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Multimechanism oral dosage forms fabricated by three dimensional printing
C W Rowe1, W E Katstra, R D Palazzolo
1Therics, Inc., Princeton, NJ, USA.
Summary
Three-dimensional printing enables complex oral drug delivery devices with tailored release profiles. This technology allows for immediate-extended, pulsed, and dual pulsatile drug release of various medications.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- 3D Printing Applications
Background:
- Traditional oral drug delivery systems often struggle to achieve precise and complex release profiles.
- The development of advanced dosage forms is crucial for optimizing therapeutic outcomes and patient compliance.
- Three-dimensional (3D) printing offers a novel approach to fabricating customized drug delivery devices.
Purpose of the Study:
- To fabricate and characterize four distinct types of complex oral drug delivery devices using 3D printing.
- To evaluate the in vitro drug release performance of these novel dosage forms.
- To demonstrate the versatility of 3D printing for creating immediate-extended, pulsed, and dual pulsatile release profiles.
Main Methods:
- Fabrication of four types of complex oral drug delivery devices utilizing 3D printing technology.
- Formulation of immediate-extended release tablets with distinct pH-based release mechanisms.
- Design of breakaway tablets, enteric dual pulsatory tablets, and dual pulsatory tablets with varying erosion and solubility characteristics.
- In vitro dissolution testing using simulated gastric fluid and USP dissolution apparatus.
Main Results:
- Immediate-extended release tablets exhibited pulsed release of chlorpheniramine maleate after a 10-min lag time, followed by 7-hour extended release.
- Breakaway tablets demonstrated erosion of the inner section within 30-45 minutes in simulated gastric fluid.
- Enteric dual pulsatory tablets released diclofenac sodium in two pulses at 1 and 8 hours, with a 4-hour lag.
- Dual pulsatory tablets showed immediate release of diclofenac within 30 minutes, followed by a second release phase after 5 hours at high pH.
Conclusions:
- 3D printing is a viable technology for fabricating complex oral drug delivery devices with controlled and tailored release characteristics.
- The developed devices successfully achieved desired release profiles, including immediate-extended, pulsed, and dual pulsatile release.
- This approach holds significant potential for personalized medicine and the development of next-generation oral dosage forms.