Patent application EP16175595A (EP), filed 2016-06-21
Publication number: EP3260115A1
Title: METHOD FOR THE PRODUCTION OF A DOSAGE FORM
Abstract: The present invention relates to a method for producing a dosage form, granules consisting of surface reacted calcium carbonate, and tablets and/or capsules obtained by the method, the use of a surface-reacted calcium carbonate in a such a method, a dosage form comprising the granules, the use of the granules, or the tablets and/or capsules, or the dosage form in a pharmaceutical, nutraceutical, agricultural, cosmetic, home, food, packaging and personal care product as well as a pharmaceutical, nutraceutical, agricultural, cosmetic, home, food, packaging and personal care product comprising the granules, or the tablets and/or capsules, or the dosage form.
IPC codes: A23L  29/    00            A I
A61K   8/    00            A I
A61K   9/    16            A I
Claims: number: 1
text: A method for the production of granules comprising surface-reacted calcium carbonate, comprising the steps of:
number: 2
text: The method of claim 1, wherein the natural ground calcium carbonate is selected from calcium carbonate containing minerals selected from the group comprising marble, chalk, dolomite, limestone and mixtures thereof; or the precipitated calcium carbonate is selected from the group comprising precipitated calcium carbonates having aragonitic, vateritic or calcitic mineralogical crystal forms and mixtures thereof
number: 3
text: The method according to any one of claims 1 or 2, wherein the surface-reacted calcium carbonate
number: 4
text: The method according to any one of claims 1 to 3, wherein roller compacting step b) is carried out at a roller compaction pressure in the range from 1 to 28 kN/cm, more preferably in the range from 1 to 20 kN/cm and most preferably in the range from 2 to 10 kN/cm.
number: 5
text: The method according to any one of claims 1 to 4, further comprising a step d) of sieving the granules of step c) by at least one mesh size.
number: 6
text: The method according to claim 5, wherein sieving step d) is carried out by sieving on two or more different mesh sizes, preferably with mesh sizes of 90 µm, 180 µm, 250 µm, 355 µm, 500 µm and 710 µm.
number: 7
text: The method according to any one of claims 1 to 6, further comprising a step e1) of mixing the granules obtained in step c) and/or, if present, step d) with at least one formulating aid.
number: 8
text: The method according to claim 7, wherein the at least one formulating aid is selected from the group comprising a disintegrant, preferably selected form the group comprising modified cellulose gums, insoluble cross-linked polyvinylpyrrolidones, starch glycolates, micro crystalline cellulose, pregelatinized starch, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, homopolymers of N-vinyl-2-pyrrolidone, alkyl-, hydroxyalkyl-, carboxyalkyl-cellulose esters, alginates, microcrystalline cellulose and its polymorphic forms, ion exchange resins, gums, chitin, chitosan, clays, gellan gum, crosslinked polacrillin copolymers, agar, gelatine, dextrines, acrylic acid polymers, carboxymethylcellulose sodium/calcium, hydroxpropyl methyl cellulose phthalate, shellac or mixtures thereof, lubricants, especially an inner-phase lubricant and/or an outer-phase lubricant, impact modifiers, plasticizers, waxes, stabilizers, pigments, coloring agents, scenting agents, taste masking agents, flavoring agents, sweeteners, mouth-feel improvers, diluents, film forming agents, adhesives, buffers, adsorbents, odour-masking agents and mixtures thereof
number: 9
text: The method according to any one of claims 1 to 8, further comprising a step e2) of loading the compacted form obtained in step b) or the granules obtained in step c) or, if present, step d) with at least one active ingredient and/or inactive precursor thereof for obtaining loaded granules.
number: 10
text: The method according to claim 9, wherein the at least one active ingredient and/or inactive precursor thereof is selected from the group comprising fragrances, flavours, herbal extracts, fruit extracts, nutrients, trace minerals, repellents, food, cosmetics, flame retardants, enzymes, macromolecules, pesticides, fertilizers, preserving agents, antioxidants, reactive chemicals, pharmaceutically active agents or pharmaceutically inactive precursors of synthetic origin, semi-synthetic origin, natural origin thereof, and mixtures thereof.
number: 11
text: The method according to claim 9 or 10, wherein the at least one active ingredient and/or inactive precursor thereof is in liquid form, preferably the at least one active ingredient and/or inactive precursor thereof is provided in a solvent, preferably the solvent is selected from the group comprising water, methanol, ethanol, n-butanol, isopropanol, n-propanol, n-octanol, acetone, dimethylsulphoxide, dimethylformamide, tetrahydrofurane, vegetable oils and the derivatives thereof, animal oils and the derivatives thereof, molten fats and waxes, and mixtures thereof, and more preferably the solvent is water, ethanol and/or acetone.
number: 12
text: The method according to any one of claims 9 to 11, wherein loading step e2) is carried out by spraying or dropping the at least one active ingredient and/or inactive precursor thereof onto the compacted form obtained in step b) or the granules obtained in step c) or, if present, step d) and mixing in a device selected from the group comprising fluidized bed dryers/granulators, ploughshare mixer, vertical or horizontal mixers, high or low shear mixer and high speed blenders.
number: 13
text: The method according to any one of claims 9 to 12, further comprising a final step f) of tableting the loaded granules obtained in step e2) or filling the loaded granules obtained in step e2) into capsules.
number: 14
text: Granules consisting of surface reacted calcium carbonate as defined in any one of claims 1 to 3 and optionally mixed with at least one formulating aid as defined in claim 8 and/or loaded with at least one active ingredient and/or inactive precursor thereof as defined in claim 10.
number: 15
text: Tablets and/or capsules obtained by the method according to claim 13.
number: 16
text: A dosage form, preferably a tablet, mini-tablet or capsule, comprising the granules of claim 14.
number: 17
text: Use of the granules of claim 14, or the tablets and/or capsules of claim 15, or the dosage form of claim 16 in a pharmaceutical, nutraceutical, agricultural, cosmetic, home, food, packaging and personal care product.
number: 18
text: A pharmaceutical, nutraceutical, agricultural, cosmetic, home, food, packaging and personal care product comprising the granules of claim 14, or the tablets and/or capsules of claim 15, or the dosage form of claim 16.
number: 19
text: Use of a surface-reacted calcium carbonate as defined in any one of claims 1 to 3 in a method according to any one of claims 1 to 13.
Office action: search_report, dated 2017-12-27
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Final disposition: pending (2017-12-27)