WO2006111980A2

WO2006111980A2 - Pva based film coating and film coating compositions

Info

Publication number: WO2006111980A2
Application number: PCT/IN2005/000143
Authority: WO
Inventors: Chetan Rajsharad; Shivaji Kamble
Original assignee: Ideal Cures Pvt. Ltd.
Priority date: 2005-04-20
Filing date: 2005-05-04
Publication date: 2006-10-26
Also published as: WO2006111980A3

Abstract

A dry film coating composition for use in coating pharmaceutical tablets, nutritional supplements, food, confectionery forms, agricultural seeds, and the like, comprises polyvinyl alcohol, self emulsifying glyceryl monostearate, and preferably a plasticizer such as polyethylene glycol, glycerin or triethyl citrate, and a pigment/opacifier. A method of coating substrates such as pharmaceutical tablets, nutritional supplements, food, confectionery forms, agricultural seeds, and the like, with a film coating, comprises the steps of mixing polyvinyl alcohol, self emulsifying glyceryl monostearate, and preferably a plasticizer such as polyethylene glycol, glycerin or triethyl citrate, and a pigment/opacifier into hot water to form an aqueous coating dispersion, applying an effective amount of said coating dispersion onto said substrates to form a film coating on said substrates, and drying the film coating on said substrates.

Description

PVA BASED FILM COATING AND FILM COATING COMPOSITIONS

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention is in the field of aqueous film coating of substrates like pharmaceutical tablets, food, confectionery forms, nutritional supplements, agricultural seeds and the like and is specifically concerned with coating substrates with a polyvinyl alcohol (PVA) based coating.

2. Description of the Prior Art

The use of the polymer polyvinyl alcohol (PVA) as a film coat is previously known. However the stickiness of various PVA grades in cold water have restricted their economical use in current aqueous film coating processes. US Patent No. 5,885,617 discloses a moisture barrier film coating composition for forming a moisture barrier film coating for pharmaceutical tablets which comprises polyvinyl alcohol, soya lecithin, and optionally, a flow aid, and/or a colorant and /or an additional plasticizer. Colorcon sells this coating composition commercially under the trademark of OPADRY AMB. Our own application (PCT/IB/2005/ 01), which is incorporated herein by reference, discloses a film coating moisture barrier composition for substrates like pharmaceutical tablets comprising polyvinyl alcohol, self-emulsifying glyceryl monostearate and optionally a flow aid, an additional plasticizer and /or a colorant. The unexpected finding that self-emulsifying glyceryl monostearate acts as an anti-tack agent and as a plasticizer is the basis of the invention. In addition, though this dry film coating composition has to be reconstituted in hot water, one could use the hot water soluble PVA grades in the composition, which offer better moisture protection.

Coating compositions disclosed in PCT/IB/2005/01, produce film coatings having excellent moisture barrier properties. However, due to the inherent tackiness of PVA, the spray rate for coating pharmaceutical tablets in a Laboratory Coater fitted with a 24" pan containing 12 kilograms of tablets using an aqueous film coating solution/dispersion formed from a coating composition described in PCT/IB/2005/ is slow (about 25 to 30 grams/minute compared to other types of coating systems which can be sprayed at 50 to 70 grams/min). While a slow spray rate is a disadvantage, the moisture barrier properties obtained from the moisture barrier coating composition, for the special application when a moisture barrier film coating is required to coat a pharmaceutical substrate, outweighs such a disadvantage.

For general-purpose use (e.g., where moisture barrier properties are not required), a slow spray rate is not acceptable due to the additional processing costs that are associated with a slow spray rate.

Polyethylene glycol is a known plasticizer used in film coatings to reduce the glass transition temperature of the film-forming polymer and to make the polymer less brittle. Inclusion of polyethylene glycol in a coating system would be expected to result in making the coating system tackier, as predicted by the Williams-Landel- Ferry equation. Accordingly, adding polyethylene glycol to PVA, which is already very tacky, would be expected to result in making the coating system even more tacky, thereby making the problem of tackiness of PVA even worse.

Also, to those skilled in the art, it is well recognized that adding polyethylene glycol to a film coating system generally results in a reduction of the tensile strength of the film coating. A lower tensile strength means a weaker film, which is a drawback.

Also, to those skilled in the art, polyethylene glycol would be expected to compromise the moisture barrier properties of a PVA film coating.

