Formulations comprising therapeutically-active proteins or polyp

Details Formulations comprising therapeutically-active proteins or polyp Formulations comprising therapeutically-active proteins or polyp

1994-10-13

1998-01-13

Page, Thurman K.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Implant or insert

424484, 424449, A61K 910

Patent

active

057076413

ABSTRACT:
A pharmaceutical formulation which is adapted particularly for transdermal administration, and which comprises an aqueous emulsion or dispersion including, in addition to the aqueous phase, at least ingredients (a) and (b) of ingredients (a), (b) and (c): (a) as active ingredient, at least one therapeutically active protein or polypeptide; (b) at least one pharmaceutically acceptable emulsifier; (c) an oil phase comprising or consisting essentially of at least one ester of an aliphatic hydroxy compound containing 1-12 carbon atoms and 1-4 alcoholic hydroxy groups with an aliphatic carboxylic acid containing 8-24 carbon atoms and 1-3 carboxylic acid groups; provided that the therapeutic activity of the active ingredient in the formulation is such that the presence or the therapeutic effect of the active ingredient is detectable in the bloodstream within less than two hours after commencing transdermal administration, and further provided that when the active ingredient comprises insulin, the insulin is subjected to a pretreatment under predetermined conditions, prior to incorporation in the formulation.

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Jacobs, M.A.J.M., et al., The Pharmacodynamics and Activity of Intranasally Administered Insulin in Healthy Male Volunteers, Diabetes, 42, 1990, pp. 1649-1655.

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