Device for Delivery of Active Principles
AssigneeLaboratorio Italiano Biochimico Farmaceutico Lisapharma S.p.A.
InventorsPaolo Colombo, Patrizia Santi, Sara Nicoli, Cristina Padula, Fabio Marra
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Abstract
A device for the delivery of active principles for dermal and, in particular, transdermal application having the form of a two-layered patch consisting of a first layer having a homogeneous composition and comprising at least one active principle, a water-soluble film-forming agent and a hydrophilic adhesive polymer, and of a second layer joined in a permanent manner to the first and having a water vapour permeability of less than 500 g/m2 in 24 hours.
Claims15
Two-layered patch for dermal or transdermal administration of active principles comprising:
- a) a first layer having a homogeneous composition and comprising at least one active principle, a water-soluble film-forming agent selected from the group consisting of carboxymethylcellulose, chitosan, aqueous dispersions of acrylic and methacrylic polymers and polyvinyl alcohol, and a hydrophilic adhesive polymer, chosen from the group consisting of polyvinylpyrrolidone, tragacanth gum, arabic gum, karaya gum, xanthan gum, pectin and polyaminomethacrylate adhesives, said first layer having a residual humidity lower than 20%;
- and
- b) a second layer joined in a permanent manner to the first and having a permeability to water vapour of less than 500 g/m2 in 24 hours,
- provided that when said adhesive is polyaminomethacrylate and it is butylmethacrylate/(2-dimethylaminoethyl)-methacrylate/methylmethacrylate copolymer in which the ratio between the monomers is 1:2:1, said water-soluble film-forming agent must be different from carboxymethylcellulose.
Process for preparing a patch in accordance with claim 12 comprising the following steps:
- a) a mixture is prepared, in water, comprising the hydrophilic adhesive, the film-forming agent, the active principle, and, optionally, one or more substances with the properties of absorption promoters/humectants/plasticisers;
- b) the mixture obtained in step a) is spread in a thin layer onto an insulating film;
- and
- c) the patch is dried until a residual humidity of less than 20% is achieved.
Dependencies are inferred from the claim text.