Gellan gum tablet film coating

Details Gellan gum tablet film coating Gellan gum tablet film coating

2000-05-12

2003-10-21

Webman, Edward J. (Department: 1617)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S481000

Reexamination Certificate

active

06635282

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 gellan gum coated tablet, a tablet coated with a gellan gum composition, a gellan gum composition useful to coat a tablet, a method for coating a tablet with gellan gum, and a method of using a gellan gum coated tablet.
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 hydroxypropylmethyl-cellulose (HPMC). Usually a HPMC solution of about 10% weight with a viscosity below 1000 cps. (centipoise), with or without an 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.
In addition to the aesthetics and economics, tablet coatings are required to release the drug in the tablet. To do this, tablets coatings must have minimal or no detrimental effect on dissolution and disintegration tests that are performed on tablets.
OBJECTS OF THE INVENTION
It is an objective of the invention to provide a gellan gum film coated tablet.
It is another objective of this invention to provide a film coated tablet having a coating composition comprising gellan gum.
It is an additional objective of this invention to provide a gellan gum composition useful for coating tablets.
It is yet another objective of this invention to provide a process for preparing a film coated tablet.
It is another objective of this invention to provide a gellan gum coated placebo or a film 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, better taste, being swallowable with little or no accompanying liquid and easier to swallow than commercially available forms, and the like.
The above objectives and other objectives are met in this invention which is more particularly described hereinafter without limitation.
SUMMARY OF THE INVENTION
In one embodiment, this invention comprises a film coated tablet, the coating comprising gellan gum, a plasticizer, and a disintegration aid. Optionally, the coating further comprises a slip enhancer. In another embodiment, the tablet comprises a placebo or an active drug or pharmaceutical wherein the placebo or drug is film coated with the gellan gum film coating. In another embodiment this invention further comprises coating a tablet with an aqueous gellan gum composition comprising the steps of admixing gellan gum, a plasticizer, a disintegration aid, optionally a slip enhancer, and water under effective shear conditions to prepare an aqueous gellan gum coating composition and applying the same in an adherent fashion to a tablet whereby a gellan gum film coated tablet and optionally 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 film coated tablet, the coated tablet having a film coating comprising gellan gum, a plasticizer, a disintegration aid and optionally a slip enhancer; the tablet containing a therapeutically effective amount of a drug beneficial to said patient. Other embodiments of this invention are included herein and are described in more detail hereinafter.


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“Simple Films and coatings made with Gellan Gum” Research Disclosure, Kelco Division of Merck and Co., Inc., May1994.
“Gellan Gum Coating and Adhesion Systems” Research Disclosure, Kelco Division of Merck and Co., Inc. Jun. 1993.

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