Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Cosmetic – antiperspirant – dentifrice
Patent
1996-06-20
1998-01-13
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Cosmetic, antiperspirant, dentifrice
424405, 424408, 424409, 424489, 424497, 118 57, 118300, 118612, 118639, 118654, 20415715, 20415762, 427 215, 427475, 427478, 427480, A61K 914, A61K 302, A01N 2500, B05C 1902
Patent
active
057076367
DESCRIPTION:
BRIEF SUMMARY
This application is a 35USC 371 application of PCT/IT95/00048, filed Apr. 6, 1995.
TECHNICAL FIELD
The present invention relates to an apparatus and a method for preparing solid forms with controlled release of the active ingredient. More particularly, it relates to an apparatus for preparing solid forms with controlled release of the active ingredient utilizing the well known spray drying and spray congealing techniques, and a method for preparing said solid forms employing said apparatus. The solid forms thus obtained can be used in the pharmaceutical field for the oral administration in the form of powders with controlled release, or as intermediates for obtaining further forms such as capsules, tablets, suspensions and the like, or they can be used in cosmetic, fragrances, preservants, alimentary as well as in veterinary field or, when for releasing vegetal hormones, pesticides, or fertilizers, also in agroindustrial field.
BACKGROUND ART
The controlled release of an active ingredient from a solid form containing it, is well known in the art. Generally, said systems contain a) one or more excipients which modulate the release acting as disgregating agents or as solubilizers, wetting agents etc., and/or b) one or more polymeric or lipidic materials acting as barriers limitating the release and capable to control the release rate of the therapeutic agent. Said excipients should be logically compatible with the active ingredients and the administration site, stable in the action site, capable to interact with the active ingredient and the biologic fluids so as to provide the desired release control. They should be also easy available and not expensive. It is thus evident that the search for excipients always more sophisticated and adaptable to the different requirements is not presently ended.
Thus in U.S. Pat. No. 2,828,206 discrete, free flowing particles are described, each comprising at least one inner core of fat-soluble vitamin material, said core being coated with a shell of a fat-insoluble substance selected from the group consisting of protein, gums, carbohydrates and pectin, which is in turn coated with a member of the group consisting of fats and waxes having a melting point between 45.degree. and 95.degree. C.
GB-A-1,044,572 claims a pharmaceutical composition providing prolonged release of a drug in the gastro- intestinal tract comprising a multitude of medicinal pallets randomly coated with a fatty acid coating comprising a saturated fatty acid or mixture of saturated fatty acids having from 12 to 22 carbon atoms per molecule, said coating being modified by an inert dusting powder which serves to form channels or pores through the otherwise continuous coating.
In U.S. Pat. No. 4,341,759 granules containing a pharmaceutically active material and at least one pharmaceutically inactive release controlling component are described, wherein said granules have a core and an outer layer comprising at least one active compound and at least one inactive release controlling substance over a period of time sufficient to cause said unitary layer to form on each core to give granules of size 0.3-2 mm.
U.S. Pat. No. 4,572,833 relates to a method for preparing a pharmaceutical oral controlled release composition, in which individual units comprise units of an active substance which is subject to controlled release as a result of coating the units with a substantially water- insoluble but water-diffusable controlled release coating comprising applying, on units comprising the active substance, a film-coating mixture comprising a solvent, a film-forming substance dissolved in the solvent and a hydrophobic substance substantially micro- dispersed in the film-coating mixture in a molten, but undissolved state, the film-coating mixture being applied at a temperature above the melting point of the hydrophobic substance.
U.S. Pat. No. 3,078,216 describes an oral pharmaceutical prepara- tion having a prolonged release comprising a plurality of medicament granules, substantially all being from 12 mesh to 80 me
REFERENCES:
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John et al., "Surfactant Effects on Spray-Congealed Formulations of Sulfaethylthiadiazol-Wax", Journal of Pharmaceutical Sciences, vol. 57, No. 4, Apr. 1968, pp. 584-589.
Patent Abstract of Japan JP 9091084, See abstract.
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Cavallari Cristina
Cini Maurizio
Motta Giuseppe
Rodriguez Lorenzo
Page Thurman K.
Saitec S.R.L.
Sikha M.
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