Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Patent
1996-05-29
1998-01-27
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
424440, 426 5, 426 3, A61K 968
Patent
active
057119619
DESCRIPTION:
BRIEF SUMMARY
This application is a 371 of PCT/EP95/02816 Jul. 15, 1995.
The subject of the present invention is the preparation of chewing gums which act as vehicles for active ingredients. These active ingredients may be used alone or in combination, in their normal physical form or in the form of coated microspheres.
In a gum there may therefore be various combinations of an active ingredient in its physical form and of the same active ingredient converted into coated microspheres, in various ratios.
More specifically, the subject of the invention is the use of a particular lacquering system which enables the drug to be administered more effectively.
It should be borne in mind that an essential feature of the administration of active ingredients is that they should have a palatable taste since they are released during the progressive chewing of the gum.
For drugs which are bitter or have little taste but nevertheless have very rapid release kinetics, tests have therefore also been carried out on coating them with the use of the microencapsulation technique; according to the particular kinetic results to be achieved, sometimes, the microencapsulation technique was not used on the whole of the active ingredient under investigation but only on some of it in order to keep a proportion for immediate action and the rest for delayed action.
By way of non-limiting example, this technology is effective for drugs such as dimenhydrinate, the effect of which against nausea generally needs to be developed rapidly for a certain proportion and then to continue for as long as possible in the bloodstream. The same result is sought in analgesic, antipyretic, cough-suppressant and antihistamine drugs, etc.
This expedient also sometimes entirely eliminates the side effects of some active ingredients on palatability, the use of this technology simultaneously achieving two quite separate objects.
Chewing gum preparations are particularly acceptable to children who can ingest drugs with a pleasant taste with the use of a more congenial form of ingestion closer to a normal sweet.
Moreover, for active ingredients which are easily oxidisable, degradable or hygroscopic, certain coatings are used to stabilize them during the steps of the process to which they are subjected, ensuring that they are preserved better over time.
The present invention achieves the objects set with the use of two distinct features, that is, the use of active ingredients as they are, as microencapsulated powders, or coated, mixed with one another in various ratios, and the lacquering of the finished pharmaceutical form.
The technology used for the preparation of the gums indicated is described in broad terms, by way of non-limiting example, below.
STEP 1
The gum is sold in pellets which, in order to be easily workable and thus to be mixed with other components, are frozen to a temperature of between -20.degree. C. and -25.degree. C. in a suitable chamber.
This step enables the gum to be processed without problems like any raw chemical product presented as a non-homogeneous powder.
In fact frozen gum is easily ground with a Danioni mill to produce a fairly homogeneous granulate generally with a particle size of between 190 and 60 mesh.
The granulate thus obtained: 4-way rotary-blade or screw mixer in proportions of 1/3 of gum and 2/3 of sweet base up to 4/5 of gum and 1/5 of sweet base; the sweet base is produced with sugars such as dextrose, glucose, sucrose, invert sugar, fructose, mannose, or maltose, or with polyalcohols used as sweeteners such as sorbitol, maltitol, xylitol or marmitol, or with synthetic sweeteners such as saccharine, acesulfame or aspartame, as well as with mixtures of any of the sweeteners mentioned above in various proportions to produce a palatable finished product with an acceptable taste; granulated moist and dried on a fluid bed.
STEP 2
The mixture obtained in point 1) or the granulate obtained in point 2) is supplemented with a lubricant such as Na or Mg/Ca stearate in a proportion generally of between 0.2% and 2%, or with stearic aci
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patent: 3826847 (1974-07-01), Ogawa
patent: 4238510 (1980-12-01), Cherukuri et al.
patent: 4452821 (1984-06-01), Gergely
patent: 4792453 (1988-12-01), Reed
patent: 4929447 (1990-05-01), Yang
patent: 5458890 (1995-10-01), Williford
Reiner Alberto
Seneci Alessandro
APR Applied Pharma Research S.A.
Faulkner D.
Page Thurman K.
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