Insoluble materials such as pigments, glidants, and flow aids commonly are used in film coating compositions. For instance, pigment is used to provide a color to the film coating and talc is used as a glidant and a filler to reduce the percentage of the amount of other more costly components in the film coating composition. Use of insoluble materials in the film coating composition may not be haphazard since, as is well recognized by those skilled in the art, adding insoluble materials to a film coating composition typically decreases the tensile strength of the film coating, which means a weaker film is obtained as the amount of insoluble materials in the film coating increases.

Keith et al. U.S. Pat. No. 4,432,965 discloses a sustained release oral dosage form comprising a tablet core containing a pharmaceutically effective amount of quinidine, which is coated with a sustained, released polymeric coating which contains about 5 to about 20% by weight polyethylene glycol and from about 80 to 95% by weight polyvinyl alcohol. Keith et al. U.S. Pat. No. 4,432,965 discloses that their sustained release coating of PVA and polyethylene glycol dissolves slowly in gastric and intestinal fluids.

In addition patent US 6,448,323, which talks about film coating compositions based on PVA requires that an insoluble material such as talc is an essential part of the dry film coating composition. Talc is a glidant and helps improve the smoothness of the final coating since talc facilitates the tumbling of tablets over one another during coating. The basis of the US 6,448,323 is also the unexpected discovery of talc producing an increase in the tensile strength of the film resulting in a stronger film. This is unexpected since it would be expected that the tensile strength of a film coating would decrease as the amount of insoluble component, such as talc, increases in the film coating composition. In addition talc also reduces the tackiness of the film. The disadvantages of talc includes its heaviness and since the viscosity of PVA solution is low, talc tends to settle down at the bottom and changes the homogeneity of the coating suspension during the process of coating operation.

SUMMARY OF THE INVENTION

It is an object of the invention to provide a coating based on polyvinyl alcohol that has a smooth surface, a shiny gloss, minimal tackiness, good film adhesion, and good tensile strength. Another object of the invention is to provide a film coating based on polyvinyl alcohol which may be sprayed onto substrates such as pharmaceutical tablets, nutritional supplements, food, confectionery forms, agricultural seeds, and the like at a coating solution spray rate of about 50 to 60 grams per minute. Another object of the invention is to provide a film coating that is fast dissolving. In addition it has been unexpectedly found that by using a film coating composition comprising polyvinyl alcohol and self-emulsifying glyceryl monostearate one can obtain a film coat that has a tensile strength equivalent to the one obtained with the presence of talc in the concentration range of about 9% to 45% as described in US 6,448,323. The presence of an additional plasticizer confers additional properties on the film formed. In addition, one may add other insoluble materials like pigments to provide a color to the film coating or opacifiers like titanium dioxide for providing the desired color/gloss effects. These and other objects are accomplished by our invention, which is described below.

DETAILED DESCRIPTION OF THE INVENTION

In accordance with the invention, the inventive dry film coating composition for use in coating pharmaceutical tablet, nutritional supplement, food, confectionery forms, agricultural seed, and the like, comprises 1) polyvinyl alcohol, 2) self emulsifying glyceryl monostearate.

Preferably, the inventive dry film coating composition includes one or more of the following components: a plasticizer, a pigment/opacifier, a flavoring agent and a sweetening agent.

In accordance with the invention, a method of coating substrates, such as pharmaceutical tablets, nutritional supplements, food, confectionery forms, agricultural seeds, and the like with a film coating, comprises the steps of mixing 1) polyvinyl alcohol, and 2) self emulsifying glyceryl monostearate into hot water to form an aqueous coating dispersion, applying an effective amount of the coating dispersion onto the substrates to form a film coating on the substrates, and drying the film coating on the substrates. Optionally, but preferably, one or more of the following components is/are mixed into water with the polyvinyl alcohol, and self- emulsifying glyceryl monostearate to form the inventive coating dispersion: a plasticizer and a pigment/opacifier.

The invention also includes the aqueous coating dispersion, the coated substrates, such as coated pharmaceutical tablets, coated nutritional supplements, coated food products, coated confectionery forms, coated agricultural seeds, and the like, and the method of making the dry film coating compositions and the method of making the . coating dispersion of the invention.

Polyvinyl alcohol (PVA) is the film former of the coating. The grades of polyvinyl alcohol found useful under the invention correspond to polyvinyl alcohol that comprises partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis greater than about 83.0 mol.% and preferably in a range of about 83.0 to 89.0 mol. %.

