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💊 TABLETS

Definition

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Advantages (5)

1. Accurate dosing — each tablet contains a precise, uniform dose
2. Stable — better chemical stability compared to liquid forms
3. Convenient — easy to handle, carry, and self-administer
4. Economical — cheapest mass-produced dosage form
5. Identification — can be coated, colored, or embossed for easy recognition

Disadvantages (5)

1. Difficult for dysphagia — hard to swallow for children and elderly
2. Slow onset — must disintegrate and dissolve before absorption
3. Not suitable for irritant drugs — may cause GI irritation
4. Hygroscopic drugs — unsuitable if API absorbs moisture
5. Low bioavailability — poorly soluble drugs may show erratic absorption

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Types of Tablets (Orally Ingested — Important for Exams)

Other Types (Not Common in Exams)

• Hypodermic tablets, Implantation tablets, Troches/Lozenges (dissolve in mouth slowly), Vaginal tablets

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Preparation of Tablets — 4 Methods + Layouts ⭐

1. Wet Granulation

• Most widely used method
• API + diluent mixed → binder solution added → wet mass → screened → dried → lubricated → compressed
• Best for: moisture-stable, heat-stable drugs
• Layout: Mixing → Wet massing → Screening (wet) → Drying → Screening (dry) → Blending → Compression

2. Dry Granulation (Slugging / Roller Compaction)

• No liquid used; powder is compacted then milled into granules
• Best for: moisture-sensitive or heat-sensitive drugs
• Layout: Mixing → Slugging/Roller compaction → Milling → Blending → Compression

3. Direct Compression

• API + excipients compressed directly without granulation
• Requires directly compressible excipients (e.g., spray-dried lactose, MCC)
• Layout: Mixing → Compression
• Fastest and simplest method

4. Molding (Tablet Trituration Method)

• Mixture moistened with solvent, pressed into molds, and allowed to dry
• Used for soluble tablets (e.g., hypodermic, sublingual)
• Layout: Mixing → Moistening → Molding → Drying

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Process After Preparation (9 Steps) ⭐

1. In-process quality control (weight variation, hardness check during compression)
2. Tablet deduster — removes loose powder from tablet surface
3. Metal detector — detects metallic contamination
4. Tablet inspection — visual/automated check for physical defects
5. Coating (if required — sugar, film, or enteric)
6. Quality control testing:
   • Weight variation
   • Hardness / crushing strength
   • Friability
   • Disintegration test
   • Dissolution test
   • Content uniformity
7. Packaging (blister, strip, bottle)
8. Labeling
9. Storage / dispatch

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Tablet Defects (All)

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Tablet Coating

Types:

1. Sugar Coating — multiple layers of sucrose; older method; 7 steps (sealing, subcoating, smoothing, colouring, polishing, finishing)
2. Film Coating — thin polymer film (HPMC, EC, Eudragit); modern, faster, less weight gain
3. Enteric Coating — resists gastric pH (<2); dissolves at intestinal pH (>5.5); e.g., CAP, HPMCP

Purpose of Coating:

• Mask bitter taste/odor
• Protect from moisture and light
• Control drug release
• Ease swallowing
• Prevent GI irritation

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🔬 GRANULES

Definition ⭐

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Types of Granules

1. Effervescent granules — contain acid + base (citric acid + sodium bicarbonate)
2. Coated granules — individual granules coated for controlled/modified release
3. Granules for oral solution/suspension
4. Prolonged-release granules
5. Gastro-resistant granules

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Preparation of Granules ⭐ (All Methods — Important)

1. Wet Granulation

• Most common
• Add binder solution to powder mix → form wet mass → pass through screen → dry → final granules
• Binders: starch paste, PVP, HPMC

2. Dry Granulation

• No liquid binder
• Slugging: powder compressed into large slugs → crushed → screened
• Roller compaction: powder passed between rollers → ribbons → milled into granules
• Used for moisture/heat-sensitive materials

3. Direct (Spray) Granulation / Fluid Bed Granulation

• Powder suspended in air → binder sprayed → granules form in fluidized bed
• Efficient and fast; drying occurs simultaneously

4. Extrusion-Spheronization

• Wet mass extruded → spheronized in marumerizer → spherical pellets
• Used for pellets / multiparticulate systems

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Advantages of Granules

1. Improved flowability over powders
2. Reduced dust (less segregation)
3. Better compressibility for tablets
4. Uniform mixing → better content uniformity
5. Easier to handle and measure
6. Reduced risk of caking

Disadvantages of Granules

1. More steps → higher production cost
2. Loss of material during granulation
3. Not suitable for incompatible drug-excipient pairs (wet granulation adds heat/moisture stress)
4. Time-consuming drying step (wet granulation)

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Effervescent Granules (Definition Only)

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🌫️ POWDERS

Definition

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Advantages of Powders

1. Flexible dosing (dose can be adjusted)
2. Good bioavailability (large surface area → faster dissolution)
3. Stable — less prone to degradation than liquids
4. Easier to prepare than tablets/capsules
5. Suitable for children (mixed in food/drink)
6. Economical to manufacture

