Monohydrate Oral Suspension

DURICEF for oral suspension contains the following inactive ingredients FD C yellow no. 6, flavors (natural 

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Macrocrystals, monohydrate/macrocrystals The absorption of nitrofurantoin macrocrystals is slower when compared with nitrofurantoin oral suspension. 

A monohydrate phase of metronidazole benzoate exhibited solubility properties different from those of the commercially available anhydrous form [37], The monohydrate was found to be the thermodynamically stable form in water below 38°C. The enthalpy and entropy changes of transition for the conversion of the anhydrate to the monohydrate were determined to be -1200 cal/mol and -3.7 cal/K mol, respectively. This transition was accompanied by a drastic increase in particle size and caused physical instability of oral suspension formula-... 

The aqueous solubility of indinavir is pH dependent, with increased solubility at acidic pH. During development, the compound was initially used in the free base monohydrate form and its absorption kinetics was tested in rats and dogs in two separate formulations of (i) 0.5% methocel suspension and (ii) 0.05 M citric acid solution, for an oral dose of 10 mg kg In rats, indinavir attained a C ax value of 0.56 pM in 15 min in the methocel formulation, almost similar to that in citric acid (C ax 0-44 pM in 35 min). In dogs, there were more prominent differences in the two formulations. The C ax value in methocel suspension was 3.72 pM in 25 min as opposed to 11.4 pM in 30 min in the citric acid solution. It was also observed that the bioavailability of indinavir in both rats and dogs was quite similar ( 16%) when administered as a 10 mg kg dose in methocel suspension. However, in 0.05 M citric acid solution, the bioavailability of the drug in dogs was approximately 33% higher than that in rats. 

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