Internationally patented | US Patent n° 9.333.170 B2
(Multiform Administration Timed Release Ingredients System)
The starting point for the production of active ingredients in M.A.T.R.I.S.® form are the active ingredients themselves, subdivided into micro-particles of size between 200 and 600 µ, directly and individually coated by one or more layers of polymeric membranes, thus totally removing the need for an inert support core.
According to the kind of polymeric membranes utilized, it is possible to obtain a perfect taste and odor masking of unpleasant ingredients, as well as their controlled release over a predetermined period of time.
The M.A.T.R.I.S.® form, thanks to the particular characteristics of fine and flowable particle size, allows the active substances to spread in a quick and uniform way on the whole surface of the gastro-intestinal tract, starting the modified release at the stomach and/or intestine level, according to the properties of the used membranes.
Eliminating the need of inner inert cores, makes it possible to attain a high concentration of the active ingredients, suitable for the manufacture of the final dosage form envisaged.
The novel form of the active ingredients so obtained, enables the production of different final dosage forms of administration, with an active substance title much higher (up to 80%) than the conventional microgranules, pellets, tablets and minitablets.
Such forms are high dosage tablets and capsules, single dose sachets, both dispersible and oro-soluble, single dose bottles with metering stoppers, impossible to obtain with the traditional coating processes (granules for hard gelatin capsules and traditional tablets), thus allowing final administration forms with better possibility to add other active ingredients.
The M.A.T.R.I.S.® process is an exclusive technology originally developed by I.P.S. – International Products & Services srl, patent pending internationally and carried on in compliance with current cGMP for food supplements.
M.A.T.R.I.S. DUAL® Technology
Under patent registration.
In recent times interest was highlighted for a unique formulation of one or more active ingredients, with both a slow and a rapid release, in order to allow a finished product with a release both fast and retard.
Such a dual mode of release has been recently achieved by IPS with the setting up of the MATRIS DUAL® technology.
This technology allows the production of mini-particles, of dimensions measurable in a few hundred microns (thousands of a millimeter), each one formed by one or more active ingredients, with an initial fast release of a certain quantity of the total dose (i.e. 50%), followed by a slow release, still from the same particle, of the remaining dose.
In other words, the mini-particles are mini-devices at the same time releasing their content, both in the case of a single active ingredient and of more ingredients, at different times and pre-defined speeds.
The entirety of the mini-particles forms an actual fine granulate which can be utilized as a basic product for obtaining final forms of administration, with the desired characteristics of release, such as tablets, capsules, single dose sachets also oro-soluble, extemporary suspensions, single dose bottles with metering cap.
The starting point for the production of active ingredients in MINIACTIVES® form are neutral micro particles of round shape, with dimensions between 400 and 500 µ.
Each single particle is covered with one or more concentric layers of the ingredients, and subsequently coated with a polymeric membrane chosen among those suitable for taste masking (TM) and/or to obtain a pre-established timed release (TR).
The MINIACTIVES® Taste Masking formulation provides for a total masking of unpleasant smell and taste of certain active ingredients, leaving the time of their absorption unchanged.
The MINIACTIVES® Timed Release formulation gradually releases the active ingredients by diffusion, in a pre-determined time, thanks to a polymeric permeable and insoluble membrane coating each single particle, thus assuring a constant release, largely independent from physiological variables, such as pH, gastro-intestinal motility, presence of food and others.
Thanks to their minute size, the MINIACTIVES® technology allows the production of various dosage forms of food ingredients, perfectly tasteless and/or in timed release, such as single dose dispersible and/or oro-soluble sachets, special high dose “reservoir” tablets (see relevant technical data sheet annexed), small single dose bottles with metering stopper and high dose hard gelatin capsules, impossible to obtain with the traditional controlled release technologies.
The MINIACTIVES® process is an exclusive technology originally developed by I.P.S. – International Products & Services srl, carried on in compliance with current cGMP for food supplements.
M.A.T.R.I.S. SmarTTabs® Technology
Unlike the traditional tablets for oral administration of medicaments or food supplements in modified release form, the M.A.T.R.I.S. SmarTTabs® by I.P.S. consist in a polyvalent matrix comprising an agglomerate formed by mini-particles of active substance (about 200 to 600 microns in size), directly and individually covered by one or more layers of polymeric membranes. The membranes utilized are such as to adjust the release according to predetermined modes, thus totally removing the need of inert ingredients. In this way, the matrix allows high dosage tablets, even fractionable without altering the modified release characteristics (as it happens with the traditional retard tablets), thus allowing to obtain an optimal flexibility of the unitary dosage to be administered. The M.A.T.R.I.S. SmarTTabs® can also be crumbled, in case of swallowing difficulties, in a spoon or directly in the oral cavity and then swallowed with a minimal amount of liquid, with a perfect coverage of possible bad tastes and a smooth flow of the product down the stomach. The matrix in the formulation of disintegrating tablets, to be considered as a mere container of the modified release active substance and not as a traditional tablet, allows also to obtain extemporaneous suspensions with a great dosage variety, by disintegrating for instance half tablet = 200 mg; one tablet = 400 mg; one and a half tablet = 600 mg and so forth, in any suitable liquid and then swallowing the active substance, whose modified release characteristics were not affected, in the form of a tasteless homogeneous suspension, very suitable for geriatric and pediatric use. The M.A.T.R.I.S. SmarTTabs® cause the active substance to reach, promptly after the administration, the G.I. tract starting the modified release, at the stomach and/or intestine level according to the properties of the used membranes. Furthermore and in view of the particular characteristics of fine and flowable particle size, the active substance spreads in a quick and uniform way on the whole surface of the G.I. tract, thus avoiding the risks of decreased bioavailability and undesirable side effects, potentially due to high concentrations of the active ingredient in a specific place of the G.I. tract.
The M.A.T.R.I.S. SmarTTabs® process is carried on in compliance with cGMP for food supplements.