Preferably, the polyvinyl alcohol is micronized to facilitate dissolving the polyvinyl alcohol into the water when forming the aqueous coating solution. Preferably, the particle size of the micronized polyvinyl alcohol falls in the following quantities and mesh sizes: 40-55% is greater than 200 microns; 25-35% is between 200 and 145 microns; 20-25% is between 145 and 100 microns; 0.5-1.0% is between 100 and 80 microns; and 0.1-0.5% is below 80 microns.

The self-emulsifying glyceryl monostearate functions as both a plasticizer and a detackifier. It helps by forming an emulsion and avoids aggregation of the dispersion. Once the self-emulsifying glyceryl monostearate melts in hot water it forms an emulsion taking the PVA and keeps it in a suspended manner thus avoiding any aggregation and the requirement of talc. Also it decreases the tackiness and eliminates the requirement of any flow aid like talc / kaolin. Once an emulsion is formed in hot water by melting of the self-emulsifying glyceryl monostearate, subsequent cooling of the film coating dispersion/ solution does not cause any reprecipitation of dissolved matter and keeps the dispersion uniform. The self emulsifying glyceryl monostearate helps in the wetting of the components of the aqueous coating dispersion; helps solvate the polyvinyl alcohol; and has a plasticizing effect by locking moisture in the coating so the coating stays flexible and does not become brittle.

A plasticizer like polyethylene glycol may be added to the coating of the invention to make it non-brittle and non-cracking. Polyethylene glycol having a nominal molecular weight of greater than 1000 has been found useful, and polyethylene glycol having a molecular weight of 6000 is preferred.

Triethyl citrate, another plasticizer, may be substituted for the polyethylene glycol.

Unexpectedly, we have found that rather than increasing the tackiness of the film coating as would be expected, triethyl citrate, when used in the inventive coating composition, as a plasticizer reduces the tackiness of the resultant film coating by surprisingly acting as a mild detackifier.

Other plasticizers like propylene glycol and triacetin may also be used. It may also be useful to provide for a combination of plasticizers.

The pigment/opacifier may be any food approved colors, opacifiers, or dyes. For example, the pigment/opacifier may be aluminum lakes, iron oxides, titanium dioxide, or natural colors.

The flavoring agent used may include strawberry or mint flavors.

Sweetening agents include sucrose, aspartame, sodium saccharin and the like.

The ranges of each component of the dry coating composition of the invention are as follows, by weight:

The following examples illustrate the invention. All units and percentages in the examples are by weight. EXAMPLE 1

The dry components of the following formulation are blended together in a dry powder / mill / blender, for at least 15 minutes or until a homogenous mixture is achieved, resulting in one formulation of the inventive dry film coating composition. Optionally, the dry film coating composition of the invention may be granulated using a planetary mixer. After the dry film coating composition is loaded into the mixer and the mixer is switched on, sufficient water is slowly added until the composition forms slightly adherent granules. These granules are then passed through a 1-2 mm screen and then dried at 3O⁰C in an oven until the moisture content is below 5% The composition is then sieved again through a 1-2 mm screen and then is ready for use in a non-dusting, granular form. If not optionally granulated, the composition may be milled such as in a hammer mill. Other methods of granulation, which may be used, are spray granulation and roller compaction.

100 grams of the resulting film coating composition is dispersed into 600 grams of distilled hot water at 90-95⁰C, to form an inventive coating dispersion (15% solids), and 700 grams of this dispersion is sprayed onto 3.0 kilograms of tablets using a coater to form the inventive coating on the tablets having a theoretical weight gain of 3%. The tablets are rotated in the coater at a rotation speed of about 10-12 rpm. Hot air at about 75⁰C is used to evaporate the water in the sprayed coating dispersion and to maintain the tablet bed at 38-42⁰C. The spraying rate of coating dispersion during coating is about 20 grams per minute.

Upon completion of the coating process, the tablets show a smooth surface with excellent logo definition. The film coating on the tablets possesses an excellent long-lasting shinny gloss, minimal tackiness, good film adhesion, and good tensile strength.

In the examples illustrated below from 2-14, the components of each formulation are mixed together, formed into a coating solution, and applied to tablets, as in Example 1, to obtain film coatings having a good floss, smooth surface, minimal tackiness, good film strength and adhesion EXAMPLE 2

EXAMPLE 10

Example 11

Example 12

Example 13

Example 14

The dry ingredients of the above formulation are loaded into a suitably sized food processor and blended vigorously for 5 minutes until homogeneous. 90 grams of this formulation is then dispersed into 360 grams of purified water and stirred for 45 minutes to form an aqueous coating dispersion of 20.0% solids that is ready for spray coating.

