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Theophylline formulation by supercritical antisolvents.

Christelle Roy¹, Arlette Vega-González, Pascale Subra-Paternault

¹Laboratoire d'Ingénierie des Matériaux et des Hautes Pressions (LIMHP), C.N.R.S., Institut Galilée, Université Paris 13, 99 Avenue Jean-Baptiste Clément, 93430 Villetaneuse, France. roy@limhp.univ-paris13.fr

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Summary

Supercritical antisolvent precipitation yielded micronized theophylline particles. The semi-continuous process with carbon dioxide (CO2) produced smaller particles and altered crystal lattice, impacting drug release rates in poly lactic acid (PLA) formulations.

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Area of Science:

Pharmaceutical Technology
Materials Science
Chemical Engineering

Background:

Supercritical antisolvent (SAS) precipitation is a key technique for particle engineering.
Theophylline is a widely used bronchodilator, and its particle properties influence bioavailability.
Poly lactic acid (PLA) is a biodegradable polymer used in drug delivery systems.

Purpose of the Study:

To investigate the production of theophylline particles using SAS precipitation.
To evaluate the effect of different antisolvents (CO2, CHF3) and process modes (batch, semi-continuous) on particle characteristics.
To explore the co-precipitation of theophylline with PLA and its impact on drug release.

Main Methods:

Supercritical antisolvent precipitation using batch or semi-continuous processes.
Antisolvents employed: carbon dioxide (CO2) and trifluoromethane (CHF3).
Characterization of theophylline and theophylline-PLA composite particles using techniques like XRD.

Main Results:

Semi-continuous SAS precipitation produced smaller theophylline particles than batch.
Antisolvent choice influenced particle morphology (hexagonal for CO2, triangular for CHF3).
CO2-processed theophylline exhibited a unique crystal lattice; however, neither shape nor lattice affected dissolution kinetics.
Co-precipitation with PLA was successful under specific conditions (CHF3-batch, CO2-semi-continuous).
CO2-semi-continuous processed theophylline-PLA composites showed reduced drug release rates and prolonged release times.

Conclusions:

SAS precipitation is effective for micronizing theophylline and creating drug-polymer formulations.
Process parameters significantly influence particle size, morphology, and crystal structure.
Theophylline-PLA composite properties are retained from the processed drug, with CO2-semi-continuous processing enhancing drug release profiles.