Hello, Evarite Galois!For my opinion, phenelephrine cannot make significant influence to the tablets hardness, because of its small quantity in the formulations. The amount of acetaminophen is much bigger and its compressibility is very low, so I recommend you to pay attention to the granulation process (concentration of the binder) or to the total content of water in the tablets (crystalline water may increase the hardness of the tablets and on the other side, moister content can decrease this value). Also, it would be better to get more information for understanding the reasons for this process.

Dear Anton Obolonyk,

I would like to thank you for your response.

Yesterday, i found an article relate to my problem because i also use the mixture of acid stearic and povidone K30 (apporoximate 30% acid stearic)

Article Investigating lubricant effects on disintegration stability ...

What do you think about it?

I look forward to hearing your idea

Best regards.

Hello, Evarite Galois!

In my practice, I usually try to avoid such a large amount of lubricants. You risk facing the low compressibility of the formulation with so high ratio of stearic acid. Also, you must keep in mind the low value of melting point of stearic acid, which can cause the problems with tabletting process.

I recommend you to use 1-2% of magnesium stearate for your purposes with a strict control of mixing duration.

Best regards.

Thank you so much, Anton Obolonyk.

Hi

Tablet hardness generally depends on the concentration of binder, disintegrant, composition of other excipients, moisture present in the granules, the cam track adjustment in the tabletting machine.

Phenyl ephrine of a general dose of 10 mg is prescribed. It has a mol.wt of 203.66g/ml. It is recommended to be stored at 2-8 degrees Celsius. due to its hygroscopicity, it can absorb atmospheric moisture. The presence of moisture can effect the hardness to some extent. This can be experimentally find out by doing the tableting at various temperatures.