A 3.0-kilogram charge of tablets consisting of 2.0 kg of 3/8" standard concave placebos is loaded into a 15" coating pan with 4 mixing baffles. The aqueous coating dispersion is sprayed onto the tablet bed using a spraying gun system. During the coating procedure, the atomizing air is 35 psi, inlet air temperature is about 75° C, the tablet bed temperature remains about 38 to 42⁰C, the pan speed is 16 rpm, the coating liquid feed rate is 20 g/min, and the total coating time is 25 minutes. A theoretical 3.0% dry coating weight gain is applied and the film coating on the tablets possesses an excellent long-lasting shiny gloss, minimal tackiness, good adhesion, and good tensile strength. Regarding preparation of the inventive aqueous coating dispersion, it also may be prepared by adding the individual components of the inventive coating composition directly into water and then mixing to form the coating dispersion.

Preferably, the coating dispersion is prepared at a solids level of between 10% and 30%.

We have found that, in contrast to what is predicted by the Williams-Landel-Ferry equation, our invention produces a film coating with minimal tackiness.

We also have found that the inventive coating has good moisture barrier properties. This, too, is surprising and unexpected because polyethylene glycol and similar plasticizers are hydrophilic and would be expected to reduce the moisture barrier properties of PVA. Further, in contrast to the teachings of Keith et al. U.S. Pat. No. 4,432,965, we have found that a tablet, coated with inventive film coating is fast dissolving.

Claims

1. A dry film coating composition for use in coating pharmaceutical tablets, nutritional supplements, food, confectionery forms, and agricultural seeds, comprising, polyvinyl alcohol, the polyvinyl alcohol being in a range of about 25% to about 75% by weight of the composition, and self emulsifying glyceryl monostearate.

2 The coating composition of claim 1, wherein the polyvinyl alcohol comprising partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis greater than about 83.0 mol. %, preferably in a range of about 83.0 to 89 0 mol. %.

3. The coating composition of claim 1, wherein the polyvinyl alcohol being in a range of about 25% to about 75% by weight of the composition, preferably in a range of about 30% to about 65% by weight of the composition.

4. The coating composition of claim 1, wherein the self emulsifying glyceryl monostearate being in a range of about 5% to about 50% by weight of the composition, preferably in a range of about 10% to about 40% by weight of the composition.

5. A dry film coating composition for use in coating pharmaceutical tablets, nutritional supplements, food, confectionery forms, and agricultural seeds, comprising polyvinyl alcohol, the polyvinyl alcohol being in a range of about 25% to about 75% by weight of the composition, self emulsifying glyceryl monostearate and a plasticizer, the plasticizer being polyethylene glycol, glycerin, triethyl citrate, propylene glycol or triacetin or combinations thereof.

6. The coating composition of claim 5, the plasticizer being in a range of about 0% to about 30% by weight of the composition, preferably being in a range of about 5% to about 25% by weight of the composition.

7. The coating composition of claim 5, the polyethylene glycol preferably having a molecular weight of 200 to 20,000, more preferably having a molecular weight of 6000.

8. The coating composition of claim 1, further including a pigment/opacifier.

9. The coating composition of claim 8, wherein the pigment/opacifier being in a range of about 0% to about 40% by weight of the composition, preferably in the range of about 5% to about 35% by weight of the composition.

10. The coating composition of claim 1, further including a plasticizer, pigment / opacifier, a flavoring agent and a sweetening agent, the polyvinyl alcohol comprising partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis greater than about 83.0 mol. %, the self emulsifying glyceryl monostearate being in a range of about 8% to about 45% by weight of the composition, the polyethylene glycol having a molecular weight of 200 to 20,000, the polyethylene glycol or glycerin or triethyl citrate or triacetin or propylene glycol being in a range of about 2% to about 25% by weight of the composition, the pigment/opacifier being in a range of about 0% to about 40% by weight of the composition, the flavoring agent being in a range of about 0% to about 20% by weight of the composition, and the sweetening agent being in a range of about 0% to about 20% by weight of the composition.'

