US3885026A - Preparation of porous tablets - Google Patents

Preparation of porous tablets Download PDF

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Publication number
US3885026A
US3885026A US395796A US39579673A US3885026A US 3885026 A US3885026 A US 3885026A US 395796 A US395796 A US 395796A US 39579673 A US39579673 A US 39579673A US 3885026 A US3885026 A US 3885026A
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United States
Prior art keywords
adjuvant
tablets
process according
tablet
mix
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
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US395796A
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English (en)
Inventor
Helmut Heinemann
Werner Rothe
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Roche Diagnostics GmbH
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Boehringer Mannheim GmbH
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Publication of US3885026A publication Critical patent/US3885026A/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
    • Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y10S516/00—Colloid systems and wetting agents; subcombinations thereof; processes of
    • Y10S516/01—Wetting, emulsifying, dispersing, or stabilizing agents

Definitions

  • ABSTRACT In the production of tablets which are to undergo disintegration in use wherein the tablet components are mixed and pressed into predetermined shape, the improvement which comprises incorporating into the mix at least one inert readily volatilizable solid adjuvant, pressing the mix into shape, and thereafter volatilizing the adjuvant, whereby the resulting tablets are porous, strong, shape retaining and readily disintegratable. Volatilization can be effected by sublimation or application of 'vacuum.
  • the adjuvant preferably comprises urethane, urea, ammonium carbonate, ammonium bicarbonate, hexamethylene-tetramine, benzoic acid, phthalic anhydride, naphthalene or camphor present in about 5 to 50 percent, especially about 10 to 30 percent, by weight of the total tablet mix.
  • Tablets which break down quickly are only obtained by the addition of disintegration agents, such as carboxymethyl-cellulose, starch or the like; filling materials, such as lactose, phosphates or the like; and lubricants, such as talc, stearic acid, paraffin or the like.
  • disintegration agents such as carboxymethyl-cellulose, starch or the like
  • filling materials such as lactose, phosphates or the like
  • lubricants such as talc, stearic acid, paraffin or the like.
  • molded tablets In this case, the tablet components are formed into a paste with water or an organic solvent, in which at least one of the components partially dissolves, to give a stiff slurry which is formed in special machines to give tablets, whereafter the tablets are carefully dried. Upon evaporation of the solvent, the substances dissolved therein adhere the undissolved particles, whereby the tablets receive their strength; at the same time, small hollow spaces are formed into which solvents can again penetrate when the tablets are dropped into liquid.
  • these tablets are satisfactory with respect to speed of dissolution they are frequently too soft and brittle due to the presence of very fine canals so that difficulties arise in packing and transport.
  • the use of the process is limited due to the fact that many reagents, especially enzymes and indicators, are damaged by solvents, and organic solvent vapors necessitate special safety precautions during the production of the tablets.
  • an object of the present invention to provide a process which permits the production of readily dissolved, porous tablets in conventional tablet presses, without having to add lubricants, explosive agents or solvents.
  • the conventional process of mixing tablet components and pressing the mix into predetermined shape is modified by incorporating into the mix at least one inert readily volatilizable solid adjuvant, pressing the mix into shape, and thereafter volatilizing the adjuvant, whereby the resulting tablets are porous, strong, shape retaining and readily disintegratable.
  • adjuvants there can be used, in principle, all readily sublimable materials or materials which can readily be converted into gaseous decomposition products and which are readily tablettable and do not react with the other components of the tablets.
  • urethane urea, ammonium carbonate and bicarbonate, hexamethylenetetramine, benzoic acid, phthalic anhydride, naphthalene and camphor, urethane being especially preferred.
  • the tablet masses for water-soluble reagent tablets and pharmaceutical tablets can, in addition to one or more active materials, contain conventional soluble carrier materials, for example sodium chloride, potassium chloride, borax, phosphates, oligosaccharides, polyethylene glycols, tensides and other appropriate inorganic and organic materials.
  • the volatile solid adjuvants can account for about 5 50 percent and preferably about -30 percent of the total tablet mass. it being understood that in the case of a high proportion of adjuvant there are formed comparatively large hollow spaces and thus tablets which break down more quickly but are also more brittle than in the case of using a small proportion of adjuvant. Although the adjuvants can be completely removed, the production time for the new tablets according to the present invention is shortened when the adjuvants are allowed to remain behind in the tablets in trace amounts, for example of less than about 1% by weight.
