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WO2001026633A1 - Comprimes enrobes de gomme de caroube, de gomme de guar ou de gomme de mousse d'irlande - Google Patents

Comprimes enrobes de gomme de caroube, de gomme de guar ou de gomme de mousse d'irlande Download PDF

Info

Publication number
WO2001026633A1
WO2001026633A1 PCT/US2000/028001 US0028001W WO0126633A1 WO 2001026633 A1 WO2001026633 A1 WO 2001026633A1 US 0028001 W US0028001 W US 0028001W WO 0126633 A1 WO0126633 A1 WO 0126633A1
Authority
WO
WIPO (PCT)
Prior art keywords
drug
tablet
gum
coated
aspirin
Prior art date
Application number
PCT/US2000/028001
Other languages
English (en)
Inventor
John Flanagan
Terry L. Smith
Aaron Barkley
Richard E. Nicholson
Timothy P. Callahan
Original Assignee
Monsanto Company
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Monsanto Company filed Critical Monsanto Company
Priority to AU11950/01A priority Critical patent/AU1195001A/en
Publication of WO2001026633A1 publication Critical patent/WO2001026633A1/fr

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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
    • A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
    • A61K9/2806—Coating materials
    • A61K9/2833—Organic macromolecular compounds
    • A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin

Definitions

  • This invention relates generally to a hydrocoUoid coated tablet, to a hydrocoUoid tablet coating, to a method to prepare hydrocoUoid compositions useful to coat such tablet(s), a method for treating patients using such tablets and to an article of manufacture comp ⁇ sing such a tablet(s) More particularly, this invention relates to a tablet comp ⁇ sing one or more active mgred ⁇ ent(s) including but not limited to aspi ⁇ n, ibuprofen, naproxen sodium, acetaminophen, celecoxib, oxaprozin, sildenafil citrate, alendronate sodium, mixtures thereof and optimally an analgesic in combination with one or more of an antihistamine, antitussive, decongestant, expectorant and mixtures thereof, or the like, combinations thereof, and with other medications and the like, coated with a hydrocollo ⁇ d(s) selected from the group consisting of locust bean gum (Galactomannans), guar gum
  • Tablets are used typically to deliver a pharmacologically effective amount of a therapeutic drug to humans and animals so as to provide medicinal benefit to the human or animal
  • therapeutically effective drugs include (but are not limited to) a drug or a suitable mixture of drug(s) that possess and produce desirable physiological effects after effective consumption by the human or animal
  • drugs include but are not limited to a med ⁇ cme(s)
  • consumption methods include oral (swallowing) or rectal, for example by the human or animal so that the drug is made effectively available internally to the human or animal
  • HPMC is a useful coating for tablets
  • present tablet coating compositions which include HPMC the industry contmues to desire a product which provides enhanced tablet coating.
  • the process of preparing and method of administering an improved and enhanced tablet coating continues to be of interest.
  • a hydrocoUoid selected from the group consisting of locust bean gum (Galactomannans), guar gum, carrageenan gum, and mixtures thereof preferably with a low weight gain attribute of the coating on a coated tablet.
  • a hydrocoUoid selected from the group consisting of locust bean gum (Galactomannans), guar gum, carrageenan gum, and mixtures thereof which has a low weight coating.
  • a hydrocoUoid selected from the group consisting of locust bean gum (Galactomannans), guar gum, carrageenan gum and mixtures thereof.
  • active ingredients illustrated aspirin, acetaminophen, ibuprofen, naproxen sodium, celecoxib, oxaprozin, sildenafil citrate, alendronate sodium, and optionally their combination products with antihistamines, antitussives, decongestants and expectorants
  • This invention comprises a tablet coating comprising a hydrocoUoid selected from the group consisting of locust bean gum (Galactomannans), guar gum, carrageenan gum, mixtures thereof and the like.
  • this invention comprises a process for preparing such a suitable hydrocoUoid tablet coating composition.
  • this invention comprises a process for effectively administering a tablet coated in accordance with this invention to a human or animal patient.
  • this invention comprises the effective administration of a hydrocoUoid coated tablet of this invention may be by oral or rectal delivery to a human or animal and typically includes a medicine as a drug in a therapeutically effective amount whereby the drug is made effectively available to the patient for consumption.
  • Other embodiments follow in the specification.
  • Hydrocolloids useful in this invention are selected from the group consisting of locust bean gum (Galactomannans), guar gum, carrageenan, mixtures thereof and the like.
  • Active ingredients which may be coated in this invention include illustratively without lint pharmaceutical active ingredients such as celecoxib, oxaprozin, sildenafil citrate, alendronate sodium, and optimally an analgesic in combination with one or more of an antihistamine, antitussive, decongestant, expectorant, mixture thereof and the like, and over the counter (OTC) drugs such as those typically delivered in a suitable tablet dosage form including for example, medicines for humans and animals taken as for example by ingestion.
  • lint pharmaceutical active ingredients such as celecoxib, oxaprozin, sildenafil citrate, alendronate sodium, and optimally an analgesic in combination with one or more of an antihistamine, antitussive, decongestant, expectorant, mixture thereof and the like
  • OTC counter
  • Illustrative examples include but are not limited to analgesics and antipyretic and anti-inflammatory(s) such as aspirin, acetaminophen, ibuprofen, naproxen sodium B; - phacetine, steroids including anti-inflammatory steroids, enzymes, proteins, antibiotics, mixtures thereof and the like.
  • analgesics and antipyretic and anti-inflammatory(s) such as aspirin, acetaminophen, ibuprofen, naproxen sodium B; - phacetine, steroids including anti-inflammatory steroids, enzymes, proteins, antibiotics, mixtures thereof and the like.
  • decongestants antitussives, expectorants, antihistamines
  • any one or a combination of the active ingredients disclosed herein if desired.
  • Such decongestants, antitussives, expectorants and antihistamines are illustrated below and are not limited:
  • Decongestants Pseudoephedrine, Phenylpropanolamine, Ephedrine, Epinephrine, Phenylephrine, Naphazoline, Xylometazoline, Oxymetazoline); Antitussives (Codeine, Dextromethorphan, Diphenhydramine, Benzonatate, Chlophedianol, Noscapine, Carbetapentane Citrate); Expectorants (Guaifenesin, Iodine Products, Terpinhydrate, Ammonium Chloride, Beechwood Creosote, Potassium, Guaiacolsufonate, Syrup Ipecac); and Atnihistamines (Pheniramine, Thonzylamine, Phenyltoloxamine, Doxylamine, Diphenhydramine, Carbinoxamine, Clemastine, Tripelennamine, Pyrilamine Maleate, Chlorpheniramine, Dexchlo henir
