Kimberly B. Shepard's research while affiliated with Bend Research and other places

Publications (8)

Article
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Spray drying is a particle engineering technique used to manufacture respirable pharmaceutical powders that are suitable for delivery to the deep lung. It is amenable to processing both small molecules and biologic actives, including proteins. In this work, a simultaneous spray-drying process, termed simul-spray, is described; the process involves...
Article
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Local delivery of biotherapeutics to the lung holds great promise for treatment of lung diseases, but development of physically stable, biologically active dry powder formulations of large molecules for inhalation has remained a challenge. Here, spray drying was used to manufacture a dry powder pulmonary formulation of bevacizumab, a monoclonal ant...
Article
Full-text available
Spray drying is widely used in the manufacturing of amorphous solid dispersion (ASD) systems due to its fast drying rate, enabling kinetic trapping of the drug in amorphous form. Spray drying conditions, such as solvent composition, can have a profound impact on the properties of spray dried dispersions. In this study, the phase behavior of spray d...
Article
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Amorphous solid dispersions (ASDs) can increase bioavailability of drugs with poor aqueous solubility. However, concentration-sustaining dispersion polymers (CSPs) incorporated in ASDs can result in low drug loading and therefore large dosage-form size or multiple units to meet dose requirements, potentially decreasing patient compliance. To addres...
Article
Full-text available
PurposeThe purpose of this work is to introduce solvent-assisted secondary drying, a method used to accelerate the residual solvent removal from spray dried materials. Spray-drying is used to manufacture amorphous solid dispersions, which enhance the bioavailability of active pharmaceutical ingredients (APIs) with low aqueous solubility. In the spr...
Article
Full-text available
Although amorphous dispersions (ASDs) effectively increase bioavailability, tablet mass can be high due to the large fraction of excipients needed to stabilize the amorphous drug in the solid state, extend drug supersaturation in solution and achieve robust manufacturability. The aim of this work was to reduce tablet mass of an ASD tablet comprisin...
Article
Full-text available
Spray drying is one of the most broadly applicable and widely used methods of producing amorphous solid dispersions (ASDs). ASDs can improve the oral absorption of poorly water-soluble active pharmaceutical ingredients. Eudragit L100 is an appealing ASD excipient, due to its favorable impact on ASD physical stability and dissolution performance. Ho...
Article
Spray dried dispersions (SDDs) are increasingly being used to formulate poorly water soluble drugs. The ability to either tablet or encapsulate SDDs offers valuable flexibility in meeting drug development goals, e.g. extemporaneous preparation and blinding for clinical studies, and for meeting various commercial target product profiles. Encapsulate...

Citations

... The moisture content of the ILDF particles was measured and summarized in Table 2, column 5. The moisture levels for all three batches of our samples were 0.52 ± 0.01% (w/w), which is lower than other reported inhalable particles [65] and comparable with similar excipients like DPPC and L-leucine [44]. Table 2. Summary of the ILDF microparticles in comparison to the control (ILD) produced using our TTMD. ...
... Hence, for the sake of aerosol performance and protein stability, there was a dire need to minimise water content. The water content measurements were all higher than the target range of 3 to 4% that is ideal for inhaled powder formulations containing biologics [56]. This was not attained even with spray freeze drying, a method known to produce low residual moisture content [57], hypothetically due to the presence of 2HPβCD, since it was the common excipient across all the formulations. ...
... The samples with the highest API loading lost their fibrous characteristics right after one day of storage. Considering the SEM images, it can be expected that the T g values may be changed since the samples reacted spectacularly to the increased moisture content in their environment [58]. Table 3. Summary of the SEM images of the prepared samples before and after storage. ...
... Thus, this could reduce the tablet mass by 40% relative to the conventional Posaconazole formulation. The HLDF tablet was even able to outperform the conventional formulation in the in vivo study conducted on beagle dogs [73]. ...
... The prediction of the glass transition temperature is complicated since spray-dried powders may contain residual solvent that can act as a plasticizer (Patel et al., 2015;Shepard et al., 2020). The amount of the residual solvent itself is a function of the solvent-uptake properties of the powder, the outlet vapor activity (relative humidity in the case of aqueous systems), and the outlet temperature of the dryer . ...
... In a similar study, Mudie et al. [72] worked on a low Tg (42 °C) highly crystalline, poorly soluble (BCS class II), rapidly crystallizing drug erlotinib. This is a drug of choice in pancreatic and non-small cell lung cancer at a dose of 100 and 150 mg per day, respectively. ...
... Although a reasonably large particle size was required to achieve good flowability of the spray-dried powder in order to further compress into tablets, fine particles produced from a lab-scale spray dryer in our case could be acceptable. Larger particles could be also obtained by using large-scale spray dryers producing larger atomized droplets and with greater drying capacity (Al-Zoubi et al., 2021;Shepard et al., 2020). Owing to the span value less than 2% for each formulation, PSD was considerably low for S-AST SMEDDS powders. ...