Tablet Production White Papers & Case Studies
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Redefining Fast Melt For Pharma With 3D Printing
7/31/2018
Adults and children alike often struggle with compliance and acceptance of medication regimens due to the sizes and shape of prescribed tablets. One pharmaceutical manufacturer sought to create a convenient, easy-to-swallow dosage form by taking an alternative approach: three-dimensional printing (3DP). This white paper outlines their approach to creating an FDA validated manufacturing process for rapidly disintegrating dosage forms.
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5 Steps To Increase Energy-Efficient Mixing
3/1/2018
Mixer testing simulation trials are necessary to confirm the suitability of a specific mixing strategy. Explore five ways to increase energy efficiency in new and existing mixing processes.
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Efficiencies In Powder Dispersion For Manufacturers
3/1/2018
Uniformly dispersing powders into a liquid batch in a practical amount of time is a common problem for F&B manufacturers. This white paper explores five tips for dispersing powders more efficiently.
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How To Optimize Solid-Liquid Mixing
3/1/2018
This paper provides practical information on the efficient use of specialty mixing equipment for the preparation of low, medium and high viscosity solid-liquid mixtures under low and high shear conditions.
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Development Of Biopharmaceuticals Requiring Lyophilized Formulations
1/18/2018
Development of a drug formulation and lyophilization (freeze drying) process begins with laboratory experiments followed by scale up to larger lyophilizers.
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Improving Suspendibility Of A Water-Insoluble API For Oral Suspension
4/15/2016
In this case study, API (X) is a highly insoluble compound with a particle size of approximately 14 microns and targeted as a powder for oral suspension dosage form.
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In Vivo Study And The Impact Of The Dissolution Rate On Bioequivalence
2/5/2016
Comparative human in-vivo study of an immediate release tablet over-encapsulated by gelatin and hydroxypropyl methyl cellulose capsules – impact of dissolution rate on bioequivalence.
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Using QbD For Process Optimization Of A Novel Oral Solid Dosage Form
11/10/2015
As stated in the International Conference on Harmonisation Harmonised Tripartite Guidance on Pharmaceutical Development, ICH Q8 (R2), “The aim of pharmaceutical development is to design a quality product and its manufacturing process to consistently deliver the intended performance of the product.”1 Several tools are available as guidance issued by FDA such as “Quality Systems Approach to cGMP Manufacturing”2 that includes ideas such as Quality by Design (QbD) in the development process. This guidance, amongst others, lay the framework for expectations of regulatory reviewers in their examination of client submittal documentation.
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Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era
9/1/2015
The pharmaceutical industry has undergone a sea of change in recent years as manufacturers have adapted to the end of the era of large-volume production of mass-market blockbuster drugs. With firms now focusing in on subpopulations of patients, there is a need for lean, adaptable facilities that can switch quickly between multiple products in multiple formats. Modular facilities can meet this need. While not a panacea, for the right project characteristics, ‘Modularity in Design’ can deliver significant and quantifiable long-term value.
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The Effect Of Tablet Porosity On Dissolution
8/5/2015
Porosity is a characteristic that influences many of the critical quality attributes of finished pharmaceutical products. Porosity can help predict deformation properties during compression, pharmacokinetic behavior within the body, shelf life, moisture penetration, and bioavailability.