Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Patent
1995-06-23
1997-09-02
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
424424, 424425, 424443, 424456, 424457, 424458, 424464, 424468, 424469, 424472, 424484, 424485, 424486, 424487, 424488, 424489, 514770, 5147722, 5147723, 5147726, 514774, 514777, 514781, 514776, 514782, 514784, 514951, 514953, A61K 914, A61K 922, A61K 924, A61K 926, A61K 952
Patent
active
056629354
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/IT93/00136 filed Dec. 23, 1993.
TECHNICAL FIELD
The present invention relates to an improved process for preparing pharmaceutical forms with controlled release of the active ingredient and the forms thus obtained. More particularly, it relates to a process for preparing pharmaceutical forms with delayed or rapid release of the active ingredient, said delayed or rapid release being achieved by selecting appropriate excipient(s) to be mixed with the drug(s) and subjecting the mixture thus obtained to mechanical or electromechanical actions for a well established time and within a wide range of frequencies. The present invention elates also to the forms thus obtained, which can be administered by oral, topic or parenteral route, and which can be used also in veterinary field or, when for releasing vegetal hormones, pesticides, fragrances, preservants, also in agroindustrial field.
BACKGROUND ART
The controlled release of an active ingredient from a pharmaceutical form containing it, is well known in the art. Generally, said systems contain one or more excipients which modulate the release acting as disgregating agents or as solubilizers, wetting agents etc., and/or one or more polymeric materials acting as excipients or 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. This is due both to the diversity and sometime complexity of the drugs to be used, and to the desire to obtain pharmaceutical forms even more sophisticated and reliable.
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 pellets 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
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DATABASE WPI, Section Ch. Week 7243, Derwent Purblications Ltd., Class A03, AN 72-69291T & JP,A,47 020 327 Mar. 4, 1971.
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Page Thurman K.
Saitec S.R.L.
Spear James M.
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