EP1251833A1 - Produits trempes dans de la gomme gellane - Google Patents

Produits trempes dans de la gomme gellane

Info

Publication number
EP1251833A1
EP1251833A1 EP01905320A EP01905320A EP1251833A1 EP 1251833 A1 EP1251833 A1 EP 1251833A1 EP 01905320 A EP01905320 A EP 01905320A EP 01905320 A EP01905320 A EP 01905320A EP 1251833 A1 EP1251833 A1 EP 1251833A1
Authority
EP
European Patent Office
Prior art keywords
tablet
gellan gum
coating
gellan
dip
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.)
Withdrawn
Application number
EP01905320A
Other languages
German (de)
English (en)
Inventor
John Flanagan
Susan M. Grillo
Terry L. Smith
Timothy P. Callahan
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Monsanto Co
Original Assignee
Monsanto Co
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 Co filed Critical Monsanto Co
Publication of EP1251833A1 publication Critical patent/EP1251833A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
    • 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
    • A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
    • 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 to gellan gum dipped products. More particularly this invention relates to medicinal tablet product(s) which have been dipped in gellan gum or gellan gum blends.
  • Tablets are typically used 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 those active drugs that possess and produce desirable drug effects after effective consumption by the human or animal.
  • one or more coatings is desired on a medicinal tablet in order to obtain one or more of gloss, better appearance, identification, mouthfeel, stability, color, swallowability, improved taste and the like.
  • Gelatin is used as a tablet coating.
  • gelatin based products are manufactured using several steps that require the tablets to be dipped into gelatin. Amidst the mad cow disease concerns, where potential use of gelatin may be in jeopardy, use of gellan and gellan blends to dip tablets are an alternative. Also, the gelatin-dipping process is a time-consuming process. By developing a gellan-based system, at least one dipping step is eliminated which is a cost savings.
  • a need exists in the industry for a process for preparing gellan gum dipped pharmaceutically acceptable dipped products. Even with the foregoing and other tablet coating and dipped compositions, the industry continues to desire a process and a product which provides enhanced tablet coating (dipped) properties.
  • This invention comprises a process for preparing a gellan gum dipped product, a gellan gum dipped product and a method of use for a gellan gum dipped product.
  • a dippable gellan gum aqueous composition comprising gellan gum and a tablet (such as an active drug(s))having acceptability to the gellan gum present in the dippable gellan gum composition is contacted by dipping the tablet in the dippable composition.
  • a dipped gellan gum product is thereby prepared.
  • the dipped gellan gum product having a partial or complete coating resulting from the aforedescribed dipping is thereafter made available to a patient for consumption as by having the patient swallow the gellan gum dipped tablet.
  • gellan gum is that produced by inoculating a carefully formulated fermentation medium with the microorganism Sphingamonas elodea (ATTC 31461). Gellan Gum is available from Monsanto Company, 800 North Lindbergh
  • Gellan gum useful herein includes any form available form such as but not limited to, non-clarified, clarified, and partially-clarified native, deacetylated, partially deacetylated forms as well as mixtures thereof and the like. Kelcogel® and Gelrite® are registered trademarks of Monsanto Company. Gellan gum may be prepared according to the methods disclosed in U.S. Patent 4,326,052 and 4,385,123 both of which are incorporated herein their entirety by reference.
  • the process for preparing a coated placebo or a coated (pharmaceutical) tablet comprising an active drug herein such as aspirin, ibuprofen and the like comprises the steps of admixing gellan gum and water under effective shear, heat and ionic conditions to prepare an aqueous gellan gum coating composition and applying the aqueous gellan gum coating composition in an effective fashion to a placebo or to a tablet such as one comprising a pharmaceutical whereby a gellan coated placebo or coated pharmaceutical tablet is formed.
  • a drying step typically occurs and typically follows.
  • this invention relates to an intact active tablet useful herein comprising an active drug (biologically active ingredient) such as but not limited to those selected from the group consisting of aspirin, naproxen sodium, acetaminophen, ibuprofen, celecoxib, oxaprozin, sildenafil citrate, alendronate sodium, mixtures thereof and the like and optimally an analgesic in combination with one or more of an antihistamine, antitussive, decongestant, and expectorant and mixtures thereof and the like, dip coated with gellan gum, a method to prepare a dip coated gellan gum composition useful to effectively dip coat one or more of the aforementioned actives, mixtures thereof and the like, and to a method for effectively dip coating one or more of the aforementioned actives, mixtures thereof and the like, with gellan gum or blends thereof.