  • the adjuvants can be removed by simple heating of the tablets above the sublimation or decomposition point.
  • sensitive tablet components for example of enzymes
  • condensation separator having proved to be especially advantageous for this purpose.
  • EXAMPLE I Tablet A 1.850 kg of potassium chloride are sieved and pressed to form tablets of 8 mm diameter containing 185 mg of potassium chloride.
  • Tablet Bl 1.850 kg of potassium chloride are mixed with 350 g of urethane (ethyl-urethane), sieved and pressed to form tablets of 8 mm diameter containing 185 mg of potassium chloride and 35 mg of urethane.
  • urethane ethyl-urethane
  • the urethane is subsequently sublimed from these tablets over 5 hours in a freeze drying plant at 20C and at a pressure of IO to 10. mm Hg.
  • Tablet B2 1.850 kg of potassium chloride are mixed with 350 g of ammonium bicarbonate, sieved and pressed to form tablets of 8 mm diameter containing 185 mg of potassium chloride and 35 mg of ammonium bicarbonate.
  • ammonium bicarbonate is driven off from these tablets over 8 hours in a drying cabinet at 90C.
  • Tablet B3 1.850 kg of potassium chloride are mixed with 350 g of urea, sieved and pressed to form tablets of 8 mm diameter containing 185 mg of potassium chloride and 35 mg of urea.
  • the urea is sublimed from these tablets over 16 hours in a vacuum cabinet at 110C and 15 mm Hg.
  • Tablet B4 1.850 kg of potassium chloride are mixed with 350 g of urotropin, sieved and pressed to form tablets of 8 mm diameter containing 185 mg of potassium chloride and 35 mg of urotropin.
  • the urotropin is removed from these tablets over 16 hours in a vacuum cabinet at 90C and 15 mm Hg.
  • EXAMPLE 2 Tablet C 1.5 kg of dextrose are granulated with 300 ml of 40 percent aqueous alcohol, dried and sieved. The granulate is dry mixed with 50 g of polyethylene glycol (M.W. 5000 6000) and pressed to form tablets of 8 mm diameter containing 150 mg of dextrose.
  • M.W. 5000 6000 polyethylene glycol
  • Tablet D1 1.550 kg of dextrose-polyethylene glycol granulate are dry mixed with 300 g of urethane. The tablet mass is pressed to form tablets of 8 mm diameter containing 150 mg of dextrose and 30 mg of urethane.
  • the urethane is sublimed from these tablets over 8 hours in a drying cabinet at 40C.
  • Tablet D2 1.550 kg of dextrose-polyethylene glycol granulate are dry mixed with 300 g of ammonium carbonate. The tablet mass is pressed to form tablets of 8 mm diameter containing 150 mg of dextrose and 30 mg of ammonium carbonate.
  • ammonium carbonate is removed from these tablets over 8 hours in a drying cabinet at 75C.
  • Tablet D3 1.550 kg of dextrose-polyethylene glycol granulate are dry mixed with 300 g of benzoic acid. The tablet mass is pressed to form tablets of 8 mm diameter containing 150 mg of dextrose and 30 mg of benzoic acid.
  • the benzoic acid is sublimed from these tablets over 16 hours in a vacuum cabinet at 90C and 15 mm Hg.
  • Tablet D4 1.550 kg of dextrose-polyethylene glycol granulate are dry mixed with 300 g of camphor. The tablet mass is pressed to form tablets of 8 mm diameter containing 150 mg of dextrose and 30 mg of camphor.
  • EXAMPLE 3 Tablet E g of polyethylene glycol (M.W. 5000 6000) are dissolved in 80 ml of 40 percent aqueous ethanol. With this solution, there are mixed 388 g of glucose, which is then dried and sieved. The granulate obtained is dry mixed with 12.5 g of nicotinamide-adenine-dinucleotide (NAD), 3.75 g of 2,5-diphenyl-3-(4,5-dimethyl-thiazolyl-2)- tetrazolium bromide (MTT) and 0.75 g of N- methylphenazine-methylsulfate (PMS). The mixture is pressed to form tablets of 12 mm diameter, each tablet containing 12.5 mg of NAD, 3.75 mg of MTT and 0.75 mg of PMS.
  • NAD nicotinamide-adenine-dinucleotide
  • MTT 2,5-diphenyl-3-(4,5-dimethyl-thiazolyl-2)- t
  • Tablet F 15 g of polyethylene glycol (M.W. 5000 6000) are dissolved in 80 ml of 40 percent aqueous alcohol. With this solution, there are mixed 388 g of glucose, which is then dried and sieved. The granulate obtained is dry mixed with 12.5 g of NAD, 3.75 g of MTT, 0.75 g of PMS and 80 g of urethane. The mixture is pressed to form reagent tablets of 12 mm diameter which contain, per tablet, 12.5 mg of NAD, 3.75 mg of MTT and 0.75 mg of PMS. The urethane is sublimed from these tablets over 8 hours in a freeze drying plant at 0C and 10 to lO 3 mm Hg.
  • EXAMPLE 4 Tablet G 500 g of sodium chloride are ground,
  • Tablet H 500 g of sodium chloride are ground,
  • the various components of the tablet mix including active materials, adjuvant, carrier, etc., may range in size from about 0,0l to 1,0 and preferably about 0.05 to 0,5 mm. Desirably the average size of the adjuvant particles ranges from about 5 to 50 percent and preferably about to 30 percent of that of the balance of the particles making up the tablet mix.
  • the improvement which comprises incorporating into the mix at least one inert solid adjuvant, sublimable at a temperature up to about 1 10C pressing the mix into tablets, and thereafter subjecting the tablets to at least one of vacuum and heating to a temperature up to about 1 10C so as to sublime the adjuvant, whereby the resulting tablets are porous, strong, shape retaining and readily disintegratable.

