Development of standard operating procedure [SOP] of a unani pharmacopoeial formulation

ABSTRACT

In various Unani pharmacopoeias thousands of formulations are present which have been formulated by eminent physicians of Unani System of Medicine. The majority of these formulations are based on plant origin drugs and their efficacy may get altered as a result of seasonal variation, use of different drying methods, their storage conditions and microbiai contamination. To avoid these alterations, standardization of drugs is necessary especially in case of compound formulations the use of Standard Operating Procedures [SOPs] for their manufacturing is essential. It will help to prepare a formulation repeatedly with the same quality. The present study was designed to develop the SOP of a Unani pharmacopoeial formulation i.e., Habbc Gule Aak [HG]. Total eight batches of HG were prepared with different conditions i.e., binder, particle size, time of drying and temperature of drying'. All the eight batches of HG were evaluated thrice for the hardness, friability and disintegration time. The batch with minimum friability, hardness nearest to standard value and minimum disintegration time as per pharmacopoeias was selected as final batch and all conditions regarding powder size, binder, temperature of drying and time of drying used in the preparation of frnal batch were fixed as its Standard Operating Procedure. Out of eight batches the Batch No. 2 with 150 micron particle size [100 mesh sieve], mucilage of 30% w/w samaghe arabi [binder], dried at 80°C for 150 minutes was selected as final batch. The final batch showed minimum friability [0.05 +/- 0.01], hardness nearest to the standard value [4.59 +/- 0.30] and considerable disintegration time [33.67 +/- 0.33]. The resulting SOP will be helpful in setting the pharmacopoeial standards of HG and the methodology of the work will help in the development of SOPs for other Unani formulations too