  • tablets are medicinal tablets for humans or animals.
  • the tablets include but are not limited to tablets of an convenient composition which may or may not contain any pharmaceutically effective drug, vitamin, or nutrient or drugs suitable for human and/or animal consumption. Ibuprofen and acetaminophen are preferred actives herein.
  • Colors and pigments may be employed in coatings of this invention and include those, without limit, of Jeffries, U.S. Patent No. 3,149,040; Butler et al. U.S. Patent No. 3,297,535; and Colorcon, U.S. Patent No. 3,981,984. All three of these U.S. Patents are incorporated herein by reference in their entirety.
  • tablette includes without limit, tablet, caplet, particle, micronized particle, particulate, pellet, pill, core, powder, granule, granulated, small mass, seed, speck, sphere, crystal, bead, agglomerate, and mixtures thereof and the like.
  • the tablet will be in a form sufficient stable physically and chemically to be effectively coated in a system which involves some movement of the tablet, as for example in a fluidized bed, such as in a fluidized bed dryer or a side vented coating pan, combinations thereof and the like.
  • Virtually any tablet, placebo, the latter typically lactose or sugar or mixtures thereof and the like is acceptable herein as a tablet to be coated in the practice of this invention.
  • the amount of coating employed herein is preferably an effective adherent amount.
  • One or more layers of coating may be employed. Continuous or nearly continuous or semicontinuous coating may be employed if desired.
  • a tablet(s) to be coated herein may be preferably inserted into either a side vented coating pan or a fluid bed coating apparatus.
  • the candidate gum or mixtures thereof may be mixed into aqueous solution using a standard laboratory mixer (high shear). To facilitate getting into solution heat may or may not be used. Plasticizer or surfactant material may or may not be incorporated into the coating solution preparation.
  • the coating solution is then preferably applied as for example, by spraying (pumping systems may vary from peristaltic, to gear pumps, to positive displacement pumps, etc.) onto the tablet(s) to be coated at conventional equipment settings (air flow, spray rates, process temperatures, nozzle selection, air volumes, etc.)
  • spraying may vary from peristaltic, to gear pumps, to positive displacement pumps, etc.
  • conventional equipment settings air flow, spray rates, process temperatures, nozzle selection, air volumes, etc.
  • the percentage solids in the hydrocoUoid coating composition of this invention is generally in the range from about 0.05% to about 4% solids, while a preferred range is about 0. 1% to about 2% solids and a more preferred range is about 0.5% to about 1.5% solids.
  • a preferred range is about 0. 1% to about 2% solids and a more preferred range is about 0.5% to about 1.5% solids.
  • greater as well as lesser concentrations of solids in the hydrocoUoid coating compositions of this invention may be employed depending on a number of factors including the selection of hydrocoUoid or hydrocolloids, tablet or tablets to be coated.
  • the amount of weight gain of a tablet is generally in the range from about 0.05% to about 3%, more preferably in the range from about 0.10% to about 1% and most preferably from about 0.2% to about 0.5% although those of skill in the art will recognize that greater or lesser weight gains may be employed if desired as long as an effective weight gain is employed.
  • the temperatures and operating conditions of the process of this invention may be varied as desired to produce a quality product of this invention.
  • the amount of coating weight on the coated tablet is very important in that the lower weight gain is highly desirable as such aids in more cost effective processing and preparation of the tablets - yet a highly effective tablet coating is provided.
  • Any acceptable coating application system may be employed in this invention which has the capability to apply a gum coating composition of this invention to a suitable tablet.
  • a plain fluid bed system one with or without a Wurster insert
  • a fluid bed spray tower may be employed.
  • Air suspension coating systems useful herein include but are not limited to those described in Ullman's Encyclopedia of Industrial Chemicals Volume A16 pages 583- 0584 (1990) includes a description of the Wurster process and is incorporated herein by reference in its entirety.
  • Side vented coating pan systems, spray drying systems, continuous coating pans, conventional coating pans are useful in the practice of this invention as is a fluid bed dryer such as those with or without a Wurster type insert.
  • Examples 1- 3, hereinafter following, are provided to illustrate the preparation of acceptable coated tablets in accordance with this invention and are provided by way of illustration and are not intended to limit the invention in any way. All percents and any parts are by weight unless otherwise indicated.
  • Various application systems including fluidized feed systems and pan side vented coating systems are illustrated without limitation.
  • locust bean gum, carrageenan gum and guar gum as coatings for tablets (active drug ingredients) was successfully done in Examples 1-3 to observe visual appearance after being coated on actives as regards coating capability. Overall functionality and appearance was observed.
  • Examples 1-3 following a 15" Accela-Cota coating pan with a peristaltic pump and spraying apparatus was employed to prepare acceptable hydrocoUoid coated active (medicinal) drugs.
  • actives aspirin, acetaminophen, sodium naproxen, ibuprofen, aspirin with caffeine, buffered aspirin, multi-vitamins and combinations. These actives were added to uncoated 3/8" concave placebos where final charge was 1.9 kg.
  • Guar gum was added to DI water and heated to 60°C. After dissolving, 525.7 grams was sprayed (50°C) onto tablets of each of aspirin, acetaminophen, sodium naproxen, ibuprofen, aspirin with caffeine, buffered aspirin, and multi-vitamins and combinations to a 0.20% weight gain.
  • Carrageenan gum was added to DI water and heated to 50°C. After dissolving. 298 grams was sprayed (50°C) onto tablets of aspirin, acetaminophen, sodium naproxen, ibuprofen, aspirin with caffeine, buffered aspirin, and multi-vitamins and combinations to a 0.20% weight gain.
  • Locust Bean gum was passed through a standard screen (USP 200 mesh) to remove/break up impurities/insoluble particles. Locust Bean gum was added to DI water, and initially heated to 70°C. After dissolving was complete, 298 grams were sprayed (50°C) onto tablets to a 0.20% weight gain. In Examples 1-3 above, acceptable coated tablets were prepared by using the gums of this invention as film coating onto tablets with actives.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

