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Published on: December 15, 2015
Formulation and process considerations for beads containing Carbopol 974P, NF resin made by extrusion-spheronization
S H Neau1, M Y Chow, G A Hileman
1School of Pharmacy, University of Missouri-Kansas City, 5100 Rockhill Road, Kansas City, MO 64110-2499, USA. neaus@umkc.edu
International Journal of Pharmaceutics
|May 10, 2000
Summary
This study optimized chlorpheniramine maleate beads using extrusion and spheronization. High Carbopol concentration and specific process parameters significantly prolonged drug release, enhancing bead quality for extended therapeutic effects.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Polymer Science
Background:
- Carbopol 974P, NF resin can be used in extrusion and spheronization for drug release modulation.
- Calcium chloride inclusion in the granulating fluid can reduce polymer tack and aid bead formation.
Purpose of the Study:
- To optimize the production of high-quality chlorpheniramine maleate beads with prolonged drug release.
- To investigate the impact of formulation and process variables on bead characteristics and drug release.
Main Methods:
- Utilized a one-half fraction of a two-level factorial design with center points.
- Investigated Carbopol concentration, calcium chloride concentration, water content, spheronization speed, and time.
- Assessed product yield, bead roundness, and drug release profiles.
Main Results:
- Increased Carbopol concentration significantly reduced drug release at 25, 40, and 60 minutes (P<0.05).
- Optimal conditions involved high Carbopol, high water, low calcium chloride, low spheronization speed, and long spheronization times.
- These conditions yielded high-quality beads with extended drug release duration.
Conclusions:
- The factorial design effectively identified key parameters influencing bead quality and drug release.
- Optimized extrusion and spheronization parameters, particularly Carbopol content, are crucial for developing prolonged-release drug delivery systems.
- The study provides a robust method for producing high-quality chlorpheniramine maleate beads with predictable, extended drug release profiles.
