Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
1999-10-11
2002-11-26
Webman, Edward J. (Department: 1617)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S481000, C514S777000
Reexamination Certificate
active
06485747
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to tablet coating(s) on active drugs and to a method to prepare compositions useful to coat active drugs. More particularly this invention relates to a drug coated with gellan gum, a method to prepare a gellan gum composition useful to coat an active drug, a gellan gum composition useful to coat an active drug(s), and to a method for coating active drugs(s) with gellan gum. In particular this invention relates to an intact active tablet comprising an active ingredient 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, coated with gellan gum, a method to prepare a gellan gum composition useful to coat one or more of the aforementioned actives, mixtures thereof and the like, and to a method for coating one or more of the aforementioned actives, mixtures thereof and the like, with gellan gum.
BACKGROUND OF THE INVENTION
Tablets are typically used to deliver a pharmacologically effective amount of a therapeutic active (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. Effective consumption is achieved by oral or rectal administration to a patient for example.
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(s) which provides enhanced tablet coating properties on an active but a coating that can be applied with conventional equipment in a comparable or shorter period of time than existing technologies and systems, providing an intact coated tablet which has been effectively coated with gellan gum at a relatively low coating amount and achieving a low weight gain. The industry has recognized the need for an improved intact tablet coating especially for the aforementioned activities, 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 for the aforementioned activities economically and efficiently continues to be of interest.
OBJECTS OF THE INVENTION
It is an object of this invention to provide an intact active tablet with an active ingredient(s) wherein said active is selected from the group consisting of aspirin, naproxin sodium, naproxin sodium, acetaminophen, celecoxib, oxaprozin, sildenafil citrate, alendronate sodium, analgesic in combination with another drug, and the like, coating comprising gellan gum and gellan gum combinations.
It is another object of this invention to provide one or more ingredients (from the aforementioned active ingredients) coated with gellan gum.
It is an additional object of this invention to provide a process for preparing a gellan gum composition useful for coating such one or more of the aforementioned actives.
It is yet an additional other object of this invention to provide a process for preparing one or more such actives having a coating comprising gellan gum.
It is still another object of this invention to provide an improved process for preparing a gellan gum composition useful for coating such active drugs.
It is yet still an additional object of this invention to provide an active tablet having one or more enhanced properties such as being intact, having higher gloss, having better mouthfeel, possessing non-tackiness, being swallowable with little or no accompanying liquid having better taste and the like.
The above objects and other objects are met in this invention which is more particularly described hereinafter without limitation.
BRIEF SUMMARY OF THE INVENTION
In one embodiment, this invention comprises an intact active tablet with an active ingredient selected from the group consisting of aspirin, naproxen sodium, acetaminophen, ibuprofen, celecoxib, oxaprozin, sildenafil citrate, alendronate sodium, an analgesic in combination with one or more of an antitussive, antihistamine, decongestant and expectorant, mixtures thereof and the like having a coating comprising gellan gum. In another embodiment this invention further comprises a process for preparing a gellan gum composition useful for coating such an active such as those mentioned herein which comprises the steps of drixing 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 such as to one or more of the actives mentioned herein whereby a gellan gum coated intact active tablet is formed and thereafter optionally drying the same. In yet another embodiment of this invention, this invention comprises a method of treatment for a patient (in need of treatment) which comprises administering to a patient a therapeutically effective amount of a coated intact tablet active such as those mentioned herein, wherein said coated intact active tablet comprises an active such as these mentioned herein coated with gellan gum and which contains a therapeutically effective amount of active(s) 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®. However, Gellan gum useful herein includes any 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 which are made up of constituent sugars (Glucose, Glucuronic acid and Rhamnose) in a molar ratio of 2:1:1 and are linked together to give a primary structure consisting of a linear tetrasacchoride repeating unit. Kelcogel® and Gelrite® are registered trademarks of Monsanto Company, 800 North Lindbergh Blvd., St. Louis, Mo., 63167 U.S. 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 propylene glycol or polyethylene glycol 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 includ
Barkley Aaron
Callahan Timothy Patrick
Flanagan John
Nicholson Richard E.
Smith Terry L.
Banner & Witcoff , Ltd.
Monsanto Company
Webman Edward J.
LandOfFree
Coated active tablet(s) does not yet have a rating. At this time, there are no reviews or comments for this patent.
If you have personal experience with Coated active tablet(s), we encourage you to share that experience with our LandOfFree.com community. Your opinion is very important and Coated active tablet(s) will most certainly appreciate the feedback.
Profile ID: LFUS-PAI-O-2951226