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A preformulation study on the kinetics of hi 6 in concentrated solution


, : A preformulation study on the kinetics of hi 6 in concentrated solution. International Journal of Pharmaceutics (Kidlington) 40(3): 193-200

The degradation kinetics of HI-6 have been investigated at various temperatures and at different pHs at a concentration of 200 mg/ml. Both aqueous and other hydrophilic solvents (glycols and glycerol-water mixtures) have been used. The degradation of HI-6 follows pseudo-first-order kinetics with respect to HI-6. The observed rate seems to depend on a hydroxyl ion-catalyzed reaction (kOH) and an un/water catalyzed reaction (k0) which show influence at pH below 3. The pH profile shows a positive slope less than one, which seems to depend on an error in the determination of the rate constants at higher pH. kOH was determined to be 1 .cntdot. 109 and k0 to be 0.011 h-1 at 60.degree. C. The observed rate seems to be independent of the dielectric constant of the solvent. The activation energy k0 has been determined to be 82.0 kJ mol-1. Based upon these data the predicted shelf life (t90%) at pH 0 will not be longer than 13 days at 25.degree. C and 9 months at 0.degree. C. Thus, the systems studied seem to be unsuitable to formulate a stable intramuscular formulation of HI-6.

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