11. The coating composition of claim 1 , further including a plasticizer, a pigment / opacifier, a flavoring agent and a sweetening agent, the polyvinyl alcohol comprising partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis greater than about 83.0 mol. %, the polyvinyl alcohol being in a range of about 30% to about 65% by weight of the composition, the polyethylene glycol having a molecular weight of 6000, the polyethylene glycol or glycerin or triethyl citrate or propylene glycol or triacetin, being in a range of about 5% to about 25% by weight of the composition, the pigment/opacifier being in a range of about 5% to about 35% by weight of the composition, the flavoring agent being in a range of about 0% to about 20% by weight of the composition, and the sweetening agent being in a range of about 0% to about 20% by weight of the composition.

12. The coating composition of claim 1, further including a flavoring agent.

13. The coating composition of claim 12, wherein the flavoring agent being in a range of about 0% to about 25% by weight of the composition preferably being in a range of about 0.1% to about 20% by weight of the composition.

14. The coating composition of claim 1, further including a sweetening agent.

15. The coating composition of claim 14, wherein the sweetening agent being in a range of about 0% to about 25% by weight of the composition preferably being in a range of about 0.1% to about 20% by weight of the composition.

16. A liquid film coating dispersion for use in coating pharmaceutical tablets, nutritional supplements, food, confectionery forms, and agricultural seeds comprising polyvinyl alcohol, the polyvinyl alcohol being in a range of about 25% to about 75% by weight of the non- water ingredients of the aqueous coating dispersion, self emulsifying glyceryl monostearate, a plasticizer, the plasticizer being polyethylene glycol, glycerin, propylene glycol, triacetin or triethyl citrate, a flavoring agent, a sweetening agent and water.

17. The dispersion of claim 16, the polyvinyl alcohol comprising partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis greater than about 83.0 mol. %, preferably hydrolysis in a range of about 83.0% to 89.0 mol. %.

18. The dispersion of claim 16, the polyvinyl alcohol being in a range of about 25% to about 75% by weight of the non- water ingredients of aqueous coating dispersion, preferably being in a range of about 30% to about 65% by weight of the non- water ingredients of the aqueous coating dispersion.

19. The dispersion of claim 16, the polyethylene glycol having a molecular weight of 200 to 20,000 preferably a molecular weight of 6,000.

20 The dispersion of claim 16, the polyethylene glycol, glycerin, propylene glycol, triacetin or triethyl citrate being in a range of about 2% to about 30% by weight of the non-water ingredients of the aqueous coating dispersion, preferably in a range of about 5% to about 25% by weight of the non- water ingredients of the aqueous coating dispersion.

21. The dispersion of claim 16, the self emulsifying glyceryl monostearate being in a range of about 5% to about 50% by weight of the non-water ingredients of the aqueous coating dispersion preferably in a range of about 10% to about 40% by weight of the non- water ingredients of the aqueous coating dispersion

22. The dispersion of claim 16, further including dispersing a pigment/opacifier into the aqueous coating dispersion.

23. The dispersion of claim 22, the pigment/opacifier being in a range of about 0% to about 40% by weight of the non- water ingredients of the aqueous coating dispersion preferably in a range of about 5% to about 35% by weight of the non- water ingredients of the aqueous coating_dispersion.

24. The dispersion of claim 16, further including dispersing a plasticizer and a pigment/opacifier into the aqueous coating dispersion, theφolyvinyl alcohol comprising partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis greater .than about 83.0mol. %,_the polyethylene glycol -having Ά molecular weight of 200 to 20,000, the polyethylene glycol, glycerin, propylene glycol, triacetin or triethyl citrate, being in a range of about 2% to about 30% by weight of the non- water ingredients of the aqueous coating solution, the pigment/opacifier being in a range of about 0% to about 40% by weight of the non- water ingredients of the aqueous coating dispersion

25. The dispersion of claim 16, further including dispersing a plasticizer and a pigment/opacifier into the aqueous coating dispersion, the polyvinyl alcohol comprising partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis in a range of about 83.0 to 89.0 mol. %, the polyvinyl alcohol being in a range of about 30% to about 65% by weight of the non- water ingredients of the aqueous coating dispersion, the polyethylene glycol having a molecular weight of 6000, the polyethylene glycol or glycerin or propylene glycol or triacetin or triethyl citrate or combinations thereof, being in a range of about 5% to about 25% by weight of the non- water ingredients of the aqueous coating dispersion, the pigment/opacifier being in a range of about 5% to about 35% by weight of the non- water ingredients of the aqueous coating dispersion.

