Nonisothermal stability assessment of stable pharmaceuticals: testing of a clindamycin phosphate formulation.

Abstract:

:The stability of an antibiotic formulation (clindamycin phosphate in dextrose), which is stable at room temperature, was assessed by nonisothermal kinetic analysis at elevated temperatures. A preliminary study, conducted to establish apparent rate order, verified the appropriateness of a first-order kinetic model. The test formulation was then heated linearly from 70 to 90 degrees C over 12 hr. Data (drug concentration, temperature, and time) were fitted to the first-order model using nonlinear least-squares regression. Arrhenius parameter estimates obtained from three nonisothermal trials, and rate constants at 25 degrees C derived by extrapolation, demonstrated acceptable reproducibility and were in agreement with values derived from isothermal experiments at 30, 45, 55, 65, and 75 degrees C. First-order rate constants obtained from studies conducted for 20 months at 25 degrees C were in accord with isothermal and nonisothermal results.

journal_name

Pharm Res

journal_title

Pharmaceutical research

authors

Kipp JE,Hlavaty JJ

doi

10.1023/a:1015840320410

subject

Has Abstract

pub_date

1991-05-01 00:00:00

pages

570-5

issue

5

eissn

0724-8741

issn

1573-904X

journal_volume

8

pub_type

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