Detailed Explanation Softgel Capsules PDF

Detailed Explanation of Soft Gelatin Capsules Detailed Explanation of Soft Gelatin Capsules (Softgels) 1. Introduction to Softgels - Definition: Softgels consist of a liquid or semi-solid matrix encased within a one-piece gelatin shell. - Fill Matrix: - Can be hydrophilic (e.g., polyethylene...

Detailed Explanation of Soft Gelatin Capsules Detailed Explanation of Soft Gelatin Capsules (Softgels) 1. Introduction to Softgels - Definition: Softgels consist of a liquid or semi-solid matrix encased within a one-piece gelatin shell. - Fill Matrix: - Can be hydrophilic (e.g., polyethylene glycols), lipophilic (e.g., vegetable oils), or a combination. - Drugs inside the matrix may be dissolved or suspended. - Shell Composition: - Made of gelatin, water, and a plasticizer. - Can be transparent, opaque, colored, and flavored. - Special Coatings: May include gastro-resistant or delayed-release coatings. - Forms: - Oval or oblong shapes for oral administration. 2. Types of Softgels 1. Oral Softgels: Contain solutions or suspensions released in the stomach. 2. Chewable Softgels: Flavored shells chewed to release the fill. 3. Suckable Softgels: Flavored shells that release contents when sucked. 4. Twist-off Softgels: Have a tag that can be twisted or snipped to access the fill material. 3. Advantages of Softgels a. Improved Drug Absorption: - Hydrophobic drugs with poor disintegration properties are more readily absorbed. - Microemulsion or nanoemulsion systems enhance bioavailability (e.g., Sandimmune Neoral®). - Surfactants improve wettability and permeability. b. Patient Compliance: - Easier to swallow than tablets and hard capsules. - Lower dose requirements reduce capsule size. c. Safety During Manufacturing: - Reduces dust exposure from potent or cytotoxic drugs by encapsulating solutions or suspensions. d. Formulation of Oils and Low-Melting Drugs: - Oily liquids and low-melting drugs can be directly filled into softgels. e. Dose Uniformity: - Liquid dosing avoids poor powder flow issues, ensuring homogeneity. f. Product Stability: - Encapsulation in a gelatin shell protects against oxygen and moisture. 4. Manufacturing Process a. Historical Background: - Early 1800s: Individual softgel manufacturing. - 1933: Rotary die encapsulation introduced, enabling large-scale production. b. Steps in Manufacturing: 1. Preparation of Gelatin Mass: - Gelatin dissolved in water (~80°C) under vacuum. - Plasticizers added (e.g., glycerol for elasticity). - Coloring agents, opacifiers, and flavors may also be added. - The gelatin mass is cast into ribbons (0.5-1.5 mm thickness). 2. Preparation of Fill Matrix: - Drug dissolved or suspended in a non-aqueous vehicle. - Particle size of suspended drugs should be