Abstract
Lactose and mannitol are some of the most commonly used powders in the pharmaceutical industry. The limited research published so far highlights the effects of process and formulation parameters on the properties of the granules and the tablets produced using these two types of powders separately. However, the comparison of the performance of these two types of powders during twin screw wet granulation has received no attention. The present research is focused on understanding the granulation mechanism of different grades of two pharmaceutical powders with varying properties (i.e., primary particle size, structure, and compressibility). Three grades each of lactose and mannitol were granulated at varying liquid to solid ratios (L/S) and screw speed. It was noticed that primary powder morphology plays an important role in determining the granule size and structure, and tablet tensile strength. It was indicated that the processed powders such as spray-dried and granulated lactose and mannitol can be used in formulation for wet granulation where flowability of active pharmaceutical ingredient (API) is poor.
Highlights
In the pharmaceutical industry, granulation of powders to form structured products is one of the most important operations in solid oral dosage form manufacturing to improve flow, compaction or homogeneity of powders
Spray-dried lactose and anhydrous lactose are recommended for dry granulation and direct compaction owing to their excellent flowability and compressibility [1]
The porous structure of a particle may enhance the compressibility in dry granulation or direct compaction, but in wet granulation it can limit the binding between the particles due to absorption of water in the structure of the particles
Summary
Granulation of powders to form structured products (i.e., granules) is one of the most important operations in solid oral dosage form manufacturing to improve flow, compaction or homogeneity of powders. It can be carried out using either dry or wet approaches. Amongst various excipient (filler/diluent) powders available for the wet/dry granulation and tableting in the pharmaceutical industry, lactose and mannitol are some of the most common ones Both lactose and mannitol are commercially available in different grades (e.g., sieved, milled, spray-dried, granulated, etc.) presenting different particle characteristics (i.e., size, size distribution, degrees of fines, shape, surface, flowability, and compressibility) [1,2]. Spray-dried lactose and anhydrous lactose are recommended for dry granulation and direct compaction owing to their excellent flowability and compressibility [1]
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