Manufacturing a Syrup for Dosing Studies


An international pharmaceutical company wanted to conduct both pediatric and geriatric dosing studies for a central acetylcholinesterase inhibitor, and this company needed assistance manufacturing the appropriate formulation for the trials. PGC provided this assistance, designing and implementing the process to manufacture the desired formulation.


The company did not have the excess capacity to manufacture product for the pediatric and geriatric dosing studies, and it needed to find a partner who could manufacture ample supply in a timely manner to adhere to corporate objectives. The project required three 225-gallon active product batches and one 170-gallon placebo batch, each finished bottle containing 10 ounces of the syrup and sealed with a child-resistant closure.


Cooperating with the company's team, including members from quality assurance, manufacturing and formulation development, PGC sketched out and executed a work plan to not only design a manufacturing process to produce enough quantities for the studies but also one that is efficient and effective to minimize waste and that could be scaled easily, if needed to do so. PGC developed a process that would yield product to the company's specifications, including a specified flavoring. PGC procured specific equipment to optimize filtered-product transfer. Not only did PGC perform installation qualification and operation qualification per PGC's SOPs on this equipment, but it also determined that particles in the bottles resulting from filler O-rings were incompatible with the aqueous solution. PGC was able to recommend a solution and correct this issue by the second batch run. Upon optimizing the liquid manufacturing process for the dosing studies, PGC defined a qualified process to transfer for commercial scale when the company was ready to implement this activity.