Compositions: coating or plastic – Coating or plastic compositions – Carbohydrate or derivative containing
Reexamination Certificate
2001-01-05
2001-07-31
Brunsman, David (Department: 1755)
Compositions: coating or plastic
Coating or plastic compositions
Carbohydrate or derivative containing
C106S205710, C106S215200, C106S162800, C424S463000, C424S479000, C424S480000, C524S058000
Reexamination Certificate
active
06267808
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention relates to the field of aqueous film coating of nutritional supplements and pharmaceutical tablets, and is specifically concerned with providing bright white film coatings based on dextrose for coating nutritional supplements, such as vitamin tablets and calcium/oyster shell tablets, and pharmaceutical tablets, such as acetaminophen (APAP), aspirin (ASA), and Ibuprofen.
2. Description of the Prior Art
Hydroxypropyl methylcellulose (HPMC) has been used in coatings for substrates such as pharmaceutical tablets. For example, such coatings, including white coatings (coatings containing titanium dioxide as the colorant), made from coating compositions manufactured by Colorcon and disclosed in U.S. Pat. Nos. 4,543,370 and 4,683,256, said patents being incorporated herein by reference, have proven especially effective when used on pharmaceutical tablets.
However, in the pharmaceutical and nutritional supplement industries, it is desired to provide some pharmaceuticals, such as APAP and Ibuprofen, and some nutritional supplements with a white coating that is brighter than the white coatings obtained using HPMC-based coating compositions.
SUMMARY OF THE INVENTION
It is an object of the invention to provide a white film coating for vitamin tablets, calcium/oyster shell tablets, and pharmaceutical tablets that is brighter than the white film coatings obtained using HPMC-based coating compositions.
These and other objects are accomplished by our invention, which is described below.
DETAILED DESCRIPTION OF THE INVENTION
In accordance with the invention, our dry film coating compositions for use in forming coating dispersions for film coating nutritional supplements, pharmaceutical tablets, and the like, comprise dextrose, an auxiliary film former, and titanium dioxide.
Advantageously, the inventive dry film coating compositions may include one or more of the following components: a plasticizer, a surfactant, a flow aid, and a preservative.
In accordance with the invention, a method of coating substrates such as nutritional supplements, pharmaceutical tablets, and the like, comprises mixing dextrose, an auxiliary film-former, and titanium dioxide into water to form an inventive aqueous coating dispersion, applying the inventive coating dispersion onto said substrates to form a white film coating on said substrates, and drying the white film coating on said substrates. Optionally, but advantageously, the following components may be mixed into water with the dextrose, the auxiliary film-former, and the titanium dioxide to form the inventive coating dispersion: a plasticizer, a surfactant, a flow aid, and a preservative.
The invention also includes the coated substrates, such as coated vitamins, coated calcium/oyster shell tablets, and coated pharmaceutical tablets, the aqueous coating dispersion formed from the inventive dry film coating composition or from the components of said composition, the method of making the dry film coating compositions and the method of making the coating dispersions of the invention.
The primary film-former of the inventive dry film coating composition and of the inventive aqueous coating dispersion is dextrose.
The preferred range for dextrose is about 20% to about 50% by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating dispersion. More preferably, the range for dextrose is about 25% to about 35% by weight of the inventive dry film coating composition and of the non-water ingredients of the inventive aqueous coating dispersion.
The auxiliary film-former may be polyvinylpyrrolidone (PVP), hydroxypropyl methylcellulose, methylcellulose, hydroxypropyl cellulose (HPC), sodium carboxymethylcellulose (sodium CMC), maltodextrin, polydextrose, modified food starch, modified food starch with corn syrup solids, starch (e.g., STARCH 1500 starch), tapioca dextrin, lactose, sodium alginate, PG alginate, gum acacia, polyvinyl alcohol (PVA), any of the film coating polymers recited in Colorcon U.S. Pat. No. 4,543,370, which is incorporated herein by reference, and combinations thereof. The auxiliary film-former(s) act as strength enhancers for the film coating. Their presence in the coatings help prevent cracking of the film coating, as well as helping to prevent edge wear/chipping of the coated tablet. A preferred auxiliary film-former is sodium CMC. The preferred and the more preferred ranges for the auxiliary film-former(s) by weight of the inventive dry film forming composition and by weight of the non-water ingredients of the inventive aqueous coating dispersion are 1% to 50% (preferred) and 10% to 20% (more preferred). The preferred ranges and the more preferred ranges for various exemplary auxiliary film-former(s) are set out below.
