The goal of every pharmaceutical developer is to create quality products which generate consumer satisfaction, require low cost, and have low risk. Quality starts from the moment of conception of an idea and continues throughout production.
Tablet land is beneficial to add strength and durability to the punch tip. But, this hand land may be perceived as making it more difficult to coat the tablet.
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.
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.
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.
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.
Porosity can help predict deformation properties during compression, pharmacokinetic behavior within the body, shelf life, moisture penetration, and bioavailability.