Page 10 - Pharmaceutics III_ 02-06-01304_Fall 2025_ Pharm D_Electronic book
P. 10

Ingredient      Role                                   Note

Base            Source of $\text{CO}_2$ (e.g., Sodium
                Bicarbonate) [cite: 538]

Binding Liquid  Binder (e.g., Alcohol, or an           Water should be minimized
                alcohol/water mixture)                 to prevent a premature
                                                       reaction.

Equipment       Mortar and Pestle, Sieves (e.g., 4-12
                mesh range ), Drying oven, Balance.

2. The Granulation Procedure

The key to the wet method is controlled mixing to create the correct dampness for forming
granules without triggering a full effervescent reaction.

    • Step 1: Powder Preparation and Blending

              o Reduce all ingredients to a uniform, fine powder using a process like trituration .

              o Geometrically dilute the potent drug (if used) into the bulk excipient powders
                   (acids and base) using a mortar and pestle to ensure uniform distribution .

              o Blend all dry ingredients thoroughly.

    • Step 2: Wetting the Powder Mass

              o Slowly add the binding liquid (e.g., alcohol) to the dry, blended powder mixture
                   in the mortar .

              o Mix the powders until a damp, plastic mass is formed. The mass should hold its
                   shape when pressed but should not be excessively wet or sticky.

              o Critical Note: Perform this step rapidly to minimize contact time between the
                   powders and the moisture.

    • Step 3: Sizing (Granulation)

              o Pass the damp mass through a sieve (typically a coarse-mesh sieve, e.g., 4 or 6
                   mesh) to break the mass into wet granules .

              o Spread the wet granules on a drying tray.

    • Step 4: Drying and Final Sizing

              o Place the wet granules in a low-temperature drying oven or a fluid-bed dryer to
                   remove the remaining moisture .

              o Ensure complete drying to prevent future moisture-induced effervescence
                   during storage, which can affect stability .

              o Once fully dry, pass the granules through a final sieve (e.g., 10 or 12 mesh) to
                   achieve the final, uniform granule size .

3. Benefits of the Wet Method

                      9
   5   6   7   8   9   10   11   12   13   14   15