The preferred range and the more preferred range for the titanium dioxide (TiO
2
) are 25% to 50% (preferred) and 30% to 40% (more preferred) by weight of the inventive coating composition and by weight of the non-water ingredients of the inventive coating dispersion.
Exemplary of the plasticizer are mineral oil, polyethylene glycol having a molecular weight in the range of 200 to 8000, propylene glycol, glycerine, triacetin, acetyltriethyl citrate, triethyl citrate (Citroflex A2), tributylcitrate (Citroflex 4), and acetyltributylcitrate (Citroflex A4), and the preferred ranges for the plasticizer are set out below, together with preferred and more preferred ranges for various exemplary plasticizers.
Exemplary of the surfactant is Polysorbate 80, and the preferred ranges for the surfactant are set out below, together with preferred and more preferred ranges for an exemplary surfactant.
Exemplary of the flow aid is stearic acid, and the preferred ranges and the more preferred ranges for the flow aid are set out below, together with the preferred and the more preferred ranges for stearic acid.
Exemplary of the preservative is sodium citrate, and the preferred ranges for the preservative are set out below, together with the preferred and the more preferred ranges for sodium citrate.
AUXILIARY FILM FORMERS
Preferred
1-50%
More Preferred
10-20%
PVA
Preferred
0-10%
More Preferred
3-6%
PVP
Preferred
0-10%
More Preferred
3-6%
HPMC/Methylcellulose/
HPC
Preferred
0-50%
More Preferred
5-50%
Even More Preferred
10-20%
Polydextrose
Preferred
0-50%
More Preferred
5-50%
Even More Preferred
10-20%
Lactose
Preferred
0-20%
More Preferred
5-10%
Na CMC
Preferred
0-15%
More Preferred
1-15%
Even More Preferred
5-8%
Modified Food Starch/
Modified Food Starch with Corn Syrup Solids/
Starch 1500
Preferred
0-15%
More Preferred
1-15%
Even More Preferred
5-8%
Maltodextrin
Preferred
0-50%
More Preferred
5-50%
Even More Preferred
10-20%
Tapioca Dextrin
Preferred
0-5%
More Preferred
1-5%
Even More Preferred
3-5%
PG Alginate
Preferred
0-5%
More Preferred
3-5%
Sodium Alginate
Preferred
0-5%
More Preferred
3-5%
Gum Acacia
Preferred
0-5%
More Preferred
3-5%
SURFACTANT
Preferred
0-5%
Polysorbate 80
Preferred
0-5%
More Preferred
0.5-1%
FLOW AID
Preferred
0-15%
More Preferred
5-10%
Stearic Acid
Preferred
0-15%
More Preferred
5-10%
PLASTICIZER
Preferred
0-20%
Mineral Oil
Preferred
0-15%
More Preferred
3-5%
Polyethylene Glycol 8000
Preferred
0-20%
More Preferred
5-10%
Glycerine
Preferred
0-15%
More Preferred
5-10%
PRESERVATIVE
Preferred
0-5%
More Preferred
2-3%
Sodium Citrate
Preferred
0-5%
More Preferred
2-3%
The ranges set out above are all by weight of the dry film coating composition of the invention and of the non-water ingredients of the aqueous coating dispersion of the invention.
REFERENCES:
patent: 3420931 (1969-01-01), Daum et al.
patent: 3882228 (1975-05-01), Boncy et al.
patent: 4059460 (1977-11-01), Schollmeier et al.
patent: 4238510 (1980-12-01), Cherukuri et al.
patent: 4543370 (1985-09-01), Porter et al.
patent: 4610891 (1986-09-01), Miyamoto et al.
patent: 4652313
Burke Thomas J.
Grillo Susan M.
Hartman Melanie
Kinsey Bruce
Korchok Brian
BPSI Holdings, Inc.
Brunsman David
Roberts & Mercanti L.L.P.
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