Thermal Inkjet Application in the Preparation of Oral Dosage Forms: Dispensing of Prednisolone Solutions and Polymorphic Characterization by Solid-State Spectroscopic Techniques

The utility of thermal inkjet (TIJ) technology for preparing solid dosage forms of drugs was examined. Solutions of prednisolone in a solvent mixture of ethanol, water, and glycerol (80/17/3 by volume) were dispensed onto poly(tetrafluoroethylene)-coated fiberglass films using TIJ cartridges and a p...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2008-07, Vol.97 (7), p.2619-2636
Main Authors: Meléndez, Peter A., Kane, Kevin M., Ashvar, Claudine S., Albrecht, Mary, Smith, Pamela A.
Format: Article
Language:English
Subjects:
Biological and medical sciences
Dosage Forms
drug delivery
Drug Delivery Systems - methods
General pharmacology
Medical sciences
Microscopy, Electron, Scanning
Particle Size
Pharmaceutical technology. Pharmaceutical industry
Pharmacology. Drug treatments
physical characterization
polymorphism
prednisolone
Prednisolone - administration & dosage
Prednisolone - chemistry
Printing
Raman mapping
Raman spectroscopy
solid state
Solubility
Solvents - chemistry
Spectrum Analysis, Raman
spherulite
Surface Properties
Suspensions
Technology, Pharmaceutical - instrumentation
Technology, Pharmaceutical - methods
thermal inkjet
Thermodynamics
TIJ
X-Ray Diffraction
X-ray powder diffractometry
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Summary:The utility of thermal inkjet (TIJ) technology for preparing solid dosage forms of drugs was examined. Solutions of prednisolone in a solvent mixture of ethanol, water, and glycerol (80/17/3 by volume) were dispensed onto poly(tetrafluoroethylene)-coated fiberglass films using TIJ cartridges and a personal printer and using a micropipette for comparison. The post-dried, TIJ-dispensed samples were shown to contain a mixture of prednisolone Forms I and III based on PXRD analyses that were confirmed by Raman analyses. The starting commercial material was determined to be Form I. Samples prepared by dispensing the solution from a micropipette initially showed only Form I; subsequent Raman mapping of these samples revealed the presence of two polymorphs. Raman mapping of the TIJ-dispensed samples also showed both polymorphs. The results indicate that the solvent mixture used in the dispensing solution combined with the thermal treatment of the samples after dispensing were likely the primary reason for the generation of the two polymorphs. The advantages of using a multidisciplinary approach to characterize drug delivery systems are demonstrated using solid state mapping techniques. Both PXRD and Raman spectroscopy were needed to fully characterize the samples. Finally, this report clarifies prednisolone's polymorphic nomenclature existent in the scientific literature. © 2007 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:2619–2636, 2008
ISSN:0022-3549
1520-6017
DOI:10.1002/jps.21189