Ointment sterile

Blister/vesicant exposure is treated primarily as a thermal burn. Sulfur mustard decontamination is limited to immediate washing of exposed skin with water or soap and water, and flushing the eyes with copious amounts of water. Avoid 0.5% sodium hypochlorite solution or vigorous scrubbing as they may cause deeper tissue penetration. Typical burn therapy is accomplished with antibiotic ointment, sterile dressing, and other supportive... 

Ophthalmic Dosage Forms. Ophthalmic preparations can be solutions, eg, eye drops, eyewashes, ointments, or aqueous suspensions (30). They must be sterile and any suspended dmg particles must be of a very fine particle size. Solutions must be particle free and isotonic with tears. Thus, the osmotic pressure must equal that of normal saline (0.9% sodium chloride) solution. Hypotonic solutions are adjusted to be isotonic by addition of calculated amounts of tonicity adjusters, eg, sodium chloride, boric acid, or sodium nitrate. 

Ophthalmic ointments usually contain petrolatum as the base. The petrolatum is sterilized by dry heat and combined with the sterile dmg powder under aseptic conditions. Ophthalmic suspensions contain very fine (- 10 ji) particle sized soHds suspended in an aqueous vehicle. The vehicle is adjusted to isotonicity and viscosity-increasing excipients, chelating agents, and surfactants also may be needed. The aqueous vehicle in these cases is generally autoclaved and mixed with sterile dmg powder asceptically (30). 

After the tape mask removal the exudate is cleaned by sterile saline. Spot peeling and retaping may be done if the skin looks underpeeled, particularly in areas with severe wrinkling. It is usually accompanied by a short-duration burning sensation. The tape is left for an additional 4-6 h and then removed by the patient. We cover the face with bismuth subgalate antiseptic powder for 7 days (Fig. 8.10). Other options include occlusive moisturizers, antibiotic ointments, and biosynthetic occlusive dressings such as Meshed Omiderm. 

Eye preparations—These are specifically intended for administration to the eye in the form of solutions, lotions, or ointments. All preparations must be sterile. 

Eye ointments are prepared in a semi-sohd base (e.g. Simple Eye Ointment BP, which consists of yellow soft paraffin, eight parts hqnid paraffin, one part wool fat, one part). The base is filtered when molten to remove particles and sterilized at 160°C for 2 hours. The drug is incorporated prior to sterilization if heat stable, or added aseptically to the sterile base. Finally, the prodnct is aseptically packed in clear sterile alumirtinm or plastic tnbes. Since the prodnct contains virtnally no water, the danger of bacteria proliferating in the ointment is neghgible. Therefore, there is no recommended maximum period during which they can be nsed. 

Because of these product sensitivities, most ophthalmic pharmaceutical products are aseptically manufactured and filled into previously sterilized containers in aseptic environments using aseptic filling-and-capping techniques. This is the case for ophthalmic solutions, suspensions, and ointments, and specialized technology is involved in their manufacture. 

When an ophthalmic ointment is manufactured, all raw material components must be rendered sterile before compounding unless the ointment contains an aqueous fraction that can be sterilized by heat, filtration, or ionizing radiation. The ointment base is sterilized by heat and appropriately filtered while molten to remove extraneous foreign particulate matter. It is then placed into a sterile steam-jacketed kettle to maintain the ointment in a molten state under aseptic conditions, and the previously sterilized active ingredients) and excipients are added aseptically. While still molten, the entire ointment may be passed through a previously sterilized colloid mill for adequate dispersion of the insoluble components. 

Oils have been used as vehicles for several topical eyedrop products that are extremely sensitive to moisture. Tetracycline HC1 is an antibiotic that is stable for only a few days in aqueous solution. It is supplied as a 1% sterile suspension with Plastibase 50W and light liquid petrolatum. White petrolatum and its combination with liquid petrolatum to obtain a proper consistency is routinely used as the vehicle for ophthalmic ointments. 

The anhydrous petrolatum base may be made more miscible with water through the use of an anhydrous liquid lanolin derivative. Drugs can be incorporated into such a base in aqueous solution if desired. Poly-oxyl 40 stearate and polyethylene glycol 300 are used in an anti-infective ointment to solubilize the active principle in the base so that the ointment can be sterilized by aseptic filtration. The cosmetic-type bases, such as the oil-in-water (o/w) emulsion bases popular in dermatology, should not be used in the eye, nor should liquid emulsions, owing to the ocular irritation produced by the soaps and surfactants used to form the emulsion. 

The tube can be a source of metal particles and must be cleaned carefully before sterilization. The USP contains a test procedure and limits the level of metal particles in ophthalmic ointments. The total number of metal particles detected under 30 x magnification that are 50 pm or larger in any dimension is counted. The requirements are met if the total number of such particles counted in 10 tubes is not more than 50 and if not more than one tube is found to contain more than 8 such particles. 

Ophthalmic, nasal, and oral inhalation preparations Appearance, color, consistency, pH, clarity (solutions), particle size and resuspendibility (suspensions, ointments), strength, and sterility... 

The equipment needed is determined by the type and extent of the services chosen to provide. Hospitals already utilize laminar flow hoods for aseptic compounding of sterile solutions. The same hoods can be used to compound other sterile products such as eye drops. A balance, preferably electronic, is essential. Ointment slabs (pill tiles), along with spatulas of different types and materials, should be on hand. A few mortars and pestles (both of glass, ceramic, and/or plastic) should be obtained and some glassware. It may not be necessary to buy a roomful of equipment, but one should purchase what is needed to start the service, and build it up as the service grows and expands to different arenas. 

Antimicrobial preservatives are added to multiuse nonsterile liquids, ointments, and ereams, and sterile injectable products to protect them from microbial contamination that may be introduced inadvertently during use of the product (postmanufacturing). 

Ophthalmic ointments and solutions Sterility test, CCI, AET Test all batches on stability with the exception of the first three batches for AE 0, 12, 24, 36 months... 

A suitable negative product control for an aqueous product could be distilled water in a similar container. A negative product control for testing an ointment could be a container of liquid paraffin or ointment base that has been sterilized by dry heat pouring the liquid paraffin from a container would be adequate to simulate squeezing of ointment from a tube. 

Neomycin is available in numerous topical formulations, both alone and in combination with polymyxin, bacitracin, and other antibiotics. It is also available as a sterile powder for topical use. Gentamicin is available as an ointment or cream. 

Although ophthalmic drug products can be considered topical products, they have been grouped here with inject-ables because they are required to be sterile (21 CFR 200.50(a)(2)) and the descriptive, suitability, and quality control information is typically the same as that for an injectable drug product. Because ophthalmic drug products are applied to the eye, compatibility and safety should also address the container closure system s potential to form substances which irritate the eye or introduce particulate matter into the product (see USP <771> Ophthalmic Ointments). 

Urine is obtained using standard techniques including sterile midstream catch or catheterization. In infants, urine specimens obtained by placing a bag in the genitourinary region is undesirable due to contamination of glycerol from ointment and glycerin suppositories, unless the perineum is washed and rinsed well and no suppositories have been used recently [2, 5]. 

The patients of the second group were treated with Vishnevsky ointment, syn-thomycin emulsion, anaesthezine ointment and sterile vaseline. 

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