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Selection of solid dosage form composition through drug-excipient compatibility testing.

A T Serajuddin¹, A B Thakur, R N Ghoshal

¹Pharmaceutics R&D Department, Bristol-Myers Squibb Pharmaceutical Research Institute, New Brunswick, New Jersey 08903, USA.

Journal of Pharmaceutical Sciences

|July 7, 1999

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A new screening model predicts drug-excipient compatibility issues in solid dosage forms. This method identifies potential stability problems early in drug development, reducing formulation surprises.

Area of Science:

Pharmaceutical Sciences
Drug Development
Formulation Science

Background:

Drug-excipient interactions are critical for solid dosage form stability.
Predicting these interactions early can prevent later formulation challenges.

Purpose of the Study:

To develop and validate a screening model for predicting drug-excipient compatibility.
To identify key factors influencing drug substance stability within excipient mixtures.

Main Methods:

Drug-excipient blends (approx. 200 mg) with 20% water were stored in vials at 50°C.
Samples were analyzed after 1 and 3 weeks for chemical and physical stability.
Factors like excipient nature, drug-excipient ratio, moisture, pH, temperature, and light were investigated.

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Main Results:

The model successfully predicted potential stability issues arising from drug-excipient interactions.
Key factors influencing stability, including moisture and microenvironmental pH, were identified.
Physical changes such as polymorphic conversion and amorphous form transitions were observed.

Conclusions:

This screening model aids in selecting appropriate excipients early in drug development.
Utilizing this model can significantly reduce unexpected stability problems during long-term testing.
Early compatibility assessment streamlines the drug development process.