  • an active drug biologically active ingredient
  • a dippable gellan gum composition of this invention comprises a gellan gum composition which is dippable, i.e., a composition which will accept a tablet dipped into it.
  • a tablet is employed which physically can be dipped into a dippable gellan gum composition of this invention and upon removal of the dipped tablet from the gellan gum composition a portion (an effective amount) of the gellan gum from the gellan gum composition adheres to the dipped tablet to provide a partial or complete effective dip coating thereon.
  • the aqueous gellan gum coating composition useful to coat tablets such as aspirin, ibuprofen and the like is preferably admixed in any suitable container or the like prior to applying the gellan gum composition to or on a tablet to be coated.
  • the gellan gum and water are admixed and further mixing is carried out under effective shear to form an aqueous tablet coating composition.
  • the gellan gum coating aqueous composition prior to application of such effective shear will have a viscosity in the range from about 44 cps. to about 55,500 cps. and preferably from about 2200 to about 50,000 cps although gellan gum compositions having greater and lesser viscosities may sometimes be employed depending on a number of factors.
  • gellan gum compositions comprising gellan gum and/or gellan gum and one or more of a another ingredient such as a polymer such as, but not limited to, those selected from the group consisting of hydroxypropyl celleulose, hydroxypropyl methyl cellulose, sodium carboxymethyl cellulose, sugar, aspartame, maltodextrin, tapioca dextrin, modified food starches, carrageenan, gum acacia, locust bean gum, xanthan gum, alginates, guar, corn syrup solids, polyvinylpyrrolidone, mixtures thereof and the like may be employed in this invention.
  • the term "Gellan gum” includes gellan gum and/or compositions of gellan gum with one or more of these polymers or a sugar.
  • the aqueous gellan gum composition of this invention may be mixed in or by any suitable mixing system preferably until substantially complete mixing has been accomplished. Some heating may be necessary to achieve dispersion and hydration of gellan gum.
  • the amount of shear preferably employed is an effective amount, i.e., which produces a well mixed homogenous gellan gum composition.
  • the aforementioned admixing can be carried out by any convenient means including but not limited to use of a propeller or stirrer system although generally stirring by a convenient mechanical means is acceptable. Other forms of mixing can be employed.
  • various other ingredients may be employed in the gellan gum aqueous composition include any ingredient which is compatible or can be made compatible with an aqueous gellan gum composition useful to coat tablets of this invention (such as, but not limited to, colors, color system(s), flavor(s), sweetener(s), mint(s), fragrance(s), plasticizer(s), polymers, hydrocolloids, active ingredient(s) and mixtures thereof and the like).
  • the gellan gum aqueous composition is preferably applied to the tablet(s) to be dip coated in a batch, semi-continuous or continuous process or some combination thereof in a manner which produces a satisfactorily uniformly coated tablet.
  • the gellan gum composition may be applied to tablets to be coated using any satisfactory application and drying system or combination of some application system and some drying system.
  • the concentration of gellan gum in the dippable gellan gum composition of this invention ranges by weight from about 0.01 to about 10%, preferably from about 0.05 to about 5% and most preferred from about 0.1 to about 3%.
  • the temperature of the gellan gum aqueous composition is preferably in the range from about 25°C to about 45°C although greater or lesser temperatures may be employed if desired. It is preferred that the gellan gum composition be maintained in a solution or dispersion or an applicable state during its coating application to the tablet(s) to carry out this invention.
  • Preferred tablets are medicinal tablets for humans or animals.
  • the tablets include but are not limited to tablets of any convenient composition or shape which may or may not contain any pharmaceutically effective drug vitamin or nutrient or drugs suitable for human and/or animal consumption.
  • a gellan gum dip coating may be employed on tablets which are placebos or blanks. Tablets useful herein include but are not limited to tablets which are uncoated or have been coated one or more times.
