Meglumine is less common and not a well-known excipient because it is not commonly used in most of pharmaceutical formulations. About 70% of pharmacists working in pharmaceutical industries may not be aware of this excipient but its importance can not be ignored because of those drugs which have poor aqueous solubility.Meglumine is an amino sugar derived from sorbitol. It is also known as
Functions of Meglumine
Meglumine is used in different solid and liquid dosage forms as
- Organic Base
- To Enhance Aqueous Solubility of API.
- pH adjusting agent
- To improve stability
- X ray contrast media
- Solubilizing Agent
Meglumine appears as white to slightly yellowish crystalline powder.
Meglumine is water soluble but insoluble in chloroform.
- Meglumine should be stored in well-closed containers.
- It should not be stored in containers made of Aluminium because it reacts with aluminium and releases the hydrogen gas.
- It also reacts with copper containers and the colour of meglumine is changed.
- It should be stored in Stainless Steel containers.
Meglumine is incompatible with Glipizide.
(Ref Handbook of Pharmaceutical Excipients)
Meglumine & Telmisartan
- Telmisartan is an API which is used to treat high blood pressure.
- Telmisartan is poorly soluble in GIT.
- Bioavailability of Telmisartan is pH-dependent and it is poorly soluble at 3-7 pH.
- So Meglumine is used as a basic or alkalizing agent to create basic media and to enhance solubility and bioavailability of Telmisartan.
- For proper solubility enhancement of Telmisartan, it should form a complex with meglumine.
How to Enhance the Solubility of Telmisartan?
As mentioned above solubility of telmisartan is increased by using meglumine but here is an important practical observation that using only meglumine is not the science to enhance the aqueous solubility of Telmisartan but the exact complex formation is the key point.
Following steps should be followed to improve solubility.
- The first critical step is to always use meglumine and telmisartan after sieving.
- Do not mix any other excipient with Telmisartan and Meglumine during initial sieving because it will not form a proper complex.
- Mix Meglumine and telmisartan before sieving.
- Sieve the pre-mix through a fine mesh.
- Sieving should be done by applying pressure and for this avoid manual sieving.
- Use an oscillating granulator with a fine mesh.
- When pre mix of telmisartan and meglumine is sieved then mix other excipients with the premix and again sieve it.
- After this mix it in a suitable mixer and proceed further steps of wet granulation.
(Ref practical observations)