Dermal preparations containers

Photoexposure of unprotected skin after the administration of dermal preparations containing corticosteroids or antimycotics may cause photodegradation of the... 

Liquid preparations intended for dermal application contain the largest variety of cosolvents. They most commonly include ethanol, isopropanol, propylene glycol, glycerin, and PEG 400. Irritation and sensitization are important considerations in choosing a cosolvent for dermal use. In addition, it may be necessary to... 

Recent stndies on hnman volnnteers demonstrated that CyDs have a significant safety margin in dermal application. Optimized release of the drng from the topical preparation containing its CyD complex may be obtained by... 

Liquid preparations for cutaneous application are described as preparations with variable viscosity intended for local or transdermal application. This category comprises solutions, emulsions and suspensions for dermal use containing rnie or more active substances in a suitable base. As examples for liquid preparations shampoos and cutaneous foams are defined in Ph. Eur. 

Sterile cutaneous preparations undergo sterilisation in the final container if possible. Many active substances, base preparations and package materials for cutaneous preparations however are not resistant to the common sterilisation methods, see also Sect. 30.8. If sterilisation in the final container is not possible, cutaneous dermal preparations should be prepared aseptically and packaged in sterile packaging materials, see Chaps. 30 and 31. On the label of sterile cutaneous preparations the word sterile has to be mentioned. After opening, these preparations can only be stored for 24 h. 

Cyclodienes. These are polychlorinated cycHc hydrocarbons with endomethylene-bridged stmctures, prepared by the Diels-Alder diene reaction. The development of these insecticides resulted from the discovery in 1945 of chlordane, the chlorinated adduct of hexachlorocyclopentadiene and cyclopentadiene (qv). The addition of two Cl atoms across the double bond of the ftve-membered ring forms the two isomers of chlordane [12789-03-6] or l,2,4,5,6,7,8,8-octachloro-2,3,3t ,4,7,7t -hexahydro-4,7-methano-lJT-indene, QL-trans (mp 106.5°C) and pt-tis (32) (mp 104.5°C). The p-isomerhas signiftcantiy greater insecticidal activity. Technical chlordane is an amber Hquid (bp 175°C/267 Pa, vp 1.3 mPa at 25°C) which is soluble in water to about 9 fig/L. It has rat LD qS of 335, 430 (oral) and 840, 690 (dermal) mg/kg. Technical chlordane contains about 60% of the isomers and 10—20% of heptachlor. It has been used extensively as a soil insecticide for termite control and as a household insecticide. 

There are few studies that specifically describe the effects of heptachlor or heptachlor epoxide in humans following exposure via the oral, inhalation, or dermal routes. There are data on the health effects of chlordane from occupational studies of pesticide applicators and manufacturers, and from studies of people who consumed food contaminated with chlordane and heptachlor. Chlordane is a pesticide that is structurally similar to heptachlor, and technical-grade preparations may contain... 

Fruit compresses have been applied to the face as beauty aids for millennia. The alpha-hydroxy acids contained in fruit extracts, tartaric acid in grapes, citric acid in citrus fruits, malic acid in apples, mandelic acid in almond blossoms and apricots are thought to be active principles for skin rejuvenation. Such alpha-hydroxy acids do stimulate HA production in cultured dermal fibroblasts (unpubl. exp.). The results of such alkaline preparations may depend more on their peeling effects rather than on the ability of alpha-hydroxy acids to stimulate HA deposition. 

Preparations that are applied topically to the mouth and throat have contained glycerin, ethanol, propylene glycol, and PEG. Both systemic and local toxic effects would need to be considered in choosing a solvent system for these preparations. Table 6 contains a list of dermal and topical mouth and throat products that contain cosolvents. 

Formalin designation herein means that the study either involved direct exposure fo formalin ( 40% aqueous solution of formaldehyde containing 10-15% methanol as a stabilizing agent) or used such a solution as a stock for the preparation of dermally administered material. Percent in table refers to percent formaldehyde. 

Bacitracin is available in ophthalmic and dermatologic ointments the antibiotic also is available as a powder for the preparation of topical solutions. The ointments are applied directly to the involved surface one or more times daily. A number of topical preparations of bacitracin, to which neomycin or polymyxin or both have been added, are available, and some contain the three antibiotics plus hydrocortisone. For open infections such as infected eczema and infected dermal ulcers, the local application of the antibiotic may be of some help in eradicating sensitive bacteria. Bacitracin rarely produces hypersensitivity. Suppurative conjunctivitis and infected comeal ulcer respond well to the topical use of bacitracin when caused by susceptible bacteria. Bacitracin has been used with limited success for eradication of nasal carriage of staphylococci. Oral bacitracin has been used with some success for the treatment of antibiotic-associated diarrhea caused by C. difficile. Serious nephrotoxicity results from the parenteral use of bacitracin. Hypersensitivity reactions rarely result from topical application. 

With emphasis on safety evaluation applications, the use of radiotracers in rat and mouse dermal absorption studies are discussed. A multi-tiered experimental strategy is proposed containing judgement points providing akin absorption, tissue depletion and animal excretion rates in a cost effective manner. Techniques described include occlusive and non-occlusive treatments, sample preparations and data collection. Typical data is shown for herbicides and insecticides. 

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