  • a gellan gum coating may be the only coating and may comprise a first coating or a second or a third coating or dip coating.
  • Illustrative colors and colorants useful herein include without limitation, pigments, dyes, lakes and oxides (including titanium dioxide) and the like, may be optionally employed with gellan gum used in practicing this invention.
  • the gellan gum aqueous composition may optionally contain a suitable color or colorants for application to a colored or noncolored coated or uncoated tablet.
  • Tablets to be dip coated according to this invention may be colored, neutral or have their natural color or may be absent color. If one of more colors, dyes lakes, or pigments or mixtures thereof are employed in a gellan gum coating composition herein, such as for example, an FDA certified color, dye, lake, or pigment, the color or combination of colors is not critical and may be selected by those of skill in the art based upon a need at the time of the coating operation.
  • suitable pigments which are useful in this invention include, without limitation, FD&C and D&C lakes, titanium dioxide, magnesium carbonate, talc, pyrogenic silica, iron oxides, channel black, insoluble dyes and mixtures thereof and the like.
  • nature pigments such as riboflavin, carmine 40, curcumin, annatto, mixtures thereof and the like are acceptable herein.
  • Other examples of pigments suitable herein include, without limitation, these disclosed in Jeffries U.S. Patent No. 3,149,040 and Butler et al., U.S. Patent 3,297,535, as well as in Colorcon U.S. Patent No. ? ⁇ 81,984. These three patents are incorporated herein by reference in their entirety. In the absence of a colorant, the gellan gum composition typically produces a clear or substantially clear coating on a coated tablet.
  • the concentration of gellan gum in the dippable gellan gum composition of this invention ranges by weight from about 0.01 to about 10%, preferably from about 0.05 to about 5% and most preferred from about 0.1 to about 3%.
  • tablette includes without limitation, tablet, particle, micronized particle, particulate, pellet, pill, core, powder, granule, granulate, small mass, seed, specks, spheres, crystals, beads, agglomerates, mixtures thereof and the like.
  • the preferred tablet will be in a form sufficiently 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.
  • the application of the gellan gum aqueous composition as a coating to the tablet is preferably carried out by placing a tablet capable of receiving and adhering an effective amount of a gellan gum tablet coating composition of this invention in any acceptable coating application system.
  • An acceptable coating application system is illustratively any system which has the capability to apply an effective gellan gum coating composition of this invention to a tablet to provide an effectively, preferably uniformly dip coated tablet.
  • a preferred method of coating includes coating tablet(s) first with a colored base (for example spraying a yellow color onto the tablet) and then applying a clear gellan gum top coat.
  • the tablets are then dipped (one end only) into a pigmented system and then again (for example a red color) and dried.
  • the tablet can then be dipped into a clear gellan gum solution and allowed to dry. Additionally, the tablet can be dipped a second time and allowed to dry.
  • Dipping may be carried out by hand, machine or any convenient dipping method.
  • the gellan gum dip coated tablets of this invention may be internally consumed by humans and animals in a typical customary manner such as by swallowing, so that the biologically active dip coated drug is made available to the patient.
  • Gellan gum (amount in formula) is typically in the range by weight from about 0.01% to about 10% and preferably from about 0.05% to about 5% and most preferred from about 0.1% to about 3%.
  • Plasticizers useful herein if desired include but are not limited to:
  • Plasticizers if used are generally in the range by weight from about 0% to about 5% and preferably from about 1.0% to about 3.0% and most preferred from about 0.25% to about 0.75%.
  • Adhesion aids useful herein include but are not limited to: Lecithin, polyols, such as sorbitol, maltitol, mannitol, sylitol. Typically, adhesion aids maybe used (if desired) in the range by weight from about 0% to about 5% and are preferred in the range from about 1.0% to about 3.0% and are most preferred from about 0.25 % to about 0.75%.
  • Secondary polymers/hydrocolloids useful herein include (if desired) but are not limited to Carrageenan, Gum Acacia, Locust Bean Gum, Xanthan Gum, Alginates, Guar, Com Syrup Solids, hydroxypropyl methylcellulose (HPMC), Hydroxpropyl cellulose (HPC), lactose, Polyvinylpyrrolidone (PVP), Sodium carboxymethylcellulose (NaCMC), maltodextrin, dextrin, dextrose, polydextrose, polyvinyl alcohol (PVA). Typically, these may be useful in weight ranges from about 0% to about 5% and maybe preferably used from about 1.0% to about 3.0% and most preferred from about 0.25% to about 0.75%.