26. A method of coating substrates such as pharmaceutical tablets, nutritional supplements, food, confectionery forms, agricultural seeds, and the like, with a film coating, comprising the steps of mixing polyvinyl alcohol and self emulsifying glyceryl monostearate into hot water to form an aqueous coating dispersion, adding a plasticizer and applying an effective amount of said coating dispersion onto said substrates to form a film coating on said substrates, and drying the film coating on said substrates.

27. The method of claim 26, the polyvinyl alcohol comprising partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis greater than about 83.0 mol. %, preferably in a range of about 83.0 to 89.0 mol. %.

28. The method of claim 26, the polyvinyl alcohol being in a range of about 25% to about 75% by weight of the non- water ingredients of aqueous coating dispersion preferably in a range of about 30% to about 65% by weight of the non-water ingredients of the aqueous coating dispersion.

29. The method of claim 26, the self emulsifying glyceryl monostearate being in a range of about 5% to about 50% by weight of the non-water ingredients of the aqueous coating dispersion preferably in a range of about 10% to about 40% by weight of the non- water ingredients of the aqueous coating dispersion.

30. The method of claim 26, the plasticizer being polyethylene glycol having a molecular weight of 200 to 20,000, preferably having a molecular weight of 6,000.

31. The method of claim 26, the plasticizer being polyethylene glycol, glycerin, propylene glycol, triacetin or triethyl citrate in a range of about 2% to about 30% by weight of the non- water ingredients of the aqueous coating dispersion.

32. The method of claim 26, the plasticizer being polyethylene glycol, glycerin, propylene glycol, triacetin or triethyl citrate in a range of about 5% to about 25% by weight of the non- water ingredients of the aqueous coating dispersion.

33. The method of claim 26, further including dispersing a pigment/opacifier into the aqueous coating dispersion.

34. The method of claim 26, the pigment/ opacifier being in a range of about 0% to about 40% by weight of the non-water ingredients of the aqueous coating dispersion preferably in a range of about 5% to about 35% by weight of the non- water ingredients of the aqueous coating dispersion.

35. The method of claim 26, further including a flavoring agent into the aqueous coating dispersion.

36. The method of claim 26, the flavoring agent being in a range of about 0% to about 20% by weight of the non-water ingredients of the aqueous coating dispersion.

37. The method of claim 26, further including a sweetening agent, into the aqueous coating dispersion.

38. The method of claim 26, the sweetening agent being in a range of about 0% to about 20% by weight of the non- water ingredients of the aqueous coating dispersion.

39. The method of claim 26, further including dispersing a plasticizer, a pigment / opacifier, a flavoring agent and a sweetening agent, into the aqueous coating dispersion, the polyvinyl alcohol comprising partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis greater than about 83.0 mol. %, the polyvinyl alcohol being in a range of about 25% to about 75% by weight of the non-water ingredients of the aqueous coating dispersion, polyethylene glycol having a molecular weight of 200 to 20,000, the polyethylene glycol or glycerin or tiethyl citrate, or propylene glycol or triacetin or combinations thereof, being in a range of about 2% to about 30% by weight of the non- water ingredients of the aqueous coating dispersion, the pigment/opacifier being in a range of about 0% to about 40% by weight of the non-water ingredients of the aqueous coating dispersion, the flavoring agent being in a range of about 0% to about 20% by weight of the non- water ingredients of the aqueous coating dispersion, the sweetening agent being in a range of about 0% to about 40% by weight of the non-water ingredients of the aqueous coating dispersion.

40. The method of claim 26, further including dispersing a plasticizer, a pigment / opacifier, a flavoring agent and a sweetening agent, into the aqueous coating dispersion, the polyvinyl alcohol comprising partially hydrolyzed polyvinyl acetate which has a percentage of hydrolysis in a range of about 83.0 to 89.0 mol. %, the polyvinyl alcohol being in a range of about 30% to about 65% by weight of the non- water ingredients of the aqueous coating dispersion, polyethylene glycol having a molecular weight of 6000, the polyethylene glycol or glycerin, or tiethyl citrate, or propylene glycol or triacetin or combinations thereof, being in a range of about 5% to about 25% by weight of the non- water ingredients of the aqueous coating dispersion, the pigment/opacifier being in a range of about 10% to about 40% by weight of the non- water ingredients of the aqueous coating dispersion, the flavoring agent being in a range of about 0% to about 20% by weight of the non-water ingredients of the aqueous coating dispersion, the sweetening agent being in a range of about 0% to about 40% by weight of the non-water ingredients of the aqueous coating dispersion.