Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-06-05
2003-09-16
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C424S464000, C424S474000, C424S489000, C424S490000
Reexamination Certificate
active
06620426
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to tablet coating compositions, and, more particularly, to such composition having an advantageous combination of physical properties which is a mixture in predetermined proportions of sodium alginate and a polyvinylpyrrolidone-vinyl acetate copolymer.
2. Description of the Prior Art
Hydroxymethyl cellulose is a good film former; however, its films are brittle, opaque and non-slippery. Accordingly, it is desired to provide new and improved tablet coating compositions.
SUMMARY OF THE INVENTION
What is described herein is a tablet coating composition which includes a mixture of (a) sodium alginate and (b) a polyvinylpyrrolidone-vinyl acetate copolymer, and, optionally, (c) hydroxypropylmethyl cellulose, and/or hydroxypropyl cellulose.
This composition provides the tablet with a predetermined degree of luster, strength, smoothness, slipperiness, color, modified release and ease of polishing.
In the preferred form of the invention, composition (b) includes by weight, 60-80% vinylpyrrolidone and 20-40% vinyl acetate; preferably the composition has a K-value of about 25 to 34, calculated from its kinematic viscosity on a 1% aqueous solution.
Most preferably, the composition comprises, by weight, (a) 10-98%, (b) 2-20%, and (c) 0-88%.
Application formulations of the composition of the invention include a medicament, and/or a nutritional supplements.
DETAILED DESCRIPTION OF THE INVENTION
In this invention, tablets are coated with a predetermined mixture of (a) sodium alginate and (b) a polyvinylpyrrolidone-vinyl acetate copolymer, (Plasdone® S-630, International Specialty Products, Inc.), optionally with hydroxypropylmethyl cellulose, and/or hydroxypropyl cellulose.
Experimental
1. Process/Composition:
Aqueous solutions of sodium alginates (Manucol LD, 5 cps or Keltone LV, 50 cps), and Plasdone® S-630, and color lakes, were sprayed onto placebo tablets* in a Glatt fluid-bed Wurster coater. The coated tablets were characterized by their weight gain, and, subjectively, for coating uniformity, lustrousness, and slipperiness/tackiness when exposed to aqueous fluids.
* Placebo (lactose) tablets from Korsch Processing laboratory were convex tablets (7.5 mm diameter; average thickness 5.6 mm), and the average tablet weight was 201.3 mg.
2. Fluid Bed Conditions:
Glatt fluid-bed coater with Wurster adapter and plate B.
Batch size 400 g.
Spray rate: 10 g/min
Atomization pressure: 3 bar.
Drying air temperature: 60° C.
Flap: 35% open.
3. Coating Procedure and Results:
REFERENCES:
patent: 5641513 (1997-06-01), Lech et al.
patent: 6326028 (2001-12-01), Nivaggioli et al.
Drefko William
Moroni Antonio
Nerella Nadhamuni G.
Davis William J.
Evans Charesse
ISP Investments Inc.
Katz Walter
Maue Marilyn J.
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