a Formula of anti-hypertensive drug ,very poor water solubility
the formula contain sodium hydroxide+meglumin+mannitol
we tried wet granulation by using 70% ethanol dissolved in it sodium hydroxide.
the problem is that the granules remain wet and never dry, even after exposing to heat 50 c in oven for several hour, and if the granules exposed to room temperature and moister it become more soft.
we also suspecting in SODIUM HYDROXIDE ! which is highly liquefied at room temp and moisture.
Dear Mohammed,
If the role of sodium hydroxide is as a base, I suggest to replace it with another base such as ammonium hydroxide or etc. In case the base is used to neutralize the anti-hypertensive agent, it will more appropriate to do the neutralization in a separate step and then to incorporate the resulting salt in the formula and finally to conduct the granulation process.
Hoping this will be helpful,
Rafik
Dear Mohammed,
I totally agree with Prof. Rafik Karaman points. Sodium hydroxide being hygroscopic in nature, it has natural tendency to absorb moisture and carbon dioxide when exposed to air. Therefore, replacing it with another base can be useful to avoid this problem. Likewise, adding adsorbent like silicon dioxide, Neusilin, etc. in your formulation can prevent moisture uptake by sodium hydroxide. You can try by introducing any adsorbent up to 5% of total weight. However, it should be kept in mind that these changes might affect the tablet compaction, flowability, disintegration, etc.
Thank you
Hope you can sort out your issues soon. Best of luck.
Dear Abdeen,
As I understood from your problem, you are trying to increase the solubility of your drug, which has low water solubility. There are some other methods also to prepare the fast dissolving tablets. So, you can try with other methods.
If want to use this particular method only then change the base as other researchers have specified in their suggestions.
I guess molecule must be AC if i am not mistaken. Use CaCo3 in place of sodium hydroxide as a base. since it has meglumin also so, it would work without sodium hydroxide
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