  • Example #1 Preparation of dippable gellan gum composition:
  • a gellan gum composition useful for dip coating tablets was prepared comprising 30 grams gellan gum, 1968 grams water and two grams sodium citrate to provide a 1.5% by weight gellan gum aqueous composition useful for coating tablets.
  • This aqueous dippable gellan gum composition was prepared by weighing the water into a clean dry residue free beaker and weighing out the gellan gum (Kelcogel) and sodium citrate. The water was then mixed with a laboratory mixer to create a vortex. The gellan gum powder and sodium citrate was slowly introduced into the vortex to achieve dispersion. Stirring was continued without heat to finalize the dispersion of gellan gum. Heat was applied while stirring until the dispersion temperature was about 70°C to hydrate the gellan gum. Care was taken to avoid charring the resulting dispersion, i.e. employing sufficient stirring and avoiding overheating. The beaker was removed from the stir plate and cooled to ambient temperature to make gellan gum aqueous composition(s) available for dip coating hereinafter.
  • a coating process was carried out similar to that disclosed above and using components similar thereto.
  • Step 1 Coat tablet with yellow base coat and gellan clear topcoat #1 :
  • Step 2 Dip half the tablet into a red gellan system:
  • Step 4 Single dip-using gellan clear (for dipping) #1:
  • Example #2 Dip both ends of tablet: Utilize same procedure/steps as in Example 1 with the following exception: Repeat Step #4 and 5 gain using yellow end of the tablet.
  • Example #3 Repeat dip step for a double dip of red end of the tablet: Utilize same procedure/steps as in Example 1 with the following exceptions: Repeat step #4 and 5 again using red end of the tablet.
  • Example #4 Use less weight gain for yellow base coat: Use same procedure/steps as in Example 1 with the following exceptions:
  • Step 1 1.0% weight gain of yellow gellan base coat used.
  • Step 1 Use Gellan Clear Topcoat #2
  • Step 4 Use gellan clear (for dipping) #2
  • Step 5 Dry tablets at 160-170 degrees
  • Example #7 Use different gellan clear (for dipping') #3:
  • Step 4 Use gellan clear (for dipping) #3
  • Step 5 Dry tablets at 160-170 degrees F
  • Example #8 Gellan clear sprayed onto tablets instead of gellan clear dipping step: Step 1 : Coat tablet with white gellan base coat (no clear topcoat is applied):
  • Step 2 Dip half the tablet into a red gellan system:
  • Step 2 Heat red gellan system, while stirring, to 40 degrees C. Place 3 tablets into a clamp (or suitable tablet holder) and dip tablet from Step 1 into red gellan system, remove dipped tablet from gellan gum system, and shake off excess. Repeat Step 2 with several tablets.
  • Step 3 Drying Place tablets (3 per clamp) onto metal arms suspended above column clamp, (or suitable tablet holder) which is placed directly in the center of the airflow to enhance drying. Tablets are heated at 190-200 degrees F until dry (5-10 minutes). Repeat Step 3 with several tablets.
  • Step 4 Spraying gellan clear:
  • Step 1 Use white HPMC base coat, no clear topcoat applied
  • Step 4 Use different gellan clear (for dipping) #4
  • Step 4 Use gellan blend (for dipping) #4
  • Example #11 Gellan with Gum Acacia blend:
  • Step 4 Use gellan blend (for dipping) #5
  • Example #12 Gellan with Locust Bean Gum blend:
  • Step 4 Use gellan blend (for dipping) #6
  • Example #13 Gellan with Xanthan Gum blend:
  • Step 4 Use gellan blend (for dipping) #7
  • Step 2 Use red gellan blend system
  • Examples 1-7 and 9-14 exhibited good gloss and tablet smoothness.
  • Example 8 exhibited excellent gloss and tablet smoothness. Some minimal red color transferred to white part of tablet.
  • HPMC White Base Coat Raw Material % Grams Distilled Water 13.60 17.00 Pharmacoat 606 (Shinitsu) 80.00 100.00 HPMC White Dispersion 4.80 6.00 Polyethylene Glycol 400 1.60 2.00
  • Carrageenan (Colloid 710, TIC Gums, Inc.) 0.50 0.50
  • Carrageenan (Colloid 710, TIC Gums, Inc.) 0.50 0.50
  • Step 1 The fluidized system is similar to Aeromatic Strea 1 of Niro Inc.
  • Step 2 A hot plate is used to heat the red gellan system.
  • the tablet is being dipped into this solution. At this point, the tablet is shaken to remove excess red but is still wet.
  • the tablet is then dried in Step 3.
  • Step 3 The fluidized system's base is used as a drying source but the tablets are placed around it - no tablets are fluidized/coated here.
  • the equipment is a source of heat to dry the tablets.
  • Yellow is the pigmented yellow gellan system - see page 3, 1 * formula -
  • Red is on page 5 - Red Gellan System (2 nd from top).

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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)
  • Medicinal Preparation (AREA)

Abstract

L'invention concerne un enrobage par trempage permettant d'enrober un/des comprimé(s) qui comprend de la gomme gellane, ainsi qu'un procédé consistant à mélanger de la gomme gellane et de l'eau dans des conditions de cisaillement efficaces en vue de préparer une composition désirée d'enrobage de gomme gellane aqueuse. La composition d'enrobage de gomme gellane aqueuse est appliquée par trempage de façon à adhérer à un placebo ou à un comprimé contenant un principe actif pharmaceutique, tel que l'aspirine ou analogue, pour former un placebo enrobé de gomme gellane ou un médicament actif enrobé de gomme gellane ou une aspirine enrobé de gomme gellane et analogue.
EP01905320A 2000-02-01 2001-02-01 Produits trempes dans de la gomme gellane Withdrawn EP1251833A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US17956000P 2000-02-01 2000-02-01
US179560P 2000-02-01
PCT/US2001/003287 WO2001056550A1 (fr) 2000-02-01 2001-02-01 Produits trempes dans de la gomme gellane

Publications (1)

Publication Number Publication Date
EP1251833A1 true EP1251833A1 (fr) 2002-10-30

Family

ID=22657087

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01905320A Withdrawn EP1251833A1 (fr) 2000-02-01 2001-02-01 Produits trempes dans de la gomme gellane

Country Status (3)

Country Link
EP (1) EP1251833A1 (fr)
AU (1) AU2001233213A1 (fr)
WO (1) WO2001056550A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20170224469A1 (en) 2001-04-11 2017-08-10 Andrew Kerr Stent/graft assembly
US7122143B2 (en) 2001-09-28 2006-10-17 Mcneil-Ppc, Inc. Methods for manufacturing dosage forms
US7838026B2 (en) 2001-09-28 2010-11-23 Mcneil-Ppc, Inc. Burst-release polymer composition and dosage forms comprising the same
CA2697938A1 (fr) * 2007-09-17 2009-03-26 Mcneil-Ppc, Inc. Compositions enrobees par immersion contenant un copolymere d'alcool polyvinylique et de polyethylene glycol et une gomme
US9259394B2 (en) 2009-12-07 2016-02-16 Johnson & Johnson Consumer Inc. Partial dip coating of dosage forms for modified release

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2318782A1 (fr) * 1998-03-11 1999-09-16 Xiongwei He Compositions a base d'alcool polyvinylique

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0156550A1 *

Also Published As

Publication number Publication date
WO2001056550A1 (fr) 2001-08-09
AU2001233213A1 (en) 2001-08-14

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