High quality excipients-the need of the hour

The necessity of high quality excipients cannot be stressed more in today’s time of quality medicines. There are excipients with specific roles in the delivery matrix of a formulations and there are excipients which mainly perform the role of binder or fillers or lubricants. In this category you have sugar, lactose, starch, cellulose, mangnesium state etc, all time tested excipients.

However this segment may not have kept pace with the rest of the pharmaceutical industry and the reasons are many. One of the them is that excipients are mainly used for food industr., The pharma industry itself is to be held responsible as it has not given due importance to them, having generally banished them as fringe products or “C” category items. This when in may formulations you would have 40 to 60 percent volume made up of excipients.

The need for pure quality excipients is a must but it also important is that these excipients perform the limited but important role assigned to them of making a good tablet. It is here that the pharmacopoeia standards very often fall short. The pharmacopoeia standards give requisite importance to the chemical purity but fail to set standards for the physical parameters which are critical especially in direct compression on high speed tableting machines.

Flowability, particle size distribution, bulk density, tapped to untapped bulk density, compressive strength, loss on drying and colour are all parameters which need to quantified and tested to ensure a good sturdy formulation. A high quality excipient would ensure that the high cost API’s are not compromised during the formulation stage. The need for good manufacturing facilities for excipients with proper accreditations is the need of the hour. Though not mandatory, a excipient unit with a Type IV DMF would be more readily acceptable to the overseas formulators as also Indian formulators exporting to the regulated markets. ISO 9000 and WHO GMP certifications are other accreditations which would ensure credibility to the excipient manufacturer.

The importance given to excipents overseas can be gauged from the fact that the US, Europe and Japan have a very active excipent associations which help establish standards and interact with the formulators and the regulatory authorities.

The standards for excipent unit may be different from those applicable for a formulation unit as the excipient industry is more close to the chemical industry. But more often then not, the standards are set up with the formulation unit point of view only.

The excpient associations also greatly assist in establishment of new excipents. The fact that excipents do not command much price premium makes that much more difficult for individual excipient manufacturer to allot resources for new excipients development and also handle regulatory affairs and liaison with the formulators.

It is only recently that in India that an excipient chapter was established under the aegis of Pharmaceutical and Allied Manufacturers and Distributors Association (PAMDAL) with Ajit Singh of Associated Capsules as the founder President. It is just a beginning and much work needs to be initiated.