Topical products

The terms FD C, D C, and External D C (Ext. D C), which are part of the name of colorants, reflect the FDA s colorant certification. FD C dyes may be used for foods, dmgs, and cosmetics D C dyes are allowed in dmgs and cosmetics and Ext. D C dyes are permitted only in topical products. Straight colorants include both the organic dyes and corresponding lakes, made by extending the colorant on a substrate such as aluminum hydroxide or barium sulfate. The pure dye content of these lakes varies from 2 to 80% the organic dyes contain over 80% pure dye. Colorants certified for cosmetic use may not contain more than 0.002% of lead, not more than 0.0002% of arsenic, and not more than 0.003% of heavy metals other than lead and arsenic. 

Patients and nursing staff may use a range of applicators (pads, sponges, brushes, spatulas) during medicament administration, particularly for topical products. If reused, these easily become contaminated and may be responsible for perpetuating contamination between fresh stocks of product, as has indeed been shown in studies of cosmetic products. Disposable applicators or swabs should therefore always be used. 

Topical corticosteroids are typically reserved for patients who do not respond to topical mesalamine. Patients should be properly educated regarding appropriate use of topical products. This includes proper administration and adequate retention of topical mesalamine products in order to maximize efficacy. 

Oral or transdermal estrogen products should be prescribed at the lowest effective dose for the relief of vasomotor symptoms. Topical products in the form of creams, tablets, or rings should be prescribed for women exclusively experiencing vulvovaginal atrophy. 

Treatment with topical products is attractive to patients due to convenience, but they tend to be more expensive than... 

Theoretically, the risk of serious GI adverse events should be less than with oral NSAIDs, but long-term studies evaluating these events are lacking.38 Studies comparing topical NSAIDs with other topical products, including counterirritants, are also needed.35 Local cutaneous adverse reactions (e.g., erythema, pruritus, and irritation) occur in 1% to 2% of patients and may be due in part to the vehicle used.38... 

Rheology is the study of flow and deformation of materials under the influence of external forces. It involves the viscosity characteristics of powders, liquids, and semisolids. Rheological studies are also important in the industrial manufacture and applications of plastic materials, lubricating materials, coatings, inks, adhesives, and food products. Flow properties of pharmaceutical disperse systems can be of particular importance, especially for topical products. Such systems often exhibit rather complex rheological properties, and pharmaceutical scientists have conducted fundamental investigations in this area [58-64],... 

UVB light (290 to 320 nm) therapy is an important phototherapeutic intervention for psoriasis. The most effective wavelength is 310 to 315 nm, which led to development of a UVB narrowband light source, in which 83% of the UVB emission is at 310 to 313 nm. Topical and systemic psoriatic therapies are used adj unctively to hasten and improve the response to UVB phototherapy. Emollients enhance efficacy of UVB and can be applied just before treatments. Combining short-contact anthralin, calcipotriene, or topical retinoids to UVB may also improve results. However, topical application should be done after or at least 2 hours before UVB therapy because phototherapy can inactivate the topical product. UVB phototherapy may also be more effective when added to systemic treatments such as methotrexate and oral retinoids. 

Q37 Topical products used in hyperhidrosis may contain aluminium chloride as a (an) ... 

Q37 Topical products for removal of corns and calluses may contain sali-... 

Topical products for removal of corns and calluses often contain salicylic acid at a concentration of between 11% and 50% as a keratolytic agent in combination with lactic acid, the latter intended to aid absorption. 

To prevent interference with the adhesive properties of the patch, no topical products should be applied to the skin area where the patch is or will be placed. 

Oral agents are not as effective as topical products, especially on an immediate basis, but generally have a longer duration of action, cause less local irritation and are not associated with rebound congestion (rhinitis medicamentosa). 

Excessive use Do not exceed recommended dosage. If nervousness, dizziness, or sleeplessness occur, discontinue use and have the patient consult a physician. Do not take topical products for more than 3 days or oral products for more than 7 days. If symptoms do not improve or are accompanied by a fever, the patient should consult a physician. 

Medina, J., Elsaesser, C., Picarles, V., Grenet, O., Kolopp, M., Chibout, S.D. and De Brugerolle de Fraissinette, A. (2001) Assessment of the phototoxic potential of compounds and finished topical products using a human reconstructed epidermis. In Vitro ei Molecular Toxicology —A Journal of Basic and Applied Research, 14,157—168. 

Dosage-surface area relationships In general, about 2 g of a topical product is required to cover the scalp, face, or hand 3 g to cover an arm 4 g to cover a leg and 30 to 60 g to cover the entire body. 

Sorbitol has also been used in injectable and topical products, and has a therapeutic use as an osmotic laxative. 

Do not use topical products on weeping, denuded, or infected areas... 

Consider topical products if treatment is solely for vulvar or vaginal atrophy... 

Part ID Specific requirements for manufacture of topical products, i.e., external... 

Regulatory expectations for microbial bioburden for nonsterile pharmaceutical products are reviewed using the FDA guide to inspections of microbiological quality control laboratories [2], purified water systems [27], topical products [28], and oral solutions and suspensions [29]. 

In the guide to inspections of topical products [28], it is indicated that water deionizers are usually excellent breeding areas for microorganisms, where flow rates, temperature, surface area of resin beds, and microbial quality of the feed water all influence microbial growth. Since topical products (e.g., creams, ointments)... 

The physical characteristics, particularly the particle size of the drug substance, are very important for suspensions. As with topical products in which the drug is suspended, particles are usually very fine to micronized (to <25 microns). For syrup, elixir, or solution dosage forms in which there is nothing suspended, particle size and physical characteristics of raw materials are not that important. However, they can affect the rate of dissolution of such raw materials in the manufacturing process. Raw materials of a finer particle size may dissolve faster than those of a larger particle size when the product is compounded. 

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). 

Oral and topical products a-CD OP-1206 Oral Japan Opalmon ... 

In the pharmaceutical industry, ion-exchange resins are used for drug stabilization and as aids for tablet disintegration. Ion exchangers are also used for taste masking, for sustained-release products, as topical products for application to skin, and for ophthalmic or nasal delivery.4... 

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