Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Patent
1990-08-17
1993-10-19
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
424434, 424448, A61F 1300
Patent
active
052543463
DESCRIPTION:
BRIEF SUMMARY
This invention relates to an occlusive body (such as a patch, pad or bandage for example) for the transdermal administration of a physiologically active substance (by attachment to the skin or a buccal membrane for example) at a controlled rate over an extended period. In U.S. Pat. No 3,598,122 (Zaffaroni) there was disclosed a bandage for use in the continuous administration of systemically active drugs by absorption through the skin or oral mucosa.
U.S. Pat. No. 3,598,122 disclosed a broad range of systemically active drugs which could be employed, and indicated that any systemically active drug which is absorbed by the body surface beneath the bandage could be employed. The substances disclosed as being suitable for incorporation in the bandage included antimicrobial agents such as penicillin, tetracycline, oxytetracycline, chlortetracycline, chloramphenicol, and sulfonamides; Sedatives and Hypnotics such as pentabarbital sodium, phenobarbital, secobarbital sodium, codeine, (.alpha. bromoisoaleryl) urea, carbromal, and sodium phenobarbital; Psychic Energizers such as 3-(2-aminoprophyl) indole acetate and 3-(2-aminobutyl) indole acetate; Tranquilizers such as reserpine, chlorpromazine hydrochloride, and thiopropazate hydrochloride; Hormones such as adreno-corticosteroids, for example, 6-methyl-prednisolone, cortisone, cortisol, and triamcinolone; androgenic steroids, for example, methyltestosterone, and fluoxymesterone, estrogenic steroids, for example, estrone, 17.beta.-estradiol and ethinyl estradiol; progestational steroids, for example 17-hydroxyprogesterone acetate, medroxyprogesterone acetate, 19-norprogesterone, and norethindrone; and thyroxine; Antipyretics such as aspirin, salicylamide, and sodium salicylate; Antispasmodics such as atropine, methscopolamine bromide, methscopolamine bromide with phenobarbital; Antimalarials such as the 4-aminoquinolines, 8-aminoquinolines, and pyrimethamine; and Nutritional agents such as vitamins, essential amino acids, and essential fats.
The bandage comprised a backing member having on one surface thereof a reservoir containing a systemically active drug. The reservoir had a wall distant from the backing member and permeable to the passage of the drug. A pressure-sensitive adhesive layer, also permeable to passage of the drug, was carried by the reservoir. The drug was in a form acceptable for absorption through the skin or the mucosa of the mouth. It was explained that the percutaneous rather than oral route enabled continuous administration of the drug over a period of time, and for this purpose fibrous masses and fabrics that merely absorbed and released drug solutions in a gross and uncontrollable manner were to be avoided.
It was indicated that the percutaneous route had the advantage over the oral route of drug administration that uncertainties in the rate of dosage through the gastrointestinal tract (depending on the amount and type of food eaten, for example) were avoided. Also, charge peaks in the drug concentration in the bloodstream were thereby avoided.
The materials used to form the reservoir could also form the membrane, and suitable materials included organopolysiloxane rubbers, hydrophilic polymers of monoesters of an olefinic acid such as acrylic acid and methacrylic acid, polyvinylalcohol, polyvinylacetate, plasticised nylon, collagen, modified collagen, gelatin, and waxes such as polyethylene wax. An exemplary bandage contained megesterol acetate powder within a reservoir of dimethyl silicone rubber, which was stated to be effective over a 24 hour period. No liquid was present within the reservoir.
However U.S. Pat. No. 3,598,122 did indicate that drugs which in isolation do not pass through the skin could be dissolved in absorbable pharmacologically acceptable solvents such as C.sub.2 to C.sub.10 alcohols, C.sub.5 to C.sub.12 hydrocarbons, C.sub.4 to C.sub.10 aldehydes and ketones, C.sub.4 to CF.sub.10 esters, ethereal oils, halogenated hydrocarbons and mixtures of the above.
Furthermore, U.S. Pat. No. 3,598,122 taught that by varying the c
REFERENCES:
patent: 3598122 (1971-08-01), Zaffaroni
patent: 4067961 (1978-01-01), Laughlin
patent: 4597961 (1986-07-01), Etscorn
patent: 4725272 (1988-02-01), Gale
patent: 4752478 (1988-06-01), Bondi
patent: 4756710 (1988-07-01), Bondi
patent: 4764382 (1988-08-01), Kydonieus
O'Neill et al. Development and evaluation using hairless mouse skin of a transdermal timolol product, Int. J. Pharmaceutics, 48 pp. 247-254, 1988.
Tucker Mark J.
Tucker Mark R.
Page Thurman K.
Phelan D. Gabrielle
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