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

AAPS PharmSciTech·2008

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Preformulation considerations for controlled release dosage forms. Part II. Selected candidate support.

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Preformulation considerations for controlled release dosage forms. Part I. Selecting candidates.

Frank Chrzanowski¹

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

AAPS Pharmscitech

|April 24, 2008

Summary

This study outlines a method for selecting drug forms by evaluating physical-chemical properties. It simplifies the selection process for controlled release (CR) and immediate release (IR) dosage forms.

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems

Background:

Developing controlled release (CR) dosage forms requires careful selection of drug substance (DS) forms.
Early-stage evaluation of physical-chemical properties is crucial for efficient development.

Purpose of the Study:

To present a systematic approach for selecting optimal drug substance forms for CR and immediate release (IR) dosage forms.
To simplify the final form selection process by evaluating critical physical-chemical properties.

Main Methods:

Evaluation of candidate drug substance forms (salt, free base/acid, polymorphic, amorphic) for critical properties.
Assessment included melting point, crystallinity, solubility (water, 0.1 N HCl, SIF), hygrodynamics, and loss on drying (LOD).
Processability was assessed via corrosivity and compression behavior (sticking/filming).

Main Results:

A logical progression of property evaluation aids in eliminating unsuitable forms early.
The described method requires minimal material and simple analytical tools.
Stability-indicating assays are not necessary for initial form evaluation.

Conclusions:

The presented evaluation scheme streamlines the selection of drug substance forms for dosage form development.
This approach is applicable to both controlled release (CR) and immediate release (IR) formulations.
Early identification of problematic physical-chemical properties facilitates successful manufacturing.