GRANULES Presented by: M.Qasim Yousaf Farhan Shabbir Hamid Raza Ali Hassan Dain Butt Introduction to Granules • Granules are agglomerates of smaller powder particles, meaning they are formed by binding small particles together. • They are generally irregularly shaped, but can be made spherical based on requirement. • They are typically sized between 4 to 12 mesh sieve, though size may vary depending on the application. Characteristics of Granules • Better flowability than powders – they pour smoothly, useful in tablet machines. • More physically stable than powders – less reactive to moisture and air, less likely to cake or harden. • Wettability: Easier to wet and dissolve in liquids, unlike fluffy powders that float. • Have lower surface area compared to powders → reduced degradation by humidity. • Ideal for reconstitutable powders like antibiotic suspensions. Uses of Granules in Pharmacy • 🔹 Tablet manufacturing: Granules improve flow properties, allowing smooth and uniform filling of tablet dies from hoppers. • 🔹 Dry powders for reconstitution: Used to prepare oral suspensions just before dispensing — ensures drug stability in dry form. • 🔹 Effervescent formulations: Granules are used in products like effervescent tablets and granules for solution, which release CO₂ on contact with water. • 🔹 Improved storage stability: Granules are less hygroscopic and less likely to cake or harden than powders during storage. • 🔹 Better wettability: Granules mix and dissolve more easily in liquids, making them suitable for suspensions and solutions. • 🔹 Taste masking and patient compliance: Granules are often flavored and colored to improve palatability, especially for pediatric and geriatric patients. Methods of Granulation: • Granules are prepared by two major methods: 1. Wet Granulation a) Conventional method. b) Fluid bed processing 2. Dry Granulation a) Roll Compaction. b)Slugging. Wet Granulation a) Conventional Method Wet Granulation b) Fluid Bed Processing • Powder is moistened to form a paste. • Paste is passed through a screen or sieve to form granules of desired size. • Granules are air-dried or heat-dried on trays. • Granules are moved periodically to prevent clumping or formation of large masses. • Powder is placed in conical equipment, air is blown to suspend the particles. • A liquid binder is sprayed while drying occurs at the same time. • Result: Uniform granules or pellets of defined size. • Faster, more uniform, and efficient method than traditional wet granulation. Dry Granulation a) Roll Compaction Dry Granulation b) Slugging • Powder is passed through a roll compactor (roller press). • Compacts powder into dense sheets or ribbons using mechanical pressure. • Roll surfaces may be smooth, pocketed, or corrugated for different textures. • Sheets are granulated using a granulator to achieve uniform particle size. • Usually done in a continuous integrated system. • Powder is compressed into large, flat-faced tablets called slugs. • Compression pressure: 8,000 to 12,000 lb, depending on powder nature. • Slugs are broken down into granules using a granulator. • Often produces fines (non- agglomerated powder), which are separated and reprocessed. Effervescent Granulated Salts: Introduction Effervescent granulated salts are a type of solid dosage form made by granulating a mixture of acid and base components, which release carbon dioxide (CO₂) when dissolved in water. Advantages of Effervescent Granules • CO₂ gas masks bad taste of drug. • Granules dissolve slowly, preventing violent effervescence. • Using both citric and tartaric acid avoids problems: • Tartaric alone → brittle, crumbles • Citric alone → sticky and hard to granulate • Granule form controls reaction rate to prevent overflow and loss of gas. Methods to Prepare Effervescent Granules Effervescent Granules are prepared by two methods: 1. Dry/Fusion Method 2. Wet Method Effervescent Granules a) Dry or Fusion Method Effervescent Granules b) Wet Method • Water of crystallization from citric acid acts as the binding agent. • Procedure: • Powder citric acid, mix with other powders (same sieve size). • Mix rapidly in low humidity to avoid premature reaction. • Heat in oven at 34–40°C to release water → partial dissolution occurs. • A spongy mass is formed and sieved (No. 4/8/10) to desired granule size. • Final drying at temperature below 54°C, then sealed in containers. • Does not rely on water of crystallization. • Binding agent is water mixed with alcohol. • Procedure: • Mix all powders (can be anhydrous). • Gradually add water-alcohol mixture to form pliable mass. • Granulate and dry just like in fusion method. Thank you for listening!