Gellan gum tablet coating

Details Gellan gum tablet coating Gellan gum tablet coating

2002-04-30

2003-09-30

Webman, Edward J. (Department: 1617)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S479000

Reexamination Certificate

active

06627225

ABSTRACT:

FIELD OF THE INVENTION
This invention relates generally to tablet coatings and to a method to prepare compositions useful to coat tablets. More particularly this invention relates to a tablet coated with gellan gum, use of gellan gum as a coating, a method to prepare a gellan gum composition useful to coat tablets, a gellan gum composition useful to coat tablet(s), and to a method for coating tablet(s) with gellan gum.
BACKGROUND OF THE INVENTION
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. Typically such therapeutically effective drugs include those drugs that possess and produce desirable drug effects after effective consumption by the human or animal.
In medicinal uses, 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.
Many medicinal tablet coatings today are low viscosity hydroxypropylmethylcellulose (HPMC). Usually a HPMC solution of about 10% weight with a viscosity below 1000 cps. (centipoise), with appropriate plasticizer, is applied by a spraying system or device to a tablet in a coating process.
Even with the foregoing and other tablet coating compositions, the industry continues to desire a product which provides enhanced tablet coating properties. The industry has recognized the need for an improved tablet coating which would provide increased gloss, better mouthfeel at coating quantities at lower levels than conventionally accepted methods, for example. The process of preparing such an improved tablet coating economically and efficiently continues to be of interest.
OBJECTS OF THE INVENTION
It is an objective of this invention to provide a tablet coating comprising gellan gum.
It is another objective of this invention to provide a tablet coated with gellan gum.
It is an additional objective of this invention to provide a process for preparing a gellan gum composition useful for coating tablets.
It is yet another objective of this invention to provide a process for preparing a coated tablet such as a coated placebo or a coated pharmaceutical tablet comprising an active drug.
It is yet still an additional objective of this invention to provide a tablet having one or more enhanced properties such as higher gloss, better mouthfeel, non-tackiness, being swallowable with little or no accompanying liquid, better taste and the like.
The above objectives and other objectives are met in this invention which is more particularly described hereinafter without limitation.
BRIEF SUMMARY OF THE INVENTION
In one embodiment, this invention comprises a tablet coating comprising gellan gum. In another embodiment, this invention further comprises a placebo or an active drug or pharmaceutical wherein the placebo or drug is coated with gellan gum. In another embodiment this invention further comprises a process for preparing a gellan gum composition useful for coating a placebo or a coated pharmaceutical tablet which comprises the steps of admixing gellan gum and water under effective shear conditions to prepare an aqueous gellan gum coating composition thereof. In another embodiment this invention further comprises preparing the aforementioned aqueous gellan gum coating composition and applying the same in an adherent fashion to a placebo or a tablet containing a pharmaceutical whereby a gellan gum coated placebo or gellan gum coated pharmaceutical tablet is formed and thereafter drying the same. In yet another embodiment of this invention, this invention comprises a method of treating a patient in need of treatment which comprises administering to the patient a therapeutically effective amount of a coated tablet, wherein said coated tablet comprises a tablet coated with gellan gum and which contains a therapeutically effective amount of a therapeutically effective drug beneficial to said patient. Other embodiments of this invention are included herein and are described in more detail hereinafter.
DETAILED DESCRIPTION OF THE INVENTION
Gellan gum useful herein 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 Boulevard, St. Louis, Mo. 63167, USA. Typical brand names include KELCOGEL® and GELRITE®. Gellan gum useful herein includes any form available form such as but not limited to, non-clarified, clarified, and partially-clarified native, deacetylated and 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. Pat. Nos. 4,326,052 and 4,385,123 both of which are incorporated herein their entirety by reference.
Optional components of the gellan gum aqueous coating composition of this invention may include but are not limited to a color additive(s) and/or other coating polymers as will be readily apparent to those of skill in the art in particular after reading this specification. A typical plasticizer is glycerine although any equivalent or substantially equivalent plasticizer may be satisfactorily employed herein if desired.
The scope and utility of the present invention is not limited to any active ingredient. Active ingredients which may be effectively coated using this invention are not limited and include illustratively pharmaceutical active ingredients and over-the-counter drugs (including vitamins and nutritional supplements and the like) such as those typically delivered in a tablet dosage form. Examples include but are not limited to analgesics and antiphlogistics such as aspirin, acetaminophen, phenacetin; steroids including antinflammatory steroids; enzymes, proteins, antibiotics or antimycrophotics including penicillin and its derivatives; anesthetics, vasodiolators such as nitroglycerin, anticarcinogins, sulfonamide drugs, sedatives, tranquilizing and hypnotic agents, bronchial-dilating agents, potassium chloride, mixtures thereof and the like.
The process for preparing a coated placebo or a coated (pharmaceutical) tablet comprising an active drug herein 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.
The aqueous gellan gum coating composition useful to coat tablets 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. Initially the gellan gum and water are admixed and further mixing is carried out under effective shear to form an aqueous tablet coating composition. Typically 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.
If desired, 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, polyvinylpyrolidone, mixtures thereof and the like may be employed in this invention. As employed herein, 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

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