Experiment 5 Prepare Film Coated/Enteric Coated Tablets

Theory:
Film coating is discussion of thin film of polymer on the surface of the tablet core. Although the film coated tablets are possibly less elegant in appearance but they are considered more satisfactory than sugar coated tablets. Film coating process which places a skin tight coating of plastic like material over the compressed tablet was developed to produce coated tablets having essentially the same weight, size and shape as the originally compressed tablet.

Film Coating Formulation:

1. Film Former: A film former is capable of producing smooth thin film, reproducible under conventional coating conditions and applicable to variety of tablet shapes. There are two types of film formers: Enteric Film Formers: Cellulose acetate phthalate Acrylate polymer Hydroxypropyl methylcellulose phthalate Polyvinyl acetate phthalate Non-Enteric Film Formers: Hydroxypropyl methylcellulose USP Sodium carboxy methylcellulose USP Methyl hydroxyl ethylcellulose Ethylcellulose Hydroxypropyl cellulose Povidone USP

2. Solvent: It functions to dissolve or disperse the polymer and other additives and convey them to substrate surface. Examples: Water Chloroform Acetone Methanol Ethanol Methyl ethyl ketones Methylene chloride 3. Plasticizers: They produce flexibility and elasticity of the coating and thus provide durability. Examples: Castor oil Coconut oil Polyethylene glycol Glycerine Propylene glycol 4. Surfactants: They are used to enhance spreadability of the film during application. Examples: Sodium lauryl sulphate Hydrophilic polysorbates (tween) Hydrophobic sorbitan esters (span) 5. Colorants and Opaquants: They are used to make the appearance of the coated tablets handsome and distinctive. Examples: Iron oxide Titanium oxide Water soluble coating colors

6. Sweeteners and Flavourants: They are used to enhance the acceptability of tablet to the patient. Examples: Saccharine sodium 7. Glossants: They provide luster to the tablet without a separate polishing operation. Examples: Bees wax 8. Volatile Solvents: It is used to allow the spread of other components over the tablet while allowing rapid evaporation to permit an effective and speedy operation. Examples: Alcohol acetone mixture

Formulation:
Methocel (HPMC E-5) --------------------------28.3 g Polyethylene glycol (PEG400) ---------------- 2.8 g Specially denatured spirit --------------------- 230 ml Chloroform ----------------------------------------90 ml

Apparatus:
Beaker, Stirrer, Weighing balance, Hot air system, Coating pan, Hot air blower, Spraying gun.

Procedure:
Preparation of Coating Solution: 1. For the formulation of specially denatured spirit add 0.1% carbon tetrachloride. 2. First of all dissolve specially denatured spirit into chloroform. 3. Dissolve polyethylene glycol (PEG 400) into the solution. 4. At the end methocel (HPMC E-5) is dissolved by vigorous shaking in this solution.

 Coating the Tablets: 1. First of all clean out the coating pan and switch on the exhaust system and hot air blower having temperature 70-80C. 2. Make the tablets dust free by blowing air. 3. Load the tablets in the coating pan. 4. Then apply the hot air on the tablets. 5. Rotate one-fourth of the pan for 2-3 minutes so that the temperature of the tablets reaches 40C. 6. This rotating procedure is continued until the cores become heated. 7. Then start continuous rotating of the pan and start the spraying of coating solution on the tablets at 40C by using spraying gun. 8. After the completion of spraying, dry the tablets for 5-10 minutes in rotating pan. The speed of rotating pan should be 2530 rpm. 9. After drying, pour out the tablets from the pan and spread them on tray and dry in an oven at about 50C.

Defects of Film Coating:

The defects of film coating include: 1. Picking and Sticking: This is when the coating removes a piece of tablet from the core. It is caused by over wetting the tablets, by under-drying or poor quality of the tablet. 2. Bridging: This occurs when the coating fills in the lettering or logo on the tablet and is typically caused by improper application of solution, poor design of the tablet embossing, high coating viscosity, and high percentage of solids in the solution or improper atomization pressure. 3. Erosion: This can be a result of soft tablets, an over wetted tablet surface, inadequate drying or lack of tablet surface strength.

4. Twinning: This is a term for two tablets that stick together during coating and it is a common problem with capsule shaped tablets. 5. Peeling and Frosting: This is a defect where a coating peels away from the tablet surface in a sheet. This could be due the defect in coating solution, over wetting, or high moisture content in the tablet core. 6. Chipping: This is a result of high pan speed, a friable tablet core or a coating solution that lacks a good plasticizer. 7. Molted Color: This refers to lack of color due to poor mixing of pigments. This occurs when coating solution is improperly prepared, the actual spray rate differs from the target rate or the tablet cores are cold. 8. Orange Peel: This refers to a coating texture that resembles the surface of an orange. It is usually the result of high atomization pressure in combination with spray rates that are too high. Removal of Defects of Film Coating: The defects of film coating can be removed by: 1. Proper wetting. 2. Proper drying. 3. Using proper coating solution. 4. Using appropriate spray rate. 5. Using appropriate atomization pressure.

Advantages of Film Coating:

1. Minimal weight increase. 2. Reduction in processing time. 3. Increase process efficiency and output. 4. Increased flexibility in formulation.

5. Enhance palatability by masking unpleasant taste or objectionable

odours. 6. Ease of ingestion. 7. Improve product appearance. 8. Protect tablets from light, oxidation and moisture.

Disadvantages of Film Coating:

1. 2. 3. 4. Increased drying time. Costly. Possible toxicity hazards especially if non polar solvents are used. Environmental pollution.

Role of Ingredients:
Methocel (HPMC E-5): Granulation binding agent, Water retaining agent. Polyethylene glycol (PEG400): Lubricating agent, Wetting agent Denatured spirit: Flavoring agent, Solvent Chloroform: Solvent