Tablet Production White Papers & Case Studies

  1. The Importance Of Land Width On Pharmaceutical Tablet Design

    Tablet land is the narrow, horizontal surface perpendicular to the tablet’s periphery, which creates a junction between the tablet’s periphery and cup. The three primary reasons for incorporating a land into a tablet’s design are to increase the strength of the punch edges, increase the wear characteristics of the inner edge of the punch cup, and reduce the severity of nicks on punch edges.

  2. Improving Suspendibility Of A Water-Insoluble API For Oral Suspension

    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.

  3. Comparative Human in-vivo Study And The Impact Of The Dissolution Rate On Bioequivalence

    Rapid and consistent in-vivo drug dissolution is critical for drug absorption. In-vitro dissolutions tests are used to predict in-vivo disintegration and dissolution properties of drug products. The in-vitro disintegration and dissolution times of tablets and capsules can vary significantly based on their composition and processing.

  4. Using QbD For Process Optimization Of A Novel Oral Solid Dosage Form

    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.

  5. Modular Facility Design: A Cost-Effective Option In The Post-Blockbuster Drug Era

    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.

  6. The Effect Of Tablet Porosity On Dissolution

    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.

  7. Excipients: The Unsung Heroes Of Pharmaceuticals

    Excipients are often described as inactive ingredients that assist in the delivery and processing of the active pharmaceutical ingredients. Although this is true, excipients have a much larger influence on final product performance than the term “inactive ingredient” suggests. In fact, choosing the right excipients is a key determinant of the quality and functionality of a pharmaceutical product.

  8. Fundamentals Of Spray-Dried Dispersion Technology

    A common problem statement in the pharmaceutical industry is low oral bioavailability of drug candidates with poor aqueous solubility. The literature suggests that a significant majority of new drug candidates are in the Biopharmaceutics Classification System (BCS) class II and IV space, which includes compounds that are dissolution rate, solubility or permeability limited to absorption, or all three. As portfolios across the industry are increasingly focused on these compounds, the need for enabling technologies continues to grow.

  9. The Importance Of Steel Quality In Tablet Compression Tooling

    Steel quality is the summation of how well a steel meets its specified chemistry, the cleanliness of the steel or degree to which it is free of impurities or inclusion, homogeneity of the microstructure, grain/carbide size and in some instances if it meets the mechanical requirements for that particular steel.

  10. Fluid Bed System Triples Batch Sizes for Laboratorios Normon while Reducing Costs

    With the aim of reducing costs, Normon planned to significantly increase its batch sizes for certain products. The manufacturer needed to pay close attention to the high quality and safety standards and economic aspects, as well as flexible production sizes and times.