Research Posters

Uniform Distribution of a Low Dose API in a High Dose API Using Micronization and Wet Granulation with No Excipients
By: V. Renshaw, M. Perry, L. Brown of Pharmatek & B. Cannon, M. Zemel, O. Flores of NuSirt
Date: November 2016
Summary: Two APIs with very different particle sizes and properties, Metformin HCl and Sildenafil Citrate, were combined in one dosage form at very different dosage strengths.  The goal of this study was to develop a manufacturing process for a capsule containing 500 mg of Metformin HCl and 0.7 mg of Sildenafil Citrate uniformly distributed .  To address differences in particle size, multiple granulation and milling processes were considered.

An Assessment of the Automated Encapsulation of Micronized Powder Using the Xcelodose 600S
By: N. Barksdale, J. Keegan, K. Victoria of Pharmatek
Date: November 2014
Summary: To evaluate the ability of the Xcelodose 600S Precision Powder Micro-Dosing System to fill a micronized product and the effect on the products dissolution profile after encapsulation.

Use of Fluid Bed Granulation to Formulate a Cyclodextrin-API Complex for Solubility and Bioavailability Enhancement
By: M. Perry, N. Barksdale, X. Liu , B. Knox of Pharmatek and F. Waligora of Curis, Inc.
Date: November 2014
Summary: The solubility of CUDC-101 in aqueous media is poor, but is greatly improved when dissolved with Captisol  (SBE-β-CD). The goal of this study was to develop a granulation process and a tablet with a scalable manufacturing process for the API:cyclodextrin complex at a dose strength of 50 mg.

Application of UPLC Technology in Development of a Stability-Indicating Method for a Highly Potent Compound – Beraprost Sodium
By: M. Perry, B. Knox, X. Liu of Pharmatek and W. J. Guilford of Gemmus Pharma Inc.
Date: November 2014
Summary: To identify a stability-indicating chromatography method for the potency and purity determination of beraprost sodium for the analysis of low dose drug product (~10 μg). The compendial method for beraprost sodium is published in the Japanese Pharmacopoeia XVI. This HPLC method calls for a sample concentration of 10 mg/mL with a 15 μL injection volume (limit
of quantitation of 7.5 ng/mL), and lacks sensitivity to detect impurities in low dose beraprost sodium drug product.

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