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Editorials

Introducing the Journal of Pharmaceutical Innovation
James K. Drennen, III, Editor 
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The Journal of Pharmaceutical Innovation: an innovative, consensus building tool for the 21st century
Ajaz S. Hussain
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Perspectives

Understanding critical material properties for solid dosage form design
Anthony J. Hlinak, Kamal Kuriyan, Kenneth R. Morris, Gintaras V. Reklaitis, and Prabir K. Basu

What is the role of standardized methods for determining the impact of material properties in pharmaceutical formulation and process development? In this Perspective article, we identify material properties that are potentially important in solid dosage form design, and we review approaches linking these properties to product specifications in dry granulation process development. We also assess the potential benefits that could be obtained by standardizing the methods for determining the impact of material properties of commonly used excipients and propose a program of research to achieve the desired goal of an efficient, science-based approach for incorporating material properties in solid dosage form design.
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The need for a broader perspective if process analytical technology implementation is to be successful in the pharmaceutical sector
Ingrid Maes and Beatrijs Van Liedekerke

Process analytical technology (PAT) has the potential to deliver significant shifts in the economics of the pharmaceutical sector. In the two years since the FDA published its guidance on PAT in 2004, there has been a wealth of research and comment articles on its adoption by the industry. This article discusses whether the literature matches the reality of the challenges faced inside companies, whether company practice and studies take too narrow a view of PAT, and what issues should be considered if the full potential of PAT is to be achieved.
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Research Articles

Toward intelligent decision support for pharmaceutical product development
Chunhua Zhao, Ankur Jain, Leaelaf Hailemariam, Pradeep Suresh, Pavankumar Akkisetty, Girish Joglekar, Venkat Venkatasubramanian, Gintaras V. Reklaitis, Ken Morris, and Prabir Basu

Developing pharmaceutical product formulation in a timely manner and ensuring quality is a complex process that requires a systematic, science-based approach. Information from various categories, including properties of the drug substance and excipients, interactions between materials, unit operations, and equipment is gathered. Knowledge in different forms, including heuristics, decision trees, correlations, and first-principle models is applied. Decisions regarding processing routes, choice of excipients, and equipment sizing are made based on this information and knowledge. In this work, we report on the development of a software infrastructure to assist formulation scientists in managing the information, capturing the knowledge, and providing intelligent decision support for pharmaceutical product formulation.
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Raman spectroscopy for the determination of coating uniformity of tablets: assessment of product quality and coating pan mixing efficiency during scale-up
Arwa S. El Hagrasy, Shih-Ying Chang, Divyakant Desai, and San Kiang

Spray coating is an important unit operation in the pharmaceutical industry. The quality, stability, safety, and performance of the final product depend largely on the amount and uniformity of coating applied. Raman spectroscopy is used to develop a multivariate quantitative model using tablets collected from different stages of coating. Subsequently, the calibration is used for the determination of coating progress in small-scale batches. The method developed is used as a process analytical technology tool to assess the desired product quality attributes in commercial scale equipment. Insight into the mixing efficiency is gained by examining intra-tablet variability using the Raman method.
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Design space for a solventless photocurable pharmaceutical coating
Sagarika Bose, Brendan Kelly, and Robin H. Bogner

Solventless coating technologies can overcome many of the disadvantages associated with using solvents in pharmaceutical coating. A solventless photocurable film-coating system was investigated in which liquid photocurable prepolymer and powdered pore-forming agents were applied onto non-pareil beads in a mini-coating pan. The beads were exposed to light after each coating layer. Using lactose as a filler, an optimum range of filler to photocurable polymer ratio was 1.8 to 3.0 to achieve good process efficiency and uniformity. The ratio was sensitive to particle size and filler type. The initiator concentration and light intensity also were evaluated. The time required to coat a batch was dramatically reduced compared with conventional film coating.
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NIR spectrometry for the characterization of fuel components in a novel tamper-resistant pill bottle
Joseph P. Medendorp, Jason A. Fackler, Tom Henninger, Bill Dieter, and Robert A. Lodder

The purpose of this paper is twofold: (i) to present the Pill Safe, a novel design for a tamper-resistant prescription container, and (ii) to present use of near-infrared (NIR) spectrometry for characterization of fuel components and prediction of the burn characteristics of the fuel mixtures used to destroy tablets in the Pill Safe. In the safe, drug tablets are stacked next to fuel and attempts to force the mechanism or penetrate the bottle cause their instant destruction. The Pill Safe offers a second line of defense against the illicit distribution of dangerous prescription drugs.
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An efficient method-development strategy for quantitative chemical imaging using terahertz pulse spectroscopy
Robert P. Cogdill, Steven M. Short, Ryanne Forcht, Zhenqi Shi, Yaochun Shen, Philip F. Taday, Carl A. Anderson, and James K. Drennen III

The purpose of our research was to investigate efficient procedures for generating multivariate prediction vectors for quantitative chemical analysis of solid dosage forms using terahertz pulse imaging (TPI) reflection spectroscopy. A set of calibration development and validation tablet samples was created following a ternary mixture of anhydrous theophylline, lactose monohydrate, and microcrystalline cellulose (MCC). Spectral images of one side of each tablet were acquired over the range of 8 cm^-1 to 60 cm^-1. Calibration models were generated by partial least-squares (PLS) type II regression of the TPI spectra and by generating a pure-component projection (PCP) basis set using net analyte signal (NAS) processing. Following generation of the calibration vectors, the performance of both methods at predicting the concentration of theophylline, lactose, and MCC was compared using the validation spectra and by generating chemical images from samples with known composition patterns. Sensitivity was observed for the PLS calibration over the range of all constituents for both the calibration and the validation datasets; however, some of the calibration statistics indicate that PLS overfits the spectra. Multicomponent prediction images verified the spatial and composition fidelity of the system. The NAS–PCP calibration procedure yielded accurate linear predictions of theophylline and lactose, whereas the results for MCC prediction were poor. The poor sensitivity for MCC is assumed to be related to the relative lack of phonon absorption bands, which concurs with the characterization of MCC as being semi-crystalline. The results of this study demonstrate the use of TPI reflection spectroscopy and efficient NAS–PCP for the quantitative analysis of crystalline pharmaceutical materials.
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Suspensions of fluor-containing nanoparticles for quantifying β- emitting radionuclides in non-hazardous media
Donghua Zhu, Zhongjiang Mu, Caleb Mooty, Michelle Kovarik, and Michael Jay

Nanoparticles containing scintillants were prepared from oil-in-water microemulsions in which styrene–divinylbenzene comprised the oil phase. Primary and secondary fluors [2,5-diphenyloxazole and 1,4-bis(2-methylstyryl) benzene] were dissolved in the oil phase, which was emulsified with dodecyl trimethylammonium bromide or sodium dodecyl sulfate before polymerization by the addition of sodium persulfate. The resulting suspension qualified as non-hazardous waste by testing against US EPA standards for reactivity, pH, ignitability, and toxicity characteristic leaching. ¹⁴C-glycerol was added to the aqueous nanoparticle suspension and to a conventional organic scintillation cocktail, and the relative efficiency of detection was obtained by liquid scintillation counting. The results were compared with a mathematical model that predicted the effect of particle size and concentration on the probability of an emitted β- particle interacting with a suspended particle. The use of these nanoparticle suspensions represents an opportunity to reduce mixed low-level radioactive hazardous waste generated by liquid scintillation counting.
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