L'invention concerne un comprimé à enrobage hydrocolloïde, un enrobage hydrocolloïde pour comprimés, un procédé de préparation de compositions hydrocolloïdes servant à enrober des comprimés, un procédé pour traiter des patients au moyen de comprimés, un article manufacturé comprenant l'aspirine, l'ibuprofène, le naproxène sodique, l'acétaminophène, le célécoxib, l'oxaprozine, le sidénafil citrate, l'alendronate sodique, leurs combinaisons et similaires et éventuellement d'autres combinaisons de médicaments actifs, éventuellement un ou plusieurs analgésiques ou un ou plusieurs antihistaminiques, décongestionnants, antitussifs ou expectorants, des mélanges ou des préparations similaires à base de ceux-ci. L'invention concerne plus particulièrement un comprimé enrobé avec un ou plusieurs hydrocolloïdes sélectionnés dans le groupe constitué de la gomme de caroube (Galactomannans), de la gomme de guar ou de gomme de mousse d'Irlande, de leurs mélanges et similaires.
PCT/US2000/028001 1999-10-11 2000-10-11 Comprimes enrobes de gomme de caroube, de gomme de guar ou de gomme de mousse d'irlande WO2001026633A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU11950/01A AU1195001A (en) 1999-10-11 2000-10-11 Tablets coated with locust bean gum, guar gum or carrageenan gum

