An intravenous formulation decision tree for discovery compound formulation development

Discovery and pre-clinical animal efficacy assessment formulation development efforts are challenged by limited compound availability and stringent timelines. The implementation and use of a systematic discovery formulation scheme can facilitate this important process. We observed that nearly 85% of...

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Bibliographic Details
Published in:International journal of pharmaceutics 2003-03, Vol.253 (1), p.111-119
Main Authors: Lee, Yung-Chi, Zocharski, Philip D, Samas, Brian
Format: Article
Language:English
Subjects:
Biological and medical sciences
Buffers
Chemistry, Pharmaceutical
Decision tree
Decision Trees
Discovery
General pharmacology
High throughput
Hot Temperature
Hydrogen-Ion Concentration
Injections
Medical sciences
Pharmaceutical Preparations - administration & dosage
Pharmaceutical Preparations - chemistry
Pharmacology. Drug treatments
Physicochemical properties. Structure-activity relationships
Solubility
Solvents
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Description
Summary:Discovery and pre-clinical animal efficacy assessment formulation development efforts are challenged by limited compound availability and stringent timelines. The implementation and use of a systematic discovery formulation scheme can facilitate this important process. We observed that nearly 85% of Pfizer, Ann Arbor discovery compounds ( n>300) submitted for discovery and pre-clinical injectable formulation development in the year 2000 could be formulated by pH adjustment, cosolvent addition, or a combination of the two approaches. Based on the vehicle data generated by this laboratory, a discovery formulation decision tree, that utilizes the solubilization approaches described above, is proposed. The proposed decision tree can be adapted and modified by pharmaceutical scientists to conform to best practices put forth by their institutions for discovery animal studies requiring injectable dosage forms.
ISSN:0378-5173
1873-3476
DOI:10.1016/S0378-5173(02)00704-4