Limitations of Direct Compression Tablet

By: Pharma Tips | Views: 10225 | Date: 15-Jun-2011

1. Segregation2. Cost3. Low dilution potential4. Re-workability5. Lubricant sensitivity6. Variation in functionality


1. Segregation
Direct compression is more prone to segregation due to the difference in density of the API and excipients. The dry state of the material during mixing may induce static charge and lead to segregation. This may lead to the problems like weight variation and content uniformity.

2. Cost
Directly compressible excipients are the speciality products produced by patented spray drying, fluid bed drying, roller drying or co-crystallization. Hence, the products are relatively costly than the respective raw materials.

3. Low dilution potential
Most of the directly compressible materials can accommodate only 30-40 % of the poorly compressible active ingredients like acetaminophen that means the weight of the final tablet to deliver the 500 mg of acetaminophen would be more than 1300 mg. The large tablets may create difficulty in swallowing.

4. Re-workability
All the spray-dried directly compressible adjuvants show poor reworkability since on preparation of tablets the original spherical nature of the excipient particles is lost. API that has poor flow properties and/or low bulk density is difficult to process by direct compression.

5. Lubricant sensitivity
Lubricants have a more adverse effect on the filler, which exhibit almost no fracture or shear on compression (e.g. starch 1500). The softening effects as well as the hydrophobic effect of alkaline stearates can be controlled by optimising the length of blending time to as little as 2-5 min.

6. Variation in functionality
There is a lack of awareness in some situations that the excipient behave differently, depending upon the vendor so much so that substitution from one source to that of another is not possible. Hence, there is a need for greater quality control in purchasing of raw material to assure batch uniformity.

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