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Development of near zero-order release dosage forms using three-dimensional printing (3-DP) technology.
Chen-Chao Wang1, Monica R Tejwani Motwani, Willie J Roach
1McNeil Consumer and Specialty Pharmaceuticals, Fort Washington, Pennsylvania 19034, USA. cwang12@mccus.jnj.com
Drug Development and Industrial Pharmacy
|March 25, 2006
Summary
Three-dimensional printing created novel pseudoephedrine hydrochloride (PEH) formulations with near zero-order drug release. These stable, robust dosage forms demonstrated reliable in vivo/in vitro correlation.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Materials Science
Background:
- Controlled-release drug delivery aims to maintain therapeutic drug concentrations and improve patient compliance.
- 3-Dimensional printing (3-DP) offers precise control over drug dosage form design and drug release profiles.
- Pseudoephedrine hydrochloride (PEH) is a common decongestant requiring controlled release for sustained efficacy.
Purpose of the Study:
- To develop and characterize near zero-order controlled-release PEH formulations using 3-DP.
- To investigate the influence of polymer blend ratios on drug release kinetics.
- To establish in vivo/in vitro correlation (IVIVC) for the developed dosage forms.
Main Methods:
- Formulations were fabricated using 3-DP with Kollidon SR and hydroxypropylmethyl cellulose (HPMC) as drug carriers.
- Drug release rates were modulated by varying the Kollidon SR-HPMC ratio.
- Dosage forms featured an immediate-release core and a release-controlling shell.
- In vitro dissolution studies were conducted under various conditions (pH, stirring rate, sample number).
- Stability testing was performed under accelerated and long-term conditions.
- In vivo pharmacokinetic evaluation was conducted in healthy volunteers.
Main Results:
- Three PEH formulations exhibited near zero-order release kinetics with proportional release rates.
- Release rates increased with higher HPMC content in the polymer blend.
- Formulations demonstrated robustness against variations in dissolution medium pH, stirring rate, and sample configuration.
- Drug release profiles remained consistent after storage under stressed conditions.
- A qualitative Level A IVIVC was established, supporting the predictive capability of in vitro dissolution data.
Conclusions:
- 3-DP is a viable technology for creating robust, controlled-release PEH dosage forms with tunable release profiles.
- The Kollidon SR-HPMC ratio effectively controls drug release, enabling near zero-order kinetics.
- The developed formulations show excellent stability and predictable in vivo performance, validated by IVIVC.