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US41617499A 1999-10-11 1999-10-11
US09/416,174 1999-10-11

Publications (1)

Publication Number Publication Date
WO2001026633A1 true WO2001026633A1 (fr) 2001-04-19

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PCT/US2000/028001 WO2001026633A1 (fr) 1999-10-11 2000-10-11 Comprimes enrobes de gomme de caroube, de gomme de guar ou de gomme de mousse d'irlande

Country Status (2)

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AU (1) AU1195001A (fr)
WO (1) WO2001026633A1 (fr)

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004075828A3 (fr) * 2003-02-27 2004-10-28 Lek Pharmaceuticals Composition pharmaceutique a base d'acide alendronique, de sels ou d'esters de celui-ci et procede de preparation de cette composition
US6932861B2 (en) 2000-11-28 2005-08-23 Fmc Corporation Edible PGA coating composition
US7429619B2 (en) 2002-08-02 2008-09-30 Mcneil Consumer Healthcare Polyacrylic film forming compositions
US7635490B2 (en) 2001-09-28 2009-12-22 Mcneil-Ppc, Inc. Modified release dosage form
US7785650B2 (en) 2001-05-15 2010-08-31 Mcneil-Ppc, Inc. Method for dip coating dosage forms
US7838026B2 (en) 2001-09-28 2010-11-23 Mcneil-Ppc, Inc. Burst-release polymer composition and dosage forms comprising the same
US8114328B2 (en) 2001-09-28 2012-02-14 Mcneil-Ppc, Inc. Method of coating a dosage form comprising a first medicant
CN102600210A (zh) * 2012-04-10 2012-07-25 湖北凤凰白云山药业有限公司 一种复方氢溴酸右美沙芬糖浆剂及其制备方法
US8309118B2 (en) 2001-09-28 2012-11-13 Mcneil-Ppc, Inc. Film forming compositions containing sucralose
US10232045B2 (en) 2016-08-04 2019-03-19 Bpsi Holdings Llc Easy to swallow coatings and substrates coated therewith

Citations (6)

