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Substances for film coating of tablets

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  • Application of film coatings on tablets
  • Film coating for tablets
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Substances for film coating of tablets

The main components in most finished film-coated dosage forms are polymers, plasticizers, colorants and solvents (or liquid phase). Polymers. The ideal properties for a polymer are solubility in a wide range of solvents for variability in the composition of the finished dosage form, the ability to create a coating that has suitable mechanical properties, and appropriate solubility in gastrointestinal fluids – such that drug bioavailability is not reduced. The most suitable polymers for film coatings are cellulose ethers, especially hydroxypropyl methyl cellulose (HPMC), hydroxypropyl cellulose (HPC), which produces slightly tacky coatings, and methyl cellulose (MC), although this polymer may retard dissolution of the drug substance.
Alternatives to cellulose ethers are acrylic copolymers (such as methacrylic and methyl methacrylic copolymers) and vinyl polymers (such as polyvinyl alcohol). Polymers can be used alone or in blends to achieve an optimal drug release profile.
However, when mixtures of polymers are used, the optimal ratio of their concentrations must be determined. For example, a mixture of the water-insoluble polymer ethylcellulose and the water-soluble polymer hydroxypropylmethylcellulose can be used for controlled release of a drug substance.

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  • Información actualizada : 09 / 11 / 2024
  • En stock
  • Fabricante : 1 año para Substances for film coating of tablets

Modelo: Film coating on tablets

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At the same time, they can be used to identify the dosage form. Additionally, some physical properties of the coating, such as moisture resistance, can be improved with dyes. Dyes can be classified into water-soluble dyes and insoluble pigments.
Water-soluble dyes cannot be used in film coatings based on organic solvents, they can only be used in coatings based on aqueous compositions. Pigments are preferred because: they are less likely to affect bioavailability than some water-soluble colorants; they help reduce the water permeability of the coating; and they can be used as fillers to increase the total solid content of the coating dispersion without undesirable increases in viscosity. Solvents. Solvents for film coatings may include: alcohols, ketones, esters, chlorinated hydrocarbons and water. Solvents have an important function in the coating formation process as they help in coating the core surface. A good interaction between the solvent and the polymer is necessary to ensure optimum film properties when the coating dries. This initial interaction between solvent and polymer will maximize the elongation of the polymer chain, which in turn will provide good cohesive strength and thus the best mechanical properties. At the same time, an important function of the solvent system is to provide a controlled distribution of the polymer on the core surface to create a homogeneous coating.

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Especificaciones técnicas

Studies have shown that when the HPMC content in the blend is less than 24%, the release profile depends on the rate of water penetration into the coating, which in turn becomes a determining factor in selecting the ratio of polymer concentrations in the blend.
Most of the polymers used are available in a wide range of molecular weights, which is a major factor in the choice of coating technology. Molecular weight can have a significant effect on coating properties such as viscosity, mechanical strength, and film elasticity.
Plasticizers. A plasticizer is a liquid or solid with a high boiling point. Examples of plasticizers include glycerin, propylene glycol, polyethylene glycol, triacetin, esters of citric acid (e.g., triethyl citrate), esters of phthalic acid (e.g., triethyl phthalate). The introduction of a plasticizer can improve the elasticity of the coating Cracking the risk of mechanical damage and potentially in the coating improve the adhesion of the film coating to the core.
When the plasticizer interacts with the polymer, the minimum film formation temperature may be reduced. To form a quality film, the plasticizer must have high compatibility with the polymer and be permanently retained in the coating, especially if the main objective of the coating is the stability of the dosage form during storage.

Información adicional

The scientific literature provides numerous examples of the effect of plasticizer concentration on the physicochemical properties of the film coating and on the release of the drug substance from the coated products. For example, high plasticizer content can reduce the release of metoprolol from Eudragit RS coated microspheres and improve the release stability of theophylline from coated microspheres during storage.
Moreover, the release rate of the drug substance has been shown to be influenced by the type of plasticizer. For example, the release of propanolol from microspheres coated with a mixture of ethylcellulose and Eudragit L100-55 is faster when using the hydrophilic plasticizer triethyl citrate than when using the hydrophobic dibutyl sebacinate. Other studies have shown that the plasticizer can leach out of the coating during dissolution, thus affecting both mechanical properties and the release of LVs.
Adhesion of coating substances during film application causes the formation of undesirable aggregates, and the resulting coatings may be damaged when attempts are made to separate adhering parts. This effect can be neutralized by adding anti-adhesion agents to the coating composition or by applying these agents immediately after the spray chamber. Useful anti-adhesion agents include talc, magnesium stearate, kaolin, etc.
Dyes. Dyes are commonly used to improve the appearance of the dosage form.

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