Abstract
For the purpose of administration of aminophylline (AP) to pediatric patients with as much accuracy as possible, we attemped to prepare tablets containing a low concentration of AP. First, the effect of some additives on hardness, disintegration time and dissolution rates of the AP tablets were examined with various formula.Twenty-four kinds of tablets, containing various amounts of polyvinylpyrrolidone (PVP) and/or hydroxypropylcellulose (HPC) as binders, starch only or a mixture of starch with calcium diphosphate, dibasic as diluents, and carboxymethylcellulose as disintegrator were prepared following the wet granulation method.Tablets containing a 3% or higher concentration of binders met all of the requirements restricted by the JP XI.Tablets containing HPC and/or PVP had controlled dissolution rates.Although the disintegration time of these tablets decrease as the starch percentage increase, there appears to be a critical starch concentration level.
These results suggest AP tablets that closely resemble standard tablet in the dissolution profiles could be manufactured by adding various proportions of binders.Therefore, if a hospital changes half of a single available 100mg-AP tablet to 50mg-AP tablet, bioavailability may not be affected.