Bengaluru : The Indian excipient manufacturers are looking for appropriate grade of the lubricants which are an essential component of a drug formula. Lubricants are additives used to reduce friction and ensure consistency in production of oral solid dosage (OSD) forms.
According to Ravleen Singh Khurana, managing director, Nitika Pharmaceutical Specialities, stringent regulatory controls and increasing demand for precision products will push the pharma formulation scientists to develop the robust formulations. It will call for carrying out detailed studies thereby arriving at lubricant sensitivity needs.
The demand for special lubricants for effervescent tablets, lubricants for clean tablets and environmentally sustainable lubricants and novel lubricants will see growing demand in future, he added.
The premium customized grades are already well in demand and their requirements are going to increase. Through 90% of formulations are made using magnesium stearate, sodium stearyl fumarate because of its lower impact on the desired tablet attributes it is gaining popularity, stated Khurana at the IPEC India webinar on Future trends in OSD Lubrication attended by formulations development scientists from India and across globe.
We see a great future where all the problems related to lubricants will be resolved. The formulators will be able to design newer oral solid dosage (OSD) complex generics and other formulations with much more precision, with increased safety and efficacy, he said.
There are some novel tablet lubricants being evaluated by some excipient manufacturers. Though there are few available products but none of them have been accepted by the pharma industry in a big way as of now. However L – Leucine which is highly water soluble has been used for formulating few ODTs (orally disintegrating tablets) are in the pipeline.
There is also a considerable attention towards environmental sustainability. This has led magnesium stearate producers and stearic acid producers to buy the raw materials from RSPO (Round-table on sustainable palm oil) certified sources thereby confirm their commitment to the environment protection and sustainability. These grades are called RSPO grades.
The RSPO organization ensures that jungles of palm trees are not used to extract palm oil. Instead this, this palm oil comes from cultivated trees. Even sodium stearyl fumarate requires stearyl alcohol which comes from palm oil. Lubricant manufacturers should go for RSPO products only as it helps preserving nature. Therefore, we all must pledge to buy only RSPO grade lubricants to preserve the environment, he said.
The natural lubricants are made from organic clean label products which sans synthetic materials. Some examples of such products made from corn base products are available in the market, said Khurana.
In case of effervescent tablet, if traditional lubricants like magnesium stearate are used after the dissolution the liquid becomes hazy and the froth comes at the top giving an unaesthetic look to the tablet solution thereby reducing its palatability and subsequently the patient compliance. So, the soluble lubricants are used and also some special formulated lubricants for the use in effervescent tablet only are available in the market. One such example is Efferlube. These products not only provide good lubrication but also can help in giving a crystal clear solution, he noted.
The future trends in OSD lubrication indicate that it will meet the specific needs through customization. It will offer solutions for effervescent tablets. Considerable attention will be on external lubrication process, environmental sustainability and development of developing novel lubricants, said Khurana.