Capsules

• Pharmaceutical dosage forms


  Solid dosage forms containing API and excipients which are enclosed in a small shell of gelatin or other materials
• Gelatin


  Results of partial hydrolysis of collagen from the skin, white connective tissues, and bones of animals
• Types of capsule shell

  • Gelatin capsule
  • Vegetarian capsule
  • Modified release capsule
• Hard gelatin capsule (HGC)


  Dry-filled or two-piece capsule, capacity 65 mg - 1 g of powdered material, moisture limit unknown, method of preparation and filling unknown, capsule sizes: smallest CS unknown, largest CS unknown, common CS unknown, components: transparent - gelatin + water, opaque - gelatin + water + TiO2 + colorant, optional - sugars, vegetarian - HPMC or pullulan

  
• Soft gelatin capsule (SGC)

  One-piece capsule, usually filled with oleaginous substances, hermetically sealed, soft gelatin shells containing a liquid, a suspension, or a semisolid, moisture limit unknown, method of preparation and filling: rotary die process, applications: oral dosage forms, suppository, single dose application of topical, ophthalmic, nasal, and otic preparations, cosmetics, components: gelatin + water + plasticizers, optional - preservatives, colorants, opacifying agents, flavoring agents

  
• HPMC capsule


  Water + HPMC (cellulose obtained by the hydrolysis of plants and is made by etherification)
• Pullulan capsule


  Water + Pullulan (produced from starch by the fungus Aureobasidium pullulans)
• Modified release capsule


  Other capsules + enteric coating materials (fatty acids, waxes, shellac, plastics, plant fibers, phthalates, etc.)
• Not to use extremely soluble salts (KCl, KBr, etc.) or highly efflorescent or deliquescent materials for modified release capsules
• Diluents


  Used to produce the proper capsule fill volume or bulk and provide cohesion of powders, examples: lactose, microcrystalline cellulose, starch
• Disintegrants


  Used to assist in the breakup and distribution of the capsule's contents in the stomach, examples: pregelatinized starch, croscarmellose sodium, starch glycolate
• Lubricant or glidant


  Used to enhance the flow properties of powders or granules, examples: fumed silicon dioxide, magnesium stearate, calcium stearate, stearic acid, talc
• Wetting agent


  Facilitates wetting by the gastrointestinal fluids, thereby enhancing disintegration and dissolution and increasing the capsule's bioavailability, example: sodium lauryl sulfate
• Pin method


  1. Dipping

  2. Drying

  3. Spinning

  4. Stripping

  5. Trimming

  6. Joining
• Punch method


  1. Manual capsule filling

  2. Semi automatic capsule filling

  3. Fully automatic capsule filling
• Sealing or banding ensures closure of capsules, uses hot gelatin, provides distinct appearance, prevents filled caps from unjoining, permits color coding, provides tamper-proof feature
• Imprinting is done on empty shells, convenient method for production identification, best performed on empty capsules using edible inks
• Coating is to modify solubility characteristics of capsules to delay solubility (SR, FR)
• Plate process


  A set of molds is used, a warm sheet of gelatin is laid over the lower plate and the liquid is poured on it, a second sheet of gelatin is put in place, this is followed by the top plate of the mold and pressed under pressure

  
• Rotary die process


  Liquid gelatin flowing from an overhead tank is formed into two continuous ribbons by the rotary die machine and brought together between twin rotating dies, at the same time, metered fill material is injected between the ribbons precisely at the moment that the dies form pockets of the gelatin ribbons, these pockets of fill-containing gelatin are sealed by pressure and heat

  
• Visual inspection


  • Unpack and inspect at least 20 capsules, they should be smooth and undamaged, evidence of physical instability is demonstrated by gross changes in physical appearance: hardening or softening, cracking, swelling, mottling, discoloration of the shell
• Length


  • Tip of cap to tip of the body
• Uniformity of mass


  • Capsules comply with the test for Uniformity of mass for single-dose preparations unless otherwise specified in the individual monograph
• Assay


  • Drug assay determines the homogeneity of distribution of the drug's active/s
• Dissolution/Disintegration


  • Compliance with Dissolution and Disintegration
• We generate fears while we do nothing. We overcome these fears by taking action.