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Preparation (AREA)
US395796A 1972-09-20 1973-09-10 Preparation of porous tablets Expired - Lifetime US3885026A (en)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
DE2246013A DE2246013A1 (de) 1972-09-20 1972-09-20 Verfahren zur herstellung von poroesen tabletten

Publications (1)

Publication Number Publication Date
US3885026A true US3885026A (en) 1975-05-20

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Country Status (9)

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US (1) US3885026A (fr)
JP (1) JPS4969819A (fr)
AT (1) AT324568B (fr)
CH (1) CH579394A5 (fr)
DE (1) DE2246013A1 (fr)
FR (1) FR2199973B1 (fr)
GB (1) GB1381588A (fr)
IT (1) IT998618B (fr)
SE (1) SE395366B (fr)

Cited By (53)

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US4062932A (en) * 1975-03-10 1977-12-13 University Of Southern California Process for the catalytic oxidation of hydrogen sulfide with sulfur dioxide
US4134943A (en) * 1975-12-16 1979-01-16 Boehringer Mannheim Gmbh Production of porous tablets
US4568547A (en) * 1979-08-30 1986-02-04 Herschler R J Solid pharmaceutical compositions comprising MSM and their production
US4883182A (en) * 1985-05-31 1989-11-28 Hughes Raymond J Tamper evident capsule and insert device
US5516530A (en) * 1991-12-20 1996-05-14 Pfizer Inc. Porous shaped delivery devices and method of producing thereof
US5529789A (en) * 1992-03-17 1996-06-25 Pfizer, Inc. Method of producing porous delivery devices
US5853758A (en) * 1992-01-13 1998-12-29 Pfizer Inc. Preparation of tablets of increased strength
SG79255A1 (en) * 1998-05-15 2001-03-20 Pfizer Pharmaceutical formulations
US6284270B1 (en) 1999-08-04 2001-09-04 Drugtech Corporation Means for creating a mass having structural integrity
US6294151B1 (en) 1996-08-13 2001-09-25 Kyowa Hakko Kogyo, Co., Ltd. Isotopic urea tablets
US6376545B1 (en) 1998-11-10 2002-04-23 Teva Pharmaceutical Industries, Ltd. Dispersible compositions containing L-DOPA ethyl ester
WO2002055061A2 (fr) * 2001-01-11 2002-07-18 Particle And Coating Technologies, Inc. Procede relatif a l'elaboration de comprimes poreux a proprietes de dissolution ameliorees
US6509040B1 (en) 2001-06-22 2003-01-21 R.P. Scherer Corporation Fast dispersing dosage forms essentially free of mammalian gelatin
US20030022912A1 (en) * 2001-02-08 2003-01-30 Martino Alice C. Rapid-onset medicament for treatment of sexual dysfunction
EP1283703A1 (fr) * 2000-05-26 2003-02-19 Hanmi Pharm. Co., Ltd. Comprimes a desintegration rapide et procede de fabrication
US20030185886A1 (en) * 2000-05-26 2003-10-02 Hanmi Pharm. Co., Ltd. Process for the preparation of rapidly disintegrating tablet
US20030215500A1 (en) * 1996-06-14 2003-11-20 Motohiro Ohta Intrabuccally rapidly disintegrating tablet and a production method of the tablets
US20040023948A1 (en) * 1997-03-24 2004-02-05 Green Richard David Fast-dispersing dosage form containing 5-HT1 agonists
US6709669B1 (en) 1999-04-08 2004-03-23 R. P. Scherer Technologies, Inc. Fast-dispersing dosage forms containing fish gelatin
US20040071772A1 (en) * 2001-03-06 2004-04-15 Shoichi Narita Preparations quickly disintegrating in oral cavity
US20040070102A1 (en) * 2000-11-24 2004-04-15 Valder Christoper Edmund Novel process
