上海交通大学：《药剂学》教学资源（课件讲义）5tablets coating

TABLETS Coating Pharmacy school Chen Jian Why coat tablets? Tablet properties Protect the medicinal agent ■Smooth surface ■Mask the taste ■Physical shape Provide esthetics or distinction Mechanical strength Provide special release characteristics Coated tablets Sugar-coated tablets ■Sugar Coated Tablets 1.Waterproofing and sealing 2.Subcoating Film Coated Tablets 3.Smoothing and final rounding 4.Finishing and coloring Enteric coated tablets 5.Polishing 1

1 TABLETS Pharmacy school Chen Jian Coating Why coat tablets? „ Protect the medicinal agent „ Mask the taste „ Provide esthetics or distinction „ Provide special release characteristics Tablet properties „ Smooth surface „ Physical shape „ Mechanical strength Coated tablets „ Sugar Coated Tablets „ Film Coated Tablets „ Enteric coated tablets Sugar-coated tablets „ 1. Waterproofing and sealing „ 2. Subcoating „ 3. Smoothing and final rounding „ 4. Finishing and coloring „ 5. Polishing

Film-coating tablets Ingredients of Film-forming solutions Film-coating places a thin skin-tight Film-forming polymer coating of a plastic-like material over the ■Plasticizer compressed tablet. Colorant and opacifier ■Solvents Antiadherent Film-forming solutions polymer Plasticizer ·HPMC ·PEG ■HPC ■Glycerin ■Propylene glycol ■Acrylate acid resin ■Castor oil ■PVP ■Phthalate ■others others Solvents Enteric coated tablets ■Ethanol This formulation is preferred when, ■Isopropanol The API irritates gastric mucosa Drugs that produce nausea and vomiting. Acetone API is sensitive to low pH Water When it's necessary to release the drug undiluted. 2

2 Film-coating tablets „ Film-coating places a thin skin-tight coating of a plastic-like material over the compressed tablet. Ingredients of Film-forming solutions „ Film-forming polymer „ Plasticizer „ Colorant and opacifier „ Solvents „ Antiadherent Film-forming solutions polymer „ HPMC „ HPC „ Acrylate acid resin „ PVP „ others Plasticizer „ PEG „ Glycerin „ Propylene glycol „ Castor oil „ Phthalate „ others Solvents „ Ethanol „ Isopropanol „ Acetone „ Water Enteric coated tablets This formulation is preferred when, „ The API irritates gastric mucosa „ Drugs that produce nausea and vomiting. „ API is sensitive to low pH „ When it’s necessary to release the drug undiluted

Enteric coated tablets Aqueous polymeric dispersions Materials used for enteric coating: ■Nontoxic ·CAP PVAP ■High polymer content .Shellac ■Low viscosity 。Acrylate acid resin ·HPMCP Productive 。others Aqueous polymeric dispersions Mechanism of film formation ■Latexes ■Pseudolatexes 8888 ↑↑ Micronized polymeric powder 文xX】 XOXOOOOO R 年 Aqueous polymeric dispersions Aqueous polymeric dispersions ■Polymer Brand Polymer component ■Plasticizer Eudragit Acrylate acid resin Pigment Aquacoat EC ■Antiadherent Surelease EC ■… Sureteric PVAP 3

3 Enteric coated tablets „ Materials used for enteric coating: „ CAP „ PVAP „ Shellac „ Acrylate acid resin „ HPMCP „ others Aqueous polymeric dispersions „ Nontoxic „ High polymer content „ Low viscosity „ Productive Aqueous polymeric dispersions „ Latexes „ Pseudolatexes „ Micronized polymeric powder Mechanism of film formation Aqueous polymeric dispersions „ Polymer „ Plasticizer „ Pigment „ Antiadherent „ …… Aqueous polymeric dispersions Sureteric PVAP Surelease EC Aquacoat EC Eudragit Acrylate acid resin Brand Polymer component

Coating methods Film defects ■Pan coating ■Sticking and picking ■Roughness Fluidized bed coating .Bridging and filling ■Roll coating ■Blistering ■Compression coating Color variation ■Cracking 4

4 Coating methods „ Pan coating „ Fluidized bed coating „ Roll coating „ Compression coating Film defects „ Sticking and picking „ Roughness „ Bridging and filling „ Blistering „ Color variation „ Cracking