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Publication number Priority date Publication date Assignee Title
US4652313A (en) * 1984-10-24 1987-03-24 Crompton And Knowles Corporation Aqueous lake pigment suspension
JPS62111917A (ja) * 1985-11-11 1987-05-22 Sato Seiyaku Kk 糖衣被覆錠剤
US5096714A (en) * 1988-06-28 1992-03-17 Hauser-Kuhrts, Inc. Prolonged release drug tablet formulations
US5422121A (en) * 1990-11-14 1995-06-06 Rohm Gmbh Oral dosage unit form
EP0974344A2 (fr) * 1998-07-23 2000-01-26 Samyang Corporation Composition et forme du dosage pharmaceutique faite en polysaccharides permettant une libération controllée au côlon
WO2000045794A1 (fr) * 1999-02-08 2000-08-10 Fmc Corporation Composition d'enrobage comestible

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4652313A (en) * 1984-10-24 1987-03-24 Crompton And Knowles Corporation Aqueous lake pigment suspension
JPS62111917A (ja) * 1985-11-11 1987-05-22 Sato Seiyaku Kk 糖衣被覆錠剤
US5096714A (en) * 1988-06-28 1992-03-17 Hauser-Kuhrts, Inc. Prolonged release drug tablet formulations
US5422121A (en) * 1990-11-14 1995-06-06 Rohm Gmbh Oral dosage unit form
EP0974344A2 (fr) * 1998-07-23 2000-01-26 Samyang Corporation Composition et forme du dosage pharmaceutique faite en polysaccharides permettant une libération controllée au côlon
WO2000045794A1 (fr) * 1999-02-08 2000-08-10 Fmc Corporation Composition d'enrobage comestible

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
BAWEJA J M ET AL: "MODIFIED GUAR GUM AS FILM FORMER", PHARMAZIE,VEB VERLAG VOLK UND GESUNDHEIT. BERLIN,DD, vol. 54, no. 9, September 1999 (1999-09-01), pages 678 - 681, XP000851020, ISSN: 0031-7144 *
DATABASE WPI Section Ch Week 198726, Derwent World Patents Index; Class B07, AN 1987-181872, XP002159536 *

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6932861B2 (en) 2000-11-28 2005-08-23 Fmc Corporation Edible PGA coating composition
US7785650B2 (en) 2001-05-15 2010-08-31 Mcneil-Ppc, Inc. Method for dip coating dosage forms
US7635490B2 (en) 2001-09-28 2009-12-22 Mcneil-Ppc, Inc. Modified release dosage form
US7838026B2 (en) 2001-09-28 2010-11-23 Mcneil-Ppc, Inc. Burst-release polymer composition and dosage forms comprising the same
US8114328B2 (en) 2001-09-28 2012-02-14 Mcneil-Ppc, Inc. Method of coating a dosage form comprising a first medicant
US8309118B2 (en) 2001-09-28 2012-11-13 Mcneil-Ppc, Inc. Film forming compositions containing sucralose
US8673190B2 (en) 2001-09-28 2014-03-18 Mcneil-Ppc, Inc. Method for manufacturing dosage forms
US7429619B2 (en) 2002-08-02 2008-09-30 Mcneil Consumer Healthcare Polyacrylic film forming compositions
WO2004075828A3 (fr) * 2003-02-27 2004-10-28 Lek Pharmaceuticals Composition pharmaceutique a base d'acide alendronique, de sels ou d'esters de celui-ci et procede de preparation de cette composition
EA009333B1 (ru) * 2003-02-27 2007-12-28 Лек Фармасьютиклз Д.Д. Фармацевтическая композиция алендроновой кислоты, ее солей или сложных эфиров и способ ее получения
CN102600210A (zh) * 2012-04-10 2012-07-25 湖北凤凰白云山药业有限公司 一种复方氢溴酸右美沙芬糖浆剂及其制备方法
US10232045B2 (en) 2016-08-04 2019-03-19 Bpsi Holdings Llc Easy to swallow coatings and substrates coated therewith

Also Published As

Publication number Publication date
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