Transdermal administration of a systemic active agent to a prema

Details Transdermal administration of a systemic active agent to a prema Transdermal administration of a systemic active agent to a prema

1987-10-23

1989-08-01

Robinson, Ellis P.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Web, sheet or filament bases; compositions of bandages; or...

424446, 424447, 424448, 424449, A61K 924

Patent

active

048532274

ABSTRACT:
A method of treating a premature neonatal infant of a gestational age between about 24 and about 35 weeks with a pharmaceutically acceptable, systemically active, substantially skin compatible, water-soluble neonatal therapeutic agent having a molecular weight below about 5000, and which agent is substantially non-transmissable through normal mature intact human skin, comprising:
(a) applying to the intact neonatal skin of said infant a transdermal device comprising (i) a backing member, (ii) a substantially shape retaining hydrogel reservoir having a water content of between about 5 percent and about 95 percent preferably between 10 percent and 80 percent by weight of said reservoir and containing an effective amount of said agent, (iii) a skin contacting surface of predetermined area, and (iv) means for maintaining said reservoir in material transmitting relationship to said skin;
(b) maintaining said skin contacting surface of said device in material transmitting relationship to said intact neonatal skin of the infant for an extended period of time; and
(c) delivering said agent through the intact neonatal skin in a controlled continuous manner such that the blood plasma level of said agent is substantially within the therapeutic index of said agent for a majority of said extended period of time.

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Evans et al: J. Pediatr., vol. 107, pp. 307-311 (1985), "Percutaneous Theophylline Administration to Preterm Infant".
Kurihara-Bergstrom et al.: J. of Controlled Release, vol. 6, pp. 51-58 (1987), "Skin Development and Permeability".
Evans et al: Intl. Journal of Pharaceutics, vol. 24, pp. 259-265 (1985), "Transdermal Drug Delivery to Neonates".
Hadgraft et al: Proceedings Intern. Symp. Contr. Rel. Broact. Mater., vol. 12, pp. 349-350 (1985), "Transdermal Drug Delivery to the Neonate".
Evans et al: J. Pharm. Pharmacol, vol. 36, No. 12, p. 10p (1984), Theophylline 767, "In Vitro Release of Theophylline with a View to Systemic Percutaneous Treatment in the Preterm Infant".
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