B. BULK POWDERS: Bulk powders can be for external or internal use. They are powders supplied or dispensed in bulk. Bulk powders for internal use are usually for less potent drugs. In other words, they are for high dose drugs. For internal use, the most commonly used dispensed drugs are antacids such as Magnessium trisilicate, Magnessium hydroxide etc. Other forms of bulk powders for external use include: dusting powders.
The formulation techniques for bulk powders is the same as that in divided powders which include weighing the ingredients, mixing them appropriately, and packing them together. There may be need for dilution if the quantity of the active ingredient is small using a diluent such as lactose. There is usually a need for size reduction in order to bring the powders to about the same size. This ensures intimate mixing otherwise the large particles will segragate from the smaller ones. When mixing the ingredients, always start with the one with the lowest quantity followed by the one with a quantity higher than the previous and so on. This is to ensure that each ingredient is distributed evenly throughout and each dose contains the same quantity of the active ingredient in each of the products throughout.
Extemporaneous preparation of bulk powder is done in the mortar. Starting with the smallest quantities and subsequently add up the others by doubling up technique.
Sometimes seiving is carried out after the preparation using mesh of sieve size 250um for internal powders and 180um for external powders
ORAL BULK POWDER They are intended for internal use. They are of two types
1. High dose drug: The drug ingredients are mixed together, packed in bulk and the patient is directed on how to take part by part of the drug.
e.g. Tablespoonful - 15ml => three 5ml spoonful Desertspoonful - 10ml => two 5ml spoonful Teaspoonful - 5ml => one 5ml spoonful 2. Degradable (unstable) dose drug: Antibiotics are only stable in solid form. E.g.
Ampiclox = Ampicillin + Penicillin
These degradable dose drugs instead of being formulated in solution are made in solid bulk form and stored in dark containers. Label is given on how to reconstitute the product. A mark is made on the container of the product where the patient will be required to add water and make it up to mark or volume. Condition of storage is given to the patient such as “Keep out of reach of children”, “Store in cool place and dry place”etc.