US20040126427A1 (en) * 2002-12-31 2004-07-01 Venkatesh Gopi M. Extended release dosage forms of propranolol hydrochloride
US20040146556A1 (en) * 2002-10-30 2004-07-29 Noack Robert M. Oral extended release tablets and methods of making and using the same
US20050013857A1 (en) * 2003-05-07 2005-01-20 Yourong Fu Highly plastic granules for making fast melting tablets
US20050043296A1 (en) * 2002-10-04 2005-02-24 Michael Hawley Compositions and methods for treating sexual dysfunction
EP0914818B1 (fr) * 1996-06-14 2005-06-08 Kyowa Hakko Kogyo Co., Ltd. Comprime intra-oral a desintegration rapide
KR100481583B1 (ko) * 1996-06-14 2005-07-12 교와 핫꼬 고교 가부시끼가이샤 구강내에서빠르게붕괴하는정제
US20060057199A1 (en) * 2004-09-13 2006-03-16 Venkatesh Gopi M Orally disintegrating tablets of atomoxetine
US20060078614A1 (en) * 2004-10-12 2006-04-13 Venkatesh Gopi M Taste-masked pharmaceutical compositions
US20060105039A1 (en) * 2004-10-21 2006-05-18 Jin-Wang Lai Taste-masked pharmaceutical compositions with gastrosoluble pore-formers
US20060105038A1 (en) * 2004-11-12 2006-05-18 Eurand Pharmaceuticals Limited Taste-masked pharmaceutical compositions prepared by coacervation
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US20090110716A1 (en) * 2007-10-31 2009-04-30 Frank Bunick Orally disintegrative dosage form
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US20110071183A1 (en) * 2009-09-24 2011-03-24 Jen-Chi Chen Manufacture of lozenge product with radiofrequency
US20110070286A1 (en) * 2009-09-24 2011-03-24 Andreas Hugerth Process for the manufacture of nicotine-comprising chewing gum and nicotine-comprising chewing gum manufactured according to said process
US20110212171A1 (en) * 2010-01-08 2011-09-01 Eurand, Inc. Taste masked topiramate composition and an orally disintegrating tablet comprising the same
EP2457561A1 (fr) * 2009-07-06 2012-05-30 Kyorin Pharmaceutical Co., Ltd. Comprimé ayant une structure creuse
CN102631289A (zh) * 2004-10-28 2012-08-15 潘特克股份公司 高孔隙度的速崩固体剂型及其包括生产粉末和冻干步骤的制备方法
US8313768B2 (en) 2009-09-24 2012-11-20 Mcneil-Ppc, Inc. Manufacture of tablet having immediate release region and sustained release region
US8580313B2 (en) 2009-12-02 2013-11-12 Aptalis Pharma Limited Fexofenadine microcapsules and compositions containing them
US8858210B2 (en) 2009-09-24 2014-10-14 Mcneil-Ppc, Inc. Manufacture of variable density dosage forms utilizing radiofrequency energy
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US9233491B2 (en) 2012-05-01 2016-01-12 Johnson & Johnson Consumer Inc. Machine for production of solid dosage forms
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US9511028B2 (en) 2012-05-01 2016-12-06 Johnson & Johnson Consumer Inc. Orally disintegrating tablet
US9789066B2 (en) 2014-01-10 2017-10-17 Johnson & Johnson Consumer Inc. Process for making tablet using radiofrequency and lossy coated particles
WO2017182589A1 (fr) 2016-04-21 2017-10-26 Astrazeneca Ab Comprimés à désintégration orale
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US6290991B1 (en) 1994-12-02 2001-09-18 Quandrant Holdings Cambridge Limited Solid dose delivery vehicle and methods of making same
US6586006B2 (en) 1994-08-04 2003-07-01 Elan Drug Delivery Limited Solid delivery systems for controlled release of molecules incorporated therein and methods of making same
