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A film coating is a thin polymer-based coat that is typically sprayed onto solid pharmaceutical dosage forms, such as tablets, capsules, pellets or granules. Film coating can impact both its appearance and its pharmacokinetics making it an essential process in making the final drug product.
Materials used for enteric coatings include fatty acids, waxes, shellac, plastics, and plant fibers. Conventional materials used are solutions of film resins. However, as the solvents for such solutions are organic solvents, there is a concern about the toxicity potential of the traces of the residual solvents in the tablet coating. [11]
For most coated tablets, a cellulose ether hydroxypropyl methylcellulose (HPMC) film coating is used which is free of sugar and potential allergens. Occasionally, other coating materials are used, for example synthetic polymers, shellac, corn protein zein or other polysaccharides. Capsules are coated with gelatin.
Tablet coatings must be stable and strong enough to survive the handling of the tablet, must not make tablets stick together during the coating process, and must follow the fine contours of embossed characters or logos on tablets. Coatings are necessary for tablets that have an unpleasant taste, and a smoother finish makes large tablets easier ...
The physical properties of a tablet are tested either by manual or automated sampling and IPC testing (in-process control). Tablet "hardness", also called "breaking force", is tested to assure that the tablet's strength will survive all further processes, such as dedusting, coating and packaging.
In addition to its use in ophthalmic liquids, hypromellose has been used as an excipient in oral tablet and capsule formulations, where, depending on the grade, it functions as controlled release agent to delay the release of a medicinal compound into the digestive tract. [13] It is also used as a binder [14] and as a component of tablet coatings.
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Cellulose acetate phthalate (CAP), also known as cellacefate and cellulosi acetas phthalas, is a commonly used polymer phthalate in the formulation of pharmaceuticals, such as the enteric coating of tablets or capsules and for controlled release formulations.
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