PT  - JOURNAL ARTICLE
AU  - Stephen Brown
AU  - Louise Templeton
AU  - Derek A. Prater
AU  - Christopher J. Potter
TI  - Use of an in vitro Haemolysis Test to Predict Tissue Irritancy in an Intramuscular Formulation
DP  - 1989 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 117--120
VI  - 43
IP  - 3
4099  - http://journal.pda.org/content/43/3/117.short
4100  - http://journal.pda.org/content/43/3/117.full
SO  - PDA J Pharm Sci Technol1989 May 01; 43
AB  - As part of a drug development program, an in vitro haemolysis test has been used to predict the in vivo muscle tissue irritancy of intramuscular (i.m.) formulations of a new drug entity. Solutions of lactic acid, polyvinylpyrrolidone (PVP) 12PF and two commercial injections were also included in the study. The results indicated that the test was able to differentiate formulations in terms of haemolytic potential and the correlation between the haemolysis test results and in vivo intramuscular irritancy studies indicated that the test may be used to screen formulations for potential tissue irritancy prior to in vivo evaluation.