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Handbook of Pharmaceutical Manufacturing Formulations Liquid Products (Volume 3 of 6)

edi gunawan

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. (read more) or
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