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Preformulation considerations for controlled release dosage forms. Part III. Candidate form selection using numerical

Frank Chrzanowski¹

¹FA Chrzanowski, Inc., 17 Tinsmith Lane, Marlton, New Jersey 08053-1320, USA. frankchrzan@comcast.net

AAPS Pharmscitech

|May 27, 2008

Summary

Decision Analysis (DA) and Potential Problem Analysis (PPA) offer effective methods for selecting drug formulations. These numerical approaches, when compared to traditional logical methods, provide similar rankings for candidate forms.

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Area of Science:

Pharmaceutical Sciences
Formulation Development
Decision Science

Background:

Traditional logical-elimination methods are commonly used for selecting optimal drug candidate forms.
Novel numerical methods, Decision Analysis (DA) and Potential Problem Analysis (PPA), offer alternative quantitative approaches.
Previous comparisons between DA, PPA, and logical methods are lacking.

Purpose of the Study:

To introduce and compare Decision Analysis (DA) and Potential Problem Analysis (PPA) as quantitative selection methods for pharmaceutical formulations.
To evaluate the efficacy of DA and PPA against a traditional logical-elimination method.
To validate the applicability of DA and PPA in preformulation studies.

Main Methods:

Decision Analysis (DA): Involves weighting candidate properties and scoring outcomes, with higher total scores indicating preferred forms.
Potential Problem Analysis (PPA): Assigns seriousness factors to potential problems and uses test outcomes to determine occurrence probability; lower total seriousness-probability products are preferred.
Comparative analysis using preformulation data for five candidate forms of McN-5707, incorporating expert-derived weights and probabilities.

Main Results:

Rankings of the five candidate forms, from best to worst, were consistent across DA, PPA, and the logical-elimination method.
Independent variables (weights and seriousness factors) were derived from experienced formulator surveys.
Dependent variables (scores and probabilities) were provided by Preformulation data.

Conclusions:

Decision Analysis (DA) and Potential Problem Analysis (PPA) are validated as applicable and effective methods for candidate form selection in pharmaceutical development.
DA and PPA are particularly advantageous when dealing with numerous candidate forms or when multiple forms exhibit undesirable properties.
The consistent rankings across methods suggest robustness in candidate form selection strategies.