Patent application EP16175590A (EP), filed 2016-06-21
Publication number: EP3260114A1
Title: METHOD FOR THE PRODUCTION OF A DOSAGE FORM
Abstract: [0001]    The present invention relates to a method for producing a dosage form, granules and tablets 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 producing a dosage form, 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 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: 5
text: The method according to any one of claims 1 to 4, 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: 6
text: The method according to any one of claims 1 to 5, wherein loading step c) is carried out by spraying or dropping the at least one active ingredient and/or inactive precursor thereof onto the surface-reacted calcium carbonate and mixing it 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: 7
text: The method according to any one of claims 1 to 6, wherein roller compacting step d) 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: 8
text: The method according to any one of claims 1 to 7, further comprising a step f) of sieving the granules of step e) by at least one mesh size.
number: 9
text: The method according to any one of claims 1 to 8, further comprising a step b1) of providing at least one formulating aid and mixing and/or coating the granules obtained in step e) and/or, if present, step f) with the at least one formulating aid of step b1) in a mixing and/or coating step c1).
number: 10
text: The method according to claim 9, 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, colouring agents, scenting agents, taste masking agents, flavouring agents, sweeteners, mouth-feel improvers, diluents, film forming agents, adhesives, buffers, adsorbents, odour-masking agents and mixtures thereof.
number: 11
text: The method according to any one of claims 8 to 10, wherein sieving step f) is carried out by sieving on two or more different mesh sizes, preferably with mesh sizes of 180 µm, 250 µm, 355 µm, 500 µm and 710 µm.
number: 12
text: The method according to any one of claims 1 to 11, further comprising a step g) of tableting the granules obtained in step e) or, if present, step f) and/or step c1) or filling the granules obtained in step e) or, if present, step f) and/or step c1) into capsules.
number: 13
text: Granules obtained by the method according to any one of claims 1 to 11.
number: 14
text: Tablets and/or capsules obtained by the method according to claim 12.
number: 15
text: A dosage form, preferably a tablet, mini-tablet or capsule, comprising the granules of claim 13.
number: 16
text: Use of the granules of claim 13, or the tablets and/or capsules of claim 14, or the dosage form of claim 15 in a pharmaceutical, nutraceutical, agricultural, cosmetic, home, food, packaging and personal care product.
number: 17
text: A pharmaceutical, nutraceutical, agricultural, cosmetic, home, food, packaging and personal care product comprising the granules of claim 13, or the tablets and/or capsules of claim 14, or the dosage form of claim 15.
number: 18
text: Use of a surface-reacted calcium carbonate in a method according to any one of claims 1 to 12.
Office action: search_report, dated 2017-12-27
Rejection reasons: novelty_epc_54
Prior art cited: ref_id: EP15160194A
ref_type: patent
severity: background
ref_id: EP14199037A
ref_type: patent
severity: background
ref_id: EP15197395A
ref_type: patent
severity: background
ref_id: - HARRIS, D. C.: "Quantitative Chemical Analysis: 3rd Edition", 1991, W.H. FREEMAN & CO. (USA
ref_type: npl
severity: background
ref_id: - GANE, P.A.C.; KETTLE, J.P.; MATTHEWS, G.P.; RIDGWAY, C.J: "Void Space Structure of Compressible Polymer Spheres and Consolidated Calcium Carbonate Paper-Coating Formulations", INDUSTRIAL AND ENGINEERING CHEMISTRY RESEARCH, vol. 35, no. 5, 1996, pages 1753 - 1764
ref_type: npl
severity: background
ref_id: EP3069713A1
ref_type: patent
severity: background
ref_id: EP2719373A1
ref_type: patent
severity: background
ref_id: EP2957603A1
ref_type: patent
severity: background
ref_id: - TANJA STIRNIMANN ET AL: "Compaction of functionalized calcium carbonate, a porous and crystalline microparticulate material with a lamellar surface", INTERNATIONAL JOURNAL OF PHARMACEUTICS, vol. 466, no. 1-2, 1 May 2014 (2014-05-01), pages 266 - 275, XP055179910, ISSN: 0378-5173, DOI: 10.1016/j.ijpharm.2014.03.027
ref_type: npl
severity: background
ref_id: EP2719373
ref_type: patent
severity: background
ref_id: EP2957603
ref_type: patent
severity: background
ref_id: EP3069713
ref_type: patent
severity: novelty_destroying
ref_id: - TANJA STIRNIMANN ET AL, "Compaction of functionalized calcium carbonate, a porous and crystalline microparticulate material with a lamellar surface", INTERNATIONAL JOURNAL OF PHARMACEUTICS, (20140501), vol. 466, no. 1-2, doi:10.1016/j.ijpharm.2014.03.027, ISSN 0378-5173, pages 266 - 275, XP055179910 [A] 1-18 * the whole document *
ref_type: npl
severity: background
Final disposition: pending (2017-12-27)