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Three-dimensional (3D) printing was discovered in the 1980s, and many industries have embraced it, but the pharmaceutical industry is slow or reluctant to adopt it. Spiritam® is the first and only 3D-printed drug product approved by FDA in 2015. Since then, the FDA has not approved any 3D-printed drug product due to technical and regulatory issues. The 3D printing process cannot compete with well-established and understood conventional processes for making solid dosage forms. However, pharmaceutical companies can utilize it where mass production is not required; rather, consistency, precision, and accuracy in quality are paramount. There are many 3D printing technologies available, and not all of them are amenable to pharmaceutical manufacturing. Each 3D technology has certain prerequisites in terms of material that it can handle. Some of the pertinent technical and regulatory issues are as follows: Current Good Manufacturing Practice, in-process tests and process control, and cleaning validation. Other promising area of 3D printing use is printing medications for patients with special needs in a hospital and/or pharmacy setting with minimum regulatory oversight. This technology provides a novel opportunity for in-hospital compounding of necessary medicines to support patient-specific medications. However, aspects of the manufacturing challenges and quality control considerations associated with the varying formulation and processing methods need to be fully understood before 3D printing can emerge as a therapeutic tool. With these points in mind, this review paper focuses on 3D technologies amenable for pharmaceutical manufacturing, excipient requirement, process understanding, and technical and regulatory challenges.

The role of intrinsic and extrinsic factors on transport of a chiral drug through the skin was studied. Ketoprofen (KP) was chosen as a model chiral drug. A possible relationship between the melting characteristics and the flux values of S- and RS-KP was investigated. The potential use of chiral enhancers, menthol and linalool, was also investigated. Thermal analyses were carried out for individual enantiomers and the racemate of KP. The melting temperature of each enantiomer was 22 degreesC lower than that of the racemic compound. Peak temperatures from the melting endotherms were plotted as a function of enantiomeric composition to give the binary phase diagram. The phase diagram suggested the presence of a racemic compound, and it was verified by calculations of the liquidus curve in the dystectic region using reported methods. Powder X-ray diffraction studies also confirmed that the racemate of KP is a racemic compound. The permeability of individual enantiomers and the racemate of KP through mice skin was determined in vitro using side-by-side diffusion cells. Transfer of R- and S-KP from aqueous solutions of both the racemate and pure enantiomer showed no significant differences in the rates of permeation, indicating that the rate of transfer of KP across the mice skin from these solutions was independent of the stereochemistry of the drug. No evidence of racemization during the transfer process was observed. The permeation-enhancing ratio of linalool was higher, but not significant, than that of l-menthol. The predicted ratio of enantiomer to racemate flux through the skin by the MTMT concept (1. 97) is in close agreement with the experimentally determined ratio (1.79) across mouse skin.

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The culture of scholarship is best described as an environment of creativity and productivity that extends from active investigations designed to create, advance, or transform new knowledge. This new knowledge becomes scholarship when it is assessed by peer-review and made public. The culture requires active support by the administration as reflected in a dynamic infrastructure, a well-defined method of evaluation, and a system of rewards that adheres to the established evaluation criteria. In addition, the culture is facilitated by a contingent of productive senior faculty members who sustain the environment and are available to mentor junior investigators as they develop independent careers. This manuscript begins with a brief overview of the development of scholarship in American academia followed by examples of the common expressions of scholarship in pharmacy education and how they are encompassed by the definition. Subsequent sections discuss the support and development of research, an analysis of the rewards to faculty for scholarly activities, and the relationship between scholarship and professional pharmacy education. The final section includes recommendations that colleges, as well as AACP and ACPE, can pursue to further develop and sustain a culture of scholarship in pharmacy education.

A solid dispersion of Coenzyme Q10 and Eudragit L 100-55 was prepared using solvent evaporation method. Solid dispersion, physical mixture, and pure compound were then characterized using differential scanning calorimetry and powder x-ray diffraction. Solubility of CoQ10 in different surfactant media was measured, and a suitable dissolution medium was developed to compare the dissolution patterns of the solid dispersion, physical mixture, and the pure compound. Combining labrasol with different surfactants in dissolution media demonstrated an additive effect on CoQ10 solubility. The solubility of CoQ10 in a 4% Labrasol/2% Cremophor EL solution was 562 microg/ml, which was five times higher than the combined solubility in 5% Labrasol (91 microg/ml) and 5% Cremophor EL (7.8 microg/ml). Moderate change in the crystalline pattern of CoQ10 was observed, which was attributed to solvent displacement rather than the degree of crystallinity change. The dissolution test indicated that the in-vitro release of Coenzyme Q10 from its solid dispersion was much faster than its physical mixture, which in turn was faster than the pure drug. The amount of drug released in 12 hours from solid dispersion, physical mixture, and the pure drug was 100, 26.5 and 12.5% respectively. CoQ10 was photostable throughout the dissolution experiments.

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The in‐vitro stability of insulin in the presence of α‐chymotrypsin and trypsin has been evaluated in the presence of different concentrations of chicken and duck ovomucoid (CkOVM and DkOVM), a new class of enzyme inhibitor derived from the egg white of avian species. The inhibitory effect was compared with that of aprotinin. The effectiveness of DkOVM was also determined in the presence of agents that accelerate α‐chymotrypsin‐mediated degradation of insulin in solution by deaggregation. Insulin solutions (18μM) were incubated at 37°C with 0.1 μM chymotrypsin and 0.5 μM trypsin in lOOmM Tris buffer containing 1 mM calcium chloride and different concentrations of CkOVM and DkOVM. Samples were treated with cold Tris containing 1% (v/v) trifluoroacetic acid to stop the enzyme action and analysed by reversed‐phase high‐performance liquid chromatography. Similar studies were performed with aprotinin, EDTA (0.05 mM) and sodium glycocholate (30mM) in the presence of α‐chymotrypsin and DkOVM. DkOVM was effective against α‐chymotrypsin‐mediated degradation of insulin at enzyme‐to‐inhibitor ratios of 1:0–5, 1:1 and 1:2. CkOVM was ineffective against α‐chymotrypsin even at an enzyme‐to‐inhibitor ratio of 1:4. In contrast, both DkOVM and CkOVM were completely effective against trypsin‐mediated degradation of insulin at an enzyme‐to‐inhibitor ratio of 1:1. This effect was comparable with that of aprotinin at an enzyme‐to‐inhibitor ratio of 1:1. Inhibition of the enzyme was reduced in the presence of sodium glycocholate and EDTA. DkOVM effectively stabilized insulin against degradation for a study period of 1 h in the presence of α‐chymotrypsin and trypsin. Because insulin is extensively degraded by α‐chymotrypsin, DkOVM might be used to enhance the oral delivery of insulin.