Introduction to Solid Oral Dosage Forms
Types: |
Tablets, Capsules, Lozenges, Pastilles, Powders, Granules |
Advantages: |
Convenient, stable, accurate dosing, taste masking, potential for controlled release |
Disadvantages: |
Difficult to swallow, unsuitable for liquid drugs |
Alternative Tablet Manufacturing Methods
Pre-compression: |
Used when moisture/heat-sensitive; uses slugs or roller compaction |
Direct Compression: |
Simple and cost-effective; uses flowable drug/diluent mix (e.g. Avicel, Zeparox) |
Capsule vs Tablet decision factors
Company policy, market research, competitor products |
Equipment, production costs, unit dose, dissolution rate, drug stability |
Quality Control (QC)
Official tests (BP/EP) |
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For all tablets: |
Uniformity of content |
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Uncoated tablets: |
Weight uniformity, disintegration, dissolution |
Unofficial tests |
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Hardness, friability |
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Tablets
Definition: |
Solid mass compacted using a tablet machine: typically 50-500mg |
Properties: |
Strong, Bioavailable, stable, elegant, uniform in weight and content |
Types: |
Standard, Soluble/Dispersible, Effervescent, Chewable, Buccal, Sublingual, Enteric-coated, Controlled release |
Tablet coatings
Purposes: |
Protect drug, taste/appearance, ID, stability, controlled release |
Types: |
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Sugar coating: |
Multistage, increases weight, glossy finish |
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Film coating: |
Popular, automated, controlled release capable, minimal weight gain |
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Press coating: |
Rare, separates incompatible ingredients |
QC test details
Disintegration: |
6 tubes in 37°C bath; usually ≤15 minutes |
Dissolution: |
Basket/paddle/cell method; ≥70–75% drug released in 45 mins |
Hardness (Crushing): |
Measured force to break tablet |
Friability: |
Weight loss after 100 rotations (≤1% allowed) |
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Tablet Manufacturing – Moist Granulation
Mixing with Diluents: |
Lactose, cellulose, calcium salts, starches, sugars |
Blending with Binder: |
Water, methylcellulose, starch paste, gelatin, etc. |
Screening: |
Mesh size affects granule size |
Drying: |
Tray/fluid bed dryer; granules re-screened post-drying |
Additives: |
Lubricants: |
Stearates, PEGs, sodium benzoate |
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Glidants: |
Talc, fumed silica |
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Disintergrants: |
Starch, alginic acid, cellulose |
Capsule Manufacturing
Hard capsules: |
Filled with powders, granules, tablets, pastes |
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Must not react with gelatin or leak |
Softgels: |
Filled, formed, sealed in one go using rotary die machine |
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Fill is sealed between two gelatin ribbons |
Specialised Solid Forms
Lozenges: |
Local effect; slow dissolve in mouth, no disintegrant |
Chewables: |
Rapid breakdown in mouth, no disintegrant |
Dispersible/Soluble Tablets: |
Dissolve/disperse in water; water-compatible disintegrant required |
Effervescent Tablets: |
Rapid disintegration via fizz; no standard lubricants |
Sublingual/Buccal Tablets: |
Dissolve in mouth for fast absorption; no disintegration needed |
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Tablet compression
Stages: |
Lower punch creates cavity → powder fills → upper punch compresses → tablet ejected |
Machines: |
Single stroke press: |
Small-scale |
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Rotary press: |
Large-scale, 10,000+ tablets/min |
Issues: |
Picking, sticking, capping, lamination, weight variation, mottling |
Functional Coatings
Enteric Coating: |
pH-dependent solubility; protects from stomach acid |
Controlled release: |
Diffusion-controlled, Erosion-based, Osmotic systems |
Capsules
Shell: |
Gelatin (Type A – acid hydrolysis; Type B – base hydrolysis) |
Types: |
Hard capsules: |
Two-piece, filled with dry/semi-solid materials |
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Soft capsules (softgels): |
One-piece, filled with non-aqueous liquids |
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