Tablet Manufacturing and Lactose as a Filler Quiz

Tablet Manufacturing Processes and Considerations

• Direct compression (DC) is limited to 20% poorly compressible drug, with a 50 mg tablet size being within the accepted range.
• Increasing excipients can increase tablet weight, and wet granulation can improve compressibility.
• Granulation is a process for flowability, compressibility, preventing segregation, avoiding dustiness, and achieving controlled release.
• Wet granulation involves mixing, wet massing, screening, drying, dry screening, and adding excipients for tabletting.
• Wet granulation advantages include versatility and flexibility, but it has limitations related to cost, stability, and dissolution.
• Dry granulation involves mixing, slug compression, milling, dry screening, and adding excipients for tabletting.
• Dry granulation is ideal for moisture- and heat-sensitive materials, but it requires heavy-duty equipment and may produce uneven color distribution.
• Wet granulation uses liquid binders and is suitable for poorly compressible and poorly flowing materials, while dry granulation forms granules without added moisture and is faster.
• The choice between direct compression, dry granulation, and wet granulation depends on compressibility and flow properties.
• The shape and dimension of tablets are determined by punches and dies in tabletting compaction processes.
• The tabletting compaction process involves compression and consolidation to reduce the bulk volume of powder in the die cavity and bond particles.
• Tablet making involves particle rearrangement, deformation, and bonding stages, with particles deforming elastically and undergoing plastic and brittle fracture.

Overview of Lactose as a Filler in Tablet Formulation

• Fillers, also known as diluents or bulking agents, help in forming active pharmaceutical ingredients (API) into tablet form by providing sufficient bulk volume for compression.
• Ideal properties of fillers include being chemically inert, compatible with drugs and other excipients, non-hygroscopic, water-soluble, and having good compactibility and flow properties.
• Examples of fillers include lactose, mannitol, sorbitol, calcium phosphate/carbonate, cellulose, and starch, with lactose being the most common.
• Lactose has advantages such as being readily dissolved in water and having good taste, but it can cause lactose intolerance and undergo chemical reactions towards amines, affecting tablet stability, efficiency, and safety.
• Lactose can exist in different types, such as crystalline lactose (granulation) and modified lactose (direct compression), each with varying properties and uses.
• Crystalline α-lactose monohydrate is not directly compressible and requires wet granulation to produce hard tablets, while crystalline β-lactose monohydrate is directly compressible and less prone to moisture uptake.
• Modified lactose, such as spray-dried lactose, is amorphous and more easily dissolved, but it is less stable and more expensive than its crystalline counterpart due to the extra processing step of spray drying.
• The amorphous nature of modified lactose makes it chemically and physically less stable, leading to issues with moisture absorption and particle instability.
• The Maillard reaction, a chemical reaction between amino acids and reducing sugars, can cause discoloration and affect tablet formulation when using lactose.
• Lactose undergoes different processes such as sieving, milling, and spray drying to produce different types with varying properties and applications.
• Lactose is widely used as a filler in tablet formulation due to its advantageous properties, cost-effectiveness, and suitability for various manufacturing processes.
• Understanding the properties and types of lactose as a filler is crucial for pharmaceutical formulation and tablet production to ensure product quality and stability.