Disadvantages of Powders

1. Inaccurate dosing (if measured by patients)
2. Bitter/unpleasant taste not easily masked
3. Hygroscopic — absorb moisture; caking may occur
4. Not suitable for volatile or deliquescent drugs
5. Bulky — inconvenient to carry
6. Dust hazard for potent/toxic drugs

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Classification of Powders

By Route of Administration:

• Oral powders (e.g., ORS, antacid powders)
• Topical/dusting powders (e.g., talc, zinc oxide powder)
• Insufflations — blown into body cavities
• Inhalation powders (DPIs — Dry Powder Inhalers)
• Ear/nose powders

By Composition:

• Simple powders — single ingredient
• Compound powders — multiple ingredients

Logic for MCQs:

• Powders may also be classified by particle size (USP classification — see table above)
• By physical nature: effervescent, hygroscopic, eutectic powders

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Manufacturing + Preparation of Powders

1. Comminution (size reduction) — milling, grinding (e.g., ball mill, hammer mill, fluid energy mill)
2. Sizing/Screening — use sieves to achieve uniform particle size
3. Mixing/Blending — ensure homogeneity
   • Methods: trituration, tumbling, geometric dilution (for potent drugs)
4. Special handling:
   • Eutectic mixtures — add inert adsorbent (MgO, kaolin)
   • Hygroscopic substances — add light MgO or dried starch
   • Volatile ingredients — add last; minimize exposure
5. Quality control — uniformity of mass, particle size analysis

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Packaging of Powders ⭐ (MCQs)

Types:

1. Bulk containers — wide-mouth glass/plastic jars (for dusting powders, antacid powders)
2. Unit dose sachets — single-dose foil/paper sachets (e.g., ORS, electrolyte powders)
3. Divided papers (Chart) — traditional powder papers folded individually
4. Inhalation devices — blister packs for DPIs (e.g., Turbuhaler, Diskhaler)
5. Shaker-top containers — for topical dusting powders

Factors influencing packaging:

• Moisture sensitivity → desiccant, airtight seal
• Light sensitivity → amber/opaque containers
• Hygroscopicity → moisture-proof packaging
• Volatile ingredients → hermetically sealed

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💊 CAPSULES

Definition

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Types of Capsules

1. Hard gelatin capsules (HGC) — two-piece; filled with powder, pellets, or granules
2. Soft gelatin capsules (SGC / Softgels) — one-piece; filled with liquid, semi-solid, or suspension
3. HPMC (Vegetarian) capsules — plant-based alternative to gelatin
4. Pullulan capsules — derived from fermentation; low moisture content
5. Enteric capsules — coated to resist gastric dissolution

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Hard Gelatin Capsules — Types/Sizes (Name Only) ⭐

• Size 000 = ~1.37 mL fill capacity
• Size 5 = ~0.13 mL fill capacity
• Most commonly used in humans: sizes 0, 1, 2

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Capsule Shell Preparation

• Gelatin (main structural material — bone/hide origin; Bloom strength 150–280)
• Plasticizers — glycerin, sorbitol (to prevent brittleness)
• Colorants — FD&C approved dyes
• Opacifying agent — titanium dioxide (for light-sensitive contents)
• Preservatives — sodium lauryl sulfate, parabens
• Water — 13–16% moisture content in final shell

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Hard Gelatin Capsules for Human Use ⭐ (Important)

Shell Parts:

• Cap (shorter) and Body (longer)
• Body is filled and the cap snaps onto the body
• Modern capsules have locking rings to prevent separation

Filling Methods:

1. Manual filling — spatula and tray method (small-scale)
2. Semi-automatic — partially automated, hand supervision
3. Fully automatic machines — e.g., Zanasi, MG2, Bosch; fill 150,000–500,000 caps/hr

Finishing Steps after Filling:

• Joining → Locking → Polishing → Printing

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Manufacturing Steps of Hard Gelatin Capsules ⭐ (Important)

1. Preparation of gelatin solution — gelatin dissolved in hot purified water (60–70°C); colorants, plasticizers added; maintained at 50°C
2. Dipping — stainless steel pins (mandrels) dipped into warm gelatin solution
3. Withdrawal — pins withdrawn with even gelatin film
4. Drying — dried in drying kilns using dehumidified air (controlled humidity 35% RH)
5. Stripping — dried gelatin stripped from pins using bronze/bronze jaws
6. Trimming — cut to exact length (cap and body)
7. Joining — cap and body loosely joined
8. Inspection — visual and automated inspection for defects
9. Printing — logos, product name printed (optional)
10. Packaging — filled into bulk bags or boxes

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Soft vs. Hard Gelatin Capsules

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Key MCQ Tips:

• Granule size range: 0.2–4 mm
• Powder particle size — USP grades are based on sieve number
• Capsule sizes: 000 (largest) to 5 (smallest)
• Gelatin shell moisture: 13–16%
• Hard gelatin shell Bloom strength: 150–280
• Wet granulation uses a binder solution; dry granulation uses slugging or roller compaction
• Direct compression is fastest and simplest tablet preparation method
• Effervescent granules: citric/tartaric acid + sodium bicarbonate
• Capping and lamination are the most common tablet compression defectsAll four topics from your outline are covered. Here's a quick summary of what's included: