Ron Scarboro, Azurity Pharmaceuticals, explains how cross-functional development, disciplined reformulation, and post-approval metrics can help proven medicines work in everyday use.
|Articles|June 2, 2020
- Pharmaceutical Technology-06-02-2020
- Volume 44
- Issue 6
Triple Shaft Mixer with Powder Induction Manifold
The 600-gallon VersaMix Model VM-600 from Ross is qualified for high-speed subsurface powder induction with a proprietary Ross Solids/Liquid Injection Manifold (SLIM).
The 600-gallon VersaMix Model VM-600 from Ross is qualified for high-speed subsurface powder induction with a proprietary Ross Solids/Liquid Injection Manifold (SLIM). The SLIM function allows for the incorporation of powder or liquid phases into the rotor-stator mix head, causing instant wet-out as it rotates at 3600 RPM.
Available in laboratory sizes up to 4000 gallons, the mixer uses a dual-post triple-shaft design for the processing of substantial powder phases along with an anchor agitator to move the product from the high shear rotor stator head to a high-speed dispersing head, which deagglomerates any remaining fisheyes. The SLIM feature also enables the device to mix large batches and accelerate loading phases.
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Formulating for Convenience and Complianceover 6 years ago
Reducing Risk with Abuse‑Deterrent Formulationsover 6 years ago
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This week, drug formulation and manufacturing experts showcased their knowledge, and companies exhibited their products, at CPHI Milan.
FDA approves Teva’s Weltruza, a once-monthly subcutaneous olanzapine for schizophrenia whose copolymer depot eliminates post-injection monitoring.
Equivalence test using two one-sided tests are widely used for demonstrating the comparability of treatment effects in different research fields. The method described in the manuscript aims to use simulations in Microsoft Excel to compute power for 2 one-sided tests for two groups with unequal variances.
Richard Jaenisch examines whether FDA's NAM pathway truly shortens drug pipelines or just shifts the evidentiary burden elsewhere.
Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel, clear up some of the confusion about what does and does not need to be complied with regarding standards set by international pharmacopoeias.
Mitigating nitrosamine risk requires assessing each product individually, says Bram Baert, Global Head of Regulatory Affairs at Capsugel, and Sandrine Picco, Senior Analytical Specialist on Capsugel's Innovaform Accelerator Team, in this interview with PharmTech.
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