed petrolatum-containing preparations are also used for wound care and wound dressings. Petrolatum is an oily substance that exerts a soothing effect by softening the skin, smoothes its surface, and is effective against disorders causing dryness or flaking. It has a moisturizing effect on the skin, thereby helping to revitalize it. Petrolatum (white soft paraffin) is obtained by bleaching yellow soft paraffin. According to the United States Pharmacopeia (USP), a suitable stabilizer may be added to its composition.
Petrolatum is incorporated into topical pharmaceutical preparations as an emollient ointment base. It is not easily absorbed through the skin. It is also used in creams, transdermal preparations, and cosmetic products. Hypersensitivity reactions associated with its topical use have been reported. Polycyclic aromatic hydrocarbon impurities it contains may cause allergic reactions. The amount of these impurities depends on the source of the petrolatum and its degree of purification. Hypersensitivity reactions caused by white petrolatum are less frequent than those caused by yellow petrolatum. For this reason, white petrolatum is preferred in cosmetic products and pharmaceutical preparations.
Yellow petrolatum is obtained from petroleum. It is a purified mixture of semi-solid saturated hydrocarbons with the general formula CnH2n+2. Yellow petrolatum is a pale yellow or yellow, translucent, soft-consistency mass. It is odorless and tasteless. It is practically insoluble in acetone, alcohol, glycerin, and water; soluble in benzene, carbon disulfide, chloroform, ether, hexane, and many fixed and volatile oils. The United States Pharmacopeia (USP) permits the addition of a suitable stabilizer to its composition. It should be stored in well-closed containers in a dry, cool place and protected from light. Petrolatum is quite a stable substance; however, it may cause stability issues due to trace amounts of impurities it carries. These impurities can oxidize under the influence of light, causing discoloration and resulting in undesirable odors. Such oxidation can be prevented by the addition of an antioxidant such as butylated hydroxyanisole, butylated hydroxytoluene, or alpha-tocopherol. It should not be heated for prolonged periods above the temperature required to render it completely fluid (approximately 70°C).Preparation of the formula:Phenol is dissolved in glycerin and mixed with petrolatum by geometric dilution.
Wishing you a good week…
Source:
1- TEB Formulary
2- RxMediaPharma®2017 Interactive Drug Information Source
Spec. Pharm. Ahmet Nezihi Pekcan
Pekcan Pharmacy – Konya
[email protected]
Tel: (332) 3520657http://www.majistralformul.com/
