ABSTRACT
The manufacture and control of oral solutions and oral suspensions presents some unusual problems not common to other dosage forms. Although bioequivalency concerns are minimal (except for products in which dissolution is a rate-limiting or absorption-determining step, as in phenytoin suspension), other issues have frequently led to recalls of liquid products. These include microbiological, potency, and stability problems. In addition, because the population using these oral dosage forms includes newborns, pediatrics, and geriatrics, who may not be able to take oral solid dosage forms and who may have compromised drug metabolic or other clearance function, defective dosage forms can pose a greater risk if the absorption profiles are significantly altered from the profiles used in the development of drug safety profiles.