WO1996008979A1 (fr) 1994-09-22 1996-03-28 Quadrant Holdings Cambridge Limited Compositions de rehydratation et de nutrition a utiliser pendant une activite sportive, et leurs procedes de preparation
US6964771B1 (en) 1995-06-07 2005-11-15 Elan Drug Delivery Limited Method for stably incorporating substances within dry, foamed glass matrices
US5762961A (en) * 1996-02-09 1998-06-09 Quadrant Holdings Cambridge Ltd. Rapidly soluble oral solid dosage forms, methods of making same, and compositions thereof
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US6632648B1 (en) 1996-05-14 2003-10-14 Elan Drug Delivery Limited Methods of terminal sterilization of fibrinogen
US6468782B1 (en) 1996-12-05 2002-10-22 Quadrant Healthcare (Uk) Limited Methods of preserving prokaryotic cells and compositions obtained thereby
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US7871598B1 (en) 2000-05-10 2011-01-18 Novartis Ag Stable metal ion-lipid powdered pharmaceutical compositions for drug delivery and methods of use
DK1280520T4 (en) 2000-05-10 2018-06-25 Novartis Ag Phospholipid based powders for drug delivery
US8404217B2 (en) 2000-05-10 2013-03-26 Novartis Ag Formulation for pulmonary administration of antifungal agents, and associated methods of manufacture and use
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Cited By (103)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4062932A (en) * 1975-03-10 1977-12-13 University Of Southern California Process for the catalytic oxidation of hydrogen sulfide with sulfur dioxide
US4134943A (en) * 1975-12-16 1979-01-16 Boehringer Mannheim Gmbh Production of porous tablets
US4568547A (en) * 1979-08-30 1986-02-04 Herschler R J Solid pharmaceutical compositions comprising MSM and their production
US4883182A (en) * 1985-05-31 1989-11-28 Hughes Raymond J Tamper evident capsule and insert device
US5516530A (en) * 1991-12-20 1996-05-14 Pfizer Inc. Porous shaped delivery devices and method of producing thereof
US5853758A (en) * 1992-01-13 1998-12-29 Pfizer Inc. Preparation of tablets of increased strength
US5529789A (en) * 1992-03-17 1996-06-25 Pfizer, Inc. Method of producing porous delivery devices
US8945618B2 (en) 1996-06-14 2015-02-03 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
US8071128B2 (en) 1996-06-14 2011-12-06 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
US8357396B2 (en) 1996-06-14 2013-01-22 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
EP1598061A1 (fr) * 1996-06-14 2005-11-23 Kyowa Hakko Kogyo Co., Ltd. Comprimé intra-oral à désintégration rapide
KR100481583B1 (ko) * 1996-06-14 2005-07-12 교와 핫꼬 고교 가부시끼가이샤 구강내에서빠르게붕괴하는정제
EP0914818B1 (fr) * 1996-06-14 2005-06-08 Kyowa Hakko Kogyo Co., Ltd. Comprime intra-oral a desintegration rapide
US20030215500A1 (en) * 1996-06-14 2003-11-20 Motohiro Ohta Intrabuccally rapidly disintegrating tablet and a production method of the tablets
US8956650B2 (en) 1996-06-14 2015-02-17 Kyowa Hakko Kirin Co., Ltd. Intrabuccally rapidly disintegrating tablet and a production method of the tablets
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CH579394A5 (fr) 1976-09-15
FR2199973A1 (fr) 1974-04-19
SE395366B (sv) 1977-08-15
AT324568B (de) 1975-09-10
IT998618B (it) 1976-02-20
DE2246013A1 (de) 1974-03-28
GB1381588A (en) 1975-01-22
JPS4969819A (fr) 1974-07-05
FR2199973B1 (fr) 1979-01-05

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