ABSTRACT

The manufacture and control of oral solutions and oral suspensions present unique problems to the industry. While bioequivalency concerns are minimal (except for antibiotic suspensions, for example), other issues have led to recalls, including microbiological, potency, and stability problems. Additionally, because the population using these oral dosage forms includes newborn, pediatric, and geriatric patients who may not be able to take oral solid dosage forms and may be compromised, defective dosage forms